RESOLUTE Global: 5 Years of Zotarolimus DES Stenting

This study assessed the cumulative incidence of cardiovascular evens after zotarolimus eluting stent implantation.

Individual studies often lack enough statistical power to show differences in low frequency adverse events. The Resolute zotarolimus eluting stent was evaluated across 10 prospective clinical trials designed with identical adverse events definitions.

The Global Resolute clinical trial program included a total of 7,618 patients, from the Resolute first-in-human (n=139) to the Resolute International (n=2349); all 10 studies were carried out in the US, China or Japan, specifically.

The cumulative incidence of cardiac events at 5 years was 13.4% for target vessel failure, which included 5% of cardiac death, 4.4% of target vessel acute myocardial infarction and 6.3% ischemia driven target vessel revascularization.

Dual antiaggregation therapy rate at 1. 3 and 5 years was 91%, 37% and 32% respectively.

The cumulative incidence of probable or definite thrombosis at 5 years was 1.2%, which included 0.7% of thrombosis the first year and an annualized risk of 0.1% per year as from the second year and up to the fifth.

The use of dual antiaggregation at 5 years varied geographically; it reached 63% in Japan and only 11% in Europe.

Conclusion

This the largest study of patients receiving the zotarolimus eluting stent so far. Most of events associated to this device, including target vessel myocardial infarction and stent thrombosis, occurred the first year and risk decreased significantly as time went by.

Original Title: 5-Year Safety and Efficacy of Resolute Zotarolimus-Eluting Stent: The RESOLUTE Global Clinical Trial Program.

Reference: Yeh RW et al. JACC CardiovascInterv. 2017 Feb 13;10(3):247-254.

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