PROMUS Element Plus US Post-Approval Study

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01589978
• Collaborator: (none)
• Enrollment: 2,681
• Locations: 52
• Arm: 1
• Duration (Months): 73
• Patients Per Site: 51.6
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

This study is designed to observe clinical outcomes in patients receiving the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Patients will have symptomatic heart disease or documented silent ischemia. This is a prospective, open-label consecutively-enrolling study. Clinical follow-up is through 5 years. Approximately 2,689 patients are to be enrolled in up to 65 centers in the United States.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: PROMUS Element Plus Coronary Stent System; Drug: Aspirin; Drug: P2Y12 antagonist	Phase 4

Detailed Description

The wide-spread use of drug-eluting stents (DES) has evolved as standard of care in de novo lesions. The PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries ≥2.25 mm to ≤4.00 mm in diameter in lesions ≤34 mm in length. The proposed study will compile real-world clinical outcomes data for the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.

Patients enrolled in this study are expected to follow antiplatelet therapy recommendations per American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines for percutaneous coronary intervention (PCI). Recommended medications include aspirin, which should be taken for 3 days prior to the procedure or as a peri-procedural loading dose and then continued indefinitely. Additionally, one of the following P2Y12 antagonists may be given in a peri-procedural loading dose and in a maintenance dose per physician discretion: clopidogrel, prasugrel, ticagrelor, or ticlopidine.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2681 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A U.S. Post-Approval Study of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm

Intervention/Treatment

Experimental: PROMUS Element Subjects who receive the PROMUS Element everolimus-eluting coronary stent

Device: PROMUS Element Plus Coronary Stent System; PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent) and a drug product (a formulation of everolimus contained in a polymer coating).; Other Names: PROMUS Element stent ; Drug: Aspirin; Aspirin should be taken daily (81 mg) for 3 days prior to the procedure or as a peri-procedural loading dose of 250-500 mg. A maintenance dose of aspirin of at least 81 mg daily, or as indicated by the treating physician, should be continued indefinitely.; Other Names: Acetyl salicylic acid ; Drug: P2Y12 antagonist; Patients to take one of the following P2Y12 antagonists; maintenance doses to be continued per ACC/AHA/SCAI guidelines for PCI. Clopidogrel: Per treating physician, peri-procedural loading dose (300-600 mg), subsequent maintenance dose (75 mg daily) Prasugrel: Per treating physician, peri-procedural loading dose (60 mg), subsequent maintenance dose (10 or 5 mg daily per product labeling) Ticagrelor: Per treating physician, peri-procedural loading dose (180 mg), subsequent maintenance dose (90 mg 2x daily); maintenance aspirin doses >100 mg may reduce ticagrelor effectiveness and should be avoided. Ticlopidine: Per treating physician, if allergy/intolerance to clopidogrel, prasugrel, and/or ticagrelor, loading dose (500 mg), subsequent maintenance dose (250 mg 2x daily); Other Names: PLAVIX (clopidogrel) TICLID (ticlopidine) EFFIENT (prasugrel) BRILINTA (ticagrelor)

Outcome Measures

Primary Outcome Measures

1. Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients [12 months]

   Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if rate meets the performance goal (3.2%)

Secondary Outcome Measures

1. Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients [12 months]

   ARC definite/probable ST rate in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if the annual ST rate increase after the first year meets the performance goal (1.0%)

2. Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients [≤24 hours, 30 days, 180 days, annually through 5 years]

   DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)

3. Rate of Longitudinal Stent Deformation [Index Procedure]

   Compression/elongation of a stent along its long axis resulting from interaction with an ancillary device (e.g., guide catheter) which catches the stent end or an internal stent strut; can occur with advancement or withdrawal of ancillary device. Under fluoroscopy, longitudinal compression usually results in increased strut density and elongation in decreased strut density ('pseudo-fracture'); both can occur in the same stent.

4. Major Adverse Cardiac Event Rate (MACE) [≤24 hours, 30 days, 180 days, annually through 5 years]

   Composite of cardiac death, myocardial infarction, and target vessel revascularization

5. Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent [≤24 hours, 30 days, 180 days, annually through 5 years]

   Composite of cardiac death, myocardial infarction, and target vessel revascularization related to the PROMUS Element stent

6. Myocardial Infarction (MI) Rate [≤24 hours, 30 days, 180 days, annually through 5 years]

   New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN

7. Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent [≤24 hours, 30 days, 180 days, annually through 5 years]

   New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN

8. Cardiac Death Rate [≤24 hours, 30 days, 180 days, annually through 5 years]

   Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded

9. Rate of Cardiac Death Events Related to the PROMUS Element Stent [≤24 hours, 30 days, 180 days, annually through 5 years]

   Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded

10. Target Vessel Revascularization (TVR) Rate [≤24 hours, 30 days, 180 days, annually through 5 years]

    Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.

11. Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent [≤24 hours, 30 days, 180 days, annually through 5 years]

    Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.

12. Cardiac Death or Myocardial Infarction (MI) Rate [≤24 hours, 30 days, 180 days, annually through 5 years]

    See individual descriptions of events.

13. Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent [≤24 hours, 30 days, 180 days, annually through 5 years]

    See individual descriptions of events.

14. Target Vessel Failure (TVF) Rate [≤24 hours, 30 days, 180 days, annually through 5 years]

    Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF.

15. Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent [≤24 hours, 30 days, 180 days, annually through 5 years]

    Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF.

16. All Death Rate [≤24 hours, 30 days, 180 days, annually through 5 years]

    All death includes cardiac death and non-cardiac death.

17. Non-cardiac Death Rate [≤24 hours, 30 days, 180 days, annually through 5 years]

    Non-cardiac death is defined as death not due to cardiac causes. Cardiac death is death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded.

18. All Death or Myocardial Infarction Rate [≤24 hours, 30 days, 180 days, annually through 5 years]

    See description of individual events.

19. Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients [12 Months]

    Any revascularization of the target vessel, myocardial infarction related to the target vessel, or death related to the target vessel. See individual components for descriptions. Statistical testing will determine if the rate meets the performance goal (12.6%)

20. ARC ST Rate in PLATINUM-like Population. [Annually through 5 years]

    Using the Academic Research Consortium (ARC) definition, the (definite/probable) stent thrombosis (ST) rate in the PLATINUM-like* population will be analyzed. Statistical testing will be used to determine if the annual increase after the first year in ST rates observed in PLATINUM-like patients meets the performance goal of 1.0% (expected rate of 0.4% + a delta of 0.6%).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The population will include consecutive, consented patients.

Exclusion Criteria:

• There are no exclusion criteria in this all-comers study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Huntsville Hospital - The Heart Center, PC	Huntsville	Alabama	United States	35801
2	Springhill Medical Center	Mobile	Alabama	United States	36608
3	NEA Baptist Memorial Hospital	Jonesboro	Arkansas	United States	72401
4	St. Bernard's Medical Center	Jonesboro	Arkansas	United States	72401
5	Loma Linda University Medical Center	Loma Linda	California	United States	92354
6	Mercy General Hospital	Sacramento	California	United States	95819
7	Christiana Hospital	Newark	Delaware	United States	19718
8	Brandon Regional Hospital	Brandon	Florida	United States	33511
9	North Florida Regional Medical Center	Gainesville	Florida	United States	32605
10	Memorial Regional Hospital	Hollywood	Florida	United States	33021
11	Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
12	Orlando Regional Medical Center	Orlando	Florida	United States	32806
13	Bay Medical Center	Panama City	Florida	United States	32401
14	Martin Memorial Health Systems - Martin Memorial Medical Center	Stuart	Florida	United States	34996
15	Piedmont Hospital	Atlanta	Georgia	United States	30309
16	Coliseum Medical Center	Macon	Georgia	United States	31217
17	Redmond Regional Medical Center	Rome	Georgia	United States	30165
18	Blessing Hospital	Quincy	Illinois	United States	62301
19	IU Health North Medical Center	Carmel	Indiana	United States	46032
20	Franciscan St. Francis Hospital	Indianapolis	Indiana	United States	46237
21	Community Heart and Vascular Hospital	Indianapolis	Indiana	United States	46250
22	St. Joseph Hospital	Lexington	Kentucky	United States	40504
23	Cardiovascular Research, LLC	Shreveport	Louisiana	United States	71103
24	Eastern Maine Medical Center	Bangor	Maine	United States	04401
25	Cape Cod Hospital	Hyannis	Massachusetts	United States	02601
26	Lakeland Hospitals at St. Joseph	Saint Joseph	Michigan	United States	49085
27	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
28	North Memorial Medical Center	Minneapolis	Minnesota	United States	55422
29	United Hospital - St. Paul Heart Clinic	Saint Paul	Minnesota	United States	55102
30	Forest County General Hospital	Hattiesburg	Mississippi	United States	39401
31	St. John's Regional Health Center (Springfield)	Springfield	Missouri	United States	65804
32	Cox Medical Centers	Springfield	Missouri	United States	65807
33	Hackensack University Medical Center	Hackensack	New Jersey	United States	07601
34	New York University Medical Center	New York	New York	United States	10011
35	St. Elizabeth Medical Center	Utica	New York	United States	13501
36	Novant Health Presbyterian Medical Center	Charlotte	North Carolina	United States	28204
37	St. Francis Hospital	Tulsa	Oklahoma	United States	74136
38	Doylestown Hospital	Doylestown	Pennsylvania	United States	18901
39	Presbyterian University of Pennsylvania Medical Center	Philadelphia	Pennsylvania	United States	19104
40	University Medical Center-Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
41	St. Francis Health System - St. Francis Hospital	Greenville	South Carolina	United States	29607
42	Grand Strand Regional Medical Center	Myrtle Beach	South Carolina	United States	29572
43	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57701
44	Avera Heart Hospital of South Dakota	Sioux Falls	South Dakota	United States	57108
45	South Austin Hospital	Austin	Texas	United States	78745
46	VA North Texas Health Care System	Dallas	Texas	United States	75216
47	Presbyterian Hospital of Dallas	Dallas	Texas	United States	75231
48	University of Utah Hospital and Clinics	Salt Lake City	Utah	United States	84132
49	Chippenham Medical Center	Richmond	Virginia	United States	23225
50	Carilion Roanoke Memorial Hospital	Roanoke	Virginia	United States	24014
51	Meriter Hospital	Madison	Wisconsin	United States	53713
52	Marshfiled Clinic	Weston	Wisconsin	United States	55476

