Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

Sponsor

Medtronic Cardiovascular (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT01586910

Collaborator

(none)

1,746

Enrollment

Locations

Arms

175

Anticipated Duration (Months)

20.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System.

Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

Condition or Disease	Intervention/Treatment	Phase
Severe Aortic Stenosis	Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Procedure: Surgical Aortic Valve Replacement (SAVR) Device: Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1746 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI)

Actual Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Jul 1, 2018

Anticipated Study Completion Date :

Nov 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Medtronic CoreValve® System TAVI Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)	Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Device: Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Active Comparator: SAVR Surgical Aortic Valve Replacement (SAVR)	Procedure: Surgical Aortic Valve Replacement (SAVR)

Arm

Intervention/Treatment

Experimental: Medtronic CoreValve® System TAVI

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Device: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Device: Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)

Active Comparator: SAVR

Surgical Aortic Valve Replacement (SAVR)

Procedure: Surgical Aortic Valve Replacement (SAVR)

Outcome Measures

Primary Outcome Measures

All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability [24 months]
All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline.

Secondary Outcome Measures

Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) [30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.]
MACCE is defined as a composite of: All-cause death Myocardial infarction (MI) All stroke, and Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Percentage of Participants With Individual MACCE Components [30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.]
MACCE is defined as a composite of: All-cause death Myocardial infarction (MI) All stroke, and Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Percentage of Participants With Major Adverse Events (MAE) [30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.]
Major Adverse Events (MAE) include all death, MI, all stroke, reintervention, cardiac perforation, cardiac tamponade, cardiogenic shock, valve malpositioning, prosthetic valve dysfunction, acute kidney injury, major vascular complication, life threatening or disabling bleed, major bleed, and valve endocarditis.
Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation [30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.]
Change in NYHA Class From Baseline [Baseline to 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.]
Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement. New York Heart Association (NYHA) Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Change in Distance Walked During 6-minute Walk Test (6MWT) [From baseline to 30 days, baseline to 12 months, and baseline to 24 months]
Change in distance walked during 6MWT from baseline
Ratio of Days Alive Out of Hospital Versus Total Days Alive [12 and 24 months]
Quality of Life (QoL) Change From Baseline [Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.]
QoL summary score change from baseline using the following measures: Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. 36 Item Short Form Health Survey (SF-36): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.
Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance [discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete]
Using the following measure: -Transvalvular mean gradient
Effective Orifice Area as an Assessment of Prosthetic Valve Performance [discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete]
Using the following measure: -Effective Orifice Area (cm^2)
Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance [discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete]
Using the following measure: - Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)
Percentage of Participants With Aortic Valve Disease Related Hospitalizations [30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.]
Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths [30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete]
Percentage of Participants With Stroke and TIAs [30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.]
Strokes (of any severity) and Transient Ischemic Attacks (TIAs)
Peri-procedural Neurological Injury [discharge or 7 days post index procedure (whichever occurred first)]
Neurological injury (stroke, TIA, or encephalopathy)
Index Procedure Related Major Adverse Events (MAEs) [Procedure through 30 day visit]
Index procedure related MAEs were defined as events occurring during, or as a direct result of, the index procedure.
Length of Index Procedure Hospital Stay [Number of days from admission to discharge (expected average of 7 days)]
Presence of Atrial Fibrillation [post-procedure, discharge, 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.]
Device Success (Medtronic CoreValve® System Subjects Only) [Number of days from admission to discharge (expected average of 7 days)]
Absence of procedural mortality Correct positioning of a single prosthetic heart valve into the proper anatomical location Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)
Procedural Success (Medtronic CoreValve® System Subjects Only) [Number of days from admission to discharge (expected average of 7 days)]
Defined by device success and absence of in-hospital major adverse cardiovascular and cerebrovascular events (MACCE)
Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only) [6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.]
Prosthetic Valve Dysfunction (PVD) was defined according to Valve Academic Research Consortium (VARC) II using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total aortic regurgitation (AR) reported as moderate or severe was considered PVD defined as: Mean aortic valve gradient ≥20 mmHg AND ((EOA ≤0.9 cm2 if BSA <1.6 or ≤1.1 cm2 if BSA ≥1.6) OR DVI <0. 35 m/s) OR moderate or severe total AR
Percentage of Participants With Early Safety Endpoint [30 Days]
Percentage of participants with VARC II early safety composite at 30 days
Percentage of Participants With Clinical Efficacy (After 30 Days) [6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete]
Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all strokes (disabling and non-disabling), hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA III or IV, and valve-related dysfunction.
Percentage of Participants With Time-Related Safety [30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is available.]
The VARC II time-related valve safety composite was defined as the rate of valve-related dysfunction (mean aortic valve gradient ≥ 20 mm Hg, EOA ≤ 0.9-1.1 cm2 depending on body surface area and/or DVI <0.35, AND/ OR moderate or severe prosthetic valve regurgitation), aortic valve reintervention, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, and VARC II bleeding events.
Resheath and Recapture Success (Evolut R Only) [Procedure]
The Evolut™ R system provides operators with the ability to resheath or recapture the valve before it is completely deployed in the event of initial suboptimal positioning. Successful resheath was defined as successfully retrieving a portion of the valve into the capsule of the delivery catheter, and successful recapture was defined as successfully recapturing the entirety of the valve into the capsule of the delivery catheter.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject must have co-morbidities such that Heart Team agrees predicted risk of operative mortality is ≥3% and <15% at 30 days (Intermediate Clinical Risk classification). Heart team evaluation of clinical surgical mortality risk for each patient includes the calculated STS score for predicted risk of surgical mortality augmented by consideration of the overall clinical status and co-morbidities unmeasured by the STS risk calculation;
Heart Team unanimously agree on treatment proposal and eligibility for randomization* based on their clinical judgement (including anatomy assessment, risk factors, etc.);
Subject has severe aortic stenosis presenting with;

Critical aortic valve area defined as an initial aortic valve area of ≤1.0cm2 or aortic valve area index < 0.6cm2/m2 AND
Mean gradient > 40mmHg or Vmax > 4m/sec by resting echocardiogram or simultaneous pressure recordings at cardiac catherization [or with dobutamine stress, if subject has left ventricular ejection fraction (LVEF) <55%] or velocity ratio < 0.25;

Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater;
Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits;
Subject meets the legal minimum age to provide informed consent based on local regulatory requirements;

Exclusion Criteria:

Subject has refused surgical aortic valve replacement (SAVR) as a treatment option; (not applicable for Single Arm)
Any condition considered a contraindication for placement of a bioprosthetic valve (i.e., subject requires a mechanical valve);
A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated;
Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy;
Ongoing sepsis, including active endocarditis;
Any condition considered a contraindication to extracorporeal assistance;
Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to randomization* (Subjects with recent placement of drug eluting stent(s) should be assessed for ability to safely proceed with SAVR within the protocol timeframe);
Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within six weeks of randomization*;
Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support;
Recent (within 6 months of randomization*) cerebrovascular accident (CVA) or transient ischemic attack (TIA);
Active gastrointestinal (GI) bleeding that would preclude anticoagulation;
Subject refuses a blood transfusion;
Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits);
Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery (Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned);
Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions;
Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams;
Currently participating in an investigational drug or another device trial (excluding registries);
Evidence of an acute myocardial infarction ≤30 days before the index procedure;
Need for emergency surgery for any reason;
True porcelain aorta (i.e. Heart Team agrees the aorta is not clampable for SAVR);
Extensive mediastinal radiation;
Liver failure (Child-C);
Reduced ventricular function with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram;
Uncontrolled atrial fibrillation (e.g. resting heart rate > 120 bpm);
Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements;
End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min;
Pulmonary Hypertension (systolic pressure> 80mmHg);
Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc;
Frailty assessments identify:

Subject is < 80 years of age and three or more of the following apply
Subject is ≥ 80 years of age and two or more of the following apply

Wheelchair bound
Resides in an institutional care facility (e.g., nursing home, skilled care center)
Body Mass Index < 20 kg/m2
Grip Strength < 16 kg
Katz Index Score ≤ 4
Albumin < 3.5 g/dL;
Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement/intervention; (Not applicable for Single Arm)

Note: Additional anatomical and vascular exclusion criteria may apply.

Note: * For purposes of the single arm phase of the trial, "randomization" will refer to trial enrollment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner Good Samaritan Medical Center	Phoenix	Arizona	United States	85006
2	Cedars-Sinai Medical Center	Hollywood	California	United States	90048
3	Scripps Green Hospital	La Jolla	California	United States	92037
4	Keck Medical Center of USC	Los Angeles	California	United States	90033
5	El Camino Hospital	Mountain View	California	United States	94040
6	VA Palo Alto Health Care System	Palo Alto	California	United States	94304
7	Southern California Permenente Medical Group	Pasadena	California	United States	91101
8	Stanford University Medical Center	Stanford	California	United States	94305
9	Hartford Hospital	Hartford	Connecticut	United States	06102
10	Yale New Haven Hospital	New Haven	Connecticut	United States	06520-8047
11	Washington Hospital Center	Washington	District of Columbia	United States	20010
12	Morton Plant Hospital	Clearwater	Florida	United States	33756
13	University of Miami	Coral Gables	Florida	United States	33146
14	Delray Medical Center	Delray Beach	Florida	United States	33484
15	Emory University	Atlanta	Georgia	United States	30308
16	Piedmont Healthcare, Inc.	Atlanta	Georgia	United States	30309
17	The Queen's Medical Center	Honolulu	Hawaii	United States	96813
18	Loyola University of Chicago	Maywood	Illinois	United States	60153
19	St. Vincent Heart Center of Indiana	Indianapolis	Indiana	United States	46290
20	Iowa Heart Center / Mercy Medical Center	West Des Moines	Iowa	United States	50266
21	University of Kansas Hospital	Kansas City	Kansas	United States	66160
22	Cardiovascular Institute of the South	Houma	Louisiana	United States	70360
23	The Johns Hopkins University	Baltimore	Maryland	United States	21205
24	Beth Israel Deaconess Medical Center, Inc.	Boston	Massachusetts	United States	02215
25	University of Michigan Health Systems	Ann Arbor	Michigan	United States	48109-5864
26	Detroit Medical Center	Detroit	Michigan	United States	48201-2018
27	Henry Ford	Detroit	Michigan	United States	48202
28	St. John Hospital & Medical Center	Detroit	Michigan	United States	48236
29	Spectrum Health Hospitals	Grand Rapids	Michigan	United States	49503
30	Abbott NW - MN Heart Institute Foundation	Minneapolis	Minnesota	United States	55407
31	Mayo Clinic - St. Mary's Hospital	Rochester	Minnesota	United States	55905
32	Saint Luke's Hospital/MAHI	Kansas City	Missouri	United States	64111
33	Alegent Creighton Health Research Center	Omaha	Nebraska	United States	68124
34	Cooper University Hospital	Camden	New Jersey	United States	08103
35	Morristown Medical Center	Morristown	New Jersey	United States	07960
36	North Shore University Hospital	Manhasset	New York	United States	11030
37	Winthrop University Hospital	Mineola	New York	United States	11501
38	New York University School of Medicine	New York	New York	United States	10016
39	Mount Sinai School of Medicine	New York	New York	United States	10029
40	Columbia University Medical Center	New York	New York	United States	10032
41	Lenox Hill Hospital	New York	New York	United States	10075
42	University of Rochester	Rochester	New York	United States	14642
43	St. Francis Hospital	Roslyn	New York	United States	11576
44	Carolinas HealthCare System	Charlotte	North Carolina	United States	28203
45	Duke University Medical Center	Durham	North Carolina	United States	27710
46	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
47	Good Samaritan Hospital	Cincinnati	Ohio	United States	45220
48	University Hospitals Case Medical Center	Cleveland	Ohio	United States	44106
49	The Ohio State University	Columbus	Ohio	United States	43210
50	The OhioHealth Research Institute	Columbus	Ohio	United States	43214
51	Oklahoma Heart Institute	Oklahoma City	Oklahoma	United States	73120
52	Geisinger Medical Center	Danville	Pennsylvania	United States	17822
53	University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States	19104
54	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
55	Pinnacle Health Cardiovascular Institute	Wormleysburg	Pennsylvania	United States	17043
56	Baptist Memorial Hospital Memphis	Memphis	Tennessee	United States	38120
57	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
58	Baylor Heart and Vascular Hospital	Dallas	Texas	United States	75226
59	The Methodist DeBakey Heart & Vascular Center	Houston	Texas	United States	77030
60	The Heart Hospital - Baylor Plano	Plano	Texas	United States	75093
61	Intermountain Medical Center	Murray	Utah	United States	84107
62	University of Vermont	Burlington	Vermont	United States	05401
63	Sentara Cardiovascular	Norfolk	Virginia	United States	23507
64	Bon Secours St. Mary's Hospital	Richmond	Virginia	United States	23226
65	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53215
66	London Health Sciences Centre, University Hospital	London	Ontario	Canada
67	Sunnybrook Research Institute	Toronto	Ontario	Canada	M4N 3M5
68	Toronto General Hospital (University Health Network)	Toronto	Ontario	Canada	M5G 2C4
69	McGill University Health Center - Royal Victoria Hospital	Montreal	Quebec	Canada	H3A 1A1
70	Montreal Heart Institute	Montreal		Canada
71	Rigshospitalet	Copenhagen		Denmark
72	Universitäts-Herzzentrum Freiburg • Bad Krozingen	Bad Krozingen		Germany	79106
73	Universitätsklinikum Bonn	Bonn		Germany
74	Deutsches Herzzentrum Muenchen	Munich		Germany
75	Amphia Hospital Breda	Breda		Netherlands
76	Medisch Centrum Leeuwarden	Leeuwarden		Netherlands
77	St. Antonius Hospital, R & D Cardiology	Nieuwegein		Netherlands
78	Erasmus Medical Center - Rotterdam	Rotterdam		Netherlands
79	Servicio de Cardiologia del Hospital Virgen de la Victoria	Malaga		Spain
80	Hospital Universitario Central de Asturias	Oviedo		Spain
81	Karolinska Universitetssjukhuset Stockholm	Stockholm		Sweden	171 76
82	Bern University Hospital	Bern		Switzerland
83	Universitatsspital Zurich	Zurich		Switzerland
84	Leeds General Infirmary	Leeds		United Kingdom
85	Glenfield Hospital, Leicester, UK	Leicester		United Kingdom	LE5 4PW
86	St. George's Hospital London	London		United Kingdom	SW170QT

Sponsors and Collaborators

Medtronic Cardiovascular

Investigators

Principal Investigator: Stephan Windecker, MD, PhD, Bern University Hospital
Principal Investigator: Rüdiger Lange, MD, PhD, Deutsches Herzzentrum München
Principal Investigator: Thomas Walther, MD, PhD, Kerckhoff Klinik
Principal Investigator: Michael J. Reardon, MD, The Methodist Hospital Research Institute
Principal Investigator: David H. Adams, MD, Icahn School of Medicine at Mount Sinai
Study Chair: Nicolas M. Van Mieghem, MD, Erasmus Medical Center
Study Chair: Patrick W. Serruys, MD, PhD, National Heart & Lung Institute of Imperial College in London

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - May 31, 2016

More Information

Publications

None provided.

