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Published on: January 28, 2020
Health-Status Outcomes with Invasive or Conservative Care in Coronary Disease
John A Spertus1, Philip G Jones1, David J Maron1
1From Saint Luke's Mid America Heart Institute Kansas City (J.A.S., P.G.J.) and the University of Missouri-Kansas City (J.A.S., P.G.J., D.J.C.), Kansas City; Department of Medicine, Stanford University School of Medicine, Stanford, CA (D.J.M.); Duke Clinical Research Institute and Duke University, Durham, NC (S.M.O., K.B., K.P.A., D.B.M.); New York University Grossman School of Medicine (H.R.R., J.D.N., S.M., S.B., J.S.H.), Icahn School of Medicine at Mount Sinai (G.W.S.), and the Cardiovascular Research Foundation (G.W.S.), New York; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (Y.R.); the Department of Biostatistics, Vanderbilt University School of Medicine, Nashville (F.E.H.); Veterans Affairs (VA) New England Healthcare System, Boston University School of Medicine, Boston (W.E.B.); MedStar Washington Hospital Center, Washington, DC (W.S.W.); Atlanta VA Healthcare System, Emory University School of Medicine, Atlanta (K.M.); and Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec (CIUSSS MCQ), University of Montreal, Campus Mauricie, Trois-Rivieres, QC (A.D.), and the Montreal Heart Institute, Montreal (G.G.) - both in Canada.
Insights
The invasive strategy improved angina-related health status in stable ischemic heart disease patients compared to a conservative approach. Benefits were most significant for patients experiencing frequent angina.
Area of Science:
- Cardiology
- Clinical Trials
- Health Outcomes Research
Background:
- The ISCHEMIA trial investigated clinical events in stable ischemic heart disease patients.
- A secondary objective focused on evaluating angina-related health status.
- This analysis included patients with moderate to severe ischemia.
Purpose of the Study:
- To assess the impact of an invasive versus conservative strategy on patient-reported health status.
- To determine if an invasive approach improves quality of life in ischemic heart disease.
- To analyze health status differences based on baseline angina frequency.
Main Methods:
- Utilized the Seattle Angina Questionnaire (SAQ) to measure symptoms, function, and quality of life.
- Employed mixed-effects cumulative probability models within a Bayesian framework.
- Assessed outcomes at multiple time points up to 36 months post-randomization.
Main Results:
- The invasive strategy led to significantly greater improvements in SAQ summary scores compared to the conservative strategy.
- Improvements were more pronounced in patients with higher baseline angina frequency.
- Asymptomatic patients showed minimal differences in health status between the groups.
Conclusions:
- An invasive strategy enhances angina-related health status in patients with stable ischemic heart disease and moderate to severe ischemia.
- The benefits are most substantial for patients who experience angina symptoms at baseline.
- Health status improvements in asymptomatic patients were modest.
Background:
In the ISCHEMIA trial, an invasive strategy with angiographic assessment and revascularization did not reduce clinical events among patients with stable ischemic heart disease and moderate or severe ischemia. A secondary objective of the trial was to assess angina-related health status among these patients.
Methods:
We assessed angina-related symptoms, function, and quality of life with the Seattle Angina Questionnaire (SAQ) at randomization, at months 1.5, 3, and 6, and every 6 months thereafter in participants who had been randomly assigned to an invasive treatment strategy (2295 participants) or a conservative strategy (2322). Mixed-effects cumulative probability models within a Bayesian framework were used to estimate differences between the treatment groups. The primary outcome of this health-status analysis was the SAQ summary score (scores range from 0 to 100, with higher scores indicating better health status). All analyses were performed in the overall population and according to baseline angina frequency.
Results:
At baseline, 35% of patients reported having no angina in the previous month. SAQ summary scores increased in both treatment groups, with increases at 3, 12, and 36 months that were 4.1 points (95% credible interval, 3.2 to 5.0), 4.2 points (95% credible interval, 3.3 to 5.1), and 2.9 points (95% credible interval, 2.2 to 3.7) higher with the invasive strategy than with the conservative strategy. Differences were larger among participants who had more frequent angina at baseline (8.5 vs. 0.1 points at 3 months and 5.3 vs. 1.2 points at 36 months among participants with daily or weekly angina as compared with no angina).
Conclusions:
In the overall trial population with moderate or severe ischemia, which included 35% of participants without angina at baseline, patients randomly assigned to the invasive strategy had greater improvement in angina-related health status than those assigned to the conservative strategy. The modest mean differences favoring the invasive strategy in the overall group reflected minimal differences among asymptomatic patients and larger differences among patients who had had angina at baseline. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).
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