Occluded Artery Trial (OAT)

NCT00004562 | Completed Phase 3 Results DMC

• 2 other identifiers: 130U01HL062509-01A1
• Study Type: interventional
• Target: 2,201
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  Measured over a maximum 9-year follow-up period - 6 year median

Secondary Outcomes (1)

• Number of Participants With Secondary Outcomes (Safety Events)

  Measured over a maximum 9-year follow-up period - 6 year median

Study Arms (2)

Optimal Medical Therapy Only (MED)

ACTIVE COMPARATOR

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

Drug: Beta adrenergic blockers; Drug: Platelet inhibitors; Drug: ACE Inhibitors

Percutaneous Coronary Intervention (PCI)

EXPERIMENTAL

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

Drug: Beta adrenergic blockers; Drug: Platelet inhibitors; Procedure: PTCA and stents; Drug: ACE Inhibitors

Interventions

Beta adrenergic blockers DRUG

Participants will receive beta adrenergic blockers.

Also known as: beta blockers

Optimal Medical Therapy Only (MED); Percutaneous Coronary Intervention (PCI)

Platelet inhibitors DRUG

Participants will receive platelet inhibitors.

Also known as: Antiplatelet drugs

Optimal Medical Therapy Only (MED); Percutaneous Coronary Intervention (PCI)

PTCA and stents PROCEDURE

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

Also known as: Percutaneous Transluminal Coronary Angioplasty, and, Stent Placement

Percutaneous Coronary Intervention (PCI)

ACE Inhibitors DRUG

Participants will receive ACE inhibitors.

Also known as: angiotensin-converting-enzyme inhibitor

Optimal Medical Therapy Only (MED); Percutaneous Coronary Intervention (PCI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10010, United States

Location

Related Publications (29)

• Hochman JS, Lamas GA, Knatterud GL, Buller CE, Dzavik V, Mark DB, Reynolds HR, White HD; Occluded Artery Trial Research Group. Design and methodology of the Occluded Artery Trial (OAT). Am Heart J. 2005 Oct;150(4):627-42. doi: 10.1016/j.ahj.2005.07.002.

  PMID: 16209957 BACKGROUND

• Skolnick AH, Reynolds HR, White HD, Menon V, Carvalho AC, Maggioni AP, Pearte CA, Gruberg L, Azevedo RE, Schroeder E, Forman SA, Lamas GA, Hochman JS, Dzavik V. 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. 2012 Mar 1;109(5):614-9. doi: 10.1016/j.amjcard.2011.10.015. Epub 2011 Dec 14.

  PMID: 22172242 BACKGROUND

• Deyell MW, Buller CE, Miller LH, Wang TY, Dai D, Lamas GA, Srinivas VS, Hochman JS. Impact of National Clinical Guideline recommendations for revascularization of persistently occluded infarct-related arteries on clinical practice in the United States. Arch Intern Med. 2011 Oct 10;171(18):1636-43. doi: 10.1001/archinternmed.2011.315. Epub 2011 Jul 11.

  PMID: 21747002 BACKGROUND

• Udelson JE, Pearte CA, Kimmelstiel CD, Kruk M, Kufera JA, Forman SA, Teresinska A, Bychowiec B, Marin-Neto JA, Hochtl T, Cohen EA, Caramori P, Busz-Papiez B, Adlbrecht C, Sadowski ZP, Ruzyllo W, Kinan DJ, Lamas GA, Hochman JS. 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. 2011 Mar;161(3):611-21. doi: 10.1016/j.ahj.2010.11.020.

  PMID: 21392619 BACKGROUND

• Devlin G, Reynolds HR, Mark DB, Rankin JM, Carvalho AC, Vozzi C, Sopko G, Caramori P, Dzavik V, Ragosta M, Forman SA, Lamas GA, Hochman JS. Loss of short-term symptomatic benefit in patients with an occluded infarct artery is unrelated to non-protocol revascularization: results from the Occluded Artery Trial (OAT). Am Heart J. 2011 Jan;161(1):84-90. doi: 10.1016/j.ahj.2010.09.009.

