WASHINGTON, D.C.—The two-year data comparing Medtronic’s Endeavor zotarolimus-eluting stent and Boston Scientific’s Taxus paclitaxel-eluting stent in patients with coronary artery disease demonstrated similar efficacy outcomes; however, safety results seem to trending slightly in favor of Endeavor, according to a late breaking clinical trial presented Tuesday at the 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
Principal investigator Martin L. Leon, MD, co-director of TCT from Columbia University Medical Center in New York City, presented the two-year follow-up for the ENDEAVOR IV investigators. The study includes more than 1,500 patients in both groups.
He said that for the primary endpoint, the incidence of target vessel failure (TVF) at 24 months was 13.1 percent for Taxus and 11 percent for Endeavor, which is not statistically significant “There is no evidence of late catch-up between one year and two year data,” Leon stated.
The incidence of target lesion revascularization (TLR) was 6 percent for the Endeavor group and 4.7 percent in the Taxus group.
For the safety endpoints at 24 months shows that MI out to two years 30 events in Taxus group, and 15 events in the Endeavor group, which Leon defined as the “first major finding,” indicating a difference in the safety profile of the stents.
The ARC definite probably stent thrombosis outcomes between one to two years were 0.1 percent for Endeavor, and 0.8 percent for Taxus. Leon noted that the Taxus events clustered after one year, in contrast to the Endeavor events of stent thrombosis.
“The Endeavor is performing very much like a bare-metal stents, and is performing well among second-generation stents,” he said.
Leon concluded that for efficacy, the stents show continued similar TLR and TVR, even in high restenosis risk subgroups, such as diabetics, and especially in the patients with only clinical follow-up.
However, Leon said that the safety outcomes show reduced ARC definite/probable very late stent thrombosis (1 vs. 6 events), even in the setting of frequent dual-antiplatelet use; and reduced MIs linked to the decrease in very late stent thrombosis events.
He also said that the ENDEAVOR IV Safety findings consistent with the larger pooled analysis of Endeavor studies.
Leon said that in the Columbia University lab, about 75 percent of stents used are either Medtronic’s Endeavor or Abbott Vascular’s Xience. He added that in the month of August, 71 percent of labs in the U.S. are using one of the second-generation stents.