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Randomized Controlled Trial Multicenter Study Comparative Study
Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease.
- John A Spertus, Philip G Jones, David J Maron, Sean M O'Brien, Harmony R Reynolds, Yves Rosenberg, Gregg W Stone, Frank E Harrell, William E Boden, William S Weintraub, Khaula Baloch, Kreton Mavromatis, Ariel Diaz, Gilbert Gosselin, Jonathan D Newman, Stavroula Mavromichalis, Karen P Alexander, David J Cohen, Sripal Bangalore, Judith S Hochman, Daniel B Mark, and ISCHEMIA Research Group.
- From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.
- N. Engl. J. Med. 2020 Apr 9; 382 (15): 140814191408-1419.
BackgroundIn the ISCHEMIA trial, an invasive strategy with angiographic assessment and revascularization did not reduce clinical events among patients with stable ischemic heart disease and moderate or severe ischemia. A secondary objective of the trial was to assess angina-related health status among these patients.MethodsWe assessed angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ) at randomization, at months 1.5, 3, and 6, and every 6 months thereafter in participants who had been randomly assigned to an invasive treatment strategy (2295 participants) or a conservative strategy (2322). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate differences between the treatment groups. The primary outcome of this health-status analysis was the SAQ summary score (scores range from 0 to 100, with higher scores indicating better health status). All analyses were performed in the overall population and according to baseline angina frequency.ResultsAt baseline, 35% of patients reported having no angina in the previous month. SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy. Differences were larger among participants who had more frequent angina at baseline (8.5 vs. 0.1 points at 3 months and 5.3 vs. 1.2 points at 36 months among participants with daily or weekly angina as compared with no angina).ConclusionsIn the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).Copyright © 2020 Massachusetts Medical Society.
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