Responsible Party:

Medtronic Cardiovascular

ClinicalTrials.gov Identifier:

NCT01586910

Other Study ID Numbers:

IDE #G120169

First Posted:

Apr 27, 2012

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

Aortic Valve Stenosis

Constriction, Pathologic

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Period Title: Overall Study
STARTED	879	867
COMPLETED	864	796
NOT COMPLETED	15	71

Baseline Characteristics

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR	Total
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)	Total of all reporting groups
Overall Participants	864	796	1660
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	79.9 (6.2)	79.7 (6.1)	79.8 (6.2)
Sex: Female, Male (Count of Participants)
Female	366 42.4%	358 45%	724 43.6%
Male	498 57.6%	438 55%	936 56.4%
Race/Ethnicity, Customized (Count of Participants)
Asian	7 0.8%	6 0.8%	13 0.8%
Black/African American	18 2.1%	21 2.6%	39 2.3%
Hispanic or Latino Ethnicity	18 2.1%	23 2.9%	41 2.5%
NYHA Class (Count of Participants)
I	0 0%	0 0%	0 0%
II	344 39.8%	333 41.8%	677 40.8%
III	472 54.6%	411 51.6%	883 53.2%
IV	48 5.6%	52 6.5%	100 6%
Body Surface Area (meters squared) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [meters squared]	1.9 (0.2)	1.9 (0.2)	1.9 (0.2)
STS Score (% risk of mortality) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [% risk of mortality]	4.4 (1.5)	4.5 (1.6)	4.5 (1.6)
Logistic EuroSCORE (percentage of predicted mortality) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of predicted mortality]	11.9 (7.6)	11.6 (8.0)	11.8 (7.8)

Outcome Measures

1. Primary Outcome

Title	All-cause Mortality or Disabling Stroke Rate Expressed as a Posterior Probability
Description	All-cause mortality: all deaths from any cause after valve intervention. This includes all cardiovascular and non-cardiovascular deaths. Disabling Stroke: a modified rankin (mRS) score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-strike baseline.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
Median (95% Confidence Interval) [Percentage of Participants]	12.6 1.5%	14.0 1.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Medtronic CoreValve® System TAVI, SAVR
	Comments	Primary Hypothesis: TAVR with the Medtronic TAVR is non-inferior to SAVR for all-cause mortality or disabling stroke rate during a fixed follow-up of 24 months.
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority margin was 0.07. Posterior threshold for non-inferiority was 0.971

Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments

Method of Estimation	Estimation Parameter	Posterior Median of the Difference
	Estimated Value	-1.4
	Confidence Interval	(2-Sided) % to
	Parameter Dispersion	Type: Value:
	Estimation Comments	95% Bayesian credible interval for the difference (TAVR-SAVR) was (-5.2%, 2.3%). The 95% credible interval is the 2.5th and 97.5th percentiles of the posterior distribution.

2. Secondary Outcome

Title	Percentage of Participants With Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Description	MACCE is defined as a composite of: All-cause death Myocardial infarction (MI) All stroke, and Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time Frame	30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
30 days	5.7 0.7%	7.3 0.9%
6 months	9.5 1.1%	10.7 1.3%
12 months	13.0 1.5%	13.0 1.6%
18 months	15.6 1.8%	14.8 1.9%
24 months	18.5 2.1%	18.2 2.3%

3. Secondary Outcome

Title	Percentage of Participants With Individual MACCE Components
Description	MACCE is defined as a composite of: All-cause death Myocardial infarction (MI) All stroke, and Reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time Frame	30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
30 day All Cause Mortality	2.1 0.2%	1.6 0.2%
30 day MI	0.8 0.1%	0.9 0.1%
30 day Stroke	3.3 0.4%	5.4 0.7%
30 day Reintervention	0.8 0.1%	0.1 0%
6 month All Cause Mortality	4.2 0.5%	4.7 0.6%
6 month MI	1.2 0.1%	1.4 0.2%
6 month Stroke	4.6 0.5%	6.6 0.8%
6 month Reintervention	1.8 0.2%	0.3 0%
12 month All Cause Mortality	6.5 0.8%	6.7 0.8%
12 month MI	1.9 0.2%	1.4 0.2%
12 month Stroke	5.2 0.6%	6.9 0.9%
12 month Reintervention	2.0 0.2%	0.5 0.1%
18 month All Cause Mortality	8.5 1%	7.9 1%
18 month MI	2.2 0.3%	1.8 0.2%
18 month Stroke	5.7 0.7%	7.5 0.9%
18 month Reintervention	2.4 0.3%	0.5 0.1%
24 month All Cause Mortality	11.5 1.3%	10.5 1.3%
24 month MI	2.7 0.3%	2.2 0.3%
24 month Stroke	6.0 0.7%	8.5 1.1%
24 month Reintervention	2.4 0.3%	0.5 0.1%

4. Secondary Outcome

Title	Percentage of Participants With Major Adverse Events (MAE)
Description	Major Adverse Events (MAE) include all death, MI, all stroke, reintervention, cardiac perforation, cardiac tamponade, cardiogenic shock, valve malpositioning, prosthetic valve dysfunction, acute kidney injury, major vascular complication, life threatening or disabling bleed, major bleed, and valve endocarditis.
Time Frame	30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
30 days	23.7 2.7%	30.3 3.8%
6 months	28.5 3.3%	33.6 4.2%
12 months	33.0 3.8%	35.8 4.5%
18 months	36.6 4.2%	38.4 4.8%
24 months	40.0 4.6%	41.8 5.3%

5. Secondary Outcome

Title	Percentage of Participants With Conduction Disturbance Requiring Permanent Pacemaker Implantation
Description
Time Frame	30 day, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
30 days	25.6 3%	6.5 0.8%
6 months	27.2 3.1%	7.6 1%
12 months	28.3 3.3%	8.6 1.1%
18 months	30.1 3.5%	9.2 1.2%
24 months	30.9 3.6%	9.8 1.2%

6. Secondary Outcome

Title	Change in NYHA Class From Baseline
Description	Change from baseline (continuous variable). A positive number corresponds to NYHA worsening; a negative number corresponds to NYHA improvement. New York Heart Association (NYHA) Classification: Class I: Subjects with cardiac disease but without resulting limitations of physical activity. Class I: Subjects with cardiac disease resulting in slight limitation of physical activity. Class III: Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.
Time Frame	Baseline to 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
30 day	-1.2 (0.8)	-1.0 (0.9)
6 month	-1.3 (0.8)	-1.3 (0.8)
12 month	-1.3 (0.8)	-1.3 (0.8)
18 month	-1.2 (0.8)	-1.2 (0.8)
24 month	-1.2 (0.8)	-1.2 (0.8)

7. Secondary Outcome

Title	Change in Distance Walked During 6-minute Walk Test (6MWT)
Description	Change in distance walked during 6MWT from baseline
Time Frame	From baseline to 30 days, baseline to 12 months, and baseline to 24 months

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
30 days	35.4 (99.2)	-14.4 (108.7)
12 months	37.1 (103.5)	17.8 (102.0)
24 months	26.5 (115.4)	11.7 (102.7)

8. Secondary Outcome

Title	Ratio of Days Alive Out of Hospital Versus Total Days Alive
Description
Time Frame	12 and 24 months

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
12 months	0.96 (0.12)	0.93 (0.15)
24 months	0.96 (0.12)	0.95 (0.15)

9. Secondary Outcome

Title	Quality of Life (QoL) Change From Baseline
Description	QoL summary score change from baseline using the following measures: Kansas City Cardiomyopathy Questionnaire (KCCQ): Quantifies physical function, symptoms, social function, self-efficacy and knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. 36 Item Short Form Health Survey (SF-36): Measures functional health and well-being. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. European QoL (EQ-5D): Measures 5 domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that can be converted to utilities using an algorithm. Utilities range from 0 to 1, with 1 representing perfect health, and 0 corresponding to the worst imaginable health state.
Time Frame	Baseline, 30 days, 3 months, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
30 day KCCQ- Overall	18.4 (22.8)	5.9 (27.0)
30 day KCCQ- Clinical	14.9 (21.2)	4.0 (26.0)
30 day SF-36-Physical	5.7 (10.4)	-1.1 (11.0)
30 day SF-36-Mental	2.6 (12.3)	-0.6 (13.7)
30 day EQ-5D	0.06 (0.18)	-0.02 (0.21)
3 month SF-36-Physical	7.4 (10.5)	5.6 (10.5)
3 month SF-36-Mental	4.6 (11.7)	4.6 (12.6)
3 month EQ-5D	0.06 (0.18)	0.05 (0.18)
6 month KCCQ- Overall	21.9 (22.3)	21.3 (22.3)
6 month KCCQ- Clinical	16.5 (21.5)	15.9 (21.7)
6 month SF-36-Physical	6.3 (10.3)	6.3 (10.5)
6 month SF-36-Mental	3.9 (11.4)	3.6 (11.9)
6 month EQ-5D	0.04 (0.18)	0.05 (0.17)
12 month KCCQ- Overall	20.6 (22.3)	20.5 (22.2)
12 month KCCQ- Clinical	15.1 (21.4)	14.8 (21.6)
12 month SF-36-Physical	5.2 (9.9)	5.2 (10.2)
12 month SF-36-Mental	4.0 (11.3)	4.1 (12.0)
12 month EQ-5D	0.04 (0.16)	0.03 (0.18)
18 month KCCQ- Overall	19.7 (21.5)	20.2 (22.1)
18 month KCCQ- Clinical	14.0 (20.7)	14.0 (21.9)
18 month SF-36-Physical	4.2 (10.4)	4.3 (10.8)
18 month SF-36-Mental	4.3 (11.1)	3.8 (11.9)
18 month EQ-5D	0.03 (0.17)	0.03 (0.17)
24 month KCCQ- Overall	18.9 (21.2)	18.6 (22.9)
24 month KCCQ- Clinical	12.7 (20.5)	12.3 (22.5)
24 month SF-36-Physical	3.9 (9.9)	4.0 (10.8)
24 month SF-36-Mental	3.6 (11.3)	3.7 (12.2)
24 month EQ-5D	0.02 (0.17)	0.02 (0.19)

10. Secondary Outcome

Title	Transvalvular Mean Gradient (in mmHg) as an Assessment of Prosthetic Valve Performance
Description	Using the following measure: -Transvalvular mean gradient
Time Frame	discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with a valve implanted

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	863	794
discharge	8.82 (3.89)	12.39 (5.71)
6 months	8.28 (3.88)	11.10 (4.72)
12 months	8.34 (3.89)	11.57 (5.16)
24 months	8.20 (3.85)	11.55 (5.43)

11. Secondary Outcome

Title	Effective Orifice Area as an Assessment of Prosthetic Valve Performance
Description	Using the following measure: -Effective Orifice Area (cm^2)
Time Frame	discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with a valve implanted

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	863	794
discharge EOA	2.13 (0.57)	1.82 (0.63)
6 months EOA	2.14 (0.61)	1.80 (0.57)
12 months EOA	2.13 (0.59)	1.78 (0.59)
24 months EOA	2.15 (0.63)	1.77 (0.55)

12. Secondary Outcome

Title	Degree of Aortic Valve Regurgitation as an Assessment of Prosthetic Valve Performance
Description	Using the following measure: - Degree of Aortic Valve Regurgitation (Transvalvular and Paravalvular)
Time Frame	discharge, 6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with a valve implanted

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	863	794
Discharge : Total Aortic Regurgitation- None	24.9 2.9%	67.9 8.5%
Discharge : Total Aortic Regurgitation- Trace	35.7 4.1%	24.6 3.1%
Discharge : Total Aortic Regurgitation- Mild	35.9 4.2%	6.8 0.9%
Discharge : Total Aortic Regurgitation- Moderate	3.2 0.4%	0.7 0.1%
Discharge : Total Aortic Regurgitation- Severe	0.2 0%	0.0 0%
6 months : Total Aortic Regurgitation- None	28.4 3.3%	67.0 8.4%
6 months : Total Aortic Regurgitation- Trace	32.2 3.7%	24.3 3.1%
6 months : Total Aortic Regurgitation- Mild	34.7 4%	7.8 1%
6 months : Total Aortic Regurgitation- Moderate	4.6 0.5%	0.8 0.1%
6 months : Total Aortic Regurgitation- Severe	0.1 0%	0.2 0%
12 months : Total Aortic Regurgitation- None	32.0 3.7%	67.6 8.5%
12 months : Total Aortic Regurgitation- Trace	28.8 3.3%	23.5 3%
12 months : Total Aortic Regurgitation- Mild	34.1 3.9%	8.3 1%
12 months : Total Aortic Regurgitation- Moderate	5.1 0.6%	0.7 0.1%
12 months : Total Aortic Regurgitation- Severe	0.0 0%	0.0 0%
24 months : Total Aortic Regurgitation- None	35.1 4.1%	67.7 8.5%
24 months : Total Aortic Regurgitation- Trace	30.5 3.5%	25.3 3.2%
24 months : Total Aortic Regurgitation- Mild	30.0 3.5%	6.2 0.8%
24 months : Total Aortic Regurgitation- Moderate	4.2 0.5%	0.6 0.1%
24 months : Total Aortic Regurgitation- Severe	0.2 0%	0.2 0%

13. Secondary Outcome

Title	Percentage of Participants With Aortic Valve Disease Related Hospitalizations
Description
Time Frame	30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
30 days	2.8	4.1
6 months	6.6	5.8
12 months	8.6	7.4
18 months	10.8	8.4
24 months	12.8	9.5

14. Secondary Outcome

Title	Percentage of Participants With Cardiovascular Deaths and Valve-Related Deaths
Description
Time Frame	30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
30 day cardiovascular deaths	2.0 0.2%	1.6 0.2%
30 day valve related deaths	0.0 0%	0.0 0%
6 month cardiovascular deaths	3.2 0.4%	3.9 0.5%
6 month valve related deaths	0.0 0%	0.1 0%
12 month cardiovascular deaths	4.7 0.5%	5.3 0.7%
12 month valve related deaths	0.0 0%	0.1 0%
18 month cardiovascular deaths	5.9 0.7%	6.1 0.8%
18 month valve related deaths	0.0 0%	0.1 0%
24 month cardiovascular deaths	7.8 0.9%	7.1 0.9%
24 month valve related deaths	0.0 0%	0.1 0%

15. Secondary Outcome

Title	Percentage of Participants With Stroke and TIAs
Description	Strokes (of any severity) and Transient Ischemic Attacks (TIAs)
Time Frame	30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
30 days	4.4 0.5%	6.3 0.8%
6 months	6.9 0.8%	7.8 1%
12 months	8.0 0.9%	8.6 1.1%
18 months	8.8 1%	9.4 1.2%
24 months	9.5 1.1%	11.2 1.4%

16. Secondary Outcome

Title	Peri-procedural Neurological Injury
Description	Neurological injury (stroke, TIA, or encephalopathy)
Time Frame	discharge or 7 days post index procedure (whichever occurred first)

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an index procedure

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	863	795
Number [percentage of participants]	4.8 0.6%	12.3 1.5%

17. Secondary Outcome

Title	Index Procedure Related Major Adverse Events (MAEs)
Description	Index procedure related MAEs were defined as events occurring during, or as a direct result of, the index procedure.
Time Frame	Procedure through 30 day visit

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an index procedure

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	863	795
Number [percentage of participants]	23.5 2.7%	30.4 3.8%

18. Secondary Outcome

Title	Length of Index Procedure Hospital Stay
Description
Time Frame	Number of days from admission to discharge (expected average of 7 days)

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an index procedure

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	863	795
Mean (Standard Deviation) [days]	5.7 (4.9)	9.8 (8.0)

19. Secondary Outcome

Title	Presence of Atrial Fibrillation
Description
Time Frame	post-procedure, discharge, 30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete.

