ILUMIEN I: Observational Study of OCT in a Patients Undergoing FFR

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01663896
• Collaborator: (none)
• Enrollment: 418
• Locations: 36
• Actual Duration (Months): 33.6
• Patients Per Site: 11.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to define and evaluate optical coherence tomography (OCT) stent guidance parameters through prospective data collection in percutaneous coronary intervention (PCI) procedures of de novo lesions.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: OCT stent guidance

Detailed Description

Optical coherence tomography (OCT) is an imaging modality that uses near-infrared light to produce high resolution, real-time images that are clearer and more quickly produced than those produced by intravascular ultrasound (IVUS). OCT imaging is performed utilizing an imaging catheter with a single optical fiber core that both emits light and records its reflection while simultaneously rotating 360° during continuous pullback within the coronary artery. Fractional Flow Reserve (FFR) is a pressure-derived, lesion-specific, physiological index determining the hemodynamic severity of intracoronary lesions. FFR is measured by placing a pressure guidewire across the lesion of interest and pharmacologically inducing hyperemia. The ratio of distal to proximal pressure allows the physician to physiologically determine if the narrowing is the cause of ischemia. the goal of this study is to define new parameters for stent optimization, benefitting from the unique Fourier-domain (FD-OCT) capabilities.

This stage I study will identify the parameters which will be prospectively tested in a second stage II protocol.

In hospital, 30 day, and 12 month outcomes data will be correlated with OCT baseline findings in order to identify optimal stent implant parameters.

Study Design

• Study Type: Observational
• Actual Enrollment: 418 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Observational Study of Optical Coherence Tomography (OCT) in Patients Undergoing Fractional Flow Reserve (FFR) and Percutaneous Coronary Intervention Stage I (ILUMIEN I)
• Actual Study Start Date: Dec 11, 2012
• Actual Primary Completion Date: Mar 12, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Single or multi vessel disease Pre- and post-PCI fractional flow reserve (FFR) and OCT were performed in participants.	Device: OCT stent guidance; Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT

Outcome Measures

Primary Outcome Measures

1. Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting [In-hospital until discharge]

   Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes in-hospital.

2. Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting [30 Days]

   Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 30 days

3. Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC)) [12 months]

   Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months

Secondary Outcome Measures

1. Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT [1 Year]

   Assessment of OCT on Physician Decision Making includes: Frequency of changes in treatment strategy based on OCT parameter real time assessment vs. angiographic assessment OCT parameters as assessed by Core Lab

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age ≥ 18 years.

2. Patient provides signed written informed consent before any study-specific procedure.

3. De novo coronary artery disease in target vessel.

4. Single or multi vessel disease. For multi vessel disease up to two vessels and three lesions treated, with no more than two lesions per vessel. Vessel is defined as, left anterior descending, left circumflex, and right coronary arteries. Any branch within the vessel is considered part of the vessel.

5. Elective or ad hoc PCI, stable angina, acute coronary syndrome (unstable angina and NSTEMI).

6. Angiographically significant (>50% visual estimation) stenosis present in at least one native coronary artery.

7. Mandatory use of FFR and OCT pre and post PCI. PCI strongly recommended in subjects with an FFR ≤ 0.80 in target vessel.

Exclusion Criteria:

1. Subjects with STEMI, emergent PCI, or in cardiogenic shock.

2. Subjects with target left main lesion.

3. Subjects with restenosis or stent thrombosis in the target vessel.

4. Planned use of bare metal stent.

5. Known renal insufficiency (examples being but not limited to eGFR < 60 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL, or on dialysis).

6. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).

7. Extreme angulation (> 90°) or excessive tortuosity (> two 45° angles) proximal to or within the target lesion.

8. Vessel(s) and lesion(s) not amenable for PCI, for example diffuse disease.

9. Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results.

10. Currently participating in another clinical study that interferes with study results.

11. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure.

