San Francisco, CA—In the first trial comparing the safety and efficacy of third-generation drug-eluting stents, zotarolimus-eluting and everolimus-eluting stents both performed well with no differences between the two devices.
The study randomly assigned 1,811 patients to either ZES (Resolute Integrity, Medtronic; n=906) or EES (Promus Element, Boston Scientific; n=905). Only one patient was lost to follow-up, in the ZES group. The study was an all-comers trial with very few exclusion criteria, and included any patient requiring DES with stable angina and any ACS including STEMI. There was a notably high percentage of patients presenting with STEMI (ZES, 19.3% vs. EES, 21.5%).
The results indicated non-inferiority, showing no difference in the primary endpoint of target vessel failure (cardiac death target-vessel MI, and clinically driven TVR at 1 year) between the two groups (see Figure). There were also no differences between groups with regard to the individual component endpoints; target vessel-related MI occurred in 2.2% of ZES patients and 1.3% of EES patients (P=.154) and showed flat curves after early events, which von Birgelen suggested represent a safety signal for both stents.
There were also very low rates of stent thrombosis in both groups. Five patients in the ZES group had definite or probable stent thrombosis at 1 year vs. eight patients in the EES group (0.55% vs. 0.88%; P=.40). Subgroup analyses showed no differences in the primary endpoint across all subgroups studied.
Von Birgelen said that every patient in the trial was reviewed for longitudinal stent deformation: Nine patients in the EES group did have stent deformation vs. none in the ZES group (P=.002). Importantly, however, the deformation was not associated with any adverse clinical events.
“Use of third-generation… stents in an ‘all-comers’ population resulted in excellent clinical outcomes, especially in view of the large number of patients treated for acute MI,” von Birgelen concluded.
In a discussion of the trial, Alexandra J. Lansky, MD, of Yale School of Medicine, New Haven, Conn., said the trial is reassuring. “What we’re seeing is a growing body of evidence of these third-generation stents performing extremely well,” she said.
Stephan Windecker, MD, of Swiss Cardiovascular Center Bern, Switzerland, added that this study should largely put to rest concerns that mechanical differences have any clinical relevance.
Birgelen reports receiving consulting fees, honoraria, institutional research grants, and travel support from several device manufacturers, including trial sponsors Boston Scientific and Medtronic CardioVascular.
Lansky reports no relevant conflicts of interest.
Windecker reports receiving research/grant support from several device manufacturers.