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Peter M Maurer, MPH, Boston Scientific Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT01589978
• Other Study ID Numbers: S2066
• First Posted: May 2, 2012
• Last Update Posted: Jul 26, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by Boston Scientific Corporation: drug-eluting stent; DES; atherosclerosis; everolimus
• Additional relevant MeSH terms: Coronary Artery Disease; Aspirin; Salicylic Acid; Salicylates; Ticlopidine; Clopidogrel; Ticagrelor; Prasugrel Hydrochloride

Study Results

Participant Flow

Arm/Group Title	PROMUS Element Overall Population
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent. Subgroups within the Overall Population Group: PLATINUM-Like Patients N=776 (at time of Primary endpoint) Defined as: all patients without acute MI, graft stenting, CTO, ISR, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate or severe calcification by visual estimate in target lesion or target vessel proximal to target lesion, three-vessel stenting, cardiogenic shock, left main disease, or acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or patient on dialysis). For PLATINUM-like patients, lesion length and RVD should meet one of two criteria: 1) lesion length ≤28 mm and diameter ≥2.25 mm and <2.5 mm, or 2) lesion length ≤24 mm and diameter ≥2.5 mm and ≤4.25 mm. Long Lesion Patients N=340 Defined as: patients treated with at least one 32mm or 38mm (excluding patients only treated with 2.25 mm diameter and 32 mm length WH stent size) study stent.
Period Title: Overall Study
STARTED	2681
COMPLETED	2681
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Overall Participants	2681
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.7 (11.1)
Sex: Female, Male (Count of Participants)
Female	807 30.1%
Male	1874 69.9%
Region of Enrollment (participants) [Number]
United States	2681 100%
Cardiac History (participants) [Number]
History of CAD	1625 60.6%
History of MI	1409 52.6%
History of CHF	275 10.3%
Stable Angina	620 23.1%
Unstable Angina	1347 50.2%
Silent Ischemia	149 5.6%
History of PCI	1159 43.2%
History of CABG	457 17%
Cardiac Risk Factors (participants) [Number]
Smoking, Ever	1600 59.7%
Current Diabetic Mellitus	989 36.9%
Hyperlipidemia Requiring Medication	2016 75.2%
History of Hypertension Requiring Medication	2077 77.5%
Family History of CAD	1625 60.6%
Lesion Characteristics: Target Lesion Vessel (lesions) [Number]
Left Anterior Descending Artery	1339
Circumflex Artery	848
Right Coronary Artery	1165
Left Main	54
Graft	199
Lesion Characteristics: Lesion Length (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	17.0 (10.3)
Lesion Characteristics: Reference Vessel Diameter (mm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm]	2.94 (0.51)
Lesion Characteristics: Pre-Procedure Thrombolysis in Myocardial Invarction (TIMI) Flow (lesions) [Number]
0	359
1	157
2	487
3	2539

Outcome Measures

1. Primary Outcome

Title	Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients
Description	Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if rate meets the performance goal (3.2%)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Note: PLATINUM-like population for the Primary Endpoint at 12 months includes PROMUS Element patients from the PLATINUM trials (WH and SV) (N=862), PLATINUM-like patients from PE-Prove (N=269), and PLATINUM-like patients from PROMUS Element Plus US Post-Approval Study (N=776) (as stated as a subgroup in the Participant Flow Module.

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	1907
Number [percentage of patients]	1.78

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PROMUS Element
	Comments	One-sided, single binomial test will be performed to compare observed rate against performance goal, the normal approximation of the test statistic will be used. The performance goal is met if the one-sided upper 95% confidence bound for the observed binary rate is less than performance goal.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Given the performance goal of 3.2%, with expected rate for PROMUS Element Plus of 2.2% and a one-sided 5% significance level, approximately 1,706 PLATINUM-like patients will provide at least 80% power to reject the null hypothesis if it is false.
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients
Description	ARC definite/probable ST rate in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length ≤28 mm with reference vessel diameter ≥2.25 mm and <2.5 mm, or lesion length ≤24 mm with diameter ≥2.5 mm and ≤4.25 mm); statistical testing will assess if the annual ST rate increase after the first year meets the performance goal (1.0%)
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

PROMUS Element PLATINUM-Like patients (a subgroup of the overall population as described in the Participant Flow Module), N=776.

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	776
Number [percentage of patients]	0.3

3. Secondary Outcome

Title	Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients
Description	DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2681
Number [percentage of patients]	0.7

4. Secondary Outcome

Title	Rate of Longitudinal Stent Deformation
Description	Compression/elongation of a stent along its long axis resulting from interaction with an ancillary device (e.g., guide catheter) which catches the stent end or an internal stent strut; can occur with advancement or withdrawal of ancillary device. Under fluoroscopy, longitudinal compression usually results in increased strut density and elongation in decreased strut density ('pseudo-fracture'); both can occur in the same stent.
Time Frame	Index Procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2681
Number [stents]	2

5. Secondary Outcome

Title	Major Adverse Cardiac Event Rate (MACE)
Description	Composite of cardiac death, myocardial infarction, and target vessel revascularization
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2554
Number [percentage of patients]	6.9

6. Secondary Outcome

Title	Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent
Description	Composite of cardiac death, myocardial infarction, and target vessel revascularization related to the PROMUS Element stent
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2554
Number [percentage of patients]	4.7

