Current pharmacologic strategies fail to achieve effective reperfusion in 30 percent or more of acute myocardial infarction (MI) patients, and many patients with occluded infarct-related arteries (IRAs) 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 acute MI patients in the U. S. Hence, a substantial number of acute MI patients pass the time when reperfusion therapy has well documented benefit (12-24 hours) with a persistently closed IRAs. Several lines of experimental and clinical evidence suggest that late reperfusion of these patients could provide clinically significant reductions in mortality and morbidity. Hypothesis. Opening an occluded IRA 3-21 days after an acute MI in high-risk asymptomatic patients (ejection fraction less than 50 percent or proximal occlusion of a large coronary artery) will reduce the composite end point of mortality, recurrent MI, and hospitalization for NYHA Class IV congestive heart failure (CHF) over an average 3-year follow-up.
Study aims. In the Open Artery Trial (OAT) 3,200 patients will be randomly allocated in equal proportions to the two treatments over two years. One treatment will consist of conventional medical management (including aspirin, beta blockers, ACE inhibitors, and risk factor modification). The experimental treatment will consist of conventional medical therapy plus percutaneous coronary intervention and coronary stenting. The primary specific aim is to compare the composite outcome of all-cause mortality, non-fatal MI and hospitalization for Class IV CHF based on an average 3-year follow-up among patients assigned to the two treatments. Three secondary specific aims are to compare: 1) the individual components of the study composite primary end point in the two treatments; 2) the medical costs of the two treatments; and 3) health-related quality of life in the two treatments. Role of Data Coordinating Center. This application is made for support of a Data Coordinating Center (DCC) at the Maryland Medical Research Institute. The DCC is responsible for statistical design and power calculations, random treatment assignments, data management, support for the Mortality and Morbidity Classification Committee, rapid communication and generation of performance data for review with the Study Chair and Co-Chair of the Clinical Coordinating Center and data analysis to assess treatment effects.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL062511-02
Application #
6293254
Study Section
Special Emphasis Panel (ZHL1-CSR-R (O3))
Project Start
1999-09-30
Project End
2004-08-31
Budget Start
2000-09-01
Budget End
2001-08-31
Support Year
2
Fiscal Year
2000
Total Cost
$722,664
Indirect Cost
Name
Maryland Medical Research Institute, Inc
Department
Type
DUNS #
069392181
City
Baltimore
State
MD
Country
United States
Zip Code
21210
Adlbrecht, Christopher; Huber, Kurt; Reynolds, Harmony R et al. (2014) Effects of timing, location and definition of reinfarction on mortality in patients with totally occluded infarct related arteries late after myocardial infarction. Int J Cardiol 174:90-5
Kruk, Mariusz; Menon, Venu; K?dziela, Jacek et al. (2013) Impact of percutaneous coronary intervention on biomarker levels in patients in the subacute phase following myocardial infarction: the Occluded Artery Trial (OAT) biomarker ancillary study. BMC Cardiovasc Disord 13:91
Menon, Venu; Ruzyllo, Witold; Carvalho, Antonio C et al. (2013) Infarct artery distribution and clinical outcomes in occluded artery trial subjects presenting with non-ST-segment elevation myocardial infarction (from the long-term follow-up of Occluded Artery Trial [OAT]). Am J Cardiol 111:930-5
Overgaard, Christopher B; Džavík, Vladimír; Buller, Christopher E et al. (2013) Percutaneous revascularization and long term clinical outcomes of diabetic patients randomized in the Occluded Artery Trial (OAT). Int J Cardiol 168:2416-22
Hastings, Ramin S; Hochman, Judith S; Dzavik, Vladimir et al. (2012) Effect of late revascularization of a totally occluded coronary artery after myocardial infarction on mortality rates in patients with renal impairment. Am J Cardiol 110:954-60
Freixa, Xavier; Dzavik, Vladimir; Forman, Sandra A et al. (2012) Long-term outcomes after a strategy of percutaneous coronary intervention of the infarct-related artery with drug-eluting stents or bare metal stents vs medical therapy alone in the Occluded Artery Trial (OAT). Am Heart J 163:1011-8
Reynolds, Harmony R; Forman, Sandra A; Tamis-Holland, Jacqueline E et al. (2012) Relationship of female sex to outcomes after myocardial infarction with persistent total occlusion of the infarct artery: analysis of the Occluded Artery Trial (OAT). Am Heart J 163:462-9
Jhaveri, Rahul R; Reynolds, Harmony R; Katz, Stuart D et al. (2012) 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 18:813-21
Skolnick, Adam H; Reynolds, Harmony R; White, Harvey D et al. (2012) Comparison of late results of percutaneous coronary intervention among stable patients ?65 versus >65 years of age with an occluded infarct related artery (from the Occluded Artery Trial). Am J Cardiol 109:614-9
Udelson, James E; Pearte, Camille A; Kimmelstiel, Carey D et al. (2011) The Occluded Artery Trial (OAT) Viability Ancillary Study (OAT-NUC): influence of infarct zone viability on left ventricular remodeling after percutaneous coronary intervention versus optimal medical therapy alone. Am Heart J 161:611-21

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