Medtronic has reported that new clinical data from a second, large international study enrolled 'All Comers,' regardless of disease complexity and comorbidities, has demonstrated strong performance of the Resolute drug-eluting stent (DES).
Medtronic said that the findings include one-year results for Resolute International, two subsets from Resolute All Comers, and four-year results for the Resolute feasibility study, which supported the CE (Conformite Europeenne) mark of the Resolute DES.
In the Resolute International clinical study, at one year on the primary and secondary endpoints, the event rates are low in comparison to All-Comers population that consists of a relatively high number of patients with complex disease.
Resolute All Comers is the randomized controlled trial designed to compare Medtronic’s Resolute DES and Abbott’s Xience V DES head-to-head in two patient subsets, acute myocardial infarction (AMI) and multi-vessel intervention (MVI).
As per the results, in the AMI subset, defined by stent thrombosis (ST) segment elevation myocardial infarction (STEMI) within 12 hours of the procedure, there was a statistically equivalent but numerically lower rate of target lesion failure (TLF) in the Resolute arm versus the Xience arm.
In the MVI subset, there was also a statistically equivalent but numerically lower rate of TLF in the Resolute arm versus the Xience arm, whose results are similar to Resolute International for these subsets.
As per the study, at one year, the Resolute DES was shown to match the Xience V DES on important measures of both safety and efficacy.
According to the Resolute Feasibility study, at four years of patient follow-up, the results showed stable clinical efficacy with a low TLR rate of 2.3% and no stent thrombosis.