Medtronic’s Resolute zotarolimus-eluting stent was found to be as safe and effective as Abbott Vascular’s Xience V everolimus-eluting stent in a predominantly off-label population, based on the results of the RESOLUTE all-comers trial, presented Tuesday by Patrick W. Serruys MD, PhD, at EuroPCR in Paris.
Serruys, an interventional cardiologist from the Thoraxcenter, Erasmus Medical Center in Rotterdam, the Netherlands, and colleagues designed the RESOLUTE all-comers trial to enroll any patient with symptomatic coronary artery disease and randomize them to either the Resolute arm, which ended up with 1,152 patients, or the Xience V arm, which had 1,140 patients, at 17 European sites. They conducted rapid enrollment over six months.
According to the researchers, the only patients who were excluded were those with a known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, everolimus, zotarolimus and contrast material. Also excluded were those patients with planned, elective surgery within six months of PCI (unless dual anti-platelet therapy could be maintained); those who were pregnant; or those participating in another trial.
The trial’s primary endpoint was 12-month target lesion failure (TLF), composite of cardiac death, target vessel MI and clinically driven TLR, Serruys reported.
For patient characteristics, the patients were matched almost identically. Each arm had a mean age of 64 years, 77 percent were men, 1.5 lesions were treated per patient and the Syntax Score was 15. Interestingly, 67 percent in the Resolute arm were off-label uses, as were 66 percent in the Xience V arm.
For the primary endpoint of TLF, which was defined as cardiac death, target vessel MI and ischemia driven target lesion revascularization (ID-TLR) at one year, the Resolute arm was 8.2 percent and 8.3 percent in the Xience V arm. Specifically, Resolute had a lower incidence of cardiac death (1.3 vs. 1.7 percent); Resolute had a slightly higher incidence of target vessel MI (4.2 vs. 4.1 percent); and likewise, Resolute had a higher incidence of ID-TLR (3.9 vs. 3.4).
Also, for the composite clinical endpoints, Serruys reported that Resolute had lower incidence of target vessel failure (8 vs. 8.8 percent) and major adverse coronary events (8.7 vs. 9.7 percent), compared with Xience V.
While there was slightly more, early incidence of definite and definite/probable stent thrombosis in the Resolute arm, those findings did not translate into differences in cardiac death or target vessel MI, according to Serruys. Though the rates were slightly higher in the Resolute arm, the stent thrombosis rates were low with both stents—1.2 versus 0.3 percent for definite stent thrombosis out to 360 days; and 1.6 versus 0.7 percent in the definite/probable stent thrombosis rates out to 360 days.
For the secondary endpoint, the in-stent late loss at 13 months was 0.27 percent in the Resolute arm (188 lesions) and 0.19 percent in the Xience V arm (177 lesions).
Based on the findings, the researchers concluded that both the Resolute and the Xience V were "associated with a relatively low frequency of adverse events even in this complex, all-comers patient population."