Initial Invasive or Conservative Strategy for Stable Coronary Disease.
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Maron David J, Hochman Judith S, Reynolds Harmony R, Bangalore Sripal, O'Brien Sean M, Boden William E, Chaitman Bernard R, Senior Roxy, López-Sendón Jose, Alexander Karen P, Lopes Renato D, Shaw Leslee J, Berger Jeffrey S, Newman Jonathan D, Sidhu Mandeep S, Goodman Shaun G, Ruzyllo Witold, Gosselin Gilbert, Maggioni Aldo P, White Harvey D, Bhargava Balram, Min James K, Mancini G B John, Berman Daniel S, Picard Michael H, Kwong Raymond Y, Ali Ziad A, Mark Daniel B, Spertus John A, Krishnan Mangalath N, Elghamaz Ahmed, Moorthy Nagaraja, Hueb Whady A, Demkow Marcin, Mavromatis Kreton, Bockeria Olga, Peteiro Jesus, Miller Todd D, Szwed Hanna, Doerr Rolf, Keltai Matyas, Selvanayagam Joseph B, Steg P Gabriel, Held Claes, Kohsaka Shun, Mavromichalis Stavroula, Kirby Ruth, Jeffries Neal O, Harrell Frank E, Rockhold Frank W, Broderick Samuel, Ferguson T Bruce, Williams David O, Harrington Robert A, Stone Gregg W, Rosenberg Yves, ISCHEMIA Research Group
Аннотация
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.).