For patients with stable coronary disease and moderate or severe ischemia, an 11-year analysis found no statistically significant survival difference between starting with procedures and beginning with medical therapy.
Published Saturday, Nov. 7, in JAMA, the follow-up included 5,179 participants randomized at 320 sites in 37 countries. Researchers recorded 1,071 deaths, 782 of them during extended follow-up. Median follow-up was nine years, with some records extending to 13.4 years.
At 11 years, estimated all-cause mortality was 25.8% among participants initially assigned to invasive care and 26.9% among those assigned to conservative care. The adjusted hazard ratio was 0.97, with a 95% confidence interval of 0.86 to 1.09.
Both groups received guideline-directed medical therapy. The invasive approach added coronary angiography and revascularization when feasible. Participants assigned to medical therapy first could undergo procedures if that treatment failed.
Earlier results from the original ISCHEMIA trial found larger angina-related health-status gains with invasive care, particularly among people who had more frequent angina at the outset. The extended follow-up focused on survival; it did not collect later data on nonfatal cardiovascular events, medication use, procedures, angina or quality of life. The initial phase had a median follow-up of 3.2 years.
The trial excluded people with significant left main coronary artery disease, a left ventricular ejection fraction below 35%, acute coronary syndrome within the previous two months, or unacceptable angina. In a NYU Langone Health announcement, Judith S. Hochman, MD, a study co-lead author and ISCHEMIA chair, said, “it is unlikely to help patients live longer.” The announcement also quoted Hochman saying procedures remain lifesaving for heart attacks and threatened heart attacks.
The paper’s authors said they are developing individualized risk scores based on long-term mortality data to inform shared treatment decisions. The study was funded by the National Heart, Lung, and Blood Institute (NHLBI).
