John A Spertus1, Philip G Jones1, David J Maron1, Daniel B Mark1, Sean M O'Brien1, Jerome L Fleg1, Harmony R Reynolds1, Gregg W Stone1, Mandeep S Sidhu1, Bernard R Chaitman1, Glenn M Chertow1, Judith S Hochman1, Sripal Bangalore1. 1. From Saint Luke's Mid America Heart Institute and the University of Missouri-Kansas City, Kansas City (J.A.S., P.G.J.), and the Center for Comprehensive Cardiovascular Care, St. Louis University School of Medicine, St. Louis (B.R.C.) - all in Missouri; the Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M., G.M.C.); Duke Clinical Research Institute, Durham, NC (D.B.M., S.M.O.); the National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (J.L.F.); and New York University Grossman School of Medicine (H.R.R., J.S.H., S.B.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York, and Albany Medical College and Albany Medical Center, Albany (M.S.S.) - all in New York.
Abstract
BACKGROUND: In the ISCHEMIA-CKD trial, the primary analysis showed no significant difference in the risk of death or myocardial infarction with initial angiography and revascularization plus guideline-based medical therapy (invasive strategy) as compared with guideline-based medical therapy alone (conservative strategy) in participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease (an estimated glomerular filtration rate of <30 ml per minute per 1.73 m2 or receipt of dialysis). A secondary objective of the trial was to assess angina-related health status. METHODS: We assessed health status with the Seattle Angina Questionnaire (SAQ) before randomization and at 1.5, 3, and 6 months and every 6 months thereafter. The primary outcome of this analysis was the SAQ Summary score (ranging from 0 to 100, with higher scores indicating less frequent angina and better function and quality of life). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate the treatment effect with the invasive strategy. RESULTS:Health status was assessed in 705 of 777 participants. Nearly half the participants (49%) had had no angina during the month before randomization. At 3 months, the estimated mean difference between the invasive-strategy group and the conservative-strategy group in the SAQ Summary score was 2.1 points (95% credible interval, -0.4 to 4.6), a result that favored the invasive strategy. The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3). By 6 months, the between-group difference in the overall trial population was attenuated (0.5 points; 95% credible interval, -2.2 to 3.4). CONCLUSIONS:Participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease did not have substantial or sustained benefits with regard to angina-related health status with an initially invasive strategy as compared with a conservative strategy. (Funded by the National Heart, Lung, and Blood Institute; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).
RCT Entities:
BACKGROUND: In the ISCHEMIA-CKD trial, the primary analysis showed no significant difference in the risk of death or myocardial infarction with initial angiography and revascularization plus guideline-based medical therapy (invasive strategy) as compared with guideline-based medical therapy alone (conservative strategy) in participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease (an estimated glomerular filtration rate of <30 ml per minute per 1.73 m2 or receipt of dialysis). A secondary objective of the trial was to assess angina-related health status. METHODS: We assessed health status with the Seattle Angina Questionnaire (SAQ) before randomization and at 1.5, 3, and 6 months and every 6 months thereafter. The primary outcome of this analysis was the SAQ Summary score (ranging from 0 to 100, with higher scores indicating less frequent angina and better function and quality of life). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate the treatment effect with the invasive strategy. RESULTS: Health status was assessed in 705 of 777 participants. Nearly half the participants (49%) had had no angina during the month before randomization. At 3 months, the estimated mean difference between the invasive-strategy group and the conservative-strategy group in the SAQ Summary score was 2.1 points (95% credible interval, -0.4 to 4.6), a result that favored the invasive strategy. The mean difference in score at 3 months was largest among participants with daily or weekly angina at baseline (10.1 points; 95% credible interval, 0.0 to 19.9), smaller among those with monthly angina at baseline (2.2 points; 95% credible interval, -2.0 to 6.2), and nearly absent among those without angina at baseline (0.6 points; 95% credible interval, -1.9 to 3.3). By 6 months, the between-group difference in the overall trial population was attenuated (0.5 points; 95% credible interval, -2.2 to 3.4). CONCLUSIONS:Participants with stable ischemic heart disease, moderate or severe ischemia, and advanced chronic kidney disease did not have substantial or sustained benefits with regard to angina-related health status with an initially invasive strategy as compared with a conservative strategy. (Funded by the National Heart, Lung, and Blood Institute; ISCHEMIA-CKD ClinicalTrials.gov number, NCT01985360.).
Authors: Steven P Sedlis; Claudine T Jurkovitz; Pamela M Hartigan; Paul Kolm; David S Goldfarb; Jeffrey D Lorin; Marcin Dada; David J Maron; John A Spertus; G B John Mancini; Koon K Teo; William E Boden; William S Weintraub Journal: Am J Cardiol Date: 2013-09-03 Impact factor: 2.778
Authors: Jacob V Spertus; Laura A Hatfield; David J Cohen; Suzanne V Arnold; Martin Ho; Philip G Jones; Martin Leon; Bram Zuckerman; John A Spertus Journal: Circ Cardiovasc Qual Outcomes Date: 2019-06-13
Authors: Sripal Bangalore; David J Maron; Jerome L Fleg; Sean M O'Brien; Charles A Herzog; Gregg W Stone; Daniel B Mark; John A Spertus; Karen P Alexander; Mandeep S Sidhu; Glenn M Chertow; William E Boden; Judith S Hochman Journal: Am Heart J Date: 2018-08-01 Impact factor: 4.749
Authors: J A Spertus; J A Winder; T A Dewhurst; R A Deyo; J Prodzinski; M McDonell; S D Fihn Journal: J Am Coll Cardiol Date: 1995-02 Impact factor: 24.094
Authors: Robert L Frye; Phyllis August; Maria Mori Brooks; Regina M Hardison; Sheryl F Kelsey; Joan M MacGregor; Trevor J Orchard; Bernard R Chaitman; Saul M Genuth; Suzanne H Goldberg; Mark A Hlatky; Teresa L Z Jones; Mark E Molitch; Richard W Nesto; Edward Y Sako; Burton E Sobel Journal: N Engl J Med Date: 2009-06-07 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: Suzanne V Arnold; David A Morrow; Yang Lei; David J Cohen; Elizabeth M Mahoney; Eugene Braunwald; Paul S Chan Journal: Circ Cardiovasc Qual Outcomes Date: 2009-06-02
Authors: Ruth Masterson Creber; Arnaldo Dimagli; Cristiano Spadaccio; Annie Myers; Marco Moscarelli; Michelle Demetres; Matthew Little; Stephen Fremes; Mario Gaudino Journal: Eur Heart J Qual Care Clin Outcomes Date: 2022-05-05
Authors: 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 Journal: N Engl J Med Date: 2020-03-30 Impact factor: 91.245
Authors: Andrew J Foy; Edward J Filippone; Eric Schaefer; Matt Nudy; Mohammed Ruzieh; Anne-Marie Dyer; Vernon M Chinchilli; Gerald V Naccarelli Journal: JAMA Netw Open Date: 2021-10-01