Trial Outcomes & Findings for Occluded Artery Trial (OAT) (NCT NCT00004562)
NCT ID: NCT00004562
Last Updated: 2014-04-21
Results Overview
Number of Patients with Events (death from any cause, nonfatal reinfarction, and hospitalization for New York Heart Association (NYHA) Class IV congestive heart failure). Events were centrally adjudicated.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2201 participants
Primary outcome timeframe
Measured over a maximum 9-year follow-up period - 6 year median
Results posted on
2014-04-21
Participant Flow
The primary analysis of the trial included 2166 patients who had been enrolled through December 2005 with an average follow-up of 2.9 years. An additional 35 patients were enrolled through June 2006 during an extended period of enrollment in the nuclear viability ancillary study. All 2201 patients are included here.
Participant milestones
| Measure |
Percutaneous Coronary Intervention Group
Percutaneous Coronary Intervention with stent placement and optimal medical therapy
|
Medical Therapy Group
Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
|
|---|---|---|
|
Overall Study
STARTED
|
1101
|
1100
|
|
Overall Study
COMPLETED
|
999
|
1009
|
|
Overall Study
NOT COMPLETED
|
102
|
91
|
Reasons for withdrawal
| Measure |
Percutaneous Coronary Intervention Group
Percutaneous Coronary Intervention with stent placement and optimal medical therapy
|
Medical Therapy Group
Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
102
|
91
|
Baseline Characteristics
Occluded Artery Trial (OAT)
Baseline characteristics by cohort
| Measure |
Percutaneous Coronary Intervention Group
n=1101 Participants
Percutaneous Coronary Intervention with stent placement and optimal medical therapy
|
Medical Therapy Group
n=1100 Participants
Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
|
Total
n=2201 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
58.7 Years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
58.7 Years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
242 Participants
n=5 Participants
|
242 Participants
n=7 Participants
|
484 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
859 Participants
n=5 Participants
|
858 Participants
n=7 Participants
|
1717 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
888 participants
n=5 Participants
|
875 participants
n=7 Participants
|
1763 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
33 participants
n=5 Participants
|
36 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
141 participants
n=5 Participants
|
136 participants
n=7 Participants
|
277 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
39 participants
n=5 Participants
|
53 participants
n=7 Participants
|
92 participants
n=5 Participants
|
|
Current cigarette smoker
Current Cigaratte Smoker
|
428 participants
n=5 Participants
|
431 participants
n=7 Participants
|
859 participants
n=5 Participants
|
|
Current cigarette smoker
Non-Smoker
|
664 participants
n=5 Participants
|
660 participants
n=7 Participants
|
1324 participants
n=5 Participants
|
|
Current cigarette smoker
Unknown
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Prior History of Characteristics and Risk Factors
Angina
|
240 participants
n=5 Participants
|
255 participants
n=7 Participants
|
495 participants
n=5 Participants
|
|
Prior History of Characteristics and Risk Factors
Myocardial infarction
|
129 participants
n=5 Participants
|
118 participants
n=7 Participants
|
247 participants
n=5 Participants
|
|
Prior History of Characteristics and Risk Factors
Cerebrovascular disease
|
48 participants
n=5 Participants
|
34 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Prior History of Characteristics and Risk Factors
Peripheral-vessel disease
|
44 participants
n=5 Participants
|
39 participants
n=7 Participants
|
83 participants
n=5 Participants
|
|
Prior History of Characteristics and Risk Factors
Heart Failure
|
27 participants
n=5 Participants
|
25 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Prior History of Characteristics and Risk Factors
PCI
|
51 participants
n=5 Participants
|
54 participants
n=7 Participants
|
105 participants
n=5 Participants
|
|
Prior History of Characteristics and Risk Factors
CABG
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Prior History of Characteristics and Risk Factors
Diabetes
|
203 participants
n=5 Participants
|
251 participants
n=7 Participants
|
454 participants
n=5 Participants
|
|
Prior History of Characteristics and Risk Factors
Diabetes - Insulin Use
|
63 participants
n=5 Participants
|
61 participants
n=7 Participants
|
124 participants
n=5 Participants
|
|
Prior History of Characteristics and Risk Factors
Hypertension
|
528 participants
n=5 Participants
|
543 participants
n=7 Participants
|
1071 participants
n=5 Participants
|
|
Infarct-related artery
Left anterior descending coronary artery
|
383 participants
n=5 Participants
|
410 participants
n=7 Participants
|
793 participants
n=5 Participants
|
|
Infarct-related artery
Left circumflex coronary artery
|
177 participants
n=5 Participants
|
158 participants
n=7 Participants
|
335 participants
n=5 Participants
|
|
Infarct-related artery
Right coronary artery
|
541 participants
n=5 Participants
|
532 participants
n=7 Participants
|
1073 participants
n=5 Participants
|
|
Interval between MI and randomization
|
8 days
n=5 Participants
|
8 days
n=7 Participants
|
8 days
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured over a maximum 9-year follow-up period - 6 year medianNumber of Patients with Events (death from any cause, nonfatal reinfarction, and hospitalization for New York Heart Association (NYHA) Class IV congestive heart failure). Events were centrally adjudicated.
