Invasive, conservative approaches similar in patients with diabetes, stable CAD: ISCHEMIA
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In patients with diabetes and chronic coronary disease, researchers found no incremental benefit employing routine invasive management compared with initial medical therapy, according to results from the ISCHEMIA trials.
Furthermore, in the cohort, patients with diabetes had a nearly 50% increased hazard for death or MI compared with those without diabetes, regardless of which strategy they were assigned to.
As previously reported by Healio, the ISCHEMIA and ISCHEMIA-CKD trials included patients with chronic coronary disease who were randomly assigned to an invasive or conservative approach. The invasive approach involved medical therapy plus angiography and revascularization if feasible, whereas the conservative approach entailed medical therapy alone, with subsequent revascularization if medical therapy failed. For the present analysis, Jonathan D. Newman, MD, MPH, assistant professor of medicine at the NYU Grossman School of Medicine, and colleagues combined the ISCHEMIA and ISCHEMIA-CKD cohorts after no trial-specific effects were found.
All-cause death or MI served as the primary outcome measure.
The pooled analyses of the ISCHEMIA trials featured 5,900 participants (median age, 64 years; 24% women; median estimated glomerular filtration rate, 80 mL/min/1.73 m2) with complete baseline data.
Overall, 43% of patients had diabetes. From this cohort, 30% were insulin-treated and the median HbA1c was 7%.
Among patients with diabetes, the hazard of death or MI was increased nearly 50% compared with those without diabetes (HR = 1.49; 95% CI, 1.31-1.7; P < .001).
At follow-up (median 3.1, years), adjusted event-free survival was 0.54 (95% bootstrapped CI, 0.48-0.6) for patients with diabetes and 0.66 (95% bootstrapped CI, 0.61-0.71) for patients without diabetes, resulting in a 12% absolute decrease in event-free survival for those with diabetes.
In analysis by sex, female patients with insulin-treated diabetes had an adjusted event-free survival of 0.52 (95% bootstrapped CI, 0.42-0.56) compared with 0.49 (95% bootstrapped CI, 0.42-0.56) for their male counterparts. Researchers also found no significant differences in death or MI between treatment strategies for patients with diabetes (P = .75) or without diabetes (P = .76), or for clinical (female sex or insulin use) or anatomic (CAD severity or left ventricular function) features of patients with diabetes.
“Despite higher risk for death or MI, chronic coronary disease patients with diabetes did not derive incremental benefit from routine invasive management compared with initial medical therapy alone,” the researchers wrote. “Future analyses will characterize the effects of a conservative or invasive approach on health status outcomes for ISCHEMIA trials’ patients with diabetes.”
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