  PMID: 21167338 BACKGROUND

• Steigen TK, Buller CE, Mancini GB, Jorapur V, Cantor WJ, Rankin JM, Thomas B, Webb JG, Kronsberg SS, Atchison DJ, Lamas GA, Hochman JS, Dzavik V. Myocardial perfusion grade after late infarct artery recanalization is associated with global and regional left ventricular function at one year: analysis from the Total Occlusion Study of Canada-2. Circ Cardiovasc Interv. 2010 Dec;3(6):549-55. doi: 10.1161/CIRCINTERVENTIONS.109.918722. Epub 2010 Nov 9.

  PMID: 21062997 BACKGROUND

• Jorapur V, Lamas GA, Sadowski ZP, Reynolds HR, Carvalho AC, Buller CE, Rankin JM, Renkin J, Steg PG, White HD, Vozzi C, Balcells E, Ragosta M, Martin CE, Srinivas VS, Wharton Iii WW, Abramsky S, Mon AC, Kronsberg SS, Hochman JS. Renal impairment and heart failure with preserved ejection fraction early post-myocardial infarction. World J Cardiol. 2010 Jan 26;2(1):13-8. doi: 10.4330/wjc.v2.i1.13.

  PMID: 20885993 BACKGROUND

• Steg PG, Kerner A, Mancini GB, Reynolds HR, Carvalho AC, Fridrich V, White HD, Forman SA, Lamas GA, Hochman JS, Buller CE; OAT Investigators. Impact of collateral flow to the occluded infarct-related artery on clinical outcomes in patients with recent myocardial infarction: a report from the randomized occluded artery trial. Circulation. 2010 Jun 29;121(25):2724-30. doi: 10.1161/CIRCULATIONAHA.109.933200. Epub 2010 Jun 14.

  PMID: 20547926 BACKGROUND

• Kruk M, Buller CE, Tcheng JE, Dzavik V, Menon V, Mancini GB, Forman SA, Kurray P, Busz-Papiez B, Lamas GA, Hochman JS. Impact of left ventricular ejection fraction on clinical outcomes over five years after infarct-related coronary artery recanalization (from the Occluded Artery Trial [OAT]). Am J Cardiol. 2010 Jan 1;105(1):10-6. doi: 10.1016/j.amjcard.2009.08.644.

  PMID: 20102883 BACKGROUND

• Buller CE, Rankin JM, Carere RG, Buszman PE, Pfisterer ME, Dzavik V, Thomas B, Forman S, Ruzyllo W, Mancini GB, Michalis LK, Abreu PF, Lamas GA, Hochman JS. Percutaneous coronary intervention in the Occluded Artery Trial: procedural success, hazard, and outcomes over 5 years. Am Heart J. 2009 Sep;158(3):408-15. doi: 10.1016/j.ahj.2009.05.035.

  PMID: 19699864 BACKGROUND

• Malek LA, Reynolds HR, Forman SA, Vozzi C, Mancini GB, French JK, Dziarmaga M, Renkin JP, Kochman J, Lamas GA, Hochman JS. Late coronary intervention for totally occluded left anterior descending coronary arteries in stable patients after myocardial infarction: Results from the Occluded Artery Trial (OAT). Am Heart J. 2009 Apr;157(4):724-32. doi: 10.1016/j.ahj.2008.12.008.

  PMID: 19332202 BACKGROUND

• 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.

  PMID: 19309733 BACKGROUND

• Mark DB, Pan W, Clapp-Channing NE, Anstrom KJ, Ross JR, Fox RS, Devlin GP, Martin CE, Adlbrecht C, Cowper PA, Ray LD, Cohen EA, Lamas GA, Hochman JS; Occluded Artery Trial Investigators. Quality of life after late invasive therapy for occluded arteries. N Engl J Med. 2009 Feb 19;360(8):774-83. doi: 10.1056/NEJMoa0805151.

