Occluded Artery Trial (OAT)

NCT ID: NCT00004562

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30
• Study Completion Date: 2011-06-30

Brief Summary

The purpose of this study is to determine whether opening an occluded infarcted artery 3-28 days after an acute myocardial infarction in high-risk asymptomatic patients reduces the composite endpoint of mortality, recurrent myocardial infarction, and hospitalization for class IV congestive heart failure over an average 2.9-year follow-up with extended follow up for an average of six years. Long term follow-up of patients were completed in March 2010. Final collection of all regulatory documentation was completed June 2011.

Detailed Description

BACKGROUND:

The benefits of establishing early coronary reperfusion in acute myocardial infarction (MI) have now been unequivocally established. However, current pharmacologic strategies fail to achieve effective reperfusion in 30 percent or more of patients, and many patients with occluded infarct arteries do not meet current criteria for use of these agents. Early angioplasty, an effective reperfusion method, is available to a small proportion of potentially eligible US acute MI patients. Hence a substantial number of acute MI patients pass the time when reperfusion therapy has any documented benefit (12 - 24 hours) with a persistently closed infarct vessel. Several lines of experimental and clinical evidence suggest that late reperfusion of these patients could provide clinically significant reductions in mortality and morbidity.

DESIGN NARRATIVE:

Multicenter, randomized, controlled. Patients at 217 clinical sites in the United States, Canada and Internationally were randomly allocated to two treatment arms over five years. One treatment consists of conventional medical management including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification. The other treatment consists of conventional medical therapy plus percutaneous coronary intervention and coronary stenting. Clinical outcomes will be compared using an intention-to-treat analysis. The primary composite endpoint is mortality, recurrent myocardial infarction, and hospitalization for NYHA Class IV congestive heart failure over a three year follow-up. Individual components of the study composite primary endpoint will be compared in the two treatment arms, as will the medical costs of the two treatments and the health-related quality of life. The cost-effectiveness of percutaneous revascularization will be assessed in the study population.

Conditions

Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Heart Failure, Congestive; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Optimal Medical Therapy Only (MED)

Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification

Group Type: ACTIVE_COMPARATOR

Beta adrenergic blockers

Intervention Type: DRUG

Participants will receive beta adrenergic blockers.

Platelet inhibitors

Intervention Type: DRUG

Participants will receive platelet inhibitors.

ACE Inhibitors

Intervention Type: DRUG

Participants will receive ACE inhibitors.

Percutaneous Coronary Intervention (PCI)

Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting

Group Type: EXPERIMENTAL

Beta adrenergic blockers

Intervention Type: DRUG

Participants will receive beta adrenergic blockers.

Platelet inhibitors

Intervention Type: DRUG

Participants will receive platelet inhibitors.

PTCA and stents

Intervention Type: PROCEDURE

Participants will undergo percutaneous coronary intervention (PTCA) and coronary stenting.

ACE Inhibitors

Intervention Type: DRUG

Participants will receive ACE inhibitors.

Interventions

Beta adrenergic blockers

Participants will receive beta adrenergic blockers.

Intervention Type: DRUG

Platelet inhibitors

Participants will receive platelet inhibitors.

Intervention Type: DRUG

PTCA and stents

Participants will undergo percutaneous coronary intervention (PTCA) and coronary stenting.

Intervention Type: PROCEDURE

ACE Inhibitors

Participants will receive ACE inhibitors.

Intervention Type: DRUG

Other Intervention Names

beta blockers; Antiplatelet drugs; Percutaneous Transluminal Coronary Angioplasty; and; Stent Placement; angiotensin-converting-enzyme inhibitor

Eligibility Criteria

Inclusion Criteria

• Recent MI (3-28 days) (Day 1 is the calendar day of the MI system onset)
• TIMI flow 0 or 1 in infarct related artery (IRA)
• Meets criteria for high risk: EF <50% or site of occlusion is proximal, in left anterior descending (proximal to the second major diagonal branch); large right coronary artery; or circumflex, if supplying large obtuse marginal, and part of inferior wall (i.e., large dominant or co-dominant vessel).