12. Life expectancy less than 1 year.

13. Potential for non-compliance to protocol requirements and follow-up.

14. Planned or prior heart transplantation or listed for heart transplant.

15. Any condition that precludes the subject from undergoing PCI, for example subjects with heparin induced thrombocytopenia, or contrast allergy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital - Univ. of Alabama at Birmingham (UAB)	Birmingham	Alabama	United States	35233
2	Scripps Clinic, Green Hospital	La Jolla	California	United States
3	Florida Hospital Orlando	Orlando	Florida	United States
4	Emory University Hospital	Atlanta	Georgia	United States
5	Loyola University Chicago	Maywood	Illinois	United States	60153
6	Central Baptist Hospital	Lexington	Kentucky	United States
7	Baptist Health East	Louisville	Kentucky	United States
8	St. Luke's Hospital/Mid America Heart	Kansas City	Missouri	United States
9	Rutgers Cardiovascular Institute	New Brunswick	New Jersey	United States
10	Mount Sinai Medical Center	New York	New York	United States
11	Heart Hospital of Austin	Austin	Texas	United States
12	Dallas VA Medical Center	Dallas	Texas	United States
13	University of Texas Medical Branch at Galveston	Galveston	Texas	United States
14	Swedish Medical Center	Seattle	Washington	United States
15	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin	United States
16	The Prince Charles Hospital	Chermside	Queensland	Australia
17	Med. Univ. Vienna	Vienna		Austria
18	OLV Hospital	Aalst		Belgium
19	Gasthuisberg Leuven	Leuven		Belgium
20	Montreal Heart Institute	Montreal	Quebec	Canada
21	University of Hong Kong	Hong Kong	Hong Kong	China
22	University Hospital Brno	Brno		Czechia
23	CHU Clermont Ferrand	Clermont-Ferrand		France
24	CHC du Marie Lannelongue	Le Plessis Robinson		France
25	Clinique Pasteur	Toulouse		France
26	Deutsches Herzzentrum	Munich		Germany
27	Ospedali Riuniti di Bergamo	Bergamo		Italy
28	Centro Cardiologico Monzino	Milan		Italy
29	Ospedale San Giovanni Addolorata	Rome		Italy
30	Kobe University Graduate School of Medicine	Hyogo		Japan
31	Nara Medical University Hospital	Nara		Japan
32	Osaka Saiseikai Nakatsu Hospital	Osaka		Japan
33	Wakayama Medical University	Wakayama		Japan
34	Thoraxcentre Erasmus MC	Rotterdam		Netherlands
35	Hospital Univ. Clinico San Carlos	Madrid		Spain
36	Royal Brompton Hospital	London		United Kingdom

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT01663896
• Other Study ID Numbers: SJM-CVD-0612
• First Posted: Aug 13, 2012
• Last Update Posted: Jul 2, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Abbott Medical Devices: OCT, FFR, percutaneous coronary intervention
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

Participant Flow

Recruitment Details	Initially a total of 1069 subjects gave consent from 36 investigational sites, of which 418 qualified subjects completed enrollment in February 2014 at 35 investigational sites. First subject was enrolled on Dec 11, 2012 and the last subject completed the 12 month follow-up on Mar 12, 2015.
Pre-assignment Detail	Of the 1069 subjects, 616 were failed to screen and 35 were not qualified for inclusion. Thus 418 subjects underwent pre-intervention fractional flow reserve (FFR) and optical coherence tomography (OCT), percutaneous coronary intervention (PCI), and post intervention FFR and OCT. The subjects were followed up through 12 month post stent implant.

