Medtronic has presented first results of the Resolute All Comers study at the clinical trial session of the 2010 EuroPCR meeting. In the 2,292-patient randomized trial, the Resolute zotarolimus-eluting stent from Medtronic was found to be as safe and effective as the Xience V everolimus-eluting stent from Abbott Laboratories.
Medtronic claimed that this is the first major device study to directly compare company’s Resolute drug-eluting stent (DES) to the current platform. The design of the Resolute All Comers study included patients that are not typically enrolled in comparative clinical studies, making the results highly representative of real-world clinical practice.
According to the study, at one year, the Resolute DES was shown to be as effective as the Xience DES in reducing the need for repeat procedures, and both second-generation stents were associated with low and similar rates of death from cardiac causes and heart attacks attributed to the treated vessel. The primary endpoint of the study was target lesion failure (TLF). The Resolute DES posted TLF rates of 8.2 % versus 8.3 % for the Xience DES.
The Resolute drug-eluting stent is indicated for improving coronary luminal diameter and reducing restenosis in patients with symptomatic ischemic heart disease in de novo coronary artery lesions in native coronary arteries with a reference vessel diameter of 2.25mm to 4.0mm. In the US, the Resolute DES is not available for sale and is limited by federal law to investigational use only.
Patrick Serruys, professor and director of the Thoraxcenter at Erasmus University in Rotterdam, the Netherlands, and one of three principal investigators for Resolute All Comers, said: “Given the rigorous design and conduct of this, multicenter randomized clinical trial, it is clear that the Resolute drug-eluting stent has distinguished itself as an important treatment option for a wide range of patients undergoing percutaneous coronary intervention.”