Zotarolimus-, Everolimus-Eluting Stents Found Equally Safe, Effective

Study results showed that both treatment groups had nearly 100% rates of lesion success and 96% rates of procedure success.

In intent-to-treat analyses, the 1-year rate of target vessel failure – a composite of cardiac death, target vessel–related myocardial infarction, and clinically driven target vessel revascularization – was 8.2% with zotarolimus-eluting stents and 8.1% with everolimus-eluting stents. The absolute difference of 0.1% and upper limit of the one-sided 95% confidence interval of 2.53% were well within the predefined noninferiority margin of 4.48% (P for noninferiority = .001; P for superiority = .94).

The findings were similar across patient subgroups stratified by disease and lesion characteristics, and similar for each of the three components of the composite end point individually.

There was an interaction between treatment group and diabetes status (P = .045), but more-detailed analysis failed to show a significant benefit of one stent over the other. "This is a trend which is hypothesis generating and interesting," Dr. von Birgelen commented. "It may raise some more pooling of data and analysis."

The trial’s main results were much the same when the investigators used a broader, patient-oriented composite end point of all deaths, any myocardial infarction, and any revascularization (11.2% vs. 10.5%; P for superiority = .69).

The zotarolimus- and everolimus-eluting stent groups also had very low and statistically indistinguishable rates of definite or probable stent thrombosis (0.86% vs. 1.16%). These rates are "relatively low, certainly when you consider the complexity of patients and lesions that were studied in this trial," he noted.

"Zotarolimus-eluting Resolute stents were noninferior to everolimus-eluting Xience V stents in terms of safety and efficacy for treating real-world patients with a vast majority of complex lesions and off-label indications for drug-eluting stents, which were implanted with liberal use of postdilatation," Dr. von Birgelen concluded.

Follow-up continues, he added. "It makes sense, and we must learn from the first-generation drug-eluting stents that we should follow up these patients longer than just 1 year. There is a 2-year follow-up already running at this moment, and we will follow these patients even further," he said.

Dr. von Birgelen reported that he is a consultant to and has received speaker honoraria and/or traveling expenses from Abbott Vascular, Medtronic, and Boston Scientific. Dr. Waksman reported that he had no relevant conflicts of interest. Dr. Hodgson reported that he receives research or grant support from Boston Scientific, Volcano, and St. Jude Medical, and that he is a consultant to, is a speaker for, or receives honoraria from Volcano.