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ENDEAVOR III: In-segment late loss greater with zotarolimus-eluting stent
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WASHINGTON — The zotarolimus-eluting Endeavor stent had significantly greater in-stent late loss than the sirolimus-eluting Cypher stent and did not achieve the noninferiority endpoint in ENDEAVOR III, the first head-to-head comparison of drug-eluting stents conducted in the United States.
In-segment late loss with Endeavor (Medtronic) was 0.34 mm at the eight-month follow-up vs. 0.13 mm with Cypher (Cordis), according to results presented by David E. Kandzari, MD, from Duke University Medical Center. The trial had been powered to show noninferiority at a difference ≤0.20 mm. Cypher also had superior in-stent late loss compared with Endeavor (0.15 mm vs. 0.60 mm, respectively).
No significant differences were reported between Endeavor and Cypher in the secondary clinical endpoints of major adverse coronary events, target lesion revascularization, target vessel revascularization and target vessel failure at nine months.
Endeavor had a superior device success rate vs. Cypher (98.8% vs. 94.7%), defined as <50% residual in-segment percent diameter stenosis with assigned stent, and superior procedure success (98.1% vs. 91.2%, respectively), defined as <50% residual in-segment percent diameter stenosis with assigned stent and without in-hospital major adverse coronary events, Kandzari said.
The clinical and angiographic findings from ENDEAVOR III in a U.S. population were consistent with the international ENDEAVOR II trial. Enrollment has begun for ENDEAVOR IV, which will compare the Endeavor stent with the Taxus stent.
For ENDEAVOR III, 327 patients were randomly assigned to treatment with the Endeavor stent and 109 to the Cypher. Average lesion length in patients receiving Endeavor was 14.98 mm, compared to 14.95 mm for patients who received Cypher. Patients received an average of 1.1 stents totaling 22.3 mm in the Endeavor arm, compared to 1.2 stents totaling 23 mm in the Cypher arm. Endeavor had a higher rate of volume obstruction than Cypher (16.1% vs. 2.7%) and a lower rate of late incomplete apposition (0.5% vs. 5.9%).
Discussant Patrick Serruys, MD, PhD, from the Thoraxcenter in The Netherlands, noted the comparable results between the two stents and questioned whether in-segment late loss was an appropriate benchmark. Serruys said it can be misleading since it may be a hybrid of other more significant measurements.