Long-Term COURAGE Data Published

November 12, 2015—Survival rates among percutaneous coronary intervention (PCI) patients who were followed for up to 15 years in the COURAGE trial, were published by Steven L. Sedlis, MD, et al in The New England Journal of Medicine (NEJM, 2015;373:1937–1946). The COURAGE investigators concluded that during the extended follow-up of up to 15 years, they did not find a difference in survival between an initial strategy of PCI plus medical therapy and medical therapy alone in patients with stable ischemic heart disease.

The background of the COURAGE trial is that between June 1999 and January 2004, the investigators randomly assigned 2,287 patients with stable ischemic heart disease to an initial management strategy of optimal medical therapy alone (medical-therapy group) or optimal medical therapy plus PCI (PCI group) and did not find a significant difference in the rate of survival during a median follow-up of 4.6 years. Those results were published in April 2007 by William E. Boden, MD, et al in NEJM (2007; 356:1503-1516).

For this current evaluation, as summarized in NEJM, the COURAGE investigators obtained permission from the patients at the Department of Veterans Affairs (VA) sites and some non-VA sites in the United States to use their Social Security numbers to track their survival after the original trial period ended. The VA National Corporate Data Warehouse and the National Death Index were searched for survival information and the dates of death from any cause. Survival was defined as calculated survival according to the Kaplan–Meier method and used a Cox proportional-hazards model to adjust for significant between-group differences in baseline characteristics.

Extended survival information was available for 1,211 patients (53% of the original population). The median duration of follow-up for all patients was 6.2 years (range, 0–15); the median duration of follow-up for patients at the sites that permitted survival tracking was 11.9 years (range, 0–15). A total of 561 deaths (180 during the follow-up period in the original trial and 381 during the extended follow-up period) occurred: 284 deaths (25%) in the PCI group and 277 (24%) in the medical-therapy group (adjusted hazard ratio, 1.03; 95% confidence interval, 0.83 to 1.21; P = .76), reported the investigators in NEJM.