Batroxobin for prevention of restenosis in diabetic patients after infrapopliteal arterial angioplasty: a small randomized pilot trial.
BACKGROUND
We designed a small randomized clinical trial to prospectively test the hypothesis that batroxobin is more effective than aspirin alone to prevent restenosis in patients with diabetes undergoing angioplasty of infrapopliteal arteries.


METHODS
After a successful angioplasty, a total of 52 diabetic patients with symptomatic infrapopliteal obstructions were randomized to either the treated group (n = 26) or the control group (n = 26). Patients in the treated group received 5 IU batroxobin through an intravenous drip once every alternate day, for a total of six doses. The primary end point was restenosis and reocclusion, which was documented by magnetic resonance angiography or duplex scanning at 12-month follow-up. The clinical symptoms relief and ankle-brachial index (ABI) were compared before and after the procedure, and during follow-up. Kaplan-Meier curves were constructed to evaluate restenosis or reocclusion-free, limb salvage, and amputation-free rates.


RESULTS
Restenosis and reocclusion occurred in 22.0% and 34.5% lesions in the treated and the control group, respectively (p = 0.0307). Statistical differences were observed between the ABI before the angioplasty procedure(p < 0.05) and the ABI at the 12-month follow-up (p = 0.0094) of the two groups. Clinical symptoms improvement and tissue healing occurred in 23 and 19 patients in the batroxobin group and the control group, respectively (p = 0.0544). Twelve months after angioplasty, Kaplan-Meier analysis showed that the restenosis and reocclusion-free rate was 74.0% and 54.8%, the limb salvage rate was 96.2% and 92.3%, and the amputation-free rate was 84.6% and 84.6%, in the treated and control group, respectively.


CONCLUSIONS
This pilot trial revealed that batroxobin usage was effective in preventing restenosis and reocclusion after infrapopliteal arterial angioplasty, and it might provide better clinical symptoms relief; however, it did not report preferable limb salvage or amputation-free rates.
Wang
Jue
J
Department of Radiology, Sixth Affiliated People's Hospital, Medical School of Shanghai Jiao Tong University, Shanghai, People's Republic of China.
Zhu
Yue-Qi
YQ
Liu
Fang
F
Li
Ming-Hua
MH
Zhao
Jun-Gong
JG
Tan
Hua-Qiao
HQ
Wang
Jian-Bo
JB
Cheng
Ying-Sheng
YS
Zhang
Pei-Lei
PL
D000368:Aged; D000671:Amputation, Surgical; D017130:Angioplasty / Q000009:adverse effects; D055109:Ankle Brachial Index; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000628:therapy*; D001241:Aspirin / Q000627:therapeutic use; D012103:Batroxobin / Q000008:administration & dosage / Q000627:therapeutic use*; D002681:China; D003251:Constriction, Pathologic; D003925:Diabetic Angiopathies / Q000175:diagnosis / Q000628:therapy*; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D018810:Magnetic Resonance Angiography; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000473:pathology; D011446:Prospective Studies; D012044:Regression Analysis; D018570:Risk Assessment; D012307:Risk Factors; D055502:Secondary Prevention; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex
D005343:Fibrinolytic Agents; D012103:Batroxobin; D001241:Aspirin