Arm/Group Title	Optical Coherence Tomography (OCT)
Arm/Group Description	Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
Period Title: Overall Study
STARTED	418
COMPLETED	375
NOT COMPLETED	43

Baseline Characteristics

Arm/Group Title	Optical Coherence Tomography (OCT)
Arm/Group Description	Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
Overall Participants	418
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.7 (10.2)
Sex: Female, Male (Count of Participants)
Female	104 24.9%
Male	314 75.1%
Region of Enrollment (Count of Participants)
United States	153 36.6%
Czechia	14 3.3%
Japan	97 23.2%
United Kingdom	7 1.7%
Spain	11 2.6%
Canada	4 1%
Austria	5 1.2%
Netherlands	4 1%
Belgium	44 10.5%
China	25 6%
Italy	32 7.7%
Australia	11 2.6%
France	5 1.2%
Germany	6 1.4%

Outcome Measures

1. Primary Outcome

Title	Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Description	Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes in-hospital.
Time Frame	In-hospital until discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Optical Coherence Tomography (OCT)
Arm/Group Description	A subject who provides a signed Informed Consent Form, meets eligibility criteria, undergoes angiography and pre-intervention FFR, OCT, PCI, and post intervention FFR and OCT.
Measure Participants	418
Device-oriented MACE (Cardiac death)	0
Device-oriented MACE(MI-AEC definition)	6.7
Device-oriented MACE(MI-3rd Universal definition)	6.2
Device-oriented MACE(TLR)	0.2
Patient-oriented MACE(All-cause mortality)	0.2
Patient-oriented MACE(MI-ARC Definition)	6.7
Patient-oriented MACE(MI-3rd Universal definition)	6.2
Patient-oriented MACE(Any Revascularization)	0.2
Stent Thrombosis(Definite)	0
Stent Thrombosis(Probable)	0
Stent Thrombosis(Possible)	0
Stent Thrombosis(Early)	0
Stent Thrombosis(Late)	0
Stent Thrombosis(Very Late)	0

2. Primary Outcome

Title	Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting
Description	Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 30 days
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Optical Coherence Tomography (OCT)
Arm/Group Description	A subject who provides a signed Informed Consent Form, meets eligibility criteria, undergoes angiography and pre-intervention FFR, OCT, PCI, and post intervention FFR and OCT.
Measure Participants	416
Device-oriented MACE (Cardiac death)	0
Device-oriented MACE(MI-AEC definition)	7.2
Device-oriented MACE(MI-3rd Universal definition)	6.7
Device-oriented MACE(TLR)	0.7
Patient-oriented MACE(All-cause mortality)	0.2
Patient-oriented MACE(MI-ARC Definition)	7.9
Patient-oriented MACE(MI-3rd Universal definition)	7.5
Patient-oriented MACE(Any Revascularization)	1.7
Stent Thrombosis(Definite)	0
Stent Thrombosis(Probable)	0
Stent Thrombosis(Possible)	0
Stent Thrombosis(Early)	0.2
Stent Thrombosis(Late)	0
Stent Thrombosis(Very Late)	0

3. Primary Outcome

Title	Incidence of OCT Peri-procedural Guidance Parameter(s) for Stenting (Academic Research Consortium(ARC))
Description	Incidence of OCT peri-procedural guidance parameter(s) for stenting and their relation to patient outcomes through 12 months
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Optical Coherence Tomography (OCT)
Arm/Group Description	A subject who provides a signed Informed Consent Form, meets eligibility criteria, undergoes angiography and pre-intervention FFR, OCT, PCI, and post intervention FFR and OCT.
Measure Participants	399
Device-oriented MACE (Cardiac death)	0
Device-oriented MACE(MI-AEC definition)	8.3
Device-oriented MACE(MI-3rd Universal definition)	7.8
Device-oriented MACE(TLR)	2.5
Patient-oriented MACE(All-cause mortality)	1.8
Patient-oriented MACE(MI-ARC Definition)	9.3
Patient-oriented MACE(MI-3rd Universal definition)	8.8
Patient-oriented MACE(Any Revascularization)	5.5
Stent Thrombosis(Definite)	0.3
Stent Thrombosis(Probable)	0
Stent Thrombosis(Possible)	0.5
Stent Thrombosis(Early)	0.3
Stent Thrombosis(Late)	0.5
Stent Thrombosis(Very Late)	0

