Randomized Trial of a Distal Embolic Protection Device During Percutaneous Intervention of Saphenous Vein Aorto-Coronary Bypass Grafts

作者: Donald S. Baim , Dennis Wahr , Barry George , Martin B. Leon , Joel Greenberg

DOI: 10.1161/01.CIR.0000012783.63093.0C

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摘要: Background— Stents provide effective treatment for stenotic saphenous venous aorto-coronary bypass grafts, but their placement carries a 20% incidence of procedure-related complications, which potentially are related to the distal embolization atherosclerotic debris. We report first multicenter randomized trial evaluate use embolic protection device during stenting such lesions. Methods and Results— Of 801 eligible patients, 406 were randomly assigned stent over shaft device, 395 conventional 0.014-inch angioplasty guidewire (control group). The primary end point—a composite death, myocardial infarction, emergency bypass, or target lesion revascularization by 30 days—was observed in 65 patients (16.5%) control group 39 (9.6%) (P=0.004). This 42% relative reduction major adverse cardiac events was driven inf...

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