7. Secondary Outcome

Title	Myocardial Infarction (MI) Rate
Description	New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2554
Number [percentage of patients]	1.1

8. Secondary Outcome

Title	Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent
Description	New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus ≥one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2554
Number [percentage of patients]	0.7

9. Secondary Outcome

Title	Cardiac Death Rate
Description	Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2554
Number [percentage of patients]	1.4

10. Secondary Outcome

Title	Rate of Cardiac Death Events Related to the PROMUS Element Stent
Description	Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2554
Number [percentage of patients]	1.3

11. Secondary Outcome

Title	Target Vessel Revascularization (TVR) Rate
Description	Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2554
Number [percentage of patients]	5.6

12. Secondary Outcome

Title	Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent
Description	Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2554
Number [percentage of patients]	3.5

13. Secondary Outcome

Title	Cardiac Death or Myocardial Infarction (MI) Rate
Description	See individual descriptions of events.
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2554
Number [percentage of patients]	2.3

14. Secondary Outcome

Title	Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent
Description	See individual descriptions of events.
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2554
Number [percentage of patients]	1.8

15. Secondary Outcome

Title	Target Vessel Failure (TVF) Rate
Description	Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF.
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2554
Number [percentage of patients]	6.7

16. Secondary Outcome

Title	Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent
Description	Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF.
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2554
Number [percentage of patients]	4.7

17. Secondary Outcome

Title	All Death Rate
Description	All death includes cardiac death and non-cardiac death.
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2554
Number [percentage of patients]	2.3

18. Secondary Outcome

Title	Non-cardiac Death Rate
Description	Non-cardiac death is defined as death not due to cardiac causes. Cardiac death is death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded.
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2554
Number [percentage of patients]	0.9

19. Secondary Outcome

Title	All Death or Myocardial Infarction Rate
Description	See description of individual events.
Time Frame	≤24 hours, 30 days, 180 days, annually through 5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	2554
Number [percentage of patients]	3.2

20. Secondary Outcome

Title	Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients
Description	Any revascularization of the target vessel, myocardial infarction related to the target vessel, or death related to the target vessel. See individual components for descriptions. Statistical testing will determine if the rate meets the performance goal (12.6%)
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
Measure Participants	276
Number [percentage of patients]	3.26

21. Secondary Outcome

Title	ARC ST Rate in PLATINUM-like Population.
Description	Using the Academic Research Consortium (ARC) definition, the (definite/probable) stent thrombosis (ST) rate in the PLATINUM-like* population will be analyzed. Statistical testing will be used to determine if the annual increase after the first year in ST rates observed in PLATINUM-like patients meets the performance goal of 1.0% (expected rate of 0.4% + a delta of 0.6%).
Time Frame	Annually through 5 years

Outcome Measure Data

Analysis Population Description

Note: PLATINUM-like population for the Primary Endpoint at 12 months includes PROMUS Element patients from the PLATINUM trials (WH and SV) (N=862), PLATINUM-like patients from PE-Prove (N=269), and PLATINUM-like patients from PROMUS Element Plus US Post-Approval Study (N=776) (as stated as a subgroup in the Participant Flow Module.

