International Variation in Health Status Benefits in Patients Undergoing Initial Invasive Versus Conservative Management for Chronic Coronary Disease: Insights From the ISCHEMIA Trial.
Nobuhiro Ikemura, John A Spertus, Dan Nguyen, Zhuxuan Fu, Philip G Jones, Harmony R Reynolds, Sripal Bangalore, Balram Bhargava, Roxy Senior, Ahmed Elghamaz, Shaun G Goodman, Renato D Lopes, Radoslaw Pracoń, José López-Sendón, Aldo P Maggioni, Shun Kohsaka, Gregory A Roth, Harvey D White, Kreton Mavromatis, William E Boden, Fatima Rodriguez, Judith S Hochman, David J Maron
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Abstract
Background: The ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) demonstrated greater health status benefits with an initial invasive strategy, as compared with a conservative one, for patients with chronic coronary disease and moderate or severe ischemia. Whether these benefits vary globally is important to understand to support global adoption of the results.
Methods: We analyzed participants' disease-specific health status using the validated 7-item Seattle Angina Questionnaire (SAQ: >5-point differences are clinically important) at baseline and over 1-year follow-up across 37 countries in 6 international regions. The average effect of initial invasive versus conservative strategies on 1-year SAQ scores was estimated using Bayesian proportional odds regression and compared across regions.
Results: Considerable regional variation in baseline health status was observed among 4617 participants (mean age=64.4±9.5 years, 24% women), with the mean SAQ summary scores of 67.4±19.5 in Eastern Europe participants (17% of the total), 71.4±15.4 in Asia-Pacific (18%), 74.9±16.7 in Central and South America (10%), 75.5±19.5 in Western Europe (26%), and 78.6±19.2 in North America (28%). One-year improvements in SAQ scores were greater in regions with lower baseline scores with initial invasive management (17.7±20.9 in Eastern Europe and 11.4±19.3 in North America), but similar in the conservative arm. Adjusting for baseline SAQ scores, similar health status benefits of an initial invasive strategy on 1-year SAQ scores were observed (ranging from 2.38 points [95% CI, 0.04-4.50] in North America to 4.66 points [95% CI, 2.46-6.94] in Eastern Europe), with an 88.3% probability that the difference in benefit across regions was <5 points.
Conclusions: In patients with chronic coronary disease and moderate or severe ischemia, initial invasive management was associated with a consistent health status benefit across regions, with modest regional variability, supporting the international generalizability of health status benefits from invasive management of chronic coronary disease.
期刊介绍：
Circulation: Cardiovascular Quality and Outcomes, an American Heart Association journal, publishes articles related to improving cardiovascular health and health care. Content includes original research, reviews, and case studies relevant to clinical decision-making and healthcare policy. The online-only journal is dedicated to furthering the mission of promoting safe, effective, efficient, equitable, timely, and patient-centered care. Through its articles and contributions, the journal equips you with the knowledge you need to improve clinical care and population health, and allows you to engage in scholarly activities of consequence to the health of the public. Circulation: Cardiovascular Quality and Outcomes considers the following types of articles: Original Research Articles, Data Reports, Methods Papers, Cardiovascular Perspectives, Care Innovations, Novel Statistical Methods, Policy Briefs, Data Visualizations, and Caregiver or Patient Viewpoints.
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