- Whether adding upfront percutaneous coronary intervention (PCI) to optimal medical therapy (OMT) reduces long-term risk of death or myocardial infarction (MI) in stable coronary artery disease (CAD) remains uncertain.
- This post hoc extended follow-up of the COURAGE trial included 959 patients from 15 Veterans Affairs (VA) hospitals, with outcomes ascertained from linked VA and Medicare data over a median of 15 years and a maximum of 25 years.
- The estimated 25-year incidence of death or MI did not differ between PCI plus OMT and OMT alone, suggesting that routine elective upfront PCI does not reduce long-term death or MI in stable CAD.
In stable coronary artery disease (CAD), current guidelines recommend percutaneous coronary intervention (PCI) for treatment of angina that persists despite guideline-directed medical therapy. In the COURAGE trial, adding PCI to optimal medical therapy (OMT) did not reduce death or myocardial infarction (MI) in patients with stable CAD and myocardial ischemia over a median of 4.6 years, and the COURAGE extended survival study showed no difference in survival over a median of 11.9 years. Subsequently, in the ISCHEMIA trial, an initial invasive strategy added to OMT did not reduce the primary composite end point compared with a conservative strategy over a median of 3.2 years; however, patients in the invasive arm had fewer spontaneous MIs. Two questions therefore remain unanswered: how the signal of fewer spontaneous MIs with revascularization in ISCHEMIA evolves with longer follow-up, and whether elective upfront PCI reduces the long-term risk of death or MI in stable CAD.
On November 7th, 2026, the results of the 25-year extended follow-up of “The Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE)” trial (NCT00007657) were presented at the American Heart Association Scientific Sessions in Chicago, IL, by Dr. Neel M. Butala. The purpose of this analysis was to evaluate the long-term impact of PCI in patients with stable CAD. The results were simultaneously published in the Journal of the American Medical Association.
This post hoc extended follow-up of the COURAGE randomized trial included 959 patients with stable CAD and myocardial ischemia from 15 Department of Veterans Affairs (VA) hospitals, representing 42% of the 2,287 original participants. Of these, 485 were randomized to upfront PCI plus OMT and 474 to OMT alone. Outcomes were tracked through linked VA and Medicare records for up to 25 years. The primary outcome was death or MI; secondary outcomes were death, MI, and revascularization.
Participants had a mean age of ~63 years, 98% were male, and 41% had diabetes; baseline characteristics were similar between groups. Patients were followed for a median of 15 years and up to 25 years. By 25 years, the risk of death or MI did not differ significantly between the PCI and OMT groups (HR 1.01 [95% CI, 0.88–1.15]). Results were similar for death alone (83.9% vs. 82.2%; HR 0.98 [95% CI, 0.85–1.13]) and for MI alone (54.6% vs. 54.0%; cause-specific HR 1.01 [95% CI, 0.85–1.20]). About half of patients in each group underwent revascularization during follow-up, with no significant difference between groups: 53.5% of the OMT group had a first procedure and 50.4% of the PCI group had a repeat procedure (cause-specific HR 0.87 [95% CI, 0.73–1.03]; P=0.23). The average time patients lived without death or MI did not differ at any 5-year interval, and results were consistent across subgroups, including those defined by diabetes, prior MI, ejection fraction, and number of diseased vessels.
Limitations of this study include restriction to veterans with linked medical records, who were at higher baseline risk than the full COURAGE cohort, which may limit generalizability. In addition, routinely collected data identified MI less reliably than trial adjudication, although treatment effects were consistent during the original trial period.
The authors conclude: “These findings do not support a routine strategy of elective upfront PCI to reduce long-term risk of death or MI in patients with stable CAD.”