Effect of argatroban on in-stent restenosis after extracranial and intracranial stenting： a prospective randondzed control trial

Abstract

Objective To investigate the effect of argatroban on in-stent restenosis （ISR） after extraeranial and intracranial stenting Methods A total of 140 patients who performei cerebrovascular stenting from August 2010 to December 2011 were randomly assigned to either an argatroban group （n =70） or a control group （n =70）, The patients in the argatroban group continuously received argatroban intravenous infusion therapy （20 mg/d） for 2 days before procedure and 3 days after procedure, while those in the control group did not treated with argatroban. The patients were reexamined in the hospital with digital subtraction angiography （DSA） to assess the occurrence of ISR after 6 to 9 months. The vascular event rate and influencing factors of the patients were compared in both groups at the same time. Results A totally 131 patients completed DSA or other imaging reexamination from 6 to 9 months after procedure. The follow-up rate was almost the same in the patients of both groups （2 = 0. 119, P 〉 0. 999）. The incidence of ISR in the argatroban group was significantly lower than that in the control group （7. 6% vs. 24. 6% ;χ^2 =7. 064, P =0. 008）. The patients in the argatroban group did not have any ischemic events, allergies, and liver dysfunction during perioperative period. There were no significant differences in the vascular event rate during the follow-up in the patients of both groups （χ^2 = 0. 202, P = 0. 653）. Multivariate Cox regression analysis showed that without receiving argatroban therapy （hazard ratio [HR] 3. 021, 95% [C1] 1. 098 -8. 292; P=0. 032） and vascular lesion sites （ HR 2. 762, 95% CI 1. 065 - 7. 159; P = 0. 037） were the independence risk factors for ISR at 9 months after procedure. Conclusions Argatroban may prevent the occurrence of ISR after extracranial and intracranial stenting by the inhibition of thrombosis. Key words: Intracranial Arteriosclerosis; Carotid Stenosis; Angioplasty; Stents; Anticoagulants; Antithrombins; Argatroban; Angiography, Digital Subtraction; Risk Factors; Recurrence