Ansel Gary M, Silver Mitchell J, Botti Charles F, Rocha-Singh Krishna, Bates Mark C, Rosenfield Kenneth, Schainfeld Robert M, Laster Steven B, Zander Carol
Section of Cardiology, Riverside Methodist Hospital, Columbus, Ohio, USA.
Catheter Cardiovasc Interv. 2006 Feb;67(2):288-97. doi: 10.1002/ccd.20593.
To evaluate the effect of glycoprotein IIb/IIIa inhibition during nitinol stenting, of superficial femoral occlusive disease.
Stent implantation in the superficial femoral artery has been associated with suboptimal results while Glycoprotein IIb/IIIa inhibitors have shown improved procedural results during coronary intervention. We evaluated abciximab infusion during (Smart Stent) implantation in superficial femoral obstructions.
We conducted a randomized placebo controlled trial. The two primary end points include: (1) 9-month restenosis defined as a decrease in ankle brachial index and in-stent duplex ultrasound restenosis: (2) adverse events defined as death (30 days) or repeat revascularization within 9 months.
Twenty-seven patients were randomized to abciximab and 24 patients to control (placebo). The primary end point of cumulative restenosis occurred in 15.4% of patients administered abciximab and in 12% administered placebo (P = 0.873). The primary restenosis endpoint in diabetics and total occlusions were similar at 14.3% and 15.4% respectively. The composite end point of 30-day mortality and 9-month revascularization occurred in 5.8% abciximab and 0% (P = 0.274) placebo with no 30-day deaths. Graded treadmill time and Rutherford class were all significantly improved in both groups, but the abciximab group did not appear to demonstrate any identifiable effect.
(Smart Stent) nitinol stenting of the superficial femoral artery was associated with favorable functional outcomes at 9 months. Adjunctive abciximab did not appear to demonstrate any identifiable effect.
评估糖蛋白IIb/IIIa抑制剂在镍钛合金支架置入治疗股浅动脉闭塞性疾病过程中的作用。
股浅动脉支架植入术的效果欠佳，而糖蛋白IIb/IIIa抑制剂在冠状动脉介入治疗中已显示出能改善手术效果。我们评估了阿昔单抗在股浅动脉闭塞病变（智能支架）植入过程中的输注情况。
我们进行了一项随机安慰剂对照试验。两个主要终点包括：（1）9个月时的再狭窄，定义为踝肱指数降低和支架内双功超声显示的再狭窄；（2）不良事件，定义为死亡（30天内）或9个月内再次血管重建。
27例患者被随机分配至阿昔单抗组，24例患者被分配至对照组（安慰剂组）。接受阿昔单抗治疗的患者中累积再狭窄的主要终点发生率为15.4%，接受安慰剂治疗的患者为12%（P = 0.873）。糖尿病患者和完全闭塞患者的主要再狭窄终点相似，分别为14.3%和15.4%。30天死亡率和9个月血管重建的复合终点在阿昔单抗组发生率为5.8%，安慰剂组为0%（P = 0.274），且30天内无死亡病例。两组患者的分级运动平板试验时间和卢瑟福分级均有显著改善，但阿昔单抗组似乎未显示出任何可识别的效果。
股浅动脉镍钛合金（智能支架）支架置入术在9个月时具有良好的功能结局。辅助使用阿昔单抗似乎未显示出任何可识别的效果。