4. Secondary Outcome

Title	Percentage of Change in Physician Decision-making Pre and Post PCI Due to OCT
Description	Assessment of OCT on Physician Decision Making includes: Frequency of changes in treatment strategy based on OCT parameter real time assessment vs. angiographic assessment OCT parameters as assessed by Core Lab
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Optical Coherence Tomography (OCT)
Arm/Group Description	Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
Measure Participants	418
Procedure Planning(Pre-PCI OCT)	57 13.6%
Procedure Planning(Post-PCI OCT)	27 6.5%
Physician decision-making (Pre-PCI OCT)	65 15.6%
Physician decision-making (Post-PCI OCT)	65 15.6%

Adverse Events

Time Frame	1-Year
Arm/Group Title	Optical Coherence Tomography (OCT)
Arm/Group Description	Participants undergoing PCI with intention to perform FFR and OCT pre and post PCI.
All Cause Mortality
	Optical Coherence Tomography (OCT)
	Affected / at Risk (%)	# Events
Total	8/418 (1.9%)
Serious Adverse Events
	Optical Coherence Tomography (OCT)
	Affected / at Risk (%)	# Events
Total	112/418 (26.8%)
Blood and lymphatic system disorders
Anemias	1/418 (0.2%)
Bleeding	2/418 (0.5%)
Cardiac disorders
Angina Pectoris	1/418 (0.2%)
Atrial Fibrillation	3/418 (0.7%)
Atrial Flutter	1/418 (0.2%)
Atrioventricular (AV) Dissociation	1/418 (0.2%)
Cardiac Arrest	1/418 (0.2%)
Cardiomyopathy	1/418 (0.2%)
Cardiovascular Deconditioning	1/418 (0.2%)
Coronary Artery Disease	2/418 (0.5%)
Heart Failure	2/418 (0.5%)
Left Bundle Branch Block/Complete Left Bundle Branch Block	1/418 (0.2%)
Myocardial Infarction	8/418 (1.9%)
Pericardial Tamponade	1/418 (0.2%)
Third Degree Heart Block (Complete Heart Block)	1/418 (0.2%)
Unstable Angina	3/418 (0.7%)
Ventricular Fibrillation	2/418 (0.5%)
Endocrine disorders
Diabetic Ketoacidosis	1/418 (0.2%)
Eye disorders
Visual Disturbance	1/418 (0.2%)
Gastrointestinal disorders
Abdominal Pain	1/418 (0.2%)
Acute Erosive Gastritis	1/418 (0.2%)
Diarrhea	1/418 (0.2%)
Emesis/Vomiting	1/418 (0.2%)
Gastrointestinal Bleeding	6/418 (1.4%)
General disorders
Ascites	1/418 (0.2%)
Chest Pain	24/418 (5.7%)
Discomfort	1/418 (0.2%)
Gingival Bleeding	1/418 (0.2%)
Hematochezia	1/418 (0.2%)
Melena	2/418 (0.5%)
Non-Cardiac Chest Pain	1/418 (0.2%)
Other	14/418 (3.3%)
Hepatobiliary disorders
Cholelithiasis	1/418 (0.2%)
Infections and infestations
Influenza	1/418 (0.2%)
Pneumonia	2/418 (0.5%)
Pneumonia in the Compromised Host	1/418 (0.2%)
Injury, poisoning and procedural complications
Ankle Fracture	1/418 (0.2%)
Side Branch Compromise	1/418 (0.2%)
Investigations
Abnormal Lab Value	2/418 (0.5%)
EKG Abnormalities	1/418 (0.2%)
Echo Finding	1/418 (0.2%)
Hyperkalemia	1/418 (0.2%)
Musculoskeletal and connective tissue disorders
Gout	1/418 (0.2%)
Knee Pain	1/418 (0.2%)
