Abstract 2447: Impact of Optimal Medical Therapy With or Without PCI on Long-term Cardiovascular Endpoints in Patients with Stable Coronary Artery Disease: Tertiary Outcomes from the COURAGE Trial
Background: The main results of the COURAGE Trial showed no significant differences in all-cause mortality or non-fatal MI (primary endpoint), the composite of death, MI or stroke, or hospitalization for ACS (secondary endpoints) during a median 4.6 year follow-up in the 2,287 patients with stable coronary artery disease (CAD) randomized to optimal medical therapy (OMT) with or without percutaneous coronary intervention (PCI). Because all-cause mortality as part of the primary endpoint might be viewed as a potential study limitation, we sought to assess major cause-specific cardiovascular outcomes (i.e., pre-specified tertiary endpoints) during long-term follow-up.
Methods: Statistical analyses were conducted for the following pre-specified tertiary endpoints (time to first event): cardiac death (CD); the composite of CD or MI; CD, MI, or hospitalization for ACS; CD, MI or stroke; CD, MI, ACS, or stroke; and MI or stroke during a 2.5 to 7 year (median 4.6 year) follow-up for patients randomized to PCI ≥ OMT vs. OMT alone. MI was defined as MBCK ≥ 1.5X ULN or troponin ≥ 2.0X ULN (spontaneous) or MBCK ≥3.0X ULN or troponin ≥5.0X ULN (peri-PCI).
Results: There were no significant differences between treatment arms for major pre-specified cardiovascular events in patients during long-term follow-up (see Table⇓). Rates of CD, MI and stroke, and MI and stroke trended slightly higher in the PCI group, but overall cardiovascular outcomes paralleled closely the primary and secondary composite outcomes between the two initial management strategies. Cox hazard ratios [HR] and 95% confidence intervals [CI] for tertiary outcomes reveal:
Conclusions: The addition of PCI to OMT as an initial management strategy did not reduce cardiac death, or the composites of CD, MI, ACS or stroke compared to OMT alone. There was remarkable concordance between all cardiovascular tertiary outcomes and the main study findings of COURAGE.