  PMID: 19228620 BACKGROUND

• Kruk M, Kadziela J, Reynolds HR, Forman SA, Sadowski Z, Barton BA, Mark DB, Maggioni AP, Leor J, Webb JG, Kapeliovich M, Marin-Neto JA, White HD, Lamas GA, Hochman JS. Predictors of outcome and the lack of effect of percutaneous coronary intervention across the risk strata in patients with persistent total occlusion after myocardial infarction: Results from the OAT (Occluded Artery Trial) study. JACC Cardiovasc Interv. 2008 Oct;1(5):511-20. doi: 10.1016/j.jcin.2008.08.007.

  PMID: 19194534 BACKGROUND

• 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.

  PMID: 19188505 BACKGROUND

• Menon V, Pearte CA, Buller CE, Steg PG, Forman SA, White HD, Marino PN, Katritsis DG, Caramori P, Lasevitch R, Loboz-Grudzien K, Zurakowski A, Lamas GA, Hochman JS. Lack of benefit from percutaneous intervention of persistently occluded infarct arteries after the acute phase of myocardial infarction is time independent: insights from Occluded Artery Trial. Eur Heart J. 2009 Jan;30(2):183-91. doi: 10.1093/eurheartj/ehn486. Epub 2008 Nov 21.

  PMID: 19028780 BACKGROUND

• Jorapur V, Steigen TK, Buller CE, Dzavik V, Webb JG, Strauss BH, Yeoh EE, Kurray P, Sokalski L, Machado MC, Kronsberg SS, Lamas GA, Hochman JS, Mancini GB. Distribution and determinants of myocardial perfusion grade following late mechanical recanalization of occluded infarct-related arteries postmyocardial infarction: a report from the occluded artery trial. Catheter Cardiovasc Interv. 2008 Nov 15;72(6):783-9. doi: 10.1002/ccd.21745.

  PMID: 18798327 BACKGROUND

• Lamas GA, Hochman JS. Where does the Occluded Artery Trial leave the late open artery hypothesis? Heart. 2007 Nov;93(11):1319-21. doi: 10.1136/hrt.2007.123489.

  PMID: 17933981 BACKGROUND

• Lang IM, Forman SA, Maggioni AP, Ruzyllo W, Renkin J, Vozzi C, Steg PG, Hernandez-Garcia JM, Zmudka K, Jimenez-Navarro M, Sopko G, Lamas GA, Hochman JS. Causes of death in early MI survivors with persistent infarct artery occlusion: results from the Occluded Artery Trial (OAT). EuroIntervention. 2009 Nov;5(5):610-8. doi: 10.4244/eijv5i5a98.

  PMID: 20142183 BACKGROUND

• Cantor WJ, Baptista SB, Srinivas VS, Pearte CA, Menon V, Sadowski Z, Ross JR, Meciar P, Nikolsky E, Forman SA, Lamas GA, Hochman JS. Impact of stress testing before percutaneous coronary intervention or medical management on outcomes of patients with persistent total occlusion after myocardial infarction: analysis from the occluded artery trial. Am Heart J. 2009 Apr;157(4):666-72. doi: 10.1016/j.ahj.2008.12.004. Epub 2009 Feb 23.

  PMID: 19332193 BACKGROUND

• Sadanandan S, Buller C, Menon V, Dzavik V, Terrin M, Thompson B, Lamas G, Hochman JS. The late open artery hypothesis--a decade later. Am Heart J. 2001 Sep;142(3):411-21. doi: 10.1067/mhj.2001.117774.

  PMID: 11526353 BACKGROUND

• Reynolds HR, Forman SA, Tamis-Holland JE, Steg PG, Mark DB, Pearte CA, Carvalho AC, Sopko G, Liu L, Lamas GA, Kruk M, Loboz-Grudzien K, Ruzyllo W, Hochman JS. 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. 2012 Mar;163(3):462-9. doi: 10.1016/j.ahj.2012.01.005.

