NEW YORK (Reuters Health) – The new-generation zotarolimus-eluting coronary stent was as safe and effective after 13 months’ follow-up as the everolimus-eluting stent in a study with minimal exclusion criteria, according to a New England Journal of Medicine report issued online June 16th.

The open-label Resolute All Comers Trial involved over 2000 patients undergoing percutaneous coronary intervention (PCI). Lead author Dr. Patrick W. Serruys, from Erasmus Medical Center, Rotterdam, the Netherlands, and his European colleagues randomly assigned 1119 patients to the Resolute zotarolimus stent (Medtronic CardioVascular) and 1126 to the Xience V everolimus stent (Abbott Vascular Devices).

No restrictions were placed on the number of treated lesions or the number of stents implanted. Two-thirds of patients had at least one off-label criterion, such as renal insufficiency, acute myocardial infarction within the previous 72 hours, or an ejection fraction less than 30%.

The primary composite end point of target-lesion failure — defined as death from cardiac causes, myocardial infarction, or target-lesion revascularization — occurred in 8.2% of patients in the zotarolimus group and 8.3% in the everolimus group, the authors report (p < 0.001 for noninferiority). During the first 30 days, fewer patients died in the zotarolimus group than in the everolimus group (0.2% vs 0.9%, respectively, p = 0.04), although the between-group difference was no longer significant at 12 months (1.6% vs 2.8%, p = 0.08). The rate of definite stent thrombosis at one year was higher with zotarolimus (1.2% vas 0.3%, p = 0.01). The authors point out that this did not cause an excessive rate of MI or death. Approximately 20% of patients underwent coronary angiography at 13 months, when Dr. Serruys and colleagues determined that there was no significant difference for in-stent late loss or binary restenosis. The rate of adverse events was also similar with the two types of stent. The authors conclude that these initial findings indicate that the zotarolimus-eluting stent was noninferior to the everolimus-eluting stent. The team will continue to follow the patients annually for 5 years. Reference
Medtronic CardioVascular was the sponsor of the study.

N Engl J Med 2010.