Arm/Group Title	PROMUS Element Overall Population
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent.
Measure Participants	1907
Number [percentage of participants]	0.0023 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PROMUS Element
	Comments	The expected annual increase of stent thrombosis rate is assumed to be 0.4%, based on the observed increase in incidence rate of stent thrombosis of approximately 0.4% annually for PLATINUM-like patients in the pooled TAXUS SR Express and pooled TAXUS Liberté data. Using a delta of 0.6%, the performance goal is set to 1.0% (expected rate + delta = 0.4% + 0.6% = 1.0%).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The sample size is calculated for one-sample chi-square test for a single proportion using nQuery AdvisorVersion 5.0. The expected annual increase in ST rate is estimated to be 0.4% based on the current data available from the pooled TAXUS Express and pooled TAXUS Liberté data and the PG is 1.0% using a delta of 0.6%. Given a one-sided 5% significance level, a minimum of 1,660 PLATINUM-like patients at 5-yrs will be required to provide 90% power to reject the null hypothesis if it is false.
Statistical Test of Hypothesis	p-Value	<.0001
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	Serious and non-serious adverse events were collected from the point of subject enrollment through primary endpoint (12 months).
Arm/Group Title	PROMUS Element
Arm/Group Description	Subjects who receive the PROMUS Element everolimus-eluting coronary stent
All Cause Mortality
	PROMUS Element
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	PROMUS Element
	Affected / at Risk (%)	# Events
Total	780/2681 (29.1%)
Blood and lymphatic system disorders
ANAEMIA	11/2681 (0.4%)
HAEMORRHAGIC ANAEMIA	6/2681 (0.2%)
LEUKOCYTOSIS	2/2681 (0.1%)
THROMBOCYTOPENIA	2/2681 (0.1%)
BONE MARROW FAILURE	1/2681 (0%)
FEBRILE NEUTROPENIA	1/2681 (0%)
IRON DEFICIENCY ANAEMIA	1/2681 (0%)
MICROCYTIC ANAEMIA	1/2681 (0%)
PANCYTOPENIA	1/2681 (0%)
SPONTANEOUS HAEMATOMA	1/2681 (0%)
Cardiac disorders
ANGINA PECTORIS	120/2681 (4.5%)
ANGINA UNSTABLE	93/2681 (3.5%)
CORONARY ARTERY DISEASE	49/2681 (1.8%)
CARDIAC FAILURE CONGESTIVE	46/2681 (1.7%)
ACUTE MYOCARDIAL INFARCTION	33/2681 (1.2%)
MYOCARDIAL INFARCTION	22/2681 (0.8%)
ATRIAL FIBRILLATION	23/2681 (0.9%)
CORONARY ARTERY DISSECTION	19/2681 (0.7%)
CORONARY ARTERY THROMBOSIS	15/2681 (0.6%)
ACUTE CORONARY SYNDROME	10/2681 (0.4%)
ISCHAEMIC CARDIOMYOPATHY	10/2681 (0.4%)
VENTRICULAR TACHYCARDIA	8/2681 (0.3%)
CARDIO-RESPIRATORY ARREST	7/2681 (0.3%)
CORONARY ARTERY STENOSIS	7/2681 (0.3%)
CARDIOMYOPATHY	6/2681 (0.2%)
CARDIAC ARREST	5/2681 (0.2%)
CARDIAC FAILURE CHRONIC	5/2681 (0.2%)
CARDIOGENIC SHOCK	4/2681 (0.1%)
ATRIAL FLUTTER	3/2681 (0.1%)
ATRIOVENTRICULAR BLOCK COMPLETE	3/2681 (0.1%)
CORONARY ARTERY OCCLUSION	2/2681 (0.1%)
MYOCARDIAL ISCHAEMIA	3/2681 (0.1%)
VENTRICULAR FIBRILLATION	3/2681 (0.1%)
CARDIAC FAILURE	2/2681 (0.1%)
MITRAL VALVE INCOMPETENCE	2/2681 (0.1%)
POSTINFARCTION ANGINA	2/2681 (0.1%)
SINUS BRADYCARDIA	2/2681 (0.1%)
TACHYCARDIA	2/2681 (0.1%)
AORTIC VALVE STENOSIS	1/2681 (0%)
ARRHYTHMIA	1/2681 (0%)
ATRIOVENTRICULAR BLOCK SECOND DEGREE	1/2681 (0%)
BRADYCARDIA	1/2681 (0%)
BUNDLE BRANCH BLOCK LEFT	1/2681 (0%)
CORONARY ARTERY EMBOLISM	1/2681 (0%)
HYPERTROPHIC CARDIOMYOPATHY	1/2681 (0%)
PALPITATIONS	1/2681 (0%)
