Occluded Artery Trial (OAT)

Last updated: April 3, 2014
Sponsor: NYU Langone Health
Overall Status: Completed

Phase

3

Condition

Chest Pain

Coronary Artery Disease

Cardiac Disease

Treatment

N/A

Clinical Study ID

NCT00004562
130
U01HL062509-01A1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Recent MI (3-28 days) (Day 1 is the calendar day of the MI system onset)

  • MI is defined based on at least 2 of 3 MI criteria confirmed by: 1) ischemic symptoms ≥30 minutes, 2) cardiac serum marker elevation (creatine kinase (CK) ≥2x upper limitof normal and CK-MB elevated above the upper limit of the laboratory normal) ortroponin T, or troponin I elevated at least twice the upper limit of normal, 3) EKG:New Q-waves of ≥0.03 sec and/or 1/3 of QRS complex in ≥2 related EKG leads. If cardiacserum markers are elevated (2), any one of the following EKG findings satisfyinclusion criteria; new ST-T changes (ST elevation or depression), new leftbundle-branch block (LBBB), loss of R-wave voltage ≥50% in ≥2 related leads or deep Twave inversions ≥3mm in ≥2 leads.

  • TIMI flow 0 or 1 in infarct related artery (IRA)

  • Meets criteria for high risk: EF <50% or site of occlusion is proximal, in leftanterior descending (proximal to the second major diagonal branch); large rightcoronary artery; or circumflex, if supplying large obtuse marginal, and part ofinferior wall (i.e., large dominant or co-dominant vessel).

Exclusion

Exclusion Criteria:

  • Age <18 y

  • Clinical indication for revascularization defined as follows: rest or low-thresholdangina after MI; severe inducible ischemia on low level exercise or pharmacologicalstress testing (ST decreased ≥2 mm or inability to complete stage 1 or achieve 3-4metabolic equivalents without angina, hypotension, or reversible perfusion defects inmultiple territories or decreased wall motion thickening in >2 segments onechocardiogram); 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 increasesrisk of radiographic contrast

  • Severe valvular disease

  • History of anaphylaxis to radiographic contrast

  • Infarct artery too small (reference segment diameter <2.5 mm), target segment withinor beyond extreme tortuosity (>90° angulation), or otherwise technically a poorcandidate for PCI

  • Chronic occlusion of IRA (seen on angiogram obtained before index MI or angiographicevidence of chronicity, e.g., presence of bridging collaterals)

  • NYHA classes III-IV CHF; patients may be treated for acute heart failure complicatingMI 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 therapyafter stent implantation

  • Qualifying IRA that has been grafted previously; patients with prior CABG may beenrolled if the IRA was not previously grafted

  • Dilated or hypertrophic cardiomyopathy

Study Design

Total Participants: 2201
Study Start date:
September 01, 1999
Estimated Completion Date:
June 30, 2011

Study 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.

Connect with a study center

  • New York University School of Medicine

    New York, New York 10010
    United States

    Site Not Available

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