Outcome measures
| Measure |
Percutaneous Coronary Intervention Group
n=1101 Participants
Percutaneous Coronary Intervention with stent placement and optimal medical therapy
|
Medical Therapy Group
n=1100 Participants
Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
|
|---|---|---|
|
Number of Patients That Had a First Occurrence of the Primary End Point (Composite of Death From Any Cause, Nonfatal MI, or Class IV HF)
|
230 participants
|
219 participants
|
SECONDARY outcome
Timeframe: Measured over a maximum 9-year follow-up period - 6 year medianNumber of Participants with Secondary Outcomes (death from any cause, nonfatal MI, class IV HF, cardiac death, occurrence of selected clinical outcomes including stroke, hospitalization for CHF, sustained ventricular tachycardia/ventricular fibrillation, ICD implantation, or the composite end point). Events were centrally adjudicated.
Outcome measures
| Measure |
Percutaneous Coronary Intervention Group
n=1101 Participants
Percutaneous Coronary Intervention with stent placement and optimal medical therapy
|
Medical Therapy Group
n=1100 Participants
Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
|
|---|---|---|
|
Number of Participants With Secondary Outcomes (Safety Events)
Death from all causes
|
150 participants
|
153 participants
|
|
Number of Participants With Secondary Outcomes (Safety Events)
Fatal and nonfatal reinfarction
|
77 participants
|
65 participants
|
|
Number of Participants With Secondary Outcomes (Safety Events)
Nonfatal reinfarction
|
75 participants
|
61 participants
|
|
Number of Participants With Secondary Outcomes (Safety Events)
NYHA class IV heart failure (HF)
|
51 participants
|
53 participants
|
|
Number of Participants With Secondary Outcomes (Safety Events)
Cardiovascular death
|
77 participants
|
81 participants
|
|
Number of Participants With Secondary Outcomes (Safety Events)
Death or nonfatal reinfarction
|
212 participants
|
199 participants
|
|
Number of Participants With Secondary Outcomes (Safety Events)
NYHA class III or IV HF
|
76 participants
|
74 participants
|
|
Number of Participants With Secondary Outcomes (Safety Events)
Death, reinfarction, or NYHA class III or IV HF
|
249 participants
|
235 participants
|
|
Number of Participants With Secondary Outcomes (Safety Events)
Stroke
|
29 participants
|
24 participants
|
Adverse Events
Percutaneous Coronary Intervention Group
Serious events: 226 serious events
Other events: 75 other events
Deaths: 0 deaths
Medical Therapy Group
Serious events: 227 serious events
Other events: 61 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Percutaneous Coronary Intervention Group
n=1101 participants at risk
Percutaneous Coronary Intervention with stent placement and optimal medical therapy
|
Medical Therapy Group
n=1100 participants at risk
Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
|
|---|---|---|
|
Cardiac disorders
Death from all causes
|
13.6%
150/1101 • Number of events 150
|
13.9%
153/1100 • Number of events 153
|
|
Cardiac disorders
NYHA class III or IV Heart Failure
|
6.9%
76/1101 • Number of events 76
|
6.7%
74/1100 • Number of events 74
|
Other adverse events
| Measure |
Percutaneous Coronary Intervention Group
n=1101 participants at risk
Percutaneous Coronary Intervention with stent placement and optimal medical therapy
|
Medical Therapy Group
n=1100 participants at risk
Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
|
|---|---|---|
|
Cardiac disorders
Nonfatal reinfarction
|
6.8%
75/1101 • Number of events 75
|
5.5%
61/1100 • Number of events 61
|
Additional Information
Judith S. Hochman, M.D.
New York University School of Medicine
Phone: 212-263-6927
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The NIH Public Access Policy ensures that the public has access to the published results of NIH funded research. It requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. To help advance science and improve human health, the Policy requires that these papers are accessible to the public on PubMed Central no later than 12 months after publication.
- Publication restrictions are in place
Restriction type: OTHER