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著者: 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, ISCHEMIA Research Group
雑誌名: N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.
Abstract/Text
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. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).
Copyright © 2020 Massachusetts Medical Society.
PMID 32227755 N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.
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