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Medical AI Inquiry: You was designed to assist in medical decision-making based on the provided user questions. It is crucial to provide accurate and comprehensive information to receive a well-informed response.  Labels: OBJECTIVE, METHODS, RESULTS. Meshes: Aged, Analysis of Variance, Angioplasty, Arterial Occlusive Diseases, Aspirin, Batroxobin, China, Constriction, Pathologic, Diabetic Angiopathies, Double-Blind Method, Drug Therapy, Combination, Female, Fibrinogen, Fibrinolytic Agents, Humans, Ischemia, Kaplan-Meier Estimate, Limb Salvage, Lower Extremity, Magnetic Resonance Angiography, Male, Middle Aged, Pilot Projects, Platelet Aggregation Inhibitors, Prospective Studies, Risk Assessment, Risk Factors, Survival Rate, Time Factors, Treatment Outcome, Ultrasonography, Doppler, Duplex.
user
Does batroxobin plus aspirin reduce restenosis after angioplasty for arterial occlusive disease in diabetic patients with lower-limb ischemia? Context: 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. 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. 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).
assistant
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. Final Decision: yes