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Original Article
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Volume 360:774-783 February 19, 2009 Number 8
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Quality of Life after Late Invasive Therapy for Occluded Arteries
Daniel B. Mark, M.D., M.P.H., Wenqin Pan, Ph.D., Nancy E. Clapp-Channing, R.N., M.P.H., Kevin J. Anstrom, Ph.D., John R. Ross, M.D., Rebecca S. Fox, P.A., M.Sc., Gerard P. Devlin, M.B., Ch.B., C. Edwin Martin, M.D., Christopher Adlbrecht, M.D., M.B.A., Patricia A. Cowper, Ph.D., Linda Davidson Ray, M.A., Eric A. Cohen, M.D., Gervasio A. Lamas, M.D., Judith S. Hochman, M.D., for the Occluded Artery Trial Investigators

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ABSTRACT

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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