Abstract 2985: Impact of PCI in Patients with Recent Onset Severe Angina or Stabilized ACS Treated with Optimal Medical Therapy: a COURAGE Trial High Risk Subset
Background: The COURAGE trial randomized 2,287 patients with stable coronary artery disease (CAD) to optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI). Eligibility criteria allowed entry of patients with recent onset, severe angina and recently stabilized acute coronary syndromes (ACS). We hypothesized that patients with recent onset, severe angina or recently stabilized ACS had higher risk for death or MI, and that this risk was reduced by PCI.
Methods: High risk was defined as Canadian Cardiovascular Society class III angina with first onset of symptoms ≤ 2 months prior to enrollment, recently stabilized class IV angina, or recently stabilized ACS not treated with PCI. Persistent class IV angina patients were excluded. Patients were permitted to undergo revascularization during the trial as clinically indicated for unremitting angina or ACS. The chi square test was used for between group comparisons.
Results: At baseline, 12% of COURAGE patients were classified as high risk. Within each treatment arm, high risk patients were more likely to suffer death or MI than non-high risk patients (OMT group, 26% vs. 17%, P=0.006; PCI group 24% vs. 18%, P=0.06). There was no significant difference between treatment arms for major cardiovascular events in patients at high risk (see Table⇓). As observed in the entire COURAGE cohort, revascularization was more frequent in high risk patients randomized to OMT compared with PCI (42% vs. 30%, P=0.04). Outcomes in High Risk Patients Randomized to OMT Alone or OMT + PCI
Conclusions: The addition of PCI to OMT as an initial management strategy did not reduce death, MI or other major cardiovascular events in this high risk subset of COURAGE patients with recent onset severe angina or stabilized ACS.