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
post procedure	12.8 1.5%	8.7 1.1%
discharge	14.0 1.6%	22.2 2.8%
30 days	13.6 1.6%	14.4 1.8%
6 months	14.1 1.6%	12.1 1.5%
12 months	13.4 1.6%	11.7 1.5%
18 months	13.6 1.6%	11.9 1.5%
24 months	15.1 1.7%	12.2 1.5%

20. Secondary Outcome

Title	Device Success (Medtronic CoreValve® System Subjects Only)
Description	Absence of procedural mortality Correct positioning of a single prosthetic heart valve into the proper anatomical location Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation)
Time Frame	Number of days from admission to discharge (expected average of 7 days)

Outcome Measure Data

Analysis Population Description
Participant Population =Consisted of all randomized subjects with a TAVR index procedure who were evaluable for device success.

Arm/Group Title	Medtronic CoreValve® System TAVI
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Measure Participants	863
Number [percentage of participants]	77.0 8.9%

21. Secondary Outcome

Title	Procedural Success (Medtronic CoreValve® System Subjects Only)
Description	Defined by device success and absence of in-hospital major adverse cardiovascular and cerebrovascular events (MACCE)
Time Frame	Number of days from admission to discharge (expected average of 7 days)

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with a TAVR index procedure who were evaluable for procedural success.

Arm/Group Title	Medtronic CoreValve® System TAVI
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Measure Participants	863
Number [percentage of participants]	74.7 8.6%

22. Secondary Outcome

Title	Evidence of Prosthetic Valve Dysfunction (Medtronic CoreValve® System Subjects Only)
Description	Prosthetic Valve Dysfunction (PVD) was defined according to Valve Academic Research Consortium (VARC) II using the Core Lab Echocardiography assessments including aortic regurgitation (AR) and aortic stenosis (AS) evaluations. Total aortic regurgitation (AR) reported as moderate or severe was considered PVD defined as: Mean aortic valve gradient ≥20 mmHg AND ((EOA ≤0.9 cm2 if BSA <1.6 or ≤1.1 cm2 if BSA ≥1.6) OR DVI <0. 35 m/s) OR moderate or severe total AR
Time Frame	6 months, 12 months, and 24 months. Data for 3-5 years will be posted once data is complete.

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all subjects with a valve implanted

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
6 month	6.0 0.7%	4.1 0.5%
12 month	6.7 0.8%	6.4 0.8%
24 month	6.0 0.7%	5.8 0.7%

23. Secondary Outcome

Title	Percentage of Participants With Early Safety Endpoint
Description	Percentage of participants with VARC II early safety composite at 30 days
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
Number [percentage of participants]	12.5 1.4%	15.8 2%

24. Secondary Outcome

Title	Percentage of Participants With Clinical Efficacy (After 30 Days)
Description	Combined clinical efficacy after 30 days was defined as the composite of all-cause mortality, all strokes (disabling and non-disabling), hospitalization for valve-related symptoms or worsening congestive heart failure, NYHA III or IV, and valve-related dysfunction.
Time Frame	6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is complete

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
6 months	12.8 1.5%	9.9 1.2%
12 months	23.5 2.7%	21.0 2.6%
18 months	26.3 3%	22.6 2.8%
24 months	33.9 3.9%	33.0 4.1%

25. Secondary Outcome

Title	Percentage of Participants With Time-Related Safety
Description	The VARC II time-related valve safety composite was defined as the rate of valve-related dysfunction (mean aortic valve gradient ≥ 20 mm Hg, EOA ≤ 0.9-1.1 cm2 depending on body surface area and/or DVI <0.35, AND/ OR moderate or severe prosthetic valve regurgitation), aortic valve reintervention, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, and VARC II bleeding events.
Time Frame	30 days, 6 months, 12 months, 18 months, and 24 months. Data for 3-5 years will be posted once data is available.

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all randomized subjects with an attempted implant procedure.

Arm/Group Title	Medtronic CoreValve® System TAVI	SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)	Surgical Aortic Valve Replacement (SAVR)
Measure Participants	864	796
30 days	28.8 3.3%	61.7 7.8%
6 months	38.5 4.5%	69.6 8.7%
12 months	45.1 5.2%	72.1 9.1%
18 months	42.1 4.9%	67.8 8.5%
24 months	53.0 6.1%	77.3 9.7%

26. Secondary Outcome

Title	Resheath and Recapture Success (Evolut R Only)
Description	The Evolut™ R system provides operators with the ability to resheath or recapture the valve before it is completely deployed in the event of initial suboptimal positioning. Successful resheath was defined as successfully retrieving a portion of the valve into the capsule of the delivery catheter, and successful recapture was defined as successfully recapturing the entirety of the valve into the capsule of the delivery catheter.
Time Frame	Procedure

Outcome Measure Data

Analysis Population Description
Participant Population= Consisted of all subjects in whom the resheath or recapture feature of the Evolut R system was attempted

Arm/Group Title	Medtronic CoreValve® System TAVI
Arm/Group Description	Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)
Measure Participants	31
Measure attempts	53
Resheath	100
Recapture	89.7
Resheath or Recapture	92.5

Adverse Events

	Medtronic CoreValve® System TAVI		SAVR
Time Frame	Adverse events (AEs) were collected from study enrollment through the 24 month follow-up visit. Adverse event data are currently available and reported for up to 24 months.
Adverse Event Reporting Description	All new or worsening AEs were collected through 24 months.

