Application of batroxobin plus aspirin in preventing post-intervention re-stenosis in patients with diabetic lower-limb ischemia：analysis of therapeutic effects / 介入放射学杂志

ABSTRACT

Objective To assess the clinical value of batroxobin plus aspirin therapy in reducing the incidence of arterial re-stenosis or re-occlusion in diabetic patients with lower-limb ischemia after receiving angioplasty. Methods A total of 110 diabetic patients with symptomatic arterial obstructions were randomly divided into study group (n=50) and control group (n=60). Aspirin 100 mg/d plus batroxobin 5 IU every other day for six times was used in patients of the study group, while only aspirin 100 mg/d was used in patients of the control group. The follow-up finishing point was the end of 12 months. The arterial re-stenosis or re-occlusion was evaluated with magnetic resonance angiography (MRA) and/or vascular sonography. Amputation above the ankle, death, and the cumulative rate of amputation or death were determined, and the limb salvage and survival rates were assessed by using Kaplan-Meier analysis method. Results Twelve months after the treatment, the occurrence of restenosis in the study group and the control groups was 42.8%and 28.9% respectively (P = 0.002). MR angiography and color- duplex sonography revealed that the restenosis occurrence was much higher in infrapopliteal artery (P = 0.003) and in longer (length > 10 cm) diseased artery (P = 0.001). Twelve months after angioplasty Kaplan-Meier analysis showed that the limb salvage-survival rates of the study group and the control group were 78.2%and 93.5%respectively (log-rank test, P = 0.032 4). Conclusion Combination use of batroxobin and aspirin can effectively reduce the occurrence of restenosis after arterial angioplasty, and the clinical effect is particularly better for the artery distal to the knee and the artery with longer lesion (length > 10 cm), besides this treatment can also improve limb salvage rate.