Low-molecular-weight heparin for prevention of restenosis after femoropopliteal percutaneous transluminal angioplasty: A randomized controlled trial
Low-molecular-weight heparin for prevention of restenosis after femoropopliteal percutaneous transluminal angioplasty: A randomized controlled trial
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DOI：
10.1016/j.jvs.2006.07.044
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发表时间：
2006-12-01
影响因子：
4.3
通讯作者：
van der Loo, Bemd
中科院分区：
文献类型：
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作者：
Koppensteiner, Renate;Spring, Silviana;van der Loo, Bemd
背景：血管成形术后再狭窄主要是由于内膜增生。低分子肝素（LMWHs）除了具有抗血栓特性外，还具有抗增殖作用。它们在减少再狭窄方面的潜力仍有待确定。因此，我们想验证低分子肝素加阿司匹林在减少经皮腔内血管成形术（PTA）患者再狭窄/再闭塞发生率方面比阿司匹林单用更有效的假设。此外，低分子肝素在重症肢体缺血（CLI）或仅跛行患者中的不同作用有待进一步研究。PTA治疗成功后，275例有症状的外周动脉疾病（腿行或严重肢体缺血）和股腘动脉梗阻的患者被随机分为两组，一组接受2500 IU达尔特帕林皮下注射3个月，另一组每天服用100 mg阿司匹林（n = 137），另一组每天单独服用100 mg阿司匹林（n = 138）。主要终点是12个月时双超声成像记录的再狭窄或再闭塞。结果：达尔他帕林组58例（44%）出现再狭窄/再闭塞，对照组62例（50%）出现再狭窄/再闭塞（P = 0.30）。在根据外周动脉疾病严重程度进行的亚组分析中，我们发现在接受跛行治疗的患者中，dalteparin组中有43例（43%）出现再狭窄/再闭塞，对照组中有35例（41%）出现再狭窄/再闭塞（P = 0.70）；在接受CLI治疗的患者中，达特帕林组再狭窄/再闭塞发生率（15.45%）显著低于对照组（27.72%;P = 0.01）。两组均未发生大出血事件。在股腘动脉PTA术后3个月给予2500 IU达特帕林皮下治疗未能减少12个月时的再狭窄/再闭塞。然而，在12个月的随访中，达特帕林可能对CLI患者亚组有益。
Background: Restenosis after angioplasty is essentially due to intimal hyperplasia. Low-molecular-weight heparins (LMWHs) have experimentally been shown to have antiproliferative effects in addition to their antithrombotic properties. Their potential in reducing restenosis remains to be established. Therefore, we wanted to test the hypothesis that LMWH plus aspirin is more effective than aspirin alone in reducing the incidence of restenosis/reocclusion in patients undergoing percutaneous transluminal angioplasty (PTA) of femoropopliteal arteries. Further, different effects of LMWH in patients treated for critical limb ischemia (CLI) or claudication only should be investigated.Methods. After successful PTA, 275 patients with symptomatic peripheral arterial disease (claudication or critical limb ischemia) and femoropopliteal obstructions were randomized to receive either 2500 IU of dalteparin subcutaneously for 3 months plus 100 mg of aspirin daily (n = 137), or 100 mg aspirin daily alone (n = 138). The primary end point was restenosis or reocclusion documented by duplex ultrasonography imaging at 12 months.Results: Restenosis/reocclusion occurred in 58 patients (44%) in the dalteparin group and in 62 patients (50%) in the control group (P = .30). In a subgroup analysis according to the severity of peripheral arterial disease, we found that in patients treated for claudication, restenosis/reocclusion developed in 43 (43%) in the dalteparin group, and in 35 (41%) in the control group (P = .70); in patients treated for CLI, restenosis/reocclusion was significantly lower in the dalteparin group (15, 45%) than in the control group (27, 72%; P = .01). No major bleeding events occurred in either group.Conclusions. Treatment with 2500 IU dalteparin subcutaneously given for 3 months after femoropopliteal PTA failed to reduce restenosis/reocclusion at 12 months. However, dalteparin may be beneficial in the subgroup of patients with CLI at 12 months follow-up.