Everolimus-eluting stent outcomes roll snake eyes in registry analysis

Contrary to previous gains with new interventional technology, data suggest that second-generation, everolimus-eluting stents have similar rates of death as CABG. Moreover, PCI with these stents had increased rates of MI and repeat revascularization but a lower rate of stroke.

Two registries containing data on multivessel coronary artery disease patients enrolled between 2008 and 2011 provided the basis for this analysis. Sripal Bangalore, MD, MHA, of the New York School of Medicine in New York City, and colleagues matched 9,223 everolimus-eluting stent PCI patients with 9,223 CABG patients. Mean follow-up was 2.9 years.

The expectation was that improvements would be seen over CABG with the second-generation drug-eluting stent. Instead, among the real-world cohort, this was not the case. Risk of death with PCI using everolimus-eluting stents was 3.1 percent per year; CABG, 2.9 percent. Risk of MI was 1.9 percent and 1.1 percent per year for everolimus-eluting stents vs. CABG, respectively. Revascularization risk was more than double among PCI patients (7.2 percent vs. 3.1 percent per year, PCI vs CABG, respectively). However, risk of stroke was slightly lower among PCI patients than CABG, 0.7 percent vs. 1 percent per year, respectively.

Only among short-term outcomes, those during hospitalization and up to 30 days after discharge, did PCI with everolimus-eluting stents have an advantage over CABG. Risk of death was nearly half for stented patients (0.6 percent vs. 1.1 percent, respectively) and risk of stroke was less than a third of that of CABG patients (0.2 percent vs. 1.2 percent, respectively). Little difference was noted between the two groups for risk of MI (0.5 percent vs. 0.4 percent, respectively).

Bangalore et al noted that data from the registries show a gradual reduction in the gap between PCI and CABG mortality risk, despite “[a] wealth of data from studies of second-generation drug-eluting stents, especially everolimus-eluting stents, [having] shown reductions in the risks of death, myocardial infarction, and stent thrombosis when such stents are compared with bare-metal stents or first-generation drug-eluting stents.”

These findings add questions to comparative studies, including whether CABG itself is improving or whether this reflects the performance of this kind of stent among the general population. However, these data may not contradict findings of everolimus-eluting stent safety and efficacy studies, nor do they reflect recent findings regarding everolimus-eluting bioresorbable stents, which were not part of their purview.

The study was published online March 16 by the New England Journal of Medicine and was funded by Abbott Vascular.