31 Mar Stable Coronary Heart Disease: Initial Invasive or Conservative Strategy?
MedicalResearch.com Interview with:
David J. Maron, MD, FACC, FAHA
Clinical Professor of Medicine
Chief, Stanford Prevention Research Center
Director, Preventive Cardiology
Stanford University School of Medicine
MedicalResearch.com: What is the background for this study?
Response: 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. The goals of treating patients with stable coronary disease are to reduce their risk of death and ischemic events and to improve their quality of life. All patients with coronary disease should be treated with guideline-based medical therapy (GBMT) to achieve these objectives. Before the widespread availability of drug-eluting stents, strategy trials that tested the incremental effect of revascularization added to medical therapy did not show a reduction in the incidence of death or myocardial infarction. In one trial, fractional flow reserve–guided percutaneous coronary intervention (PCI) with drug-eluting stents, added to medical therapy, decreased the incidence of urgent revascularization but not the incidence of death from any cause or myocardial infarction at a mean of 7 months, whereas the 5-year follow-up showed marginal evidence of a decrease in the incidence of myocardial infarction.
MedicalResearch.com: What are the main findings?
Response: 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 and 144 deaths in the conservative strategy (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). Patients assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy.
MedicalResearch.com: How might these findings change recommendations for invasive procedures in ischemic heart disease?
Response A conservative strategy should be recommended for people with stable coronary disease and no symptoms, assuming they meet eligibility criteria for the trial (no recent acute coronary syndrome, unprotected left main coronary artery disease, EF <35%, class III or IV heart failure, or unacceptable angina despite maximally tolerated antianginal therapy). Patients with angina should review the results of the trial with their healthcare provider and decide whether revascularization is best for them.
MedicalResearch.com: What should readers take away from your report?
Response: There is no need to rush to the cath lab. Taking time to optimize medical therapy and assess response to therapy does not expose patients to greater risk.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: We need longer follow-up to determine if the reduction in spontaneous MI seen in the invasive strategy translates into a reduction in mortality over a longer period of follow-up.
Initial Invasive or Conservative Strategy for Stable Coronary Disease
David J. Maron, M.D., Judith S. Hochman, M.D., Harmony R. Reynolds, M.D., Sripal Bangalore, M.D., M.H.A.,Sean M. O’Brien, Ph.D., William E. Boden, M.D., Bernard R. Chaitman, M.D., Roxy Senior, M.D., D.M., Jose López-Sendón, M.D., Karen P. Alexander, M.D., Renato D. Lopes, M.D., Ph.D., Leslee J. Shaw, Ph.D., et al., for the ISCHEMIA Research Group*
March 30, 2020
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