[Effectiveness of cilostazol in prevention of restenosis after endovascular reconstructive procedures on the lower extremity arteries].

Abstract

Objective: to evaluate effectiveness of Cilostazol in prevention of restenosis in the reconstruction area in patients undergoing endovascular reconstructive procedures on the lower extremity arteries.

Patients and methods: Our prospective study included 80 patients with stage IIb-III chronic lower limb ischemia due to atherosclerotic peripheral arterial disease. They were divided into two groups, 40 patients each (using the envelope randomization method). The study was approved by the local ethics committee. All patients after rentgenendovascular interventions received conservative therapy (acetylsalicylic acid at a dose of 75 mg once daily, Atorvastatin 10 mg QD with lipid spectrum control, and Clopidogrel 75 mg QD). One month after, the study group patients were switched from Clopidogrel to Cilostazol (Aducil®) taken at a dose of 100 mg twice daily for 2 months. The control group patients continued receiving therapy with Clopidogrel for 3 months. All subjects underwent laboratory (assessment of endothelial nitric oxide synthase (eNOS), prostacyclin, endothelin-1, and interleukin-6) and instrumental diagnostic procedures prior to operation and 1, 3, 6 and 12 months thereafter.

Results: There was a statistically significant increase in the level of eNOS in the study group patients after 3 (р=0.001), 6 (р=0.002), and 12 months (р<0.001) as compared with the control group. At 3, 6, and 12 months after the interventions, there was a statistically significant decrease of interleulin-6 and endothelin-1 levels in the study group as compared with the control (р<0.001). According to the findings of duplex scanning of lower limbs at 3 months, 13 (32.5%) patients in the control group and 7 (17.5%) patients in the study group developed neointimal hyperplasia and restenosis (>30%) in the arterial reconstruction zone (p<0.05). 15 (37.5%) patients in the control group and 10 (25%) patients in the study group had restenosis at 6 months (p=0.04). By 12 months, the number of patients with restenosis increased up to 26 (65%) and 18 (45%) in the control and study group, respectively (p=0.04).

Conclusion: Including Cilostazol 100 mg B.I.D. in the study group patients resulted in an increased level of endothelial nitrogen oxide synthase (p<0.05), decreased levels of endothelin- 1 (p<0.001) and interleukin-6 (p<0.001) as compared with the control group patients. Prescription of Cilostazol after endovascular interventions on lower limb arteries decreased possibility of developing restenosis in the reconstruction zone.