John A Spertus1, Philip G Jones1, David J Maron1, Sean M O'Brien1, Harmony R Reynolds1, Yves Rosenberg1, Gregg W Stone1, Frank E Harrell1, William E Boden1, William S Weintraub1, Khaula Baloch1, Kreton Mavromatis1, Ariel Diaz1, Gilbert Gosselin1, Jonathan D Newman1, Stavroula Mavromichalis1, Karen P Alexander1, David J Cohen1, Sripal Bangalore1, Judith S Hochman1, Daniel B Mark1. 1. 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.
Abstract
BACKGROUND: In 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. METHODS: We 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. RESULTS: At 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). CONCLUSIONS: In 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.).
RCT Entities:
BACKGROUND: In 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. METHODS: We 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. RESULTS: At 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). CONCLUSIONS: In 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.).
Authors: Sidney C Smith; Jerilyn Allen; Steven N Blair; Robert O Bonow; Lawrence M Brass; Gregg C Fonarow; Scott M Grundy; Loren Hiratzka; Daniel Jones; Harlan M Krumholz; Lori Mosca; Richard C Pasternak; Thomas Pearson; Marc A Pfeffer; Kathryn A Taubert Journal: Circulation Date: 2006-05-16 Impact factor: 29.690
Authors: William S Weintraub; John A Spertus; Paul Kolm; David J Maron; Zefeng Zhang; Claudine Jurkovitz; Wei Zhang; Pamela M Hartigan; Cheryl Lewis; Emir Veledar; Jim Bowen; Sandra B Dunbar; Christi Deaton; Stanley Kaufman; Robert A O'Rourke; Ron Goeree; Paul G Barnett; Koon K Teo; William E Boden; G B J Mancini Journal: N Engl J Med Date: 2008-08-14 Impact factor: 91.245
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Authors: John A Spertus; Philip G Jones; David J Maron; Daniel B Mark; Sean M O'Brien; Jerome L Fleg; Harmony R Reynolds; Gregg W Stone; Mandeep S Sidhu; Bernard R Chaitman; Glenn M Chertow; Judith S Hochman; Sripal Bangalore Journal: N Engl J Med Date: 2020-03-30 Impact factor: 91.245
Authors: David J Maron; Judith S Hochman; Harmony R Reynolds; Sripal Bangalore; Sean M O'Brien; William E Boden; Bernard R Chaitman; Roxy Senior; Jose López-Sendón; Karen P Alexander; Renato D Lopes; Leslee J Shaw; Jeffrey S Berger; Jonathan D Newman; Mandeep S Sidhu; Shaun G Goodman; Witold Ruzyllo; Gilbert Gosselin; Aldo P Maggioni; Harvey D White; Balram Bhargava; James K Min; G B John Mancini; Daniel S Berman; Michael H Picard; Raymond Y Kwong; Ziad A Ali; Daniel B Mark; John A Spertus; Mangalath N Krishnan; Ahmed Elghamaz; Nagaraja Moorthy; Whady A Hueb; Marcin Demkow; Kreton Mavromatis; Olga Bockeria; Jesus Peteiro; Todd D Miller; Hanna Szwed; Rolf Doerr; Matyas Keltai; Joseph B Selvanayagam; P Gabriel Steg; Claes Held; Shun Kohsaka; Stavroula Mavromichalis; Ruth Kirby; Neal O Jeffries; Frank E Harrell; Frank W Rockhold; Samuel Broderick; T Bruce Ferguson; David O Williams; Robert A Harrington; Gregg W Stone; Yves Rosenberg Journal: N Engl J Med Date: 2020-03-30 Impact factor: 91.245
Authors: Daniel E Forman; James A de Lemos; Leslee J Shaw; David B Reuben; Radmila Lyubarova; Eric D Peterson; John A Spertus; Susan Zieman; Marcel E Salive; Michael W Rich Journal: J Am Coll Cardiol Date: 2020-09-29 Impact factor: 24.094