Coronary intervention for persistent occlusion after myocardial infarction.
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].).
Hochman
Judith S
JS
Cardiovascular Clinical Research Center, Leon Charney Division of Cardiology, New York University School of Medicine, New York 10016, USA.
Lamas
Gervasio A
GA
Buller
Christopher E
CE
Dzavik
Vladimir
V
Reynolds
Harmony R
HR
Abramsky
Staci J
SJ
Forman
Sandra
S
Ruzyllo
Witold
W
Maggioni
Aldo P
AP
White
Harvey
H
Sadowski
Zygmunt
Z
Carvalho
Antonio C
AC
Rankin
Jamie M
JM
Renkin
Jean P
JP
Steg
P Gabriel
PG
Mascette
Alice M
AM
Sopko
George
G
Pfisterer
Matthias E
ME
Leor
Jonathan
J
Fridrich
Viliam
V
Mark
Daniel B
DB
Knatterud
Genell L
GL
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D003131:Combined Modality Therapy; D023921:Coronary Stenosis / Q000150:complications / Q000188:drug therapy / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009026:Mortality; D009203:Myocardial Infarction / Q000150:complications / Q000628:therapy*; D016016:Proportional Hazards Models; D055502:Secondary Prevention; D015607:Stents