Exclusion Criteria

• Age <18 y
• Clinical indication for revascularization defined as follows: rest or low-threshold angina after MI; severe inducible ischemia on low level exercise or pharmacological stress testing (ST decreased ≥2 mm or inability to complete stage 1 or achieve 3-4 metabolic equivalents without angina, hypotension, or reversible perfusion defects in multiple territories or decreased wall motion thickening in >2 segments on echocardiogram); left main coronary disease (≥50% stenosis); or triple-vessel disease (3 major epicardial coronaries with >70% stenoses)
• Serious illness such as cancer or pulmonary disease that limits 3-year survival
• Severe renal disease defined as serum creatinine >3.0 mg/dL that markedly increases risk of radiographic contrast
• Severe valvular disease
• History of anaphylaxis to radiographic contrast
• Infarct artery too small (reference segment diameter <2.5 mm), target segment within or beyond extreme tortuosity (>90° angulation), or otherwise technically a poor candidate for PCI
• Chronic occlusion of IRA (seen on angiogram obtained before index MI or angiographic evidence of chronicity, e.g., presence of bridging collaterals)
• NYHA classes III-IV CHF; patients may be treated for acute heart failure complicating MI and rescreened
• Cardiogenic shock or sustained hypotension: systolic BP <90 mm Hg or cardiac index <2.2 L/min per m^2
• LV aneurysm in the same location as index MI and present before index MI
• Inability to cooperate with the protocol
• Patient refusal or inability to give informed consent
• Refusal of patient's physician to allow patient to participate
• Pregnancy
• Contraindication to anticoagulation during PCI or to routine antiplatelet therapy after stent implantation
• Qualifying IRA that has been grafted previously; patients with prior CABG may be enrolled if the IRA was not previously grafted
• Dilated or hypertrophic cardiomyopathy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Judith S. Hochman, M.D.

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

References

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Dzavik V, Buller CE, Devlin G, Carere RG, Mancini GB, Cantor WJ, Buszman PE, Rankin JM, Vozzi C, Ross JR, Forman S, Barton BA, Lamas AG, Hochman JS. Angiographic and clinical outcomes of drug-eluting versus bare metal stent deployment in the Occluded Artery Trial. Catheter Cardiovasc Interv. 2009 May 1;73(6):771-9. doi: 10.1002/ccd.21930.

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Rashba EJ, Lamas GA, Couderc JP, Hollist SM, Dzavik V, Ruzyllo W, Fridrich V, Buller CE, Forman SA, Kufera JA, Carvalho AC, Hochman JS; OAT-EP Investigators. Electrophysiological effects of late percutaneous coronary intervention for infarct-related coronary artery occlusion: the Occluded Artery Trial-Electrophysiological Mechanisms (OAT-EP). Circulation. 2009 Feb 17;119(6):779-87. doi: 10.1161/CIRCULATIONAHA.108.808626. Epub 2009 Feb 2.

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Reference Type: RESULT

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Reference Type: RESULT

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Xing Z, Pei J, Huang J, Hu X, Gao S. Relationship of obesity to adverse events in myocardial infarction patients without primary percutaneous coronary intervention: results from the Occluded Artery Trial (OAT). Curr Med Res Opin. 2019 Sep;35(9):1563-1569. doi: 10.1080/03007995.2019.1603993. Epub 2019 May 10.

Reference Type: DERIVED

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Jhaveri RR, Reynolds HR, Katz SD, Jeger R, Zinka E, Forman SA, Lamas GA, Hochman JS. Heart failure in post-MI patients with persistent IRA occlusion: prevalence, risk factors, and the long-term effect of PCI in the Occluded Artery Trial (OAT). J Card Fail. 2012 Nov;18(11):813-21. doi: 10.1016/j.cardfail.2012.10.012.

Reference Type: DERIVED

PMID: 23141853 (View on PubMed)

Other Identifiers

U01HL062509-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

130

Identifier Type: -

Identifier Source: org_study_id