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Background The open-artery hypothesis postulates that late opening of an infarct-related artery after myocardial infarction will improve clinical outcomes. We evaluated the quality-of-life and economic outcomes associated with the use of this strategy.
Methods We compared percutaneous coronary intervention (PCI) plus stenting with medical therapy alone in high-risk patients in stable condition who had a totally occluded infarct-related artery 3 to 28 days after myocardial infarction. In 951 patients (44% of those eligible), we assessed quality of life by means of a battery of tests that included two principal outcome measures, the Duke Activity Status Index (DASI) (which measures cardiac physical function on a scale from 0 to 58, with higher scores indicating better function) and the Medical Outcomes Study 36-Item Short-Form Mental Health Inventory 5 (which measures psychological well-being). Structured quality-of-life interviews were performed at baseline and at 4, 12, and 24 months. Costs of treatment were assessed for 458 of 469 patients in the United States (98%), and 2-year cost-effectiveness was estimated.
Results At 4 months, the medical-therapy group, as compared with the PCI group, had a clinically marginal decrease of 3.4 points in the DASI score (P=0.007). At 1 and 2 years, the differences were smaller. No significant differences in psychological well-being were observed. For the 469 patients in the United States, cumulative 2-year costs were approximately $7,000 higher in the PCI group (P<0.001), and the quality-adjusted survival was marginally longer in the medical-therapy group.
Conclusions PCI was associated with a marginal advantage in cardiac physical function at 4 months but not thereafter. At 2 years, medical therapy remained significantly less expensive than routine PCI and was associated with marginally longer quality-adjusted survival. (ClinicalTrials.gov number, NCT00004562
[ClinicalTrials.gov]
.)
Source Information
From the Outcomes Research Group (D.B.M., W.P., N.E.C.-C., K.J.A., P.A.C., L.D.R.), Duke Clinical Research Institute, and the Departments of Medicine (D.B.M.) and Biostatistics and Bioinformatics (W.P., K.J.A.) — all at Duke University Medical Center, Durham, NC; the University Health Network, University of Toronto (J.R.R.), and the Sunnybrook Health Sciences Centre (E.A.C.) — both in Toronto; Vancouver General Hospital, Vancouver, BC, Canada (R.S.F.); Waikato Hospital, Hamilton, New Zealand (G.P.D.); Cardiac Diagnostic Associates, York, PA (C.E.M.); the Department of Internal Medicine II, Medical University of Vienna, Vienna (C.A.); the Columbia University Division of Cardiology, Mt. Sinai Medical Center, Miami Beach, FL (G.A.L.); and the New York University School of Medicine, New York (J.S.H.).
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