Musculoskeletal Pain	1/418 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	2/418 (0.5%)
Colon Cancer	2/418 (0.5%)
Colon Polyps	1/418 (0.2%)
Lung Cancer	1/418 (0.2%)
Nervous system disorders
Intracerebral Haemorrhage	1/418 (0.2%)
Ischemic Stroke	1/418 (0.2%)
Non-Endpoint Transient Ischemic Attack (TIA)	1/418 (0.2%)
Presyncope	1/418 (0.2%)
Radiculopathy	1/418 (0.2%)
Stroke	2/418 (0.5%)
Syncope	2/418 (0.5%)
Renal and urinary disorders
Hematuria	1/418 (0.2%)
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis	1/418 (0.2%)
Chronic Obstructive Pulmonary Disease (COPD)	1/418 (0.2%)
Dyspnea	1/418 (0.2%)
Idiopathic Interstitial Lung Diseases	1/418 (0.2%)
Pleural Effusion	1/418 (0.2%)
Pulmonary Embolism	1/418 (0.2%)
Respiratory Failure	1/418 (0.2%)
Surgical and medical procedures
Elective Surgery	1/418 (0.2%)
Vascular disorders
Arterial Hypertension/Hypertension	2/418 (0.5%)
Hematoma	5/418 (1.2%)
Hypotension	2/418 (0.5%)
VASC Vessel Stenosis	1/418 (0.2%)
Vessel Stenosis	10/418 (2.4%)
Other (Not Including Serious) Adverse Events
	Optical Coherence Tomography (OCT)
	Affected / at Risk (%)	# Events
Total	128/418 (30.6%)
Blood and lymphatic system disorders
Anemias	1/418 (0.2%)
Iron-Deficiency Anemia	1/418 (0.2%)
Cardiac disorders
Angina Pectoris	1/418 (0.2%)
Atrial Fibrillation	1/418 (0.2%)
Hypokinetic Septal Motion	1/418 (0.2%)
Mitral Valve Regurgitation/Mitral Insufficiency	1/418 (0.2%)
Palpitations	2/418 (0.5%)
Premature Ventricular Contraction	1/418 (0.2%)
Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	1/418 (0.2%)
Tachycardia	1/418 (0.2%)
Unsustained/Nonsustained Ventricular Tachy/Cardiac Arrhythmia	1/418 (0.2%)
Ear and labyrinth disorders
Dizziness	5/418 (1.2%)
Endocrine disorders
Hyperglycemia	2/418 (0.5%)
Eye disorders
Blurred Vision	1/418 (0.2%)
Conjunctivitis	2/418 (0.5%)
Dry Eyes	1/418 (0.2%)
Eye Infection	1/418 (0.2%)
Visual Disturbance	2/418 (0.5%)
Gastrointestinal disorders
Acute Pancreatitis	1/418 (0.2%)
Constipation	3/418 (0.7%)
Diarrhea	2/418 (0.5%)
Diverticulitis	1/418 (0.2%)
Dyspepsia	1/418 (0.2%)
Dysphagia	1/418 (0.2%)
Gastroesophageal Reflux Disease	1/418 (0.2%)
Hiatus Hernia	1/418 (0.2%)
Ingestion	1/418 (0.2%)
Viral Gastroenteritis	1/418 (0.2%)
General disorders
Abdominal Pain	1/418 (0.2%)
Abrasion	1/418 (0.2%)
Apnea	1/418 (0.2%)
Back Pain	1/418 (0.2%)
Callus	1/418 (0.2%)
Chest Pain	18/418 (4.3%)
Chest Tightness	4/418 (1%)
Edema	3/418 (0.7%)
Fatigue/Generalized Fatigue	10/418 (2.4%)
Hip Pain	5/418 (1.2%)
Knee Pain	5/418 (1.2%)
Lacerations	1/418 (0.2%)
Melena	1/418 (0.2%)
Myalgias	1/418 (0.2%)
Nausea	1/418 (0.2%)
Neck Pain	1/418 (0.2%)
Obstructive Sleep Apnea	2/418 (0.5%)
Other	14/418 (3.3%)
Pain	5/418 (1.2%)
Post-Nasal Drainage	1/418 (0.2%)
Swelling	1/418 (0.2%)
Tooth Infection	1/418 (0.2%)
Toothache	1/418 (0.2%)
Weakness	1/418 (0.2%)
Immune system disorders
