Title

Initial invasive or conservative strategy for stable coronary disease

Authors

David J. Maron, Stanford University School of Medicine
Judith S. Hochman, NYU Grossman School of Medicine
Harmony R. Reynolds, NYU Grossman School of Medicine
Sripal Bangalore, NYU Grossman School of Medicine
Sean M. O'Brien, Duke Clinical Research Institute
William E. Boden, Boston University School of Medicine
Bernard R. Chaitman, St. Louis University School of Medicine
Roxy Senior, Northwick Park Hospital
Jose López-Sendón, Hospital Universitario La Paz
Karen P. Alexander, Duke Clinical Research Institute
Renato D. Lopes, Duke Clinical Research Institute
Leslee J. Shaw, New York Presbyterian Hospital
Jeffrey S. Berger, NYU Grossman School of Medicine
Jonathan D. Newman, NYU Grossman School of Medicine
Mandeep S. Sidhu, Albany Medical College
Shaun G. Goodman, Saint Michael's Hospital University of Toronto
Witold Ruzyllo, Instytut Kardiologii im. Prymasa Tysiaclecia Stefana Kardynała Wyszynskiego
Gilbert Gosselin, Institut de Cardiologie de Montreal
Aldo P. Maggioni, Associazione Nazionale Medici Cardiologi Ospedalieri
Harvey D. White, Auckland City Hospital
Balram Bhargava, All India Institute of Medical Sciences, New Delhi
James K. Min, Cleerly Health
G. B. John Mancini, The University of British Columbia
Daniel S. Berman, Cedars-Sinai Medical Center
Michael H. Picard, Harvard Medical School
Raymond Y. Kwong
Ziad A. Ali, Cardiovascular Research Foundation
Daniel B. Mark, Duke Clinical Research Institute
John A. Spertus, UMKC School of Medicine
Mangalath N. Krishnan, Government Medical College Kozhikode
Ahmed Elghamaz
Nagaraja Moorthy, Sri Jayadeva Institute of Cardiovascular Sciences and Research

Document Type

Journal Article

Publication Date

4-9-2020

Journal

New England Journal of Medicine

Volume

382

Issue

15

DOI

10.1056/NEJMoa1915922

Abstract

© 2020 Massachusetts Medical Society. BACKGROUND Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, −1.8 percentage points; 95% CI, −4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used.

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