Batroxobin plus aspirin reduces restenosis after angioplasty for arterial occlusive disease in diabetic patients with lower-limb ischemia.
ABSTRACT 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).
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.
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ABSTRACT: The use of endovascular treatment of infrapopliteal disease has increased in popularity in recent years. An improvement in technical success rates due to the availability of newer devices has fuelled an increased interest in the subject. The pathogenesis, indications for treatment, and outcome measures of infrapopliteal disease differ from larger vessel intervention. Diabetes and renal failure are prevalent. Neuropathy and venous disease contribute to the etiology of ulceration. Most interventions are undertaken for critical limb ischemia rather than claudication. Therefore, a range of conservative, pharmacological, and invasive therapies are provided. Conventional percutaneous transluminal angioplasty (PTA) using modern low-profile systems is associated with high technical success rates. However, initial data from recent randomized, controlled trials suggest that drug-eluting stents are consistently achieving improved patency over PTA alone or over bare metal stents. This review summarizes recent advances in the treatment of infrapopliteal disease.CardioVascular and Interventional Radiology 05/2012; 35(4):715-24. · 2.09 Impact Factor