Arm/Group Title	Medtronic CoreValve® System TAVI		SAVR
Arm/Group Description	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI) Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)		Surgical Aortic Valve Replacement (SAVR)
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	98/864 (11.3%)		80/796 (10.1%)
Serious Adverse Events
	Medtronic CoreValve® System TAVI		SAVR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	718/864 (83.1%)		694/796 (87.2%)
Blood and lymphatic system disorders
ANAEMIA	102/864 (11.8%)	117	203/796 (25.5%)	222
AUTOIMMUNE HAEMOLYTIC ANAEMIA	1/864 (0.1%)	1	1/796 (0.1%)	1
BLOOD DISORDER	0/864 (0%)	0	1/796 (0.1%)	1
COAGULOPATHY	6/864 (0.7%)	6	11/796 (1.4%)	11
DISSEMINATED INTRAVASCULAR COAGULATION	0/864 (0%)	0	1/796 (0.1%)	1
HAEMOLYTIC ANAEMIA	0/864 (0%)	0	1/796 (0.1%)	1
HAEMORRHAGIC ANAEMIA	40/864 (4.6%)	40	84/796 (10.6%)	87
HYPOCHROMIC ANAEMIA	1/864 (0.1%)	1	0/796 (0%)	0
IRON DEFICIENCY ANAEMIA	7/864 (0.8%)	7	2/796 (0.3%)	2
LEUKOCYTOSIS	4/864 (0.5%)	4	7/796 (0.9%)	8
LYMPHADENOPATHY	1/864 (0.1%)	1	0/796 (0%)	0
MICROCYTIC ANAEMIA	2/864 (0.2%)	2	3/796 (0.4%)	3
NORMOCYTIC ANAEMIA	1/864 (0.1%)	1	0/796 (0%)	0
PANCYTOPENIA	4/864 (0.5%)	4	6/796 (0.8%)	6
SPLENIC HAEMATOMA	1/864 (0.1%)	1	0/796 (0%)	0
THROMBOCYTOPENIA	10/864 (1.2%)	10	44/796 (5.5%)	45
Cardiac disorders
ACUTE CORONARY SYNDROME	2/864 (0.2%)	2	0/796 (0%)	0
ACUTE LEFT VENTRICULAR FAILURE	12/864 (1.4%)	12	9/796 (1.1%)	15
ACUTE MYOCARDIAL INFARCTION	17/864 (2%)	17	19/796 (2.4%)	19
ANGINA PECTORIS	11/864 (1.3%)	11	4/796 (0.5%)	5
ANGINA UNSTABLE	4/864 (0.5%)	4	3/796 (0.4%)	3
AORTIC VALVE DISEASE	1/864 (0.1%)	1	1/796 (0.1%)	1
AORTIC VALVE INCOMPETENCE	43/864 (5%)	46	5/796 (0.6%)	5
AORTIC VALVE STENOSIS	2/864 (0.2%)	2	4/796 (0.5%)	5
ARRHYTHMIA	3/864 (0.3%)	3	3/796 (0.4%)	3
ARRHYTHMIA SUPRAVENTRICULAR	0/864 (0%)	0	1/796 (0.1%)	1
ATRIAL FIBRILLATION	86/864 (10%)	105	169/796 (21.2%)	185
ATRIAL FLUTTER	10/864 (1.2%)	11	19/796 (2.4%)	19
ATRIAL RUPTURE	0/864 (0%)	0	2/796 (0.3%)	2
ATRIAL TACHYCARDIA	0/864 (0%)	0	4/796 (0.5%)	4
ATRIAL THROMBOSIS	2/864 (0.2%)	2	0/796 (0%)	0
ATRIOVENTRICULAR BLOCK	18/864 (2.1%)	18	5/796 (0.6%)	5
ATRIOVENTRICULAR BLOCK COMPLETE	157/864 (18.2%)	157	44/796 (5.5%)	44
ATRIOVENTRICULAR BLOCK FIRST DEGREE	16/864 (1.9%)	16	2/796 (0.3%)	2
ATRIOVENTRICULAR BLOCK SECOND DEGREE	17/864 (2%)	18	6/796 (0.8%)	6
ATRIOVENTRICULAR DISSOCIATION	2/864 (0.2%)	2	0/796 (0%)	0
BRADYARRHYTHMIA	1/864 (0.1%)	1	0/796 (0%)	0
BRADYCARDIA	27/864 (3.1%)	27	17/796 (2.1%)	18
BUNDLE BRANCH BLOCK	1/864 (0.1%)	1	0/796 (0%)	0
BUNDLE BRANCH BLOCK LEFT	58/864 (6.7%)	58	1/796 (0.1%)	1
BUNDLE BRANCH BLOCK RIGHT	7/864 (0.8%)	8	3/796 (0.4%)	3
CARDIAC ARREST	21/864 (2.4%)	21	15/796 (1.9%)	15
CARDIAC FAILURE	21/864 (2.4%)	28	21/796 (2.6%)	27
CARDIAC FAILURE ACUTE	10/864 (1.2%)	11	6/796 (0.8%)	6
CARDIAC FAILURE CHRONIC	3/864 (0.3%)	3	0/796 (0%)	0
CARDIAC FAILURE CONGESTIVE	82/864 (9.5%)	104	61/796 (7.7%)	74
CARDIAC PERFORATION	12/864 (1.4%)	13	1/796 (0.1%)	1
CARDIAC SEPTAL HYPERTROPHY	1/864 (0.1%)	1	2/796 (0.3%)	2
CARDIAC TAMPONADE	12/864 (1.4%)	12	9/796 (1.1%)	9
CARDIO-RESPIRATORY ARREST	6/864 (0.7%)	6	5/796 (0.6%)	5
CARDIOGENIC SHOCK	9/864 (1%)	9	32/796 (4%)	32
CARDIOMYOPATHY	2/864 (0.2%)	2	3/796 (0.4%)	3
CARDIORENAL SYNDROME	0/864 (0%)	0	1/796 (0.1%)	1
CARDIOVASCULAR DECONDITIONING	0/864 (0%)	0	3/796 (0.4%)	3
CHRONOTROPIC INCOMPETENCE	1/864 (0.1%)	1	0/796 (0%)	0
CONDUCTION DISORDER	3/864 (0.3%)	3	0/796 (0%)	0
COR PULMONALE	1/864 (0.1%)	1	0/796 (0%)	0
CORONARY ARTERY DISEASE	6/864 (0.7%)	6	5/796 (0.6%)	5
CORONARY ARTERY EMBOLISM	0/864 (0%)	0	1/796 (0.1%)	1
CORONARY ARTERY OCCLUSION	1/864 (0.1%)	1	0/796 (0%)	0
CORONARY ARTERY STENOSIS	2/864 (0.2%)	2	1/796 (0.1%)	1
CORONARY OSTIAL STENOSIS	1/864 (0.1%)	1	1/796 (0.1%)	1
DEFECT CONDUCTION INTRAVENTRICULAR	0/864 (0%)	0	1/796 (0.1%)	1
DIASTOLIC DYSFUNCTION	0/864 (0%)	0	1/796 (0.1%)	1
DRESSLER'S SYNDROME	0/864 (0%)	0	1/796 (0.1%)	1
EXTRASYSTOLES	0/864 (0%)	0	1/796 (0.1%)	1
INTRAPERICARDIAL THROMBOSIS	1/864 (0.1%)	1	0/796 (0%)	0
ISCHAEMIC CARDIOMYOPATHY	1/864 (0.1%)	1	3/796 (0.4%)	3
LEFT VENTRICULAR DYSFUNCTION	2/864 (0.2%)	2	5/796 (0.6%)	5
LEFT VENTRICULAR FAILURE	3/864 (0.3%)	3	4/796 (0.5%)	4
LOW CARDIAC OUTPUT SYNDROME	0/864 (0%)	0	4/796 (0.5%)	4
MITRAL VALVE CALCIFICATION	0/864 (0%)	0	1/796 (0.1%)	1
MITRAL VALVE DISEASE MIXED	0/864 (0%)	0	1/796 (0.1%)	1
MITRAL VALVE INCOMPETENCE	10/864 (1.2%)	11	6/796 (0.8%)	6
MITRAL VALVE STENOSIS	0/864 (0%)	0	3/796 (0.4%)	3
MYOCARDIAL INFARCTION	4/864 (0.5%)	4	4/796 (0.5%)	4
MYOCARDIAL ISCHAEMIA	0/864 (0%)	0	3/796 (0.4%)	3
NODAL ARRHYTHMIA	3/864 (0.3%)	3	1/796 (0.1%)	1
NODAL RHYTHM	5/864 (0.6%)	5	6/796 (0.8%)	6
PALPITATIONS	0/864 (0%)	0	3/796 (0.4%)	3
PARAVALVULAR AORTIC REGURGITATION	7/864 (0.8%)	7	0/796 (0%)	0
PAROXYSMAL ATRIOVENTRICULAR BLOCK	0/864 (0%)	0	1/796 (0.1%)	1
PERICARDIAL EFFUSION	12/864 (1.4%)	12	15/796 (1.9%)	16
PERICARDIAL HAEMORRHAGE	1/864 (0.1%)	1	2/796 (0.3%)	2
PERICARDITIS	0/864 (0%)	0	5/796 (0.6%)	5
PROSTHETIC CARDIAC VALVE THROMBOSIS	1/864 (0.1%)	1	3/796 (0.4%)	3
PULMONARY VALVE INCOMPETENCE	0/864 (0%)	0	1/796 (0.1%)	1
PULSELESS ELECTRICAL ACTIVITY	2/864 (0.2%)	2	3/796 (0.4%)	3
RHYTHM IDIOVENTRICULAR	1/864 (0.1%)	1	1/796 (0.1%)	1
RIGHT VENTRICULAR DYSFUNCTION	0/864 (0%)	0	2/796 (0.3%)	2
RIGHT VENTRICULAR ENLARGEMENT	0/864 (0%)	0	1/796 (0.1%)	1
RIGHT VENTRICULAR FAILURE	4/864 (0.5%)	4	4/796 (0.5%)	4
SINUS ARREST	2/864 (0.2%)	2	2/796 (0.3%)	2
SINUS BRADYCARDIA	1/864 (0.1%)	1	3/796 (0.4%)	3
SINUS NODE DYSFUNCTION	9/864 (1%)	9	9/796 (1.1%)	10
SINUS TACHYCARDIA	2/864 (0.2%)	2	3/796 (0.4%)	3
SUPRAVENTRICULAR EXTRASYSTOLES	1/864 (0.1%)	1	1/796 (0.1%)	1
SUPRAVENTRICULAR TACHYCARDIA	7/864 (0.8%)	7	5/796 (0.6%)	5
SYSTOLIC DYSFUNCTION	0/864 (0%)	0	1/796 (0.1%)	1
TACHYCARDIA	6/864 (0.7%)	6	3/796 (0.4%)	3
TORSADE DE POINTES	0/864 (0%)	0	1/796 (0.1%)	1
TRICUSPID VALVE INCOMPETENCE	8/864 (0.9%)	8	12/796 (1.5%)	12
TRIFASCICULAR BLOCK	0/864 (0%)	0	1/796 (0.1%)	1
VENTRICULAR ARRHYTHMIA	0/864 (0%)	0	1/796 (0.1%)	1
VENTRICULAR ASYSTOLE	1/864 (0.1%)	1	1/796 (0.1%)	1
VENTRICULAR EXTRASYSTOLES	3/864 (0.3%)	3	3/796 (0.4%)	3
VENTRICULAR FIBRILLATION	5/864 (0.6%)	5	7/796 (0.9%)	7
VENTRICULAR TACHYCARDIA	15/864 (1.7%)	17	15/796 (1.9%)	16
Congenital, familial and genetic disorders
HAEMOPHILIA	1/864 (0.1%)	1	0/796 (0%)	0
LEFT VENTRICLE OUTFLOW TRACT OBSTRUCTION	0/864 (0%)	0	3/796 (0.4%)	3
Ear and labyrinth disorders
CERUMEN IMPACTION	1/864 (0.1%)	1	1/796 (0.1%)	1
MIDDLE EAR INFLAMMATION	1/864 (0.1%)	1	0/796 (0%)	0
VERTIGO	3/864 (0.3%)	3	2/796 (0.3%)	2
Endocrine disorders
GOITRE	1/864 (0.1%)	1	0/796 (0%)	0
HYPERPARATHYROIDISM PRIMARY	1/864 (0.1%)	1	0/796 (0%)	0
HYPOTHYROIDISM	0/864 (0%)	0	2/796 (0.3%)	2
Eye disorders
AMAUROSIS FUGAX	1/864 (0.1%)	1	0/796 (0%)	0
CATARACT	10/864 (1.2%)	11	7/796 (0.9%)	9
CATARACT NUCLEAR	0/864 (0%)	0	1/796 (0.1%)	1
CHARLES BONNET SYNDROME	1/864 (0.1%)	1	0/796 (0%)	0
CONJUNCTIVAL HAEMORRHAGE	1/864 (0.1%)	1	0/796 (0%)	0
DIABETIC RETINAL OEDEMA	0/864 (0%)	0	1/796 (0.1%)	1
DIPLOPIA	0/864 (0%)	0	1/796 (0.1%)	1
GLAUCOMA	0/864 (0%)	0	1/796 (0.1%)	1
MACULAR FIBROSIS	0/864 (0%)	0	1/796 (0.1%)	1
OPEN ANGLE GLAUCOMA	0/864 (0%)	0	1/796 (0.1%)	1
OPTIC ISCHAEMIC NEUROPATHY	1/864 (0.1%)	1	0/796 (0%)	0
RETINAL ARTERY OCCLUSION	1/864 (0.1%)	1	1/796 (0.1%)	1
RETINAL DETACHMENT	1/864 (0.1%)	1	1/796 (0.1%)	1
RETINAL VEIN OCCLUSION	0/864 (0%)	0	1/796 (0.1%)	1
VISION BLURRED	1/864 (0.1%)	1	0/796 (0%)	0
VISUAL IMPAIRMENT	2/864 (0.2%)	2	0/796 (0%)	0
Gastrointestinal disorders
ABDOMINAL PAIN	1/864 (0.1%)	1	4/796 (0.5%)	4
ABDOMINAL PAIN LOWER	1/864 (0.1%)	1	1/796 (0.1%)	1
ABDOMINAL PAIN UPPER	2/864 (0.2%)	2	3/796 (0.4%)	3
ABDOMINAL WALL HAEMATOMA	2/864 (0.2%)	2	1/796 (0.1%)	1
ANAL INCONTINENCE	1/864 (0.1%)	1	0/796 (0%)	0
ASCITES	2/864 (0.2%)	3	0/796 (0%)	0
COLITIS	3/864 (0.3%)	3	0/796 (0%)	0
COLITIS ISCHAEMIC	2/864 (0.2%)	2	2/796 (0.3%)	2
CONSTIPATION	4/864 (0.5%)	4	3/796 (0.4%)	4
DIARRHOEA	3/864 (0.3%)	3	7/796 (0.9%)	7
DIVERTICULAR PERFORATION	0/864 (0%)	0	2/796 (0.3%)	2
DIVERTICULUM	0/864 (0%)	0	4/796 (0.5%)	4
DIVERTICULUM INTESTINAL HAEMORRHAGIC	1/864 (0.1%)	1	0/796 (0%)	0
DUODENAL ULCER	0/864 (0%)	0	1/796 (0.1%)	1
DUODENAL ULCER PERFORATION	1/864 (0.1%)	1	1/796 (0.1%)	1
DYSKINESIA OESOPHAGEAL	0/864 (0%)	0	1/796 (0.1%)	1
DYSPEPSIA	1/864 (0.1%)	1	2/796 (0.3%)	2
DYSPHAGIA	10/864 (1.2%)	10	22/796 (2.8%)	22
FAECALOMA	0/864 (0%)	0	1/796 (0.1%)	1
FLATULENCE	0/864 (0%)	0	1/796 (0.1%)	1
GASTRIC ULCER	0/864 (0%)	0	2/796 (0.3%)	2
GASTRIC ULCER HAEMORRHAGE	1/864 (0.1%)	1	0/796 (0%)	0
GASTRITIS	2/864 (0.2%)	2	1/796 (0.1%)	1
GASTRITIS EROSIVE	2/864 (0.2%)	2	0/796 (0%)	0
GASTROINTESTINAL HAEMORRHAGE	24/864 (2.8%)	28	28/796 (3.5%)	34
GASTROINTESTINAL ULCER	0/864 (0%)	0	1/796 (0.1%)	1
GINGIVAL PAIN	1/864 (0.1%)	1	0/796 (0%)	0
HAEMATEMESIS	1/864 (0.1%)	1	3/796 (0.4%)	3
HAEMATOCHEZIA	0/864 (0%)	0	1/796 (0.1%)	1
HAEMORRHOIDS	1/864 (0.1%)	1	0/796 (0%)	0
HIATUS HERNIA	1/864 (0.1%)	1	2/796 (0.3%)	2
ILEUS	4/864 (0.5%)	4	4/796 (0.5%)	4
ILEUS PARALYTIC	0/864 (0%)	0	2/796 (0.3%)	2
