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首页> 外文期刊>Journal of vascular and interventional radiology: JVIR >Batroxobin plus aspirin reduces restenosis after angioplasty for arterial occlusive disease in diabetic patients with lower-limb ischemia.
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Batroxobin plus aspirin reduces restenosis after angioplasty for arterial occlusive disease in diabetic patients with lower-limb ischemia.

机译：在患有下肢缺血的糖尿病患者中，巴曲酶加阿司匹林可减少动脉闭塞性疾病血管成形术后的再狭窄。

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PURPOSE: Aspirin is routinely given to reduce vascular events after angioplasty. Batroxobin has been shown to effectively prevent thrombosis after angioplasty via inhibition of the fibrinogen concentration. In this randomized clinical trial, the hypothesis that batroxobin plus aspirin is more effective than aspirin alone in reducing the incidence of restenosis/reocclusion in patients with diabetes undergoing angioplasty for lower-limb ischemia. MATERIALS AND METHODS: Patients with diabetes and symptomatic arterial obstructions (N = 129) were randomized to receive aspirin 100 mg/d plus batroxobin 5 IU every other day for six doses (n = 58) or aspirin alone (n = 71). The primary outcome was restenosis documented by magnetic resonance (MR) angiography or duplex imaging at 12 months. Secondary outcomes included amputation above the ankle, death, and cumulative rate of amputation or death. Kaplan-Meier analysis was used to evaluate limb salvage and survival rates. RESULTS: After 12 months, restenosis had occurred in 43.1% and 29.7% of patients in the control and batroxobin groups, respectively (P = .0018). MR angiography and duplex imaging revealed an improved restenosis rate for infrapopliteal lesions and for lesions longer than 10 cm (P = .0016). The primary and cumulative secondary outcomes indicated significant improvements in restenosis rate, symptom relief, and amputation rates in the batroxobin group compared with the aspirin-only group. Kaplan-Meier analysis showed limb salvage and survival rates of 78.3% in the aspirin-only group and 92.2% in the batroxobin group 12 months after angioplasty (log-rank test, P = .0414). CONCLUSIONS: Batroxobin plus aspirin reduced the rate of restenosis after arterial angioplasty, particularly in lesions located below the knee and in those longer than 10 cm, with better clinical symptom relief and improved rate of limb salvage.
机译：目的：常规应用阿司匹林以减少血管成形术后的血管事件。已显示巴曲酶可通过抑制纤维蛋白原浓度有效预防血管成形术后的血栓形成。在这项随机临床试验中，巴曲酶加阿司匹林比单独使用阿司匹林在降低患有下肢缺血性血管成形术的糖尿病患者中的再狭窄/再闭塞的发生率降低方面更有效。材料与方法：糖尿病和有症状性动脉阻塞的患者（N = 129）被随机分配接受阿司匹林100 mg / d加巴曲酶5 IU，隔六天一次（n = 58）或单独接受阿司匹林（n = 71）。主要结局是在12个月时通过磁共振（MR）血管造影或双重成像记录的再狭窄。次要结局包括脚踝以上截肢，死亡以及截肢或死亡的累计发生率。 Kaplan-Meier分析用于评估肢体抢救和生存率。结果：在12个月后，对照组和巴曲酶组的患者分别发生再狭窄（43.1％）和29.7％（P = .0018）。 MR血管造影和双工成像显示，in下病变和长于10 cm的病变的再狭窄率提高（P = .0016）。与纯阿司匹林组相比，巴曲酶组的主要和累积次要结局表明再狭窄率，症状缓解和截肢率显着改善。 Kaplan-Meier分析显示，仅阿司匹林组肢体抢救和存活率在血管成形术后12个月为78.3％，巴曲酶组为92.2％（对数秩检验，P = .0414）。结论：巴曲酶加阿司匹林降低了动脉血管成形术后的再狭窄率，特别是在膝盖以下和长于10 cm的病变中，具有更好的临床症状缓解和提高了肢体抢救率。

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