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International Variation in Health Status Benefits in Patients Undergoing Initial Invasive Versus Conservative
Nobuhiro Ikemura1,2, John A Spertus1, Dan Nguyen1
1University of Missouri-Kansas City's Healthcare Institute for Innovations in Quality and Saint Luke's Mid America Heart Institute, (N.I., J.A.S., D.N., Z.F., P.G.J.).
Insights
The ISCHEMIA trial found that an initial invasive strategy for chronic coronary disease consistently improved patient health status across all global regions. These benefits, measured by the Seattle Angina Questionnaire, showed minimal regional variation, supporting widespread adoption.
Area of Science:
- Cardiology
- Clinical Trials
- Health Outcomes Research
Background:
- The ISCHEMIA trial compared invasive vs. conservative strategies for chronic coronary disease.
- Understanding global variations in health status benefits is crucial for international adoption.
Purpose of the Study:
- To analyze regional differences in health status benefits from the ISCHEMIA trial.
- To assess the global generalizability of an initial invasive strategy for chronic coronary disease.
Main Methods:
- Analyzed Seattle Angina Questionnaire (SAQ) scores at baseline and 1-year follow-up.
- Compared health status benefits across 37 countries in 6 international regions.
- Used Bayesian proportional odds regression to estimate treatment effects.
Main Results:
- Observed significant regional variation in baseline health status (SAQ scores).
- Health status improvements with invasive strategy were greater in regions with lower baseline scores.
- Consistent health status benefits (2.38-4.66 points) observed across regions, with modest variability.
Conclusions:
- Initial invasive management provides consistent health status benefits for chronic coronary disease patients globally.
- Modest regional variability suggests the international generalizability of these findings.
- Supports the adoption of invasive strategies for managing chronic coronary disease worldwide.
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.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.
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