INCARCERATED INGUINAL HERNIA	1/864 (0.1%)	1	0/796 (0%)	0
INCARCERATED UMBILICAL HERNIA	0/864 (0%)	0	1/796 (0.1%)	1
INGUINAL HERNIA	4/864 (0.5%)	4	3/796 (0.4%)	3
INTESTINAL ISCHAEMIA	2/864 (0.2%)	3	2/796 (0.3%)	2
INTESTINAL MASS	1/864 (0.1%)	1	0/796 (0%)	0
INTESTINAL OBSTRUCTION	0/864 (0%)	0	1/796 (0.1%)	1
LARGE INTESTINAL STENOSIS	1/864 (0.1%)	1	0/796 (0%)	0
LARGE INTESTINE PERFORATION	1/864 (0.1%)	1	2/796 (0.3%)	2
LARGE INTESTINE POLYP	3/864 (0.3%)	4	1/796 (0.1%)	1
LOOSE TOOTH	1/864 (0.1%)	1	0/796 (0%)	0
LOWER GASTROINTESTINAL HAEMORRHAGE	6/864 (0.7%)	7	3/796 (0.4%)	3
MELAENA	1/864 (0.1%)	1	4/796 (0.5%)	4
MESENTERIC ARTERY STENOSIS	1/864 (0.1%)	1	0/796 (0%)	0
NAUSEA	1/864 (0.1%)	1	2/796 (0.3%)	2
ODYNOPHAGIA	0/864 (0%)	0	1/796 (0.1%)	1
OESOPHAGEAL DISORDER	1/864 (0.1%)	1	0/796 (0%)	0
OESOPHAGEAL PERFORATION	0/864 (0%)	0	1/796 (0.1%)	1
OESOPHAGEAL RUPTURE	1/864 (0.1%)	1	0/796 (0%)	0
OESOPHAGEAL STENOSIS	1/864 (0.1%)	1	0/796 (0%)	0
PANCREATITIS	2/864 (0.2%)	2	1/796 (0.1%)	1
PERITONEAL HAEMORRHAGE	1/864 (0.1%)	1	0/796 (0%)	0
PERITONEAL LESION	1/864 (0.1%)	1	0/796 (0%)	0
PNEUMOPERITONEUM	0/864 (0%)	0	1/796 (0.1%)	1
RECTAL HAEMORRHAGE	4/864 (0.5%)	4	4/796 (0.5%)	4
RECTAL PROLAPSE	1/864 (0.1%)	1	0/796 (0%)	0
RECTOURETHRAL FISTULA	0/864 (0%)	0	1/796 (0.1%)	1
RETROPERITONEAL HAEMATOMA	2/864 (0.2%)	2	1/796 (0.1%)	1
RETROPERITONEAL HAEMORRHAGE	2/864 (0.2%)	2	0/796 (0%)	0
SALIVARY GLAND MASS	0/864 (0%)	0	1/796 (0.1%)	1
SMALL INTESTINAL OBSTRUCTION	2/864 (0.2%)	2	3/796 (0.4%)	3
SWOLLEN TONGUE	0/864 (0%)	0	1/796 (0.1%)	1
UMBILICAL HERNIA	0/864 (0%)	0	3/796 (0.4%)	3
UPPER GASTROINTESTINAL HAEMORRHAGE	2/864 (0.2%)	2	4/796 (0.5%)	4
VOLVULUS	0/864 (0%)	0	1/796 (0.1%)	1
VOMITING	3/864 (0.3%)	3	4/796 (0.5%)	4
General disorders
ADVERSE DRUG REACTION	0/864 (0%)	0	2/796 (0.3%)	2
ASTHENIA	9/864 (1%)	9	7/796 (0.9%)	9
CATHETER SITE DISCHARGE	1/864 (0.1%)	1	2/796 (0.3%)	2
CATHETER SITE HAEMATOMA	1/864 (0.1%)	1	0/796 (0%)	0
CATHETER SITE HAEMORRHAGE	0/864 (0%)	0	1/796 (0.1%)	1
CHEST DISCOMFORT	2/864 (0.2%)	2	2/796 (0.3%)	2
CHEST PAIN	18/864 (2.1%)	20	17/796 (2.1%)	18
COMPLICATION ASSOCIATED WITH DEVICE	1/864 (0.1%)	1	1/796 (0.1%)	1
COMPLICATION OF DEVICE INSERTION	1/864 (0.1%)	1	0/796 (0%)	0
DEATH	5/864 (0.6%)	5	4/796 (0.5%)	4
DEVICE EMBOLISATION	2/864 (0.2%)	2	0/796 (0%)	0
DRUG WITHDRAWAL SYNDROME	0/864 (0%)	0	1/796 (0.1%)	1
EFFUSION	0/864 (0%)	0	1/796 (0.1%)	1
FATIGUE	0/864 (0%)	0	1/796 (0.1%)	1
GAIT DISTURBANCE	4/864 (0.5%)	4	1/796 (0.1%)	1
GENERALISED OEDEMA	0/864 (0%)	0	1/796 (0.1%)	1
HERNIA	0/864 (0%)	0	1/796 (0.1%)	1
HYPOTHERMIA	1/864 (0.1%)	1	0/796 (0%)	0
IMPAIRED HEALING	1/864 (0.1%)	1	1/796 (0.1%)	1
IMPLANT SITE DISCHARGE	0/864 (0%)	0	1/796 (0.1%)	1
IMPLANT SITE EROSION	1/864 (0.1%)	1	0/796 (0%)	0
MALAISE	1/864 (0.1%)	1	0/796 (0%)	0
MULTIPLE ORGAN DYSFUNCTION SYNDROME	2/864 (0.2%)	2	5/796 (0.6%)	5
NON-CARDIAC CHEST PAIN	7/864 (0.8%)	7	12/796 (1.5%)	13
OEDEMA PERIPHERAL	4/864 (0.5%)	4	11/796 (1.4%)	12
PERIPHERAL SWELLING	0/864 (0%)	0	1/796 (0.1%)	1
POLYP	2/864 (0.2%)	2	0/796 (0%)	0
PUNCTURE SITE HAEMORRHAGE	2/864 (0.2%)	2	0/796 (0%)	0
PYREXIA	2/864 (0.2%)	2	8/796 (1%)	8
SUDDEN CARDIAC DEATH	2/864 (0.2%)	2	0/796 (0%)	0
SUDDEN DEATH	1/864 (0.1%)	1	1/796 (0.1%)	1
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	2/864 (0.2%)	2	6/796 (0.8%)	6
ULCER HAEMORRHAGE	0/864 (0%)	0	1/796 (0.1%)	1
VASCULAR STENT STENOSIS	0/864 (0%)	0	1/796 (0.1%)	1
VASCULAR STENT THROMBOSIS	1/864 (0.1%)	1	0/796 (0%)	0
Hepatobiliary disorders
ACUTE HEPATIC FAILURE	2/864 (0.2%)	2	0/796 (0%)	0
BILIARY COLIC	0/864 (0%)	0	1/796 (0.1%)	1
CHOLANGITIS	3/864 (0.3%)	3	1/796 (0.1%)	1
CHOLANGITIS ACUTE	1/864 (0.1%)	1	0/796 (0%)	0
CHOLECYSTITIS	2/864 (0.2%)	2	4/796 (0.5%)	4
CHOLECYSTITIS ACUTE	1/864 (0.1%)	1	2/796 (0.3%)	2
CHOLELITHIASIS	2/864 (0.2%)	2	5/796 (0.6%)	5
CHRONIC HEPATIC FAILURE	0/864 (0%)	0	1/796 (0.1%)	1
GALLBLADDER DISORDER	0/864 (0%)	0	2/796 (0.3%)	2
HEPATIC CIRRHOSIS	1/864 (0.1%)	1	2/796 (0.3%)	2
HEPATIC FAILURE	0/864 (0%)	0	1/796 (0.1%)	1
ISCHAEMIC HEPATITIS	1/864 (0.1%)	1	2/796 (0.3%)	2
LIVER DISORDER	0/864 (0%)	0	1/796 (0.1%)	1
LIVER INJURY	0/864 (0%)	0	1/796 (0.1%)	1
PORTAL VEIN THROMBOSIS	1/864 (0.1%)	1	0/796 (0%)	0
Immune system disorders
ANAPHYLACTIC REACTION	0/864 (0%)	0	1/796 (0.1%)	1
Infections and infestations
ABDOMINAL ABSCESS	1/864 (0.1%)	2	0/796 (0%)	0
ABSCESS JAW	1/864 (0.1%)	1	0/796 (0%)	0
APPENDICITIS	0/864 (0%)	0	1/796 (0.1%)	1
APPENDICITIS PERFORATED	0/864 (0%)	0	1/796 (0.1%)	1
ARTHRITIS INFECTIVE	1/864 (0.1%)	1	1/796 (0.1%)	1
BACTERAEMIA	12/864 (1.4%)	13	4/796 (0.5%)	4
BACTERIAL INFECTION	0/864 (0%)	0	1/796 (0.1%)	1
BACTERIAL SEPSIS	0/864 (0%)	0	1/796 (0.1%)	1
BRONCHITIS	6/864 (0.7%)	6	5/796 (0.6%)	5
CAMPYLOBACTER SEPSIS	1/864 (0.1%)	1	0/796 (0%)	0
CARDIAC VALVE ABSCESS	0/864 (0%)	0	1/796 (0.1%)	1
CATHETER SITE CELLULITIS	0/864 (0%)	0	1/796 (0.1%)	1
CELLULITIS	16/864 (1.9%)	17	15/796 (1.9%)	15
CLOSTRIDIUM DIFFICILE INFECTION	3/864 (0.3%)	3	5/796 (0.6%)	5
CYSTITIS	0/864 (0%)	0	2/796 (0.3%)	2
CYTOMEGALOVIRUS VIRAEMIA	1/864 (0.1%)	2	0/796 (0%)	0
DEVICE RELATED INFECTION	0/864 (0%)	0	1/796 (0.1%)	1
DEVICE RELATED SEPSIS	1/864 (0.1%)	1	1/796 (0.1%)	1
DIVERTICULITIS	4/864 (0.5%)	4	0/796 (0%)	0
EMPYEMA	1/864 (0.1%)	1	1/796 (0.1%)	1
ENCEPHALITIS	0/864 (0%)	0	1/796 (0.1%)	1
ENCEPHALITIS VIRAL	0/864 (0%)	0	2/796 (0.3%)	2
ENDOCARDITIS	6/864 (0.7%)	6	8/796 (1%)	8
ENDOCARDITIS BACTERIAL	1/864 (0.1%)	1	0/796 (0%)	0
ENTEROBACTER SEPSIS	0/864 (0%)	0	1/796 (0.1%)	1
ENTEROCOCCAL BACTERAEMIA	3/864 (0.3%)	4	0/796 (0%)	0
ENTEROCOCCAL SEPSIS	0/864 (0%)	0	1/796 (0.1%)	1
EPIDIDYMITIS	1/864 (0.1%)	1	0/796 (0%)	0
ESCHERICHIA BACTERAEMIA	2/864 (0.2%)	2	0/796 (0%)	0
ESCHERICHIA SEPSIS	0/864 (0%)	0	1/796 (0.1%)	1
ESCHERICHIA URINARY TRACT INFECTION	0/864 (0%)	0	1/796 (0.1%)	1
FUNGAL OESOPHAGITIS	1/864 (0.1%)	1	0/796 (0%)	0
GANGRENE	0/864 (0%)	0	3/796 (0.4%)	3
GASTROENTERITIS	2/864 (0.2%)	2	1/796 (0.1%)	1
GASTROENTERITIS VIRAL	1/864 (0.1%)	1	1/796 (0.1%)	1
GASTROINTESTINAL INFECTION	1/864 (0.1%)	1	0/796 (0%)	0
GASTROINTESTINAL VIRAL INFECTION	2/864 (0.2%)	2	0/796 (0%)	0
GROIN INFECTION	2/864 (0.2%)	2	1/796 (0.1%)	1
HAEMOPHILUS SEPSIS	0/864 (0%)	0	1/796 (0.1%)	1
HELICOBACTER INFECTION	0/864 (0%)	0	1/796 (0.1%)	1
HERPES ZOSTER	0/864 (0%)	0	2/796 (0.3%)	2
INCISION SITE CELLULITIS	1/864 (0.1%)	1	1/796 (0.1%)	1
INFECTED SEROMA	0/864 (0%)	0	1/796 (0.1%)	2
INFECTION	2/864 (0.2%)	2	3/796 (0.4%)	3
INFECTIOUS PLEURAL EFFUSION	0/864 (0%)	0	1/796 (0.1%)	1
INFLUENZA	1/864 (0.1%)	1	1/796 (0.1%)	1
INTERVERTEBRAL DISCITIS	2/864 (0.2%)	2	1/796 (0.1%)	1
LABYRINTHITIS	0/864 (0%)	0	1/796 (0.1%)	1
LARYNGITIS	1/864 (0.1%)	1	0/796 (0%)	0
LIVER ABSCESS	1/864 (0.1%)	1	0/796 (0%)	0
LOCALISED INFECTION	2/864 (0.2%)	2	1/796 (0.1%)	1
LUNG INFECTION	0/864 (0%)	0	2/796 (0.3%)	2
LYME DISEASE	0/864 (0%)	0	1/796 (0.1%)	1
MEDIASTINITIS	1/864 (0.1%)	1	2/796 (0.3%)	2
NASAL ABSCESS	1/864 (0.1%)	1	0/796 (0%)	0
ORCHITIS	2/864 (0.2%)	2	0/796 (0%)	0
OSTEOMYELITIS	3/864 (0.3%)	3	4/796 (0.5%)	7
OSTEOMYELITIS ACUTE	0/864 (0%)	0	2/796 (0.3%)	3
PERITONITIS	1/864 (0.1%)	1	1/796 (0.1%)	1
PNEUMONIA	58/864 (6.7%)	65	55/796 (6.9%)	60
PNEUMONIA BACTERIAL	4/864 (0.5%)	5	2/796 (0.3%)	2
PNEUMONIA CYTOMEGALOVIRAL	1/864 (0.1%)	1	0/796 (0%)	0
PNEUMONIA HAEMOPHILUS	1/864 (0.1%)	1	0/796 (0%)	0
PNEUMONIA KLEBSIELLA	0/864 (0%)	0	1/796 (0.1%)	1
POST PROCEDURAL PNEUMONIA	0/864 (0%)	0	1/796 (0.1%)	1
POSTOPERATIVE WOUND INFECTION	6/864 (0.7%)	6	13/796 (1.6%)	19
PSEUDOMONAL BACTERAEMIA	1/864 (0.1%)	1	0/796 (0%)	0
PSEUDOMONAS INFECTION	0/864 (0%)	0	1/796 (0.1%)	1
PULMONARY SEPSIS	1/864 (0.1%)	1	2/796 (0.3%)	2
PYELONEPHRITIS	0/864 (0%)	0	1/796 (0.1%)	1
PYELONEPHRITIS ACUTE	1/864 (0.1%)	1	1/796 (0.1%)	1
RESPIRATORY SYNCYTIAL VIRUS BRONCHITIS	1/864 (0.1%)	1	0/796 (0%)	0
RESPIRATORY SYNCYTIAL VIRUS INFECTION	0/864 (0%)	0	1/796 (0.1%)	1
RESPIRATORY TRACT INFECTION	3/864 (0.3%)	3	5/796 (0.6%)	5
SALMONELLA BACTERAEMIA	1/864 (0.1%)	1	0/796 (0%)	0
SEPSIS	24/864 (2.8%)	28	24/796 (3%)	25
SEPTIC ENCEPHALOPATHY	0/864 (0%)	0	2/796 (0.3%)	2
SEPTIC SHOCK	5/864 (0.6%)	5	5/796 (0.6%)	6
SINUSITIS	1/864 (0.1%)	1	1/796 (0.1%)	1
SKIN CANDIDA	0/864 (0%)	0	1/796 (0.1%)	1
SPINAL CORD INFECTION	1/864 (0.1%)	1	0/796 (0%)	0
STAPHYLOCOCCAL BACTERAEMIA	0/864 (0%)	0	2/796 (0.3%)	2
STAPHYLOCOCCAL SEPSIS	2/864 (0.2%)	2	0/796 (0%)	0
STREPTOCOCCAL BACTERAEMIA	1/864 (0.1%)	1	0/796 (0%)	0
SUBCUTANEOUS ABSCESS	0/864 (0%)	0	1/796 (0.1%)	1
TOOTH ABSCESS	2/864 (0.2%)	3	0/796 (0%)	0
TRACHEOBRONCHITIS	0/864 (0%)	0	1/796 (0.1%)	1
UPPER RESPIRATORY TRACT INFECTION	1/864 (0.1%)	1	2/796 (0.3%)	2
URINARY TRACT INFECTION	33/864 (3.8%)	41	25/796 (3.1%)	26
URINARY TRACT INFECTION BACTERIAL	1/864 (0.1%)	1	0/796 (0%)	0
UROSEPSIS	8/864 (0.9%)	10	12/796 (1.5%)	12
VASCULAR ACCESS SITE INFECTION	1/864 (0.1%)	1	0/796 (0%)	0
VIRAL CARDIOMYOPATHY	0/864 (0%)	0	1/796 (0.1%)	1
VIRAL INFECTION	1/864 (0.1%)	1	2/796 (0.3%)	2
WOUND INFECTION	1/864 (0.1%)	1	4/796 (0.5%)	4
Injury, poisoning and procedural complications
ABDOMINAL INJURY	1/864 (0.1%)	1	0/796 (0%)	0