SICK SINUS SYNDROME	1/2681 (0%)
SINUS ARRHYTHMIA	1/2681 (0%)
TACHYARRHYTHMIA	1/2681 (0%)
Congenital, familial and genetic disorders
DIVERTICULITIS MECKEL'S	1/2681 (0%)
Ear and labyrinth disorders
VERTIGO	3/2681 (0.1%)
Eye disorders
CATARACT	1/2681 (0%)
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE	15/2681 (0.6%)
UPPER GASTROINTESTINAL HAEMORRHAGE	8/2681 (0.3%)
ABDOMINAL PAIN	5/2681 (0.2%)
DYSPHAGIA	5/2681 (0.2%)
RETROPERITONEAL HAEMORRHAGE	5/2681 (0.2%)
COLITIS	4/2681 (0.1%)
DIARRHOEA	4/2681 (0.1%)
GASTRIC ULCER	4/2681 (0.1%)
SMALL INTESTINAL OBSTRUCTION	4/2681 (0.1%)
GASTROOESOPHAGEAL REFLUX DISEASE	3/2681 (0.1%)
MELAENA	3/2681 (0.1%)
PANCREATITIS	3/2681 (0.1%)
ABDOMINAL HERNIA	2/2681 (0.1%)
COLITIS ISCHAEMIC	2/2681 (0.1%)
DIABETIC GASTROPARESIS	2/2681 (0.1%)
GASTRITIS	2/2681 (0.1%)
GASTRITIS EROSIVE	2/2681 (0.1%)
INGUINAL HERNIA	2/2681 (0.1%)
LOWER GASTROINTESTINAL HAEMORRHAGE	2/2681 (0.1%)
PANCREATITIS ACUTE	2/2681 (0.1%)
RETROPERITONEAL HAEMATOMA	2/2681 (0.1%)
ANAL FISTULA	1/2681 (0%)
DUODENAL ULCER	1/2681 (0%)
GASTRIC DISORDER	1/2681 (0%)
GASTRIC HAEMORRHAGE	1/2681 (0%)
GASTRIC POLYPS	1/2681 (0%)
GASTROINTESTINAL PAIN	1/2681 (0%)
HAEMATOCHEZIA	1/2681 (0%)
HAEMORRHOIDAL HAEMORRHAGE	1/2681 (0%)
HAEMORRHOIDS	1/2681 (0%)
IMPAIRED GASTRIC EMPTYING	1/2681 (0%)
INTESTINAL HAEMORRHAGE	1/2681 (0%)
INTESTINAL POLYP	1/2681 (0%)
NAUSEA	1/2681 (0%)
ODYNOPHAGIA	1/2681 (0%)
OESOPHAGEAL ULCER	1/2681 (0%)
RECTAL HAEMORRHAGE	1/2681 (0%)
VOMITING	1/2681 (0%)
General disorders
NON-CARDIAC CHEST PAIN	78/2681 (2.9%)
DEATH	9/2681 (0.3%)
CHEST PAIN	8/2681 (0.3%)
ASTHENIA	4/2681 (0.1%)
CHEST DISCOMFORT	4/2681 (0.1%)
INFLUENZA LIKE ILLNESS	2/2681 (0.1%)
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	2/2681 (0.1%)
ULCER HAEMORRHAGE	2/2681 (0.1%)
ADVERSE EVENT	1/2681 (0%)
BLOODY DISCHARGE	1/2681 (0%)
CATHETER SITE HAEMATOMA	1/2681 (0%)
HERNIA	1/2681 (0%)
IMPAIRED HEALING	1/2681 (0%)
MALAISE	1/2681 (0%)
OEDEMA PERIPHERAL	1/2681 (0%)
PAIN	1/2681 (0%)
PYREXIA	1/2681 (0%)
Hepatobiliary disorders
CHOLELITHIASIS	4/2681 (0.1%)
CHOLECYSTITIS	3/2681 (0.1%)
GALLBLADDER DISORDER	2/2681 (0.1%)
BILIARY DYSKINESIA	1/2681 (0%)
CHOLANGITIS	1/2681 (0%)
CHOLECYSTITIS ACUTE	1/2681 (0%)
CHOLECYSTITIS CHRONIC	1/2681 (0%)
HEPATIC CIRRHOSIS	1/2681 (0%)
ISCHAEMIC HEPATITIS	1/2681 (0%)
Immune system disorders
DRUG HYPERSENSITIVITY	1/2681 (0%)
HYPERSENSITIVITY	1/2681 (0%)
Infections and infestations
PNEUMONIA	36/2681 (1.3%)
CELLULITIS	9/2681 (0.3%)
SEPSIS	8/2681 (0.3%)
URINARY TRACT INFECTION	8/2681 (0.3%)
OSTEOMYELITIS	6/2681 (0.2%)
BRONCHITIS	5/2681 (0.2%)
UROSEPSIS	4/2681 (0.1%)
APPENDICITIS	3/2681 (0.1%)
BACTERAEMIA	3/2681 (0.1%)
DIVERTICULITIS	3/2681 (0.1%)
INFLUENZA	3/2681 (0.1%)
STAPHYLOCOCCAL INFECTION	3/2681 (0.1%)
ABSCESS LIMB	2/2681 (0.1%)
BRONCHIECTASIS	2/2681 (0.1%)
GANGRENE	2/2681 (0.1%)
GASTROENTERITIS VIRAL	2/2681 (0.1%)
INFECTION	2/2681 (0.1%)
LOBAR PNEUMONIA	2/2681 (0.1%)
WOUND INFECTION	2/2681 (0.1%)
ABDOMINAL ABSCESS	1/2681 (0%)
ANOGENITAL WARTS	1/2681 (0%)
BRONCHITIS VIRAL	1/2681 (0%)
CLOSTRIDIAL INFECTION	1/2681 (0%)
ENDOCARDITIS BACTERIAL	1/2681 (0%)
GASTROENTERITIS	1/2681 (0%)
MYCOBACTERIAL INFECTION	1/2681 (0%)
OSTEOMYELITIS ACUTE	1/2681 (0%)
OSTEOMYELITIS CHRONIC	1/2681 (0%)
PNEUMONIA BACTERIAL	1/2681 (0%)
PNEUMONIA STAPHYLOCOCCAL	1/2681 (0%)
POSTOPERATIVE WOUND INFECTION	1/2681 (0%)
PURULENT DISCHARGE	1/2681 (0%)