Allergy	1/418 (0.2%)
Infections and infestations
Aspiration Pneumonia/Necrotizing Pneumonia/Aspiration of Vomitus	1/418 (0.2%)
Common Cold/Upper Respiratory Tract Infection	6/418 (1.4%)
Fever	3/418 (0.7%)
Injury, poisoning and procedural complications
Rib Fracture	1/418 (0.2%)
Trauma	1/418 (0.2%)
Investigations
Abnormal Lab Value	1/418 (0.2%)
EKG Abnormalities	4/418 (1%)
Hypokalemia	1/418 (0.2%)
Hyponatremia	1/418 (0.2%)
Peak T Waves	1/418 (0.2%)
Musculoskeletal and connective tissue disorders
Arm Fracture	2/418 (0.5%)
Arm Pain	1/418 (0.2%)
Bursitis	1/418 (0.2%)
Gout	1/418 (0.2%)
Low Back Pain	4/418 (1%)
Muscle Strain	1/418 (0.2%)
Musculoskeletal Pain	5/418 (1.2%)
Wrist Sprain	1/418 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	1/418 (0.2%)
Cyst	1/418 (0.2%)
Nervous system disorders
Carpal Tunnel	1/418 (0.2%)
Fainting/Blackout	1/418 (0.2%)
Headache	3/418 (0.7%)
Syncope	1/418 (0.2%)
Vaso Vagal Response	1/418 (0.2%)
Vertigo	1/418 (0.2%)
Psychiatric disorders
Anxiety	1/418 (0.2%)
Depression	1/418 (0.2%)
Renal and urinary disorders
Chronic Renal Failure	1/418 (0.2%)
Dysuria	1/418 (0.2%)
Hematuria	4/418 (1%)
Nephrolithiasis	1/418 (0.2%)
Urinary Tract Infections	4/418 (1%)
Reproductive system and breast disorders
Prostatitis	1/418 (0.2%)
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis	1/418 (0.2%)
Asthma	1/418 (0.2%)
Chronic Obstructive Pulmonary Disease (COPD)	4/418 (1%)
Cough	3/418 (0.7%)
Difficulty Catching Breath	1/418 (0.2%)
Dyspnea	14/418 (3.3%)
Pneumonia	1/418 (0.2%)
Sinusitis	1/418 (0.2%)
Skin and subcutaneous tissue disorders
Bruise/Purpura Simplex	2/418 (0.5%)
Cellulitis	1/418 (0.2%)
Rash	4/418 (1%)
Skin Bruise	1/418 (0.2%)
Skin Lesions	2/418 (0.5%)
Vascular disorders
Aortic Aneurysms	1/418 (0.2%)
Arterial Hypertension/Hypertension	5/418 (1.2%)
Arteriovenous (AV) Fistula	1/418 (0.2%)
Bleeding	2/418 (0.5%)
Hematoma	1/418 (0.2%)
Orthostatic Hypotension	1/418 (0.2%)
Renal Artery Stenosis	1/418 (0.2%)
Thrombus	1/418 (0.2%)
VASC Bruise	1/418 (0.2%)
VASC Hematoma	1/418 (0.2%)
VASC Pseudoaneurysm	1/418 (0.2%)
VASC Vessel Stenosis	1/418 (0.2%)
Vessel Stenosis	3/418 (0.7%)

Limitations/Caveats

Patients with acute STEMI, left main PCI, severe chronic kidney disease, and other high-risk features were excluded. No prescriptive recommendations were provided in the protocol, a wide variation in physician behavior was expected and observed.

More Information

Certain Agreements

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

Proposals for all publications, abstracts, presentations, or journal manuscripts arising from, or related to the Study will be submitted for approval to the Publications Committee. Accordingly, decisions on timing and content of publications and presentations from the Study will be coordinated with the Study Publication Committee and Sponsor.