Health status relationship to ischemia and coronary artery disease severity in the ISCHEMIA trial.

BACKGROUND

The ISCHEMIA trial randomized participants with chronic coronary disease and moderate or severe ischemia by site assessment to an initial invasive strategy plus guideline-directed medical therapy (GDMT) or to an initial conservative strategy of GDMT alone. This secondary analysis examines the association of prerandomization ischemia severity, from stress testing assessed by a core laboratory, and anatomic severity of coronary artery disease (CAD), assessed by coronary computed tomography angiography (CCTA), with 1-year health status outcomes.

METHODS

The associations of ischemia and CAD severity with 1-year health status were assessed using proportional odds models, adjusted for age, sex, and baseline health status and stratified by baseline angina; Seattle Angina Questionnaire (SAQ) Angina Frequency [AF] score <100 (and angina) vs 100 (no angina).

RESULTS

Among 4,558 participants with baseline and 1-year SAQ assessments, 2,936 (64.4%) had baseline angina. Among these, ischemia was categorized as no/mild (363), moderate (986) and severe (1,587). Among participants reporting angina at baseline, those with severe baseline ischemia had more frequent angina compared with those having less ischemia (SAQ AF, 70.6 vs 73.0, P = .029). However, the adjusted odds ratio for better 1-year overall health status, assessed by the SAQ Summary Score, was 1.29 (95% CI, CI 1.05-1.59, P = .007) for participants with severe vs those with less baseline ischemia. No differences in 1-year health status were observed by CAD severity or in asymptomatic patients categorized by ischemia or CAD severity.

CONCLUSIONS

Among participants with baseline angina in the ISCHEMIA trial, severe ischemia was independently associated with more frequent angina at baseline and at 1 year, but also with better 1-year overall health status compared with less ischemia. Anatomic CAD severity was not associated with angina severity.

GOV IDENTIFIER: URL:https://clinicaltrials.gov/ct2/show/NCT01471522. Unique identifier: NCT01471522.