PYELONEPHRITIS	1/2681 (0%)
RESPIRATORY TRACT INFECTION	1/2681 (0%)
SEPTIC SHOCK	1/2681 (0%)
STREPTOCOCCAL BACTERAEMIA	1/2681 (0%)
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM	5/2681 (0.2%)
HIP FRACTURE	4/2681 (0.1%)
ANKLE FRACTURE	2/2681 (0.1%)
CONTRAST MEDIA REACTION	2/2681 (0.1%)
DRUG TOXICITY	2/2681 (0.1%)
FALL	2/2681 (0.1%)
GRAFT THROMBOSIS	2/2681 (0.1%)
INCISIONAL HERNIA	2/2681 (0.1%)
PELVIC FRACTURE	2/2681 (0.1%)
POST PROCEDURAL COMPLICATION	2/2681 (0.1%)
RIB FRACTURE	2/2681 (0.1%)
ALCOHOL POISONING	1/2681 (0%)
ANASTOMOTIC ULCER HAEMORRHAGE	1/2681 (0%)
CERVICAL VERTEBRAL FRACTURE	1/2681 (0%)
CONCUSSION	1/2681 (0%)
DISLOCATION OF JOINT PROSTHESIS	1/2681 (0%)
FACIAL BONES FRACTURE	1/2681 (0%)
FEMUR FRACTURE	1/2681 (0%)
GASTROINTESTINAL STOMA COMPLICATION	1/2681 (0%)
GUN SHOT WOUND	1/2681 (0%)
POST PROCEDURAL HAEMORRHAGE	1/2681 (0%)
POSTOPERATIVE WOUND COMPLICATION	1/2681 (0%)
PROCEDURAL HYPERTENSION	1/2681 (0%)
PROCEDURAL PAIN	1/2681 (0%)
PUBIC RAMI FRACTURE	1/2681 (0%)
ROAD TRAFFIC ACCIDENT	1/2681 (0%)
SEROMA	1/2681 (0%)
THORACIC VERTEBRAL FRACTURE	1/2681 (0%)
TIBIA FRACTURE	1/2681 (0%)
TRAUMATIC BRAIN INJURY	1/2681 (0%)
VASCULAR GRAFT COMPLICATION	1/2681 (0%)
WOUND	1/2681 (0%)
WOUND DEHISCENCE	1/2681 (0%)
Investigations
BLOOD CREATININE INCREASED	1/2681 (0%)
BLOOD GLUCOSE DECREASED	1/2681 (0%)
BLOOD URINE	1/2681 (0%)
CATHETERISATION CARDIAC	1/2681 (0%)
Metabolism and nutrition disorders
FLUID OVERLOAD	4/2681 (0.1%)
HYPOKALAEMIA	3/2681 (0.1%)
DIABETIC KETOACIDOSIS	2/2681 (0.1%)
HYPERGLYCAEMIA	2/2681 (0.1%)
HYPERKALAEMIA	2/2681 (0.1%)
DEHYDRATION	1/2681 (0%)
DIABETES MELLITUS	1/2681 (0%)
DIABETIC FOOT	1/2681 (0%)
DYSLIPIDAEMIA	1/2681 (0%)
HYPONATRAEMIA	1/2681 (0%)
OBESITY	1/2681 (0%)
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY	3/2681 (0.1%)
ARTHRALGIA	2/2681 (0.1%)
MUSCULOSKELETAL CHEST PAIN	2/2681 (0.1%)
OSTEOARTHRITIS	2/2681 (0.1%)
ARTHRITIS	1/2681 (0%)
BACK PAIN	1/2681 (0%)
BONE PAIN	1/2681 (0%)
CERVICAL SPINAL STENOSIS	1/2681 (0%)
COSTOCHONDRITIS	1/2681 (0%)
FLANK PAIN	1/2681 (0%)
LUMBAR SPINAL STENOSIS	1/2681 (0%)
MUSCULOSKELETAL DISCOMFORT	1/2681 (0%)
MUSCULOSKELETAL PAIN	1/2681 (0%)
PAIN IN JAW	1/2681 (0%)
POLYMYALGIA RHEUMATICA	1/2681 (0%)
ROTATOR CUFF SYNDROME	1/2681 (0%)
SPINAL COLUMN STENOSIS	1/2681 (0%)
SPINAL OSTEOARTHRITIS	1/2681 (0%)
SYNOVIAL CYST	1/2681 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ENDOMETRIAL CANCER	2/2681 (0.1%)
LUNG NEOPLASM MALIGNANT	2/2681 (0.1%)
NON-SMALL CELL LUNG CANCER STAGE IV	2/2681 (0.1%)
ADENOCARCINOMA PANCREAS	1/2681 (0%)
B-CELL LYMPHOMA	1/2681 (0%)
BENIGN NEOPLASM	1/2681 (0%)
BLADDER CANCER	1/2681 (0%)
BREAST CANCER	1/2681 (0%)
BRONCHIAL CARCINOMA	1/2681 (0%)
COLON CANCER	1/2681 (0%)
GASTRIC CANCER	1/2681 (0%)
LIP AND/OR ORAL CAVITY CANCER	1/2681 (0%)
LUNG CANCER METASTATIC	1/2681 (0%)
LUNG NEOPLASM	1/2681 (0%)
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED	1/2681 (0%)
LYMPHOMA	1/2681 (0%)
MALIGNANT MELANOMA	1/2681 (0%)
METASTATIC GASTRIC CANCER	1/2681 (0%)
OESOPHAGEAL CARCINOMA	1/2681 (0%)
PANCREATIC CARCINOMA	1/2681 (0%)
PROSTATE CANCER	1/2681 (0%)
PROSTATE CANCER METASTATIC	1/2681 (0%)
SARCOMA	1/2681 (0%)
SARCOMA METASTATIC	1/2681 (0%)
TUMOUR HAEMORRHAGE	1/2681 (0%)
Nervous system disorders
SYNCOPE	17/2681 (0.6%)
CEREBROVASCULAR ACCIDENT	13/2681 (0.5%)
CAROTID ARTERY STENOSIS	11/2681 (0.4%)
