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September 23, 2009

One-Year COMPARE Results Presented at TCT


September 24, 2009—At the Transcatheter Cardiovascular Therapeutics (TCT) 2009 scientific symposium in San Francisco, the results of the COMPARE trial demonstrated improved safety and efficacy with the Xience V everolimus-eluting coronary stent system (Abbott Vascular, Santa Clara, CA) compared to the Taxus Liberté paclitaxel-eluting coronary stent system (Boston Scientific Corporation, Natick, MA), reported the conference newspaper, TCT Daily.



TCT Course Director Gregg W. Stone, MD, first presented results showing that Xience V significantly reduced target lesion failure (the study's primary endpoint) at 1-year follow-up compared with Taxus Express2 (Xience V 4.2% vs Taxus 6.8%) in the SPIRIT IV trial, the largest of the SPIRIT trials to date.



Peter C. Smits, MD, then presented results of the COMPARE trial demonstrating that in an all-comer population, the everolimus-eluting Xience V stent significantly reduced major adverse cardiac events compared with the Taxus Liberté stent. Superiority of Xience V was reached mainly due to less target lesion revascularization (TLR) and less early stent thrombosis.



The COMPARE data showed that Xience V bested Taxus in the primary endpoint of combined all-cause death, nonfatal myocardial infarction, and target vessel revascularization (TVR) at 1 year, with a rate of 9.1% in the Taxus group (n = 903) versus 6.2% (P = .023) in the Xience V group (n = 897). All-cause death and cardiac death, meanwhile, were equivalent between groups (P = .58 for all-cause death; P = .81 for cardiac death). TVR and ischemia-driven TLR were lower with Xience V (P = .0001 for TVR; P = .0002 for TLR). Xience V also outperformed Taxus in the trial's secondary endpoint of major adverse cardiac events. Furthermore, there was less stent thrombosis (ARC-defined definite and probable) in the Xience V group versus the Taxus group (P = .002).



"It was remarkable to me how similar these two trials were," commented Dr. Stone on SPIRIT IV and COMPARE during the discussion portion of the COMPARE trial. "The largest take home message is there's a difference between clinical trials we do for regulatory purposes and clinical trials we do to find the truth . . . .You have to do much larger trials in real-world populations to really see the differences between the devices, and that's a trend that needs to continue."

Abbott Vascular supplies a private label version of Xience V to Boston Scientific called the Promus everolimus-eluting coronary stent system. Promus is designed and manufactured by Abbott and supplied to Boston Scientific as part of a distribution agreement between the two companies.

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September 24, 2009

Two-Year FAME Results Show Benefit of FFR Guidance

September 24, 2009

Two-Year FAME Results Show Benefit of FFR Guidance