Batroxobin Plus Aspirin For Preventing Restenosis After Angioplasty For Arterial Occlusive Disease In Diabetic Patients With Lower-limb Ischemia

Purpose: Aspirin is routinely given to reduce vascular events after angioplasty.Batroxobin has been shown to effectively prevent thrombosis after angioplasty viainhibition of the fibrinogen concentration. In this randomized clinical trial, the hypothesisthat batroxobin plus aspirin is more effective than aspirin alone in reducing the incidenceof restenosis/reocclusion in patients with diabetes undergoing angioplasty for lower-limbischemia.Materials and Methods: Patients with diabetes and symptomatic arterial obstructions(n=110) were randomized to receive aspirin100mg/d plus batroxobin5IU every otherday for six doses (n=50) or aspirin alone (n=60). The primary outcome was restenosisdocumented by magnetic resonance (MR) angiography or duplex imaging at12months.Secondary outcomes included amputation above the ankle, death, and cumulative rate ofamputation or death. Kaplan–Meier analysis was used to evaluate limb salvage andsurvival rates.Results: After12months, restenosis had occurred in42.8%and28.9%of patients in thecontrol and batroxobin groups, respectively (P=0.002). MR angiography and dupleximaging revealed an improved restenosis rate for infrapopliteal lesions（P=0.003）and forlesions longer than10cm (P=0.001).The primary and cumulative secondary outcomesindicated significant improvements in restenosis rate, symptom relief, and amputationrates in the batroxobin group compared with the aspirin-only group. Kaplan–Meieranalysis showed limb salvage and survival rates of78.2%in the aspirin-only group and93.5%in the batroxobin group12months after angioplasty (log-rank test, P=0.0324) Conclusions: Batroxobin plus aspirin reduced the rate of restenosis after arterialangioplasty, particularly in lesions located below the knee and in those longer than10cm,with better clinical symptom relief and improved rate of limb salvage.