Dörffler-Melly J, Koopman M M W, Prins M H, Büller H R
Swiss Cardiovascular Center, Division for Angiology, University Hospital of Berne, Freiburgstrasse 4, Berne, Switzerland, 3010.
Cochrane Database Syst Rev. 2005 Jan 25(1):CD002071. doi: 10.1002/14651858.CD002071.pub2.
Peripheral arterial disease (PAD) is frequently treated by balloon angioplasty. Restenosis/reocclusion of the dilated segments occurs often depending on length of occlusion, lower leg outflow, stage of disease and presence of cardiovascular risk factors. To prevent reocclusion, patients are treated with antithrombotic agents.
To determine whether any antithrombotic drug is more effective in preventing reocclusion after peripheral endovascular treatment, compared to another antithrombotic drug, no treatment, placebo, or other vasoactive drugs.
We searched the Cochrane Peripheral Vascular Diseases Group's trials register (last searched April 2004), the Cochrane Central Register of Controlled trials (CENTRAL Issue 2, 2004), MEDLINE and EMBASE (last searched June 2004).
Randomised trials were categorised as A (double or single blinded) or B (not blinded). Participants included patients with symptomatic PAD treated by endovascular revascularisation of the pelvic or femoropopliteal arteries. Interventions were anticoagulant, antiplatelet or other vasoactive drug therapy compared with no treatment, placebo, or any other vasoactive drug. Clinical endpoints were re-obstruction, amputation, death, myocardial infarction, stroke and major bleeding.
Details of the number of randomised patients, treatment, study design, study category, allocation concealment and patient characteristics were extracted. Analysis was based on intention-to-treat data. To examine the effects of binary outcomes such as amputation and major bleeding, odds ratios were computed using a fixed effect model. The 95% confidence intervals of the effect sizes were calculated.
A 60% reduction of recurrent obstruction was found with aspirin (ASA) 330 mg combined with dipyridamol (DIP) as compared to placebo at 12 months follow-up. At six months following endovascular treatment, a positive effect on patency was found with 50 to 100 mg ASA combined with DIP (n = 356). However, this was not significant. ASA/DIP tended towards showing a superior effect on patency after femoropopliteal angioplasty compared with VKA at three, six, and twelve months. Periinterventional treatment with LMWH in femoropopliteal obstructions resulted in significantly lower restenosis/reocclusion rates than with unfractionated heparin.
AUTHORS' CONCLUSIONS: Aspirin 50 to 300 mg started prior to femoropopliteal endovascular treatment appears to be the most effective and is safe. Clopidogrel might be an alternative, but data are lacking. Abciximab might be a useful adjunctive for high risk patients with long segmental femoropopliteal interventions. Low molecular weight heparin seems to be more effective in preventing reocclusion or restenosis than unfractionated heparin.
外周动脉疾病(PAD)常采用球囊血管成形术治疗。扩张段的再狭窄/再闭塞经常发生,这取决于闭塞长度、小腿流出道、疾病阶段以及心血管危险因素的存在情况。为预防再闭塞,患者需接受抗血栓药物治疗。
确定与其他抗血栓药物、不治疗、安慰剂或其他血管活性药物相比,任何一种抗血栓药物在预防外周血管腔内治疗后再闭塞方面是否更有效。
我们检索了Cochrane外周血管疾病组的试验注册库(最后检索时间为2004年4月)、Cochrane对照试验中央注册库(2004年第2期)、MEDLINE和EMBASE(最后检索时间为2004年6月)。
随机试验分为A类(双盲或单盲)或B类(非盲)。参与者包括通过盆腔或股腘动脉血管腔内血运重建治疗的有症状PAD患者。干预措施为抗凝、抗血小板或其他血管活性药物治疗,并与不治疗、安慰剂或任何其他血管活性药物进行比较。临床终点为再阻塞、截肢、死亡、心肌梗死、中风和大出血。
提取随机分组患者数量、治疗方法、研究设计、研究类别、分配隐藏和患者特征的详细信息。分析基于意向性治疗数据。为检验截肢和大出血等二元结局的影响,使用固定效应模型计算比值比。计算效应量的95%置信区间。
在12个月随访时,与安慰剂相比,发现330毫克阿司匹林(ASA)联合双嘧达莫(DIP)可使复发阻塞减少60%。在血管腔内治疗后6个月,50至100毫克ASA联合DIP(n = 356)对通畅有积极影响。然而,这并不显著。与华法林相比,在3个月、6个月和12个月时,ASA/DIP在股腘动脉血管成形术后对通畅的影响倾向于显示出更优效果。在股腘动脉阻塞的围手术期用低分子肝素治疗导致再狭窄/再闭塞率显著低于普通肝素。
在股腘动脉血管腔内治疗前开始使用50至300毫克阿司匹林似乎是最有效且安全的。氯吡格雷可能是一种替代药物,但缺乏数据。对于长节段股腘动脉干预的高危患者,阿昔单抗可能是一种有用的辅助药物。低分子肝素在预防再闭塞或再狭窄方面似乎比普通肝素更有效。