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European Society of Cardiology In Brief

This article was originally published in The Gray Sheet

Executive Summary

SCAAR: Data from the Swedish Angiography and Angioplasty Registry (SCAAR) suggest Medtronic's Endeavor zotarolimus-eluting stent is associated with a higher risk of restenosis than Boston Scientific's Taxus Liberté and Taxus Express paclitaxel-eluting stents and Johnson & Johnson/Cordis' Cypher sirolimus-eluting stents. On September 2 at the European Society of Cardiology conference in Munich, Bo Lagerqvist, Akademiska University Hospital in Uppsala, presented restenosis rate projections based on data from the 18-year Swedish national registry (1"The Gray Sheet" Sept. 10, 2007, p. 4). Based on data from over 8,000 diabetic patients and 27,000 non-diabetic patients, SCAAR researchers found the relative risk of restenosis with Endeavor is about twice that of its competitors in diabetic patients, but about the same in non-diabetic patients. "This reinforces the need of larger randomized prospective trials with head-to-head comparisons between the different stent types both in diabetics and non-diabetics," Lagerqvist concluded. Medtronic dismissed the finding. "SCAAR is a registry which lacks the rigor and bias-elimination required for device comparison," the company said Sept. 3. "In this most recent presentation, an inexplicable focus on angiographic instead of clinical outcomes further removes the SCAAR dataset from the realm of clinically relevant discussion. Angiographic restenosis and late loss associated with this healing do not translate into clinical events among treated patients." The firm adds that in 2,500 diabetic patients in the ENDEAVOR V trial, the 12-month target lesion revascularization rate was 5.3% - comparable to the 4.5% TLR rate for all patients in the study
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