title: Batroxobin plus aspirin reduces restenosis after angioplasty for arterial occlusive disease in diabetic patients with lower-limb ischemia.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Radiology, Sixth Affiliated People's Hospital, Medical School of Shanghai Jiao Tong University, No 600, Yi Shan Road, Shanghai 200233, China.
authors.forename: Jue
authors.initials: J
authors.lastname: Wang
authors.forename: Yue-Qi
authors.initials: YQ
authors.lastname: Zhu
authors.forename: Ming-Hua
authors.initials: MH
authors.lastname: Li
authors.forename: Jun-Gong
authors.initials: JG
authors.lastname: Zhao
authors.forename: Hua-Qiao
authors.initials: HQ
authors.lastname: Tan
authors.forename: Jian-Bo
authors.initials: JB
authors.lastname: Wang
authors.forename: Fang
authors.initials: F
authors.lastname: Liu
authors.forename: Ying-Sheng
authors.initials: YS
authors.lastname: Cheng
mesh_terms: D000368:Aged; D000704:Analysis of Variance; D017130:Angioplasty / Q000009:adverse effects / Q000401:mortality; D001157:Arterial Occlusive Diseases / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use*; D012103:Batroxobin / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D003251:Constriction, Pathologic; D003925:Diabetic Angiopathies / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005340:Fibrinogen / Q000378:metabolism; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007511:Ischemia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D035002:Lower Extremity / Q000098:blood supply*; D018810:Magnetic Resonance Angiography; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex
chemical_list: D005343:Fibrinolytic Agents; D010975:Platelet Aggregation Inhibitors; D005340:Fibrinogen; D012103:Batroxobin; D001241:Aspirin