ACCIDENTAL OVERDOSE	1/864 (0.1%)	1	0/796 (0%)	0
ALCOHOL POISONING	1/864 (0.1%)	2	0/796 (0%)	0
ALLERGIC TRANSFUSION REACTION	0/864 (0%)	0	1/796 (0.1%)	1
ANAEMIA POSTOPERATIVE	17/864 (2%)	17	36/796 (4.5%)	36
ANASTOMOTIC HAEMORRHAGE	0/864 (0%)	0	1/796 (0.1%)	1
ANKLE FRACTURE	2/864 (0.2%)	2	0/796 (0%)	0
AORTIC INJURY	0/864 (0%)	0	1/796 (0.1%)	1
ARTERIAL BYPASS OCCLUSION	1/864 (0.1%)	1	0/796 (0%)	0
ARTERIAL INJURY	6/864 (0.7%)	6	1/796 (0.1%)	1
BRACHIAL PLEXUS INJURY	1/864 (0.1%)	1	0/796 (0%)	0
CARBON MONOXIDE POISONING	0/864 (0%)	0	1/796 (0.1%)	1
CARDIAC VALVE RUPTURE	1/864 (0.1%)	1	1/796 (0.1%)	1
CARDIAC VEIN PERFORATION	0/864 (0%)	0	1/796 (0.1%)	1
CERVICAL VERTEBRAL FRACTURE	2/864 (0.2%)	2	0/796 (0%)	0
CLAVICLE FRACTURE	1/864 (0.1%)	1	0/796 (0%)	0
COMPLICATIONS OF TRANSPLANTED HEART	1/864 (0.1%)	1	0/796 (0%)	0
COMPRESSION FRACTURE	1/864 (0.1%)	1	0/796 (0%)	0
CONTUSION	1/864 (0.1%)	1	0/796 (0%)	0
CORNEAL ABRASION	1/864 (0.1%)	1	0/796 (0%)	0
DEVICE DEPLOYMENT ISSUE	24/864 (2.8%)	25	0/796 (0%)	0
EXTRADURAL HAEMATOMA	0/864 (0%)	0	1/796 (0.1%)	1
FACIAL BONES FRACTURE	0/864 (0%)	0	1/796 (0.1%)	1
FALL	13/864 (1.5%)	14	9/796 (1.1%)	9
FEMORAL NECK FRACTURE	2/864 (0.2%)	2	3/796 (0.4%)	3
FEMUR FRACTURE	2/864 (0.2%)	2	3/796 (0.4%)	3
FIBULA FRACTURE	2/864 (0.2%)	2	0/796 (0%)	0
FOREARM FRACTURE	1/864 (0.1%)	1	0/796 (0%)	0
FOREIGN BODY IN EAR	0/864 (0%)	0	1/796 (0.1%)	1
HAEMODILUTION	0/864 (0%)	0	1/796 (0.1%)	1
HAND FRACTURE	0/864 (0%)	0	2/796 (0.3%)	2
HEAD INJURY	1/864 (0.1%)	1	2/796 (0.3%)	2
HEART INJURY	0/864 (0%)	0	1/796 (0.1%)	1
HIP FRACTURE	11/864 (1.3%)	11	10/796 (1.3%)	10
HUMERUS FRACTURE	4/864 (0.5%)	5	1/796 (0.1%)	1
INCISION SITE COMPLICATION	2/864 (0.2%)	2	0/796 (0%)	0
INCISION SITE HAEMORRHAGE	5/864 (0.6%)	5	0/796 (0%)	0
INCISIONAL HERNIA, OBSTRUCTIVE	0/864 (0%)	0	1/796 (0.1%)	1
INJURY	3/864 (0.3%)	3	1/796 (0.1%)	1
JOINT DISLOCATION	2/864 (0.2%)	2	3/796 (0.4%)	3
JOINT INJURY	4/864 (0.5%)	4	2/796 (0.3%)	2
LACERATION	5/864 (0.6%)	5	6/796 (0.8%)	6
LIMB TRAUMATIC AMPUTATION	2/864 (0.2%)	2	0/796 (0%)	0
LOWER LIMB FRACTURE	4/864 (0.5%)	4	1/796 (0.1%)	1
LUMBAR VERTEBRAL FRACTURE	0/864 (0%)	0	2/796 (0.3%)	2
MENISCUS INJURY	1/864 (0.1%)	1	0/796 (0%)	0
MULTIPLE FRACTURES	1/864 (0.1%)	1	0/796 (0%)	0
NERVE INJURY	0/864 (0%)	0	1/796 (0.1%)	1
OVERDOSE	1/864 (0.1%)	1	0/796 (0%)	0
PELVIC FRACTURE	0/864 (0%)	0	1/796 (0.1%)	1
PERIPROCEDURAL MYOCARDIAL INFARCTION	0/864 (0%)	0	1/796 (0.1%)	1
POST LAMINECTOMY SYNDROME	0/864 (0%)	0	1/796 (0.1%)	1
POST PROCEDURAL COMPLICATION	0/864 (0%)	0	1/796 (0.1%)	1
POST PROCEDURAL HAEMATOMA	1/864 (0.1%)	1	0/796 (0%)	0
POST PROCEDURAL HAEMORRHAGE	1/864 (0.1%)	1	19/796 (2.4%)	20
POSTOPERATIVE DELIRIUM	1/864 (0.1%)	1	2/796 (0.3%)	2
POSTOPERATIVE ILEUS	0/864 (0%)	0	4/796 (0.5%)	4
POSTOPERATIVE RESPIRATORY FAILURE	0/864 (0%)	0	4/796 (0.5%)	4
POSTOPERATIVE THORACIC PROCEDURE COMPLICATION	0/864 (0%)	0	2/796 (0.3%)	2
POSTOPERATIVE THROMBOSIS	0/864 (0%)	0	1/796 (0.1%)	1
POSTPERICARDIOTOMY SYNDROME	0/864 (0%)	0	2/796 (0.3%)	2
PROCEDURAL COMPLICATION	0/864 (0%)	0	1/796 (0.1%)	1
PROCEDURAL HAEMORRHAGE	2/864 (0.2%)	2	9/796 (1.1%)	9
PROCEDURAL HYPERTENSION	1/864 (0.1%)	1	2/796 (0.3%)	2
PROCEDURAL HYPOTENSION	5/864 (0.6%)	5	1/796 (0.1%)	1
PROCEDURAL PNEUMOTHORAX	0/864 (0%)	0	1/796 (0.1%)	1
RADIUS FRACTURE	2/864 (0.2%)	2	0/796 (0%)	0
RIB FRACTURE	3/864 (0.3%)	3	6/796 (0.8%)	6
ROAD TRAFFIC ACCIDENT	1/864 (0.1%)	1	1/796 (0.1%)	1
SEROMA	0/864 (0%)	0	1/796 (0.1%)	1
SKIN ABRASION	1/864 (0.1%)	1	0/796 (0%)	0
SPINAL COMPRESSION FRACTURE	3/864 (0.3%)	3	3/796 (0.4%)	3
SPINAL FRACTURE	2/864 (0.2%)	2	0/796 (0%)	0
SUBARACHNOID HAEMORRHAGE	5/864 (0.6%)	5	0/796 (0%)	0
SUBCUTANEOUS HAEMATOMA	1/864 (0.1%)	1	0/796 (0%)	0
SUBDURAL HAEMATOMA	6/864 (0.7%)	6	2/796 (0.3%)	2
SUTURE RELATED COMPLICATION	0/864 (0%)	0	1/796 (0.1%)	1
TENDON RUPTURE	1/864 (0.1%)	1	0/796 (0%)	0
THORACIC VERTEBRAL FRACTURE	0/864 (0%)	0	2/796 (0.3%)	2
TOOTH FRACTURE	0/864 (0%)	0	1/796 (0.1%)	1
TOXICITY TO VARIOUS AGENTS	0/864 (0%)	0	1/796 (0.1%)	1
TRAUMATIC LUNG INJURY	0/864 (0%)	0	1/796 (0.1%)	1
ULNA FRACTURE	1/864 (0.1%)	1	0/796 (0%)	0
UPPER LIMB FRACTURE	3/864 (0.3%)	3	1/796 (0.1%)	1
URETERIC INJURY	0/864 (0%)	0	1/796 (0.1%)	1
URINARY RETENTION POSTOPERATIVE	1/864 (0.1%)	1	0/796 (0%)	0
VASCULAR ACCESS COMPLICATION	1/864 (0.1%)	1	0/796 (0%)	0
VASCULAR ACCESS SITE COMPLICATION	9/864 (1%)	9	0/796 (0%)	0
VASCULAR ACCESS SITE HAEMATOMA	2/864 (0.2%)	2	0/796 (0%)	0
VASCULAR ACCESS SITE HAEMORRHAGE	3/864 (0.3%)	3	0/796 (0%)	0
VASCULAR GRAFT COMPLICATION	0/864 (0%)	0	1/796 (0.1%)	1
VASCULAR PSEUDOANEURYSM	7/864 (0.8%)	7	2/796 (0.3%)	2
VASOPLEGIA SYNDROME	0/864 (0%)	0	1/796 (0.1%)	1
VENOUS INJURY	0/864 (0%)	0	1/796 (0.1%)	1
WEANING FAILURE	0/864 (0%)	0	1/796 (0.1%)	1
WOUND	1/864 (0.1%)	1	0/796 (0%)	0
WOUND DEHISCENCE	2/864 (0.2%)	2	2/796 (0.3%)	2
WOUND SECRETION	8/864 (0.9%)	8	1/796 (0.1%)	1
WRIST FRACTURE	3/864 (0.3%)	3	2/796 (0.3%)	2
XIITH NERVE INJURY	0/864 (0%)	0	1/796 (0.1%)	1
Investigations
ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC	2/864 (0.2%)	2	5/796 (0.6%)	5
ANTICOAGULATION DRUG LEVEL BELOW THERAPEUTIC	0/864 (0%)	0	1/796 (0.1%)	1
BLOOD CREATINE PHOSPHOKINASE INCREASED	1/864 (0.1%)	1	0/796 (0%)	0
BLOOD CREATININE INCREASED	3/864 (0.3%)	3	0/796 (0%)	0
BLOOD CULTURE POSITIVE	1/864 (0.1%)	1	1/796 (0.1%)	1
BLOOD ERYTHROPOIETIN DECREASED	0/864 (0%)	0	1/796 (0.1%)	1
BLOOD FIBRINOGEN DECREASED	0/864 (0%)	0	1/796 (0.1%)	1
BLOOD GLUCOSE DECREASED	0/864 (0%)	0	1/796 (0.1%)	1
BLOOD GLUCOSE INCREASED	1/864 (0.1%)	1	0/796 (0%)	0
BLOOD POTASSIUM ABNORMAL	1/864 (0.1%)	1	0/796 (0%)	0
BLOOD POTASSIUM DECREASED	1/864 (0.1%)	1	0/796 (0%)	0
BODY TEMPERATURE INCREASED	1/864 (0.1%)	1	0/796 (0%)	0
BRAIN NATRIURETIC PEPTIDE INCREASED	0/864 (0%)	0	2/796 (0.3%)	2
C-REACTIVE PROTEIN INCREASED	0/864 (0%)	0	1/796 (0.1%)	1
CALCIUM IONISED DECREASED	1/864 (0.1%)	1	0/796 (0%)	0
CARDIAC INDEX DECREASED	1/864 (0.1%)	1	3/796 (0.4%)	3
CARDIAC INDEX INCREASED	0/864 (0%)	0	1/796 (0.1%)	1
CARDIAC MURMUR	0/864 (0%)	0	1/796 (0.1%)	1
CARDIAC OUTPUT DECREASED	1/864 (0.1%)	1	9/796 (1.1%)	9
CARDIOVASCULAR FUNCTION TEST NORMAL	0/864 (0%)	0	1/796 (0.1%)	1
COAGULATION TIME PROLONGED	0/864 (0%)	0	2/796 (0.3%)	2
CYSTOSCOPY ABNORMAL	1/864 (0.1%)	1	0/796 (0%)	0
ECHOCARDIOGRAM ABNORMAL	0/864 (0%)	0	3/796 (0.4%)	3
EJECTION FRACTION DECREASED	3/864 (0.3%)	3	1/796 (0.1%)	1
ELECTROCARDIOGRAM ABNORMAL	2/864 (0.2%)	2	0/796 (0%)	0
ELECTROCARDIOGRAM ST SEGMENT ABNORMAL	0/864 (0%)	0	1/796 (0.1%)	1
FIBRIN D DIMER INCREASED	0/864 (0%)	0	1/796 (0.1%)	1
FUNGAL TEST POSITIVE	0/864 (0%)	0	1/796 (0.1%)	1
HAEMATOCRIT DECREASED	0/864 (0%)	0	1/796 (0.1%)	1
HAEMOGLOBIN DECREASED	6/864 (0.7%)	6	5/796 (0.6%)	5
INTERNATIONAL NORMALISED RATIO ABNORMAL	0/864 (0%)	0	1/796 (0.1%)	1
INTERNATIONAL NORMALISED RATIO INCREASED	0/864 (0%)	0	5/796 (0.6%)	5
INVESTIGATION	0/864 (0%)	0	1/796 (0.1%)	1
LIVER FUNCTION TEST ABNORMAL	0/864 (0%)	0	1/796 (0.1%)	1
NUTRITIONAL CONDITION ABNORMAL	0/864 (0%)	0	1/796 (0.1%)	1
OCCULT BLOOD	0/864 (0%)	0	1/796 (0.1%)	1
OCCULT BLOOD POSITIVE	1/864 (0.1%)	1	0/796 (0%)	0
OXYGEN SATURATION DECREASED	0/864 (0%)	0	2/796 (0.3%)	2
PLATELET COUNT DECREASED	0/864 (0%)	0	1/796 (0.1%)	1
PULMONARY ARTERIAL PRESSURE ABNORMAL	1/864 (0.1%)	1	0/796 (0%)	0
PULSE ABSENT	1/864 (0.1%)	1	0/796 (0%)	0
TROPONIN INCREASED	4/864 (0.5%)	4	1/796 (0.1%)	1
URINE OUTPUT DECREASED	5/864 (0.6%)	5	3/796 (0.4%)	3
VENOUS OXYGEN SATURATION ABNORMAL	1/864 (0.1%)	1	0/796 (0%)	0
WEIGHT DECREASED	0/864 (0%)	0	2/796 (0.3%)	2
WEIGHT INCREASED	1/864 (0.1%)	1	0/796 (0%)	0
WHITE BLOOD CELL COUNT INCREASED	1/864 (0.1%)	1	2/796 (0.3%)	2
Metabolism and nutrition disorders
ABNORMAL LOSS OF WEIGHT	0/864 (0%)	0	2/796 (0.3%)	2
ACIDOSIS	0/864 (0%)	0	2/796 (0.3%)	2
CALCIPHYLAXIS	0/864 (0%)	0	1/796 (0.1%)	1
DECREASED APPETITE	0/864 (0%)	0	1/796 (0.1%)	1
DEHYDRATION	7/864 (0.8%)	8	5/796 (0.6%)	5
DIABETES MELLITUS	1/864 (0.1%)	1	1/796 (0.1%)	1
DIABETES MELLITUS INADEQUATE CONTROL	0/864 (0%)	0	2/796 (0.3%)	2
DIABETIC KETOACIDOSIS	1/864 (0.1%)	1	0/796 (0%)	0
ELECTROLYTE IMBALANCE	3/864 (0.3%)	3	3/796 (0.4%)	3
FAILURE TO THRIVE	7/864 (0.8%)	7	1/796 (0.1%)	1
FLUID OVERLOAD	13/864 (1.5%)	14	29/796 (3.6%)	29
GOUT	2/864 (0.2%)	2	1/796 (0.1%)	1
HYPERCALCAEMIA	1/864 (0.1%)	1	1/796 (0.1%)	1
HYPERGLYCAEMIA	10/864 (1.2%)	10	14/796 (1.8%)	14
HYPERKALAEMIA	3/864 (0.3%)	3	7/796 (0.9%)	7
HYPERNATRAEMIA	1/864 (0.1%)	1	2/796 (0.3%)	2
HYPERPHOSPHATAEMIA	0/864 (0%)	0	1/796 (0.1%)	1
HYPERVOLAEMIA	0/864 (0%)	0	1/796 (0.1%)	1
HYPOCALCAEMIA	1/864 (0.1%)	1	0/796 (0%)	0
HYPOGLYCAEMIA	5/864 (0.6%)	5	2/796 (0.3%)	2
HYPOKALAEMIA	6/864 (0.7%)	6	8/796 (1%)	9
HYPOMAGNEseriousMIA	2/864 (0.2%)	2	2/796 (0.3%)	2
HYPONATRAEMIA	12/864 (1.4%)	14	16/796 (2%)	18
HYPOPHOSPHATAEMIA	0/864 (0%)	0	1/796 (0.1%)	1
HYPOVOLAEMIA	1/864 (0.1%)	1	17/796 (2.1%)	17
LACTIC ACIDOSIS	1/864 (0.1%)	1	0/796 (0%)	0
MALNUTRITION	2/864 (0.2%)	2	9/796 (1.1%)	9
METABOLIC ACIDOSIS	2/864 (0.2%)	2	4/796 (0.5%)	4
TYPE 2 DIABETES MELLITUS	1/864 (0.1%)	1	0/796 (0%)	0
Musculoskeletal and connective tissue disorders
