PCI not superior to medical therapy alone in stable coronary disease: The COURAGE study

1. Over a median follow-up of 11.9 years, among patients with stable ischemic heart disease, there was no significant difference in long-term mortality between patients treated with medical therapy alone versus patients treated with the combination of percutaneous coronary intervention (PCI) and medical therapy.

2. This study extends the findings from the original Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial from a median of 4.6 years to 11.9 years of follow-up.

Evidence Rating Level: 1 (Excellent)      

Study Rundown: PCI is a cornerstone of the management of ST-segment and non-ST-segment elevation myocardial infarction given previous research linking this intervention to improved survival rates. However, the long-term survival benefit of PCI in patients with stable ischemic heart disease is uncertain. In the previously published COURAGE trial, there was no significant difference between optimal medical therapy alone and PCI with medical therapy in this population of patients over a median follow-up of 4.6 years.

In this study, a sub-cohort comprising 53% of the original COURAGE sample was followed for 15 years; the long-term survival benefit of medical therapy alone versus the combination of PCI and medical therapy was compared. During a median follow-up period of 11.9 years, there was once again no significant difference in all-cause mortality between the two groups. This finding was consistent across different subgroup analyses based on age, smoking status, gender, and multiple prior comorbidities.

The strength of this study is the consistency of findings from the original COURAGE cohort across a longer follow-up period. However, the findings are limited by a number of factors including the fact that the findings pertain only to half of the original COURAGE cohort and that the trial provides little information about newer devices and technologies employed during PCI.

Click to read the study, published today in NEJM

Relevant Reading:  Optimal medical therapy with or without PCI for stable coronary disease

In-Depth [randomized controlled trial]: This study involved 1211 patients (53% of the original population) from the COURAGE cohort who were followed for a median of 11.9 years in total (range 0 to 15). 25% of study population died during follow-up. The unadjusted HR comparing the combination of PCI with medical therapy group to medical therapy alone group was 0.98 (95% [CI], 0.83 to 1.15, P=0.77). When adjusted by baseline variables of significance, the HR was 1.03 (95% [CI], 0.83 to 1.21; P=0.76). The unadjusted comparison between outcomes in the whole study cohort remained nonsignificant across a number of important subgroup analyses including whether or not there was extended follow-up, age, smoking status, sex, multivessel CAD status, and prior conditions (including diabetes, liver disease, kidney disease).

There were numerous significant differences between the patients who were and were not followed in the extended period; however, only one of these factors (incidence of pulmonary disease in the cohort with extended follow-up) differed significantly between the two groups. The differences were driven in large part by the fact that no Canadian patients were available in extended follow-up.

Image: CC/Patrick J. Lynch

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