作者
Michael D Dake, Gary M Ansel, Michael R Jaff, Takao Ohki, Richard R Saxon, H Bob Smouse, Thomas Zeller, Gary S Roubin, Mark W Burket, Yazan Khatib, Scott A Snyder, Anthony O Ragheb, J King White, Lindsay S Machan
发表日期
2011/10
期刊
Circulation: Cardiovascular Interventions
卷号
4
期号
5
页码范围
495-504
出版商
Lippincott Williams & Wilkins
简介
Background
Sustained benefits of drug-eluting stents in femoropopliteal arteries have not been demonstrated. This prospective, multinational, randomized study was designed to compare the 12-month safety and effectiveness of a polymer-free, paclitaxel-coated nitinol drug-eluting stent (DES) with percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement in patients with femoropopliteal peripheral artery disease.
Methods and Results
Patients were randomly assigned to primary DES implantation (n=236) or PTA (n=238). Demographics and lesion characteristics were similar between groups (eg, average lesion length, approximately 65±40 mm). One hundred twenty patients had acute PTA failure and underwent secondary random assignment to provisional DES (n=61) or BMS (n=59). Primary end points were the 12-month rates of event-free survival and patency in the primary …
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