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Results of the PEPCAD-DES trial reported at TCT 2011
Date:11/11/2011

SAN FRANCISCO, CA NOVEMBER 11, 2011 A clinical trial of patients with restenosis in drug-eluting stents (DES) in native coronary arteries found that treatment with paclitaxel-coated balloon angioplasty demonstrated superior results over plain old uncoated-balloon angioplasty (POBA). Results from the PEPCAD-DES clinical trial were presented today at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.

The incidence of drug-eluting stent restenosis (DES-ISR) remains frequent due to the continuous increase in DES implantations. Treatment of in-stent restenosis (ISR) with an additional stent implantation adds another metal layer within the coronary arteries, abolishing the physiologic vasoreactivity of the vessel. Drug-eluting stents significantly reduce the occurrence of restenosis and the subsequent need for repeat vascularization.

Paclitaxel eluting-balloon angioplasty has been shown to be superior to POBA for the treatment of ISR in bare-metal stents (BMS). Whether it is also effective in ISR of different drug-eluting stents has not been extensively studied so far. The PEPCAD DES trial compared the efficacy of the paclitaxel-eluting balloon catheter for treatment of ISR in DES in native coronary arteries to uncoated balloon angioplasty to methodologically assess the efficacy of the balloon mediated drug coating.

This randomized, multicenter, single blinded trial was conducted at six centers and included 110 patients with ISR of DES in multiple stent types. They were divided into two treatment groups: 72 for drug-coated balloon (DCB) angioplasty and 38 for POBA to achieve 90% power. Inclusion criteria were: lesion in native coronary artery, DES restenosis of sirolimus-eluting, everolimus-eluting, or paclitaxel-eluting stents, indication for percutaneous coronary intervention, reference diameter ranging from 2.5 mm to 3.5 mm and a lesion length le
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Contact: Judy Romero
jromero@crf.org
Cardiovascular Research Foundation
Source:Eurekalert

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