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Initial Invasive or Conservative Strategy for Stable Coronary Disease.

Publication ,  Journal Article
Maron, DJ; Hochman, JS; Reynolds, HR; Bangalore, S; O'Brien, SM; Boden, WE; Chaitman, BR; Senior, R; López-Sendón, J; Alexander, KP; Lopes, RD ...
Published in: N Engl J Med
April 9, 2020

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.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

April 9, 2020

Volume

382

Issue

15

Start / End Page

1395 / 1407

Location

United States

Related Subject Headings

  • Quality of Life
  • Percutaneous Coronary Intervention
  • Myocardial Revascularization
  • Myocardial Ischemia
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Humans
  • General & Internal Medicine
  • Female
 

Citation

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Maron, D. J., Hochman, J. S., Reynolds, H. R., Bangalore, S., O’Brien, S. M., Boden, W. E., … ISCHEMIA Research Group, . (2020). Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med, 382(15), 1395–1407. https://doi.org/10.1056/NEJMoa1915922
Maron, David J., Judith S. Hochman, Harmony R. Reynolds, Sripal Bangalore, Sean M. O’Brien, William E. Boden, Bernard R. Chaitman, et al. “Initial Invasive or Conservative Strategy for Stable Coronary Disease.N Engl J Med 382, no. 15 (April 9, 2020): 1395–1407. https://doi.org/10.1056/NEJMoa1915922.
Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O’Brien SM, Boden WE, et al. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395–407.
Maron, David J., et al. “Initial Invasive or Conservative Strategy for Stable Coronary Disease.N Engl J Med, vol. 382, no. 15, Apr. 2020, pp. 1395–407. Pubmed, doi:10.1056/NEJMoa1915922.
Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O’Brien SM, Boden WE, Chaitman BR, Senior R, López-Sendón J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE, Rockhold FW, Broderick S, Ferguson TB, Williams DO, Harrington RA, Stone GW, Rosenberg Y, ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395–1407.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

April 9, 2020

Volume

382

Issue

15

Start / End Page

1395 / 1407

Location

United States

Related Subject Headings

  • Quality of Life
  • Percutaneous Coronary Intervention
  • Myocardial Revascularization
  • Myocardial Ischemia
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Humans
  • General & Internal Medicine
  • Female