  PMID: 22424018 BACKGROUND

• White HD, Reynolds HR, Carvalho AC, Pearte CA, Liu L, Martin CE, Knatterud GL, Dzavik V, Kruk M, Steg PG, Cantor WJ, Menon V, Lamas GA, Hochman JS. Reinfarction after percutaneous coronary intervention or medical management using the universal definition in patients with total occlusion after myocardial infarction: results from long-term follow-up of the Occluded Artery Trial (OAT) cohort. Am Heart J. 2012 Apr;163(4):563-71. doi: 10.1016/j.ahj.2012.01.016.

  PMID: 22520521 BACKGROUND

• Freixa X, Dzavik V, Forman SA, Rankin JM, Buller CE, Cantor WJ, Ruzyllo W, Reynolds HR, Lamas GA, Hochman JS. 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. 2012 Jun;163(6):1011-8. doi: 10.1016/j.ahj.2012.03.008.

  PMID: 22709754 BACKGROUND

• Hastings RS, Hochman JS, Dzavik V, Lamas GA, Forman SA, Schiele F, Michalis LK, Nikas D, Jaroch J, Reynolds HR. Effect of late revascularization of a totally occluded coronary artery after myocardial infarction on mortality rates in patients with renal impairment. Am J Cardiol. 2012 Oct 1;110(7):954-60. doi: 10.1016/j.amjcard.2012.05.024. Epub 2012 Jun 22.

  PMID: 22728005 BACKGROUND

• Hochman JS, Lamas GA, Buller CE, Dzavik V, Reynolds HR, Abramsky SJ, Forman S, Ruzyllo W, Maggioni AP, White H, Sadowski Z, Carvalho AC, Rankin JM, Renkin JP, Steg PG, Mascette AM, Sopko G, Pfisterer ME, Leor J, Fridrich V, Mark DB, Knatterud GL; Occluded Artery Trial Investigators. Coronary intervention for persistent occlusion after myocardial infarction. N Engl J Med. 2006 Dec 7;355(23):2395-407. doi: 10.1056/NEJMoa066139. Epub 2006 Nov 14.

  PMID: 17105759 RESULT

• Hochman JS, Reynolds HR, Dzavik V, Buller CE, Ruzyllo W, Sadowski ZP, Maggioni AP, Carvalho AC, Rankin JM, White HD, Goldberg S, Forman SA, Mark DB, Lamas GA; Occluded Artery Trial Investigators. Long-term effects of percutaneous coronary intervention of the totally occluded infarct-related artery in the subacute phase after myocardial infarction. Circulation. 2011 Nov 22;124(21):2320-8. doi: 10.1161/CIRCULATIONAHA.111.041749. Epub 2011 Oct 24.

  PMID: 22025606 RESULT

• 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.

  PMID: 30950656 DERIVED

• 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.

  PMID: 23141853 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Heart Failure

Interventions

Adrenergic beta-Antagonists; Platelet Aggregation Inhibitors; Stents; Angioplasty, Balloon, Coronary; Angiotensin-Converting Enzyme Inhibitors

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Hematologic Agents; Therapeutic Uses; Prostheses and Implants; Equipment and Supplies; Angioplasty, Balloon; Angioplasty; Catheterization; Therapeutics; Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Percutaneous Coronary Intervention; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures; Investigative Techniques; Protease Inhibitors; Enzyme Inhibitors

Results Point of Contact

• Title: Judith S. Hochman, M.D.
• Organization: New York University School of Medicine

judith.hochman@nyumc.org

212-263-6927

Study Officials

• Judith S. Hochman, M.D.

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2000
• First Posted: February 10, 2000
• Study Start: September 1, 1999
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2011
• Last Updated: April 21, 2014
• Results First Posted: February 11, 2013

Record last verified: 2014-04

Locations

US (1)