ENDEAVOR IV (Randomized Comparisonof Zotarolimus- and Paclitaxel-ElutingStents in Patients With CAD)
ENDEAVOR IV (Randomized Comparison of Zotarolimus-and Paclitaxel-Eluting Stents in Patients With CAD)M Leon (Columbia University, New York, NY)Transcatheter Cardiovascular Therapeutics 2007 Meeting• A randomized, single-blind study comparing the Endeavor and Taxus stents in more than 1500 patients• Primary outcome: Target vessel failure: a composite of cardiac death, MI, and target vessel revascularization at nine months
ENDEAVOR IV: ResultsENDEAVOR IV: ENDEAVOR IV:Nine- and 12-month results Eight-month angiographic follow-upEnd point Endeavor (%) Taxus (%) p End point Endeavor Taxus p9-mo TVF 6.6 7.2 <0.001* % diameter 26 16 <0.001 stenosis, in-stent12-mo TVF 7.7 9.4 0.267 % diameter 32 26 0.004 stenosis, in-segment9-mo TVR 5.4 4.9 0.728 Late loss, in-stent 0.67 0.42 <0.001 (mm)12-mo TVR 6.3 6.7 0.753 Late loss, 0.36 0.23 0.023 in-segment (mm)• Endeavor stent noninferior to Taxus • In-segment late lumen loss greaterin terms of primary end point for Endeavor stentTVF = target vessel failure; TVR = target vessel revascularization*p for noninferiority
ENDEAVOR IV: Commentary*"We think this is an important trial because its the basis for approval of the next[drug-eluting stent] in the United States. I wouldnt necessarily use the worldblockbuster. " - Dr Marty Leon"My concern is whether the failure of Endeavor to meet the noninferioritysecondary end point of in-segment late loss may become even more evident in ahigher-risk patient cohort. . . . But that still remains to be demonstrated." - Dr Patrick Serruys*All comments from Endeavor IV results get mixed reviews: Interventionalists prove a tougher crowdthan FDA panel (http://www.theheart.org/article/820229.do)
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