Evaluation of batroxobin in preventing vascular restenosis in diabetic patients after infrapopliteal arterial angioplasty:a randomized comparative study

Objective To evaluate batroxobin in preventing vascular restenosis in diabetic patients after infrapopliteal arterial angioplasty through comparing the clinical results of the combination use of batroxobin and aspirin with that of simple use of aspirin.Methods After a successful angioplasty,fifty-two diabetic patients with symptomatic infrapopliteal obstructions were randomly divided into the study group(n=26)and the control group(n=26).Patients in both groups received 100 mg aspirin everyday,but the patients in study group additionally received 5 IU batroxobin intravenous drip every other day for six times.At the end of the follow-up period lasting for 12 months,magnetic resonance angiography(MRA)or Doppler ultrasonic angiography was performed to check the the vessels to see if there was any restenosis or reocclusion.The relief degree of clinical symptoms were observed,and both preoperative and postoperative ankle-brachial index(ABI)were regularly determined and compared.Kaplan-Meier curves were constructed to evaluate restenosis/reocclusion-free rate,limb salvage rate and amputation-free rate.Results During the follow-up period the occurrence of restenosis/reocclusion in study group and control group was 22.0% and 34.5% respectively(P = 0.0307).Statistically significant difference in ABI existed between two groups both after the procedure(P 0.05) and at 12 months after the treatment(P = 0.0094).Clinical improvement and tissue healing in study group and control group were observed in 23 and 19 patients respectively(P = 0.0544).Twelve months after angioplasty,Kaplan-Meier analysis showed that the restenosis/reocclusion-free rate,the limb salvage rate and the amputation-free rate for study group were 74.0%,96.2% and 84.6% respectively,while they was 54.8%,92.3% and 84.6% respectively for control group.Conclusion The results of this study indicate that the use of batroxobin can effectively prevent the vascular restenosis or reocclusion after infrapopliteal arterial angioplasty,apparently improve the clinical therapeutic efficacy and markedly relieve the symptoms,although this technique seems not to be able to obviously increase the limb salvage or amputation-free rate.