ARTHRALGIA	4/864 (0.5%)	4	4/796 (0.5%)	4
ARTHRITIS	5/864 (0.6%)	5	3/796 (0.4%)	3
BACK PAIN	10/864 (1.2%)	10	4/796 (0.5%)	4
BURSITIS	3/864 (0.3%)	3	1/796 (0.1%)	1
CERVICAL SPINAL STENOSIS	1/864 (0.1%)	1	0/796 (0%)	0
EXOSTOSIS	0/864 (0%)	0	1/796 (0.1%)	1
FISTULA	0/864 (0%)	0	2/796 (0.3%)	2
FLANK PAIN	1/864 (0.1%)	1	0/796 (0%)	0
FOOT DEFORMITY	0/864 (0%)	0	1/796 (0.1%)	1
JAW CYST	1/864 (0.1%)	1	0/796 (0%)	0
JOINT EFFUSION	2/864 (0.2%)	2	0/796 (0%)	0
LUMBAR SPINAL STENOSIS	5/864 (0.6%)	5	1/796 (0.1%)	1
MUSCLE HAEMORRHAGE	3/864 (0.3%)	3	1/796 (0.1%)	1
MUSCULAR WEAKNESS	4/864 (0.5%)	4	1/796 (0.1%)	1
MUSCULOSKELETAL CHEST PAIN	2/864 (0.2%)	2	0/796 (0%)	0
MUSCULOSKELETAL PAIN	2/864 (0.2%)	2	2/796 (0.3%)	2
MYALGIA	1/864 (0.1%)	1	0/796 (0%)	0
OSTEOARTHRITIS	16/864 (1.9%)	17	12/796 (1.5%)	12
PAIN IN EXTREMITY	3/864 (0.3%)	3	3/796 (0.4%)	3
PLANTAR FASCIITIS	1/864 (0.1%)	1	0/796 (0%)	0
RHABDOMYOLYSIS	1/864 (0.1%)	1	1/796 (0.1%)	1
ROTATOR CUFF SYNDROME	0/864 (0%)	0	2/796 (0.3%)	2
SACROILIITIS	1/864 (0.1%)	1	0/796 (0%)	0
SPINAL COLUMN STENOSIS	2/864 (0.2%)	2	2/796 (0.3%)	2
SPINAL OSTEOARTHRITIS	1/864 (0.1%)	1	0/796 (0%)	0
SPINAL PAIN	0/864 (0%)	0	1/796 (0.1%)	1
SPONDYLOLYSIS	0/864 (0%)	0	1/796 (0.1%)	1
SYNOVIAL CYST	0/864 (0%)	0	1/796 (0.1%)	1
TEMPOROMANDIBULAR JOINT SYNDROME	1/864 (0.1%)	1	0/796 (0%)	0
TENDONITIS	1/864 (0.1%)	1	0/796 (0%)	0
TENOSYNOVITIS STENOSANS	1/864 (0.1%)	1	0/796 (0%)	0
TRIGGER FINGER	1/864 (0.1%)	1	0/796 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA	1/864 (0.1%)	1	0/796 (0%)	0
ADENOCARCINOMA	0/864 (0%)	0	2/796 (0.3%)	2
ADENOCARCINOMA OF COLON	1/864 (0.1%)	1	0/796 (0%)	0
B-CELL LYMPHOMA	1/864 (0.1%)	1	0/796 (0%)	0
BASAL CELL CARCINOMA	5/864 (0.6%)	5	7/796 (0.9%)	7
BASOSQUAMOUS CARCINOMA	1/864 (0.1%)	1	0/796 (0%)	0
BENIGN BONE NEOPLASM	0/864 (0%)	0	1/796 (0.1%)	1
BLADDER CANCER	5/864 (0.6%)	5	6/796 (0.8%)	6
BLADDER CANCER RECURRENT	1/864 (0.1%)	1	0/796 (0%)	0
BLADDER NEOPLASM	1/864 (0.1%)	1	1/796 (0.1%)	1
BONE CANCER METASTATIC	1/864 (0.1%)	1	0/796 (0%)	0
BRAIN NEOPLASM	2/864 (0.2%)	3	0/796 (0%)	0
BREAST CANCER	2/864 (0.2%)	2	3/796 (0.4%)	3
CHRONIC LEUKAEMIA	0/864 (0%)	0	1/796 (0.1%)	1
COLON ADENOMA	0/864 (0%)	0	1/796 (0.1%)	1
COLON CANCER	2/864 (0.2%)	2	4/796 (0.5%)	4
COLORECTAL CANCER	1/864 (0.1%)	1	0/796 (0%)	0
ENDOMETRIAL CANCER	1/864 (0.1%)	1	0/796 (0%)	0
GALLBLADDER CANCER	0/864 (0%)	0	1/796 (0.1%)	1
GASTROINTESTINAL CARCINOMA	1/864 (0.1%)	1	0/796 (0%)	0
GASTROINTESTINAL STROMAL TUMOUR	0/864 (0%)	0	1/796 (0.1%)	1
LENTIGO MALIGNA	1/864 (0.1%)	1	0/796 (0%)	0
LEUKAEMIA	0/864 (0%)	0	1/796 (0.1%)	1
LIPOSARCOMA	1/864 (0.1%)	1	0/796 (0%)	0
LUNG ADENOCARCINOMA	1/864 (0.1%)	1	1/796 (0.1%)	1
LUNG CANCER METASTATIC	0/864 (0%)	0	2/796 (0.3%)	2
LUNG NEOPLASM MALIGNANT	2/864 (0.2%)	2	0/796 (0%)	0
LYMPHOCYTIC LEUKAEMIA	1/864 (0.1%)	1	0/796 (0%)	0
LYMPHOMA	2/864 (0.2%)	2	1/796 (0.1%)	1
MALIGNANT MELANOMA	0/864 (0%)	0	2/796 (0.3%)	2
MALIGNANT NEOPLASM OF SPERMATIC CORD	1/864 (0.1%)	1	0/796 (0%)	0
MELANOCYTIC NAEVUS	0/864 (0%)	0	1/796 (0.1%)	1
METASTASES TO BONE	1/864 (0.1%)	1	0/796 (0%)	0
METASTATIC NEOPLASM	2/864 (0.2%)	2	0/796 (0%)	0
MYELODYSPLASTIC SYNDROME	2/864 (0.2%)	2	2/796 (0.3%)	2
NEOPLASM MALIGNANT	1/864 (0.1%)	1	1/796 (0.1%)	1
OVARIAN CANCER	1/864 (0.1%)	1	0/796 (0%)	0
OVARIAN CANCER METASTATIC	0/864 (0%)	0	1/796 (0.1%)	1
PARATHYROID TUMOUR BENIGN	1/864 (0.1%)	1	0/796 (0%)	0
PLASMA CELL MYELOMA	1/864 (0.1%)	1	0/796 (0%)	0
PROSTATE CANCER	3/864 (0.3%)	3	2/796 (0.3%)	2
PROSTATE CANCER METASTATIC	0/864 (0%)	0	2/796 (0.3%)	2
RECTAL CANCER	1/864 (0.1%)	1	0/796 (0%)	0
RENAL CANCER METASTATIC	1/864 (0.1%)	1	0/796 (0%)	0
RENAL CELL CARCINOMA	0/864 (0%)	0	1/796 (0.1%)	1
SKIN CANCER	6/864 (0.7%)	6	2/796 (0.3%)	2
SQUAMOUS CELL CARCINOMA	6/864 (0.7%)	6	5/796 (0.6%)	5
SQUAMOUS CELL CARCINOMA OF SKIN	1/864 (0.1%)	1	0/796 (0%)	0
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS	1/864 (0.1%)	1	1/796 (0.1%)	1
AMNESIA	1/864 (0.1%)	1	0/796 (0%)	0
APHASIA	2/864 (0.2%)	2	2/796 (0.3%)	2
BRAIN INJURY	0/864 (0%)	0	1/796 (0.1%)	1
BRAIN OEDEMA	0/864 (0%)	0	1/796 (0.1%)	1
CAROTID ARTERY DISEASE	1/864 (0.1%)	1	0/796 (0%)	0
CAROTID ARTERY OCCLUSION	1/864 (0.1%)	1	0/796 (0%)	0
CAROTID ARTERY STENOSIS	6/864 (0.7%)	6	4/796 (0.5%)	4
CARPAL TUNNEL SYNDROME	3/864 (0.3%)	4	1/796 (0.1%)	1
CEREBELLAR HAEMORRHAGE	1/864 (0.1%)	1	0/796 (0%)	0
CEREBELLAR INFARCTION	3/864 (0.3%)	3	1/796 (0.1%)	1
CEREBRAL ATROPHY	1/864 (0.1%)	1	0/796 (0%)	0
CEREBRAL HAEMORRHAGE	2/864 (0.2%)	2	1/796 (0.1%)	1
CEREBRAL INFARCTION	3/864 (0.3%)	3	7/796 (0.9%)	7
CEREBROVASCULAR ACCIDENT	24/864 (2.8%)	25	30/796 (3.8%)	31
COGNITIVE DISORDER	2/864 (0.2%)	2	0/796 (0%)	0
COMA	0/864 (0%)	0	1/796 (0.1%)	1
DEMENTIA	1/864 (0.1%)	1	1/796 (0.1%)	1
DEMENTIA ALZHEIMER'S TYPE	3/864 (0.3%)	3	0/796 (0%)	0
DIZZINESS	8/864 (0.9%)	9	3/796 (0.4%)	3
DYSARTHRIA	1/864 (0.1%)	1	1/796 (0.1%)	1
EMBOLIC CEREBRAL INFARCTION	0/864 (0%)	0	1/796 (0.1%)	1
EMBOLIC STROKE	1/864 (0.1%)	1	2/796 (0.3%)	2
ENCEPHALOPATHY	6/864 (0.7%)	6	6/796 (0.8%)	7
EPILEPSY	2/864 (0.2%)	2	1/796 (0.1%)	1
GENERALISED TONIC-CLONIC SEIZURE	0/864 (0%)	0	2/796 (0.3%)	2
HAEMORRHAGE INTRACRANIAL	1/864 (0.1%)	1	5/796 (0.6%)	5
HAEMORRHAGIC STROKE	4/864 (0.5%)	4	4/796 (0.5%)	4
HEADACHE	3/864 (0.3%)	3	0/796 (0%)	0
HEMIANOPIA	0/864 (0%)	0	1/796 (0.1%)	1
HEMIPARESIS	0/864 (0%)	0	2/796 (0.3%)	2
HEPATIC ENCEPHALOPATHY	1/864 (0.1%)	1	0/796 (0%)	0
HYDROCEPHALUS	0/864 (0%)	0	1/796 (0.1%)	1
HYPERREFLEXIA	0/864 (0%)	0	1/796 (0.1%)	1
HYPERTENSIVE ENCEPHALOPATHY	0/864 (0%)	0	1/796 (0.1%)	1
HYPOAESTHESIA	1/864 (0.1%)	1	1/796 (0.1%)	1
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY	1/864 (0.1%)	1	1/796 (0.1%)	1
IIIRD NERVE PARALYSIS	1/864 (0.1%)	1	0/796 (0%)	0
ISCHAEMIC STROKE	4/864 (0.5%)	4	8/796 (1%)	8
LACUNAR INFARCTION	0/864 (0%)	0	1/796 (0.1%)	1
LETHARGY	1/864 (0.1%)	1	2/796 (0.3%)	2
LOSS OF CONSCIOUSNESS	0/864 (0%)	0	1/796 (0.1%)	1
METABOLIC ENCEPHALOPATHY	5/864 (0.6%)	5	7/796 (0.9%)	7
MIGRAINE	0/864 (0%)	0	1/796 (0.1%)	1
NEURALGIA	1/864 (0.1%)	1	0/796 (0%)	0
NEUROPATHY PERIPHERAL	1/864 (0.1%)	1	1/796 (0.1%)	1
OPTIC NEURITIS	0/864 (0%)	0	1/796 (0.1%)	1
PARKINSON'S DISEASE	2/864 (0.2%)	2	1/796 (0.1%)	1
PERONEAL NERVE PALSY	1/864 (0.1%)	1	0/796 (0%)	0
POLYNEUROPATHY	2/864 (0.2%)	2	0/796 (0%)	0
PRESYNCOPE	9/864 (1%)	12	4/796 (0.5%)	4
SEIZURE	2/864 (0.2%)	2	1/796 (0.1%)	1
SEIZURE LIKE PHENOMENA	0/864 (0%)	0	1/796 (0.1%)	1
SENSORY DISTURBANCE	1/864 (0.1%)	1	0/796 (0%)	0
SEROTONIN SYNDROME	0/864 (0%)	0	1/796 (0.1%)	1
SYNCOPE	24/864 (2.8%)	24	19/796 (2.4%)	20
TOXIC ENCEPHALOPATHY	1/864 (0.1%)	1	0/796 (0%)	0
TRANSIENT ISCHAEMIC ATTACK	25/864 (2.9%)	25	10/796 (1.3%)	10
TREMOR	0/864 (0%)	0	1/796 (0.1%)	1
UNRESPONSIVE TO STIMULI	1/864 (0.1%)	1	0/796 (0%)	0
VERTEBROBASILAR INSUFFICIENCY	0/864 (0%)	0	1/796 (0.1%)	1
VOCAL CORD PARALYSIS	0/864 (0%)	0	1/796 (0.1%)	1
Product Issues
DEVICE ADHESION ISSUE	0/864 (0%)	0	2/796 (0.3%)	2
DEVICE CAPTURING ISSUE	1/864 (0.1%)	1	1/796 (0.1%)	1
DEVICE DISLOCATION	3/864 (0.3%)	3	1/796 (0.1%)	1
DEVICE FAILURE	1/864 (0.1%)	1	0/796 (0%)	0
DEVICE ISSUE	1/864 (0.1%)	1	1/796 (0.1%)	1
DEVICE LEAD ISSUE	0/864 (0%)	0	2/796 (0.3%)	2
DEVICE LEAKAGE	28/864 (3.2%)	30	2/796 (0.3%)	2
DEVICE LOOSENING	1/864 (0.1%)	1	0/796 (0%)	0
DEVICE MALFUNCTION	1/864 (0.1%)	1	2/796 (0.3%)	2
DEVICE PACING ISSUE	1/864 (0.1%)	1	0/796 (0%)	0
LEAD DISLODGEMENT	6/864 (0.7%)	6	2/796 (0.3%)	2
Psychiatric disorders
ADJUSTMENT DISORDER	0/864 (0%)	0	1/796 (0.1%)	1
AFFECTIVE DISORDER	0/864 (0%)	0	1/796 (0.1%)	2
AGITATION	3/864 (0.3%)	3	3/796 (0.4%)	3
ANXIETY	1/864 (0.1%)	1	0/796 (0%)	0
CONFUSIONAL STATE	2/864 (0.2%)	2	5/796 (0.6%)	5
DELIRIUM	5/864 (0.6%)	5	15/796 (1.9%)	16
DELIRIUM TREMENS	0/864 (0%)	0	2/796 (0.3%)	2
DEPRESSION	1/864 (0.1%)	1	0/796 (0%)	0
DEPRESSION SUICIDAL	1/864 (0.1%)	1	0/796 (0%)	0
DISORIENTATION	1/864 (0.1%)	1	0/796 (0%)	0
HALLUCINATION, AUDITORY	0/864 (0%)	0	1/796 (0.1%)	1
HALLUCINATION, VISUAL	1/864 (0.1%)	1	0/796 (0%)	0
MAJOR DEPRESSION	0/864 (0%)	0	1/796 (0.1%)	1
MENTAL STATUS CHANGES	13/864 (1.5%)	13	8/796 (1%)	8
PSYCHOTIC DISORDER	1/864 (0.1%)	1	1/796 (0.1%)	1
Renal and urinary disorders
ACUTE KIDNEY INJURY	62/864 (7.2%)	75	82/796 (10.3%)	95
ANURIA	0/864 (0%)	0	1/796 (0.1%)	1
AZOTAEMIA	1/864 (0.1%)	1	0/796 (0%)	0
BLADDER OBSTRUCTION	1/864 (0.1%)	1	0/796 (0%)	0
CHRONIC KIDNEY DISEASE	6/864 (0.7%)	6	4/796 (0.5%)	4
DYSURIA	2/864 (0.2%)	2	1/796 (0.1%)	1
END STAGE RENAL DISEASE	1/864 (0.1%)	2	1/796 (0.1%)	1
HAEMATURIA	22/864 (2.5%)	25	15/796 (1.9%)	18
HAEMORRHAGE URINARY TRACT	0/864 (0%)	0	1/796 (0.1%)	1
INCONTINENCE	2/864 (0.2%)	2	1/796 (0.1%)	1
NEPHROLITHIASIS	2/864 (0.2%)	3	2/796 (0.3%)	3
OLIGURIA	3/864 (0.3%)	3	2/796 (0.3%)	2
POLYURIA	1/864 (0.1%)	1	0/796 (0%)	0
RENAL ARTERY OCCLUSION	0/864 (0%)	0	1/796 (0.1%)	1
RENAL ARTERY STENOSIS	0/864 (0%)	0	1/796 (0.1%)	1
RENAL FAILURE	7/864 (0.8%)	8	13/796 (1.6%)	13
RENAL HAEMORRHAGE	1/864 (0.1%)	1	0/796 (0%)	0
RENAL MASS	1/864 (0.1%)	1	0/796 (0%)	0
RENAL TUBULAR DISORDER	0/864 (0%)	0	1/796 (0.1%)	1
RENAL TUBULAR NECROSIS	0/864 (0%)	0	1/796 (0.1%)	1
