PMID- 17105759 OWN - NLM STAT- MEDLINE DCOM- 20061213 LR - 20220408 IS - 1533-4406 (Electronic) IS - 0028-4793 (Print) IS - 0028-4793 (Linking) VI - 355 IP - 23 DP - 2006 Dec 7 TI - Coronary intervention for persistent occlusion after myocardial infarction. PG - 2395-407 AB - BACKGROUND: It is unclear whether stable, high-risk patients with persistent total occlusion of the infarct-related coronary artery identified after the currently accepted period for myocardial salvage has passed should undergo percutaneous coronary intervention (PCI) in addition to receiving optimal medical therapy to reduce the risk of subsequent events. METHODS: We conducted a randomized study involving 2166 stable patients who had total occlusion of the infarct-related artery 3 to 28 days after myocardial infarction and who met a high-risk criterion (an ejection fraction of <50% or proximal occlusion). Of these patients, 1082 were assigned to routine PCI and stenting with optimal medical therapy, and 1084 were assigned to optimal medical therapy alone. The primary end point was a composite of death, myocardial reinfarction, or New York Heart Association (NYHA) class IV heart failure. RESULTS: The 4-year cumulative primary event rate was 17.2% in the PCI group and 15.6% in the medical therapy group (hazard ratio for death, reinfarction, or heart failure in the PCI group as compared with the medical therapy group, 1.16; 95% confidence interval [CI], 0.92 to 1.45; P=0.20). Rates of myocardial reinfarction (fatal and nonfatal) were 7.0% and 5.3% in the two groups, respectively (hazard ratio, 1.36; 95% CI, 0.92 to 2.00; P=0.13). Rates of nonfatal reinfarction were 6.9% and 5.0%, respectively (hazard ratio, 1.44; 95% CI, 0.96 to 2.16; P=0.08); only six reinfarctions (0.6%) were related to assigned PCI procedures. Rates of NYHA class IV heart failure (4.4% vs. 4.5%) and death (9.1% vs. 9.4%) were similar. There was no interaction between treatment effect and any subgroup variable (age, sex, race or ethnic group, infarct-related artery, ejection fraction, diabetes, Killip class, and the time from myocardial infarction to randomization). CONCLUSIONS: PCI did not reduce the occurrence of death, reinfarction, or heart failure, and there was a trend toward excess reinfarction during 4 years of follow-up in stable patients with occlusion of the infarct-related artery 3 to 28 days after myocardial infarction. (ClinicalTrials.gov number, NCT00004562 [ClinicalTrials.gov].). CI - Copyright 2006 Massachusetts Medical Society. FAU - Hochman, Judith S AU - Hochman JS AD - Cardiovascular Clinical Research Center, Leon Charney Division of Cardiology, New York University School of Medicine, New York 10016, USA. FAU - Lamas, Gervasio A AU - Lamas GA FAU - Buller, Christopher E AU - Buller CE FAU - Dzavik, Vladimir AU - Dzavik V FAU - Reynolds, Harmony R AU - Reynolds HR FAU - Abramsky, Staci J AU - Abramsky SJ FAU - Forman, Sandra AU - Forman S FAU - Ruzyllo, Witold AU - Ruzyllo W FAU - Maggioni, Aldo P AU - Maggioni AP FAU - White, Harvey AU - White H FAU - Sadowski, Zygmunt AU - Sadowski Z FAU - Carvalho, Antonio C AU - Carvalho AC FAU - Rankin, Jamie M AU - Rankin JM FAU - Renkin, Jean P AU - Renkin JP FAU - Steg, P Gabriel AU - Steg PG FAU - Mascette, Alice M AU - Mascette AM FAU - Sopko, George AU - Sopko G FAU - Pfisterer, Matthias E AU - Pfisterer ME FAU - Leor, Jonathan AU - Leor J FAU - Fridrich, Viliam AU - Fridrich V FAU - Mark, Daniel B AU - Mark DB FAU - Knatterud, Genell L AU - Knatterud GL CN - Occluded Artery Trial Investigators LA - eng SI - ClinicalTrials.gov/NCT00004562 GR - U01 HL062509-05S1/HL/NHLBI NIH HHS/United States GR - U01 HL062257/HL/NHLBI NIH HHS/United States GR - U01 HL062509-05/HL/NHLBI NIH HHS/United States GR - U01 HL062509-01A1/HL/NHLBI NIH HHS/United States GR - U01 HL062509-04/HL/NHLBI NIH HHS/United States GR - U01 HL062509-02/HL/NHLBI NIH HHS/United States GR - U01 HL062511/HL/NHLBI NIH HHS/United States GR - R01 HL067683/HL/NHLBI NIH HHS/United States GR - U01 HL062509-03/HL/NHLBI NIH HHS/United States GR - R01 HL67683/HL/NHLBI NIH HHS/United States GR - U01 HL062509/HL/NHLBI NIH HHS/United States PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20061114 PL - United States TA - N Engl J Med JT - The New England journal of medicine JID - 0255562 SB - IM CIN - N Engl J Med. 2006 Dec 7;355(23):2475-7. PMID: 17105760 CIN - Nat Clin Pract Cardiovasc Med. 2007 May;4(5):250-1. PMID: 17375052 CIN - N Engl J Med. 2007 Apr 19;356(16):1681; author reply 1683-4. PMID: 17442915 CIN - N Engl J Med. 2007 Apr 19;356(16):1682; author reply 1683-4. PMID: 17447281 CIN - N Engl J Med. 2007 Apr 19;356(16):1682; author reply 1683-4. PMID: 17447282 CIN - N Engl J Med. 2007 Apr 19;356(16):1681-2; author reply 1683-4. PMID: 17447283 CIN - N Engl J Med. 2007 Apr 19;356(16):1681; author reply 1683-4. PMID: 17447284 MH - Aged MH - *Angioplasty, Balloon, Coronary MH - Combined Modality Therapy MH - Coronary Stenosis/complications/drug therapy/*therapy MH - Female MH - Follow-Up Studies MH - Heart Failure/epidemiology/etiology MH - Humans MH - Kaplan-Meier Estimate MH - Male MH - Middle Aged MH - Mortality MH - Myocardial Infarction/complications/*therapy MH - Proportional Hazards Models MH - Secondary Prevention MH - Stents PMC - PMC1995554 MID - NIHMS27202 EDAT- 2006/11/16 09:00 MHDA- 2006/12/14 09:00 PMCR- 2007/10/05 CRDT- 2006/11/16 09:00 PHST- 2006/11/16 09:00 [pubmed] PHST- 2006/12/14 09:00 [medline] PHST- 2006/11/16 09:00 [entrez] PHST- 2007/10/05 00:00 [pmc-release] AID - NEJMoa066139 [pii] AID - 10.1056/NEJMoa066139 [doi] PST - ppublish SO - N Engl J Med. 2006 Dec 7;355(23):2395-407. doi: 10.1056/NEJMoa066139. Epub 2006 Nov 14.