Angioplasty or bypass for superficial femoral artery disease? - A randomised controlled trial
Angioplasty or bypass for superficial femoral artery disease? - A randomised controlled trial
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DOI：
10.1016/j.ejvs.2004.04.003
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发表时间：
2004-08-01
影响因子：
5.7
通讯作者：
Jacobs, MJ
中科院分区：
文献类型：
--
作者：
van der Zaag, ES;Legemate, DA;Jacobs, MJ
的目标。为了评估血管成形术或膝上搭桥是治疗症状性股浅动脉闭塞病变的最佳方法，我们进行了一项多中心随机试验。患者和方法。在1995年10月至1998年8月期间，纳入了56名患者，所有患者的症状都与5-15厘米长的股浅动脉闭塞病变有关。31例患者随机接受经皮腔内血管成形术（PTA）；25个病人做了搭桥手术。所有患者在手术后1、6和12个月随访。本研究的主要结果是股动脉再次闭塞。30例患者接受了分配的PTA， 24例患者接受了搭桥手术。PTA术后1年累计通畅率为43%，搭桥术后为82%。PTA后，超过一半的患者再次闭塞，绝对风险降低31% (CI: 6-56%)，有利于搭桥手术。PTA与搭桥手术的闭塞风险比为2.24 （95% CI: 0.9-5.58）。尽管有18个参与中心，但只有56名患者被随机分配到PTA我们的搭桥手术。根据我们的结果，每三个接受搭桥手术而不是PTA治疗的患者中，就有一个额外的再闭塞被预防。因此，我们得出结论，对于股浅长动脉（SFA）狭窄或闭塞，手术比PTA更有利于通畅。
Aim. To evaluate whether angioplasty or above-knee bypass is the best treatment for symptomatic superficial femoral artery occlusive lesions, we performed a multicentre randomised trial.Patients and methods. Between October 1995 and August 1998, 56 patients were enrolled, all with symptoms related to a 5-15 cm long occlusive lesion of the superficial femoral artery. Thirty-one patients were randomly assigned to percutaneous transluminal angioplasty (PTA); 25 patients to bypass surgery. All patients were followed at 1, 6 and 12 months after the procedure. The primary outcome of our study was re-occlusion of the femoral artery.Results. Thirty patients underwent the allocated PTA and 24 patients underwent bypass surgery. Cumulative 1-year primary patency after PTA was 43 and 82% after bypass surgery. After PTA more than half of the patients had a re-occlusion with an absolute risk reduction of 31% (CI: 6-56%) in favour of bypass surgery. The hazard ratio for occlusion comparing PTA with bypass surgery is 2.24 (95% CI: 0.9-5.58).Conclusion. Despite 18 participating centres only 56 patients were randomised to PTA our bypass surgery. Based on our results, for every three patients treated with bypass surgery instead of PTA, one additional re-occlusion is prevented. Therefore, we conclude that with respect to patency, for long superficial femoral artery (SFA) stenoses or occlusions, surgery is better than PTA.