STAG HORN CALCULUS	1/864 (0.1%)	1	0/796 (0%)	0
URETEROLITHIASIS	0/864 (0%)	0	1/796 (0.1%)	1
URETHRAL OBSTRUCTION	0/864 (0%)	0	1/796 (0.1%)	1
URETHRAL STENOSIS	1/864 (0.1%)	1	1/796 (0.1%)	1
URINARY BLADDER HAEMORRHAGE	0/864 (0%)	0	1/796 (0.1%)	1
URINARY RETENTION	29/864 (3.4%)	32	21/796 (2.6%)	21
URINE FLOW DECREASED	1/864 (0.1%)	1	0/796 (0%)	0
Reproductive system and breast disorders
ACQUIRED PHIMOSIS	0/864 (0%)	0	1/796 (0.1%)	1
BENIGN PROSTATIC HYPERPLASIA	2/864 (0.2%)	2	1/796 (0.1%)	1
PENILE OEDEMA	0/864 (0%)	0	1/796 (0.1%)	1
PENILE PAIN	0/864 (0%)	0	1/796 (0.1%)	1
UTERINE POLYP	1/864 (0.1%)	1	1/796 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
ACUTE LUNG INJURY	1/864 (0.1%)	1	0/796 (0%)	0
ACUTE PULMONARY OEDEMA	3/864 (0.3%)	4	1/796 (0.1%)	1
ACUTE RESPIRATORY DISTRESS SYNDROME	1/864 (0.1%)	1	1/796 (0.1%)	1
ACUTE RESPIRATORY FAILURE	13/864 (1.5%)	15	16/796 (2%)	16
ASPIRATION	2/864 (0.2%)	2	4/796 (0.5%)	4
ASTHMA	2/864 (0.2%)	2	0/796 (0%)	0
ATELECTASIS	3/864 (0.3%)	3	10/796 (1.3%)	11
CHOKING SENSATION	0/864 (0%)	0	1/796 (0.1%)	1
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	13/864 (1.5%)	14	16/796 (2%)	21
COUGH	2/864 (0.2%)	2	2/796 (0.3%)	2
DEPENDENCE ON RESPIRATOR	0/864 (0%)	0	1/796 (0.1%)	1
DYSPNOEA	22/864 (2.5%)	25	11/796 (1.4%)	11
DYSPNOEA EXERTIONAL	4/864 (0.5%)	4	4/796 (0.5%)	4
EPISTAXIS	5/864 (0.6%)	5	10/796 (1.3%)	10
HAEMOPTYSIS	2/864 (0.2%)	2	1/796 (0.1%)	1
HAEMOTHORAX	1/864 (0.1%)	1	8/796 (1%)	8
HYPERCAPNIA	0/864 (0%)	0	2/796 (0.3%)	2
HYPOXIA	7/864 (0.8%)	7	8/796 (1%)	8
LARYNGEAL ATROPHY	0/864 (0%)	0	1/796 (0.1%)	1
LARYNGEAL STENOSIS	1/864 (0.1%)	1	0/796 (0%)	0
LUNG CONSOLIDATION	0/864 (0%)	0	1/796 (0.1%)	1
LUNG INFILTRATION	0/864 (0%)	0	1/796 (0.1%)	1
MEDIASTINAL HAEMATOMA	1/864 (0.1%)	1	3/796 (0.4%)	3
MEDIASTINAL HAEMORRHAGE	0/864 (0%)	0	8/796 (1%)	8
MEDIASTINAL MASS	1/864 (0.1%)	1	1/796 (0.1%)	1
NASAL OBSTRUCTION	0/864 (0%)	0	1/796 (0.1%)	1
OROPHARYNGEAL PAIN	1/864 (0.1%)	1	1/796 (0.1%)	1
PLEURAL EFFUSION	38/864 (4.4%)	43	102/796 (12.8%)	123
PLEURITIC PAIN	1/864 (0.1%)	1	0/796 (0%)	0
PNEUMONIA ASPIRATION	10/864 (1.2%)	10	8/796 (1%)	8
PNEUMONITIS	0/864 (0%)	0	2/796 (0.3%)	2
PNEUMOTHORAX	8/864 (0.9%)	9	18/796 (2.3%)	18
PULMONARY CONGESTION	1/864 (0.1%)	1	2/796 (0.3%)	2
PULMONARY EMBOLISM	8/864 (0.9%)	8	10/796 (1.3%)	10
PULMONARY FIBROSIS	3/864 (0.3%)	3	1/796 (0.1%)	1
PULMONARY HAEMATOMA	0/864 (0%)	0	2/796 (0.3%)	2
PULMONARY HAEMORRHAGE	0/864 (0%)	0	2/796 (0.3%)	2
PULMONARY HYPERTENSION	0/864 (0%)	0	2/796 (0.3%)	2
PULMONARY OEDEMA	10/864 (1.2%)	11	11/796 (1.4%)	11
RESPIRATORY ACIDOSIS	1/864 (0.1%)	1	5/796 (0.6%)	5
RESPIRATORY ARREST	1/864 (0.1%)	1	2/796 (0.3%)	2
RESPIRATORY DISTRESS	5/864 (0.6%)	5	11/796 (1.4%)	11
RESPIRATORY FAILURE	27/864 (3.1%)	30	50/796 (6.3%)	56
SLEEP APNOEA SYNDROME	2/864 (0.2%)	2	1/796 (0.1%)	1
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS	1/864 (0.1%)	1	0/796 (0%)	0
ANGIOEDEMA	1/864 (0.1%)	1	1/796 (0.1%)	1
DECUBITUS ULCER	1/864 (0.1%)	1	3/796 (0.4%)	3
DIABETIC ULCER	0/864 (0%)	0	1/796 (0.1%)	1
ECCHYMOSIS	2/864 (0.2%)	2	0/796 (0%)	0
ERYTHEMA	0/864 (0%)	0	1/796 (0.1%)	1
PANNICULITIS	0/864 (0%)	0	1/796 (0.1%)	1
PETECHIAE	1/864 (0.1%)	1	0/796 (0%)	0
RASH	0/864 (0%)	0	1/796 (0.1%)	1
SKIN FISSURES	0/864 (0%)	0	1/796 (0.1%)	1
SKIN LESION	0/864 (0%)	0	1/796 (0.1%)	1
SKIN ULCER	1/864 (0.1%)	1	3/796 (0.4%)	3
SUBCUTANEOUS EMPHYSEMA	0/864 (0%)	0	1/796 (0.1%)	1
Surgical and medical procedures
CARDIAC PACEMAKER BATTERY REPLACEMENT	1/864 (0.1%)	1	0/796 (0%)	0
CARDIAC PACEMAKER REPLACEMENT	1/864 (0.1%)	1	1/796 (0.1%)	1
CATARACT OPERATION	1/864 (0.1%)	1	4/796 (0.5%)	5
CHOLECYSTECTOMY	0/864 (0%)	0	1/796 (0.1%)	1
COLOSTOMY CLOSURE	0/864 (0%)	0	1/796 (0.1%)	1
EAR OPERATION	0/864 (0%)	0	1/796 (0.1%)	1
HERNIA REPAIR	0/864 (0%)	0	1/796 (0.1%)	1
HIP ARTHROPLASTY	4/864 (0.5%)	4	0/796 (0%)	0
IMPLANTABLE DEFIBRILLATOR REPLACEMENT	0/864 (0%)	0	1/796 (0.1%)	1
KNEE ARTHROPLASTY	1/864 (0.1%)	1	2/796 (0.3%)	2
PREVENTIVE SURGERY	1/864 (0.1%)	1	0/796 (0%)	0
ROTATOR CUFF REPAIR	1/864 (0.1%)	1	0/796 (0%)	0
SPINAL FUSION SURGERY	0/864 (0%)	0	1/796 (0.1%)	1
TRANSFUSION	0/864 (0%)	0	1/796 (0.1%)	1
WOUND DRAINAGE	0/864 (0%)	0	2/796 (0.3%)	2
WOUND TREATMENT	1/864 (0.1%)	1	0/796 (0%)	0
Vascular disorders
ANEURYSM	1/864 (0.1%)	1	0/796 (0%)	0
AORTIC ANEURYSM	1/864 (0.1%)	1	1/796 (0.1%)	1
AORTIC ARTERIOSCLEROSIS	0/864 (0%)	0	1/796 (0.1%)	1
AORTIC DISSECTION	5/864 (0.6%)	6	0/796 (0%)	0
AORTIC RUPTURE	1/864 (0.1%)	1	3/796 (0.4%)	3
AORTIC STENOSIS	0/864 (0%)	0	1/796 (0.1%)	1
ARTERIAL RUPTURE	2/864 (0.2%)	2	0/796 (0%)	0
ARTERIOSCLEROSIS	0/864 (0%)	0	1/796 (0.1%)	1
ARTERIOVENOUS FISTULA	0/864 (0%)	0	4/796 (0.5%)	4
ARTERY DISSECTION	1/864 (0.1%)	1	0/796 (0%)	0
BRACHIOCEPHALIC VEIN THROMBOSIS	1/864 (0.1%)	1	0/796 (0%)	0
CIRCULATORY COLLAPSE	1/864 (0.1%)	1	0/796 (0%)	0
DEEP VEIN THROMBOSIS	11/864 (1.3%)	11	11/796 (1.4%)	11
DRY GANGRENE	0/864 (0%)	0	1/796 (0.1%)	1
FEMORAL ARTERY DISSECTION	8/864 (0.9%)	8	2/796 (0.3%)	2
FEMORAL ARTERY EMBOLISM	1/864 (0.1%)	1	0/796 (0%)	0
FEMORAL ARTERY PERFORATION	3/864 (0.3%)	3	0/796 (0%)	0
HAEMATOMA	24/864 (2.8%)	24	5/796 (0.6%)	5
HAEMODYNAMIC INSTABILITY	3/864 (0.3%)	3	3/796 (0.4%)	3
HAEMORRHAGE	17/864 (2%)	17	20/796 (2.5%)	20
HYPERTENSION	34/864 (3.9%)	35	29/796 (3.6%)	32
HYPERTENSIVE CRISIS	2/864 (0.2%)	4	3/796 (0.4%)	3
HYPOTENSION	51/864 (5.9%)	52	87/796 (10.9%)	89
HYPOVOLAEMIC SHOCK	4/864 (0.5%)	4	10/796 (1.3%)	10
ILIAC ARTERY PERFORATION	1/864 (0.1%)	1	0/796 (0%)	0
ILIAC ARTERY RUPTURE	1/864 (0.1%)	1	0/796 (0%)	0
INTERMITTENT CLAUDICATION	2/864 (0.2%)	2	0/796 (0%)	0
LABILE BLOOD PRESSURE	3/864 (0.3%)	3	0/796 (0%)	0
LYMPHOCELE	1/864 (0.1%)	1	0/796 (0%)	0
MALIGNANT HYPERTENSION	2/864 (0.2%)	2	0/796 (0%)	0
NECROSIS ISCHAEMIC	1/864 (0.1%)	1	0/796 (0%)	0
ORTHOSTATIC HYPOTENSION	4/864 (0.5%)	4	7/796 (0.9%)	7
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	2/864 (0.2%)	3	2/796 (0.3%)	2
PERIPHERAL ARTERY DISSECTION	2/864 (0.2%)	2	0/796 (0%)	0
PERIPHERAL ARTERY OCCLUSION	6/864 (0.7%)	6	0/796 (0%)	0
PERIPHERAL ARTERY STENOSIS	12/864 (1.4%)	12	3/796 (0.4%)	3
PERIPHERAL ISCHAEMIA	5/864 (0.6%)	5	2/796 (0.3%)	3
PERIPHERAL VASCULAR DISORDER	2/864 (0.2%)	3	2/796 (0.3%)	2
PERIPHERAL VENOUS DISEASE	1/864 (0.1%)	2	1/796 (0.1%)	1
SHOCK	1/864 (0.1%)	1	7/796 (0.9%)	7
SHOCK HAEMORRHAGIC	1/864 (0.1%)	1	2/796 (0.3%)	2
SUBCLAVIAN ARTERY THROMBOSIS	0/864 (0%)	0	1/796 (0.1%)	1
SUBCLAVIAN VEIN THROMBOSIS	1/864 (0.1%)	1	0/796 (0%)	0
THROMBOPHLEBITIS	0/864 (0%)	0	1/796 (0.1%)	1
THROMBOSIS	0/864 (0%)	0	2/796 (0.3%)	2
VARICOSE VEIN	0/864 (0%)	0	1/796 (0.1%)	1
VENOUS THROMBOSIS	1/864 (0.1%)	1	0/796 (0%)	0
Other (Not Including Serious) Adverse Events
	Medtronic CoreValve® System TAVI		SAVR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	803/864 (92.9%)		754/796 (94.7%)
Blood and lymphatic system disorders
ANAEMIA	80/864 (9.3%)	84	99/796 (12.4%)	100
LEUKOCYTOSIS	70/864 (8.1%)	71	146/796 (18.3%)	154
THROMBOCYTOPENIA	133/864 (15.4%)	140	188/796 (23.6%)	198
Cardiac disorders
ATRIAL FIBRILLATION	112/864 (13%)	120	230/796 (28.9%)	239
ATRIOVENTRICULAR BLOCK FIRST DEGREE	80/864 (9.3%)	82	67/796 (8.4%)	68
BUNDLE BRANCH BLOCK LEFT	258/864 (29.9%)	265	55/796 (6.9%)	59
Gastrointestinal disorders
CONSTIPATION	0/864 (0%)	0	53/796 (6.7%)	56
NAUSEA	0/864 (0%)	0	42/796 (5.3%)	43
General disorders
OEDEMA PERIPHERAL	45/864 (5.2%)	48	47/796 (5.9%)	49
Infections and infestations
URINARY TRACT INFECTION	65/864 (7.5%)	77	88/796 (11.1%)	102
Metabolism and nutrition disorders
FLUID OVERLOAD	0/864 (0%)	0	122/796 (15.3%)	127
HYPERGLYCAEMIA	53/864 (6.1%)	54	102/796 (12.8%)	102
HYPERKALAEMIA	0/864 (0%)	0	41/796 (5.2%)	42
HYPOKALAEMIA	46/864 (5.3%)	49	53/796 (6.7%)	55
HYPONATRAEMIA	0/864 (0%)	0	52/796 (6.5%)	56
Psychiatric disorders
CONFUSIONAL STATE	0/864 (0%)	0	44/796 (5.5%)	47
Renal and urinary disorders
ACUTE KIDNEY INJURY	79/864 (9.1%)	91	125/796 (15.7%)	138
Respiratory, thoracic and mediastinal disorders
ATELECTASIS	62/864 (7.2%)	64	151/796 (19%)	154
DYSPNOEA	48/864 (5.6%)	50	0/796 (0%)	0
PLEURAL EFFUSION	70/864 (8.1%)	76	216/796 (27.1%)	223
Vascular disorders
HAEMATOMA	47/864 (5.4%)	49	0/796 (0%)	0
HYPERTENSION	123/864 (14.2%)	139	100/796 (12.6%)	107
HYPOTENSION	47/864 (5.4%)	50	82/796 (10.3%)	83

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title	Peggy Yunker
Organization	Medtronic, Inc.
Phone	763-514-4000
Email	surtavi@medtronic.com

Responsible Party:

Medtronic Cardiovascular

ClinicalTrials.gov Identifier:

NCT01586910

Other Study ID Numbers:

IDE #G120169

First Posted:

Apr 27, 2012

Last Update Posted:

Apr 29, 2022

Last Verified:

Apr 1, 2022

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

Study Details

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Statistical Analysis 1

Outcome Measure Data

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Outcome Measure Data

Outcome Measure Data

Outcome Measure Data

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Adverse Events

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