TRANSIENT ISCHAEMIC ATTACK	7/2681 (0.3%)
ENCEPHALOPATHY	4/2681 (0.1%)
PRESYNCOPE	3/2681 (0.1%)
CEREBRAL INFARCTION	2/2681 (0.1%)
DYSARTHRIA	2/2681 (0.1%)
HEADACHE	2/2681 (0.1%)
SUBARACHNOID HAEMORRHAGE	2/2681 (0.1%)
BASAL GANGLIA INFARCTION	1/2681 (0%)
BRAIN STEM STROKE	1/2681 (0%)
CAROTID ARTERY DISEASE	1/2681 (0%)
CARPAL TUNNEL SYNDROME	1/2681 (0%)
CEREBRAL HAEMORRHAGE	1/2681 (0%)
CONVULSION	1/2681 (0%)
ENCEPHALITIS	1/2681 (0%)
HYPOAESTHESIA	1/2681 (0%)
LETHARGY	1/2681 (0%)
LOSS OF CONSCIOUSNESS	1/2681 (0%)
PARAESTHESIA	1/2681 (0%)
RADICULAR PAIN	1/2681 (0%)
SCIATICA	1/2681 (0%)
Psychiatric disorders
ANXIETY	1/2681 (0%)
BIPOLAR DISORDER	1/2681 (0%)
CONVERSION DISORDER	1/2681 (0%)
DELIRIUM	1/2681 (0%)
DEPRESSION	1/2681 (0%)
Renal and urinary disorders
RENAL FAILURE ACUTE	13/2681 (0.5%)
RENAL FAILURE CHRONIC	4/2681 (0.1%)
NEPHROLITHIASIS	3/2681 (0.1%)
RENAL ARTERY STENOSIS	3/2681 (0.1%)
RENAL FAILURE	3/2681 (0.1%)
URINARY RETENTION	3/2681 (0.1%)
HAEMATURIA	2/2681 (0.1%)
RENAL TUBULAR NECROSIS	2/2681 (0.1%)
BLADDER OBSTRUCTION	1/2681 (0%)
CALCULUS URETERIC	1/2681 (0%)
RENAL COLIC	1/2681 (0%)
RENAL DISORDER	1/2681 (0%)
URETHRAL MEATUS STENOSIS	1/2681 (0%)
URETHRAL STENOSIS	1/2681 (0%)
Reproductive system and breast disorders
POSTMENOPAUSAL HAEMORRHAGE	1/2681 (0%)
PROSTATITIS	1/2681 (0%)
Respiratory, thoracic and mediastinal disorders
DYSPNOEA	24/2681 (0.9%)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	19/2681 (0.7%)
ACUTE RESPIRATORY FAILURE	13/2681 (0.5%)
PULMONARY EMBOLISM	7/2681 (0.3%)
RESPIRATORY FAILURE	6/2681 (0.2%)
DYSPNOEA EXERTIONAL	4/2681 (0.1%)
EPISTAXIS	3/2681 (0.1%)
PNEUMONIA ASPIRATION	4/2681 (0.1%)
PULMONARY OEDEMA	4/2681 (0.1%)
ASTHMA	3/2681 (0.1%)
COUGH	2/2681 (0.1%)
HYPOXIA	2/2681 (0.1%)
LUNG INFILTRATION	2/2681 (0.1%)
PLEURAL EFFUSION	2/2681 (0.1%)
PNEUMOTHORAX	2/2681 (0.1%)
RESPIRATORY DISTRESS	2/2681 (0.1%)
ACUTE PULMONARY OEDEMA	1/2681 (0%)
ALLERGIC BRONCHITIS	1/2681 (0%)
CHRONIC RESPIRATORY FAILURE	1/2681 (0%)
HAEMOPTYSIS	1/2681 (0%)
MEDIASTINAL MASS	1/2681 (0%)
PNEUMONITIS	1/2681 (0%)
PULMONARY FIBROSIS	1/2681 (0%)
PULMONARY HYPERTENSION	1/2681 (0%)
ABDOMINAL PAIN UPPER	2/2681 (0.1%)
Skin and subcutaneous tissue disorders
ANGIOEDEMA	1/2681 (0%)
Surgical and medical procedures
CAROTID ENDARTERECTOMY	1/2681 (0%)
Vascular disorders
INTERMITTENT CLAUDICATION	9/2681 (0.3%)
DEEP VEIN THROMBOSIS	8/2681 (0.3%)
HYPERTENSION	7/2681 (0.3%)
HYPOTENSION	7/2681 (0.3%)
AORTIC STENOSIS	4/2681 (0.1%)
ARTERIOSCLEROSIS	3/2681 (0.1%)
FEMORAL ARTERY OCCLUSION	3/2681 (0.1%)
HAEMATOMA	3/2681 (0.1%)
PERIPHERAL ISCHAEMIA	3/2681 (0.1%)
PERIPHERAL VASCULAR DISORDER	3/2681 (0.1%)
HYPERTENSIVE CRISIS	2/2681 (0.1%)
MALIGNANT HYPERTENSION	2/2681 (0.1%)
ACCELERATED HYPERTENSION	1/2681 (0%)
AORTIC ANEURYSM	1/2681 (0%)
ARTERIAL THROMBOSIS	1/2681 (0%)
ARTERIAL THROMBOSIS LIMB	1/2681 (0%)
FEMORAL ARTERY ANEURYSM	1/2681 (0%)
HOT FLUSH	1/2681 (0%)
ISCHAEMIA	1/2681 (0%)
ISCHAEMIC LIMB PAIN	1/2681 (0%)
LYMPHOEDEMA	1/2681 (0%)
ORTHOSTATIC HYPOTENSION	1/2681 (0%)
PERIPHERAL COLDNESS	1/2681 (0%)
SHOCK	1/2681 (0%)
TAKAYASU'S ARTERITIS	1/2681 (0%)
THROMBOPHLEBITIS	1/2681 (0%)
VENOUS THROMBOSIS LIMB	1/2681 (0%)
Other (Not Including Serious) Adverse Events
	PROMUS Element
	Affected / at Risk (%)	# Events
Total	5/2681 (0.2%)
Cardiac disorders
Myocardial Infarction	5/2681 (0.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.