A Clinical Trial Of Using Antiplatelet Therapy To Prevent Restenosis Following Peripheral Artery Angioplasty And Stenting

Objective:It is proved that Percutaneous Transluminal Angioplasty and Stenting is a effective treatment of PAOD,but its benefits is seriosly limited by local thrombotic occlusion and restenosis.The clopidogrel plus aspirin regimen is believed to offers a favorable benefit/risk ratio with regard to safety and efficacy in preventing restenosis after the implantation of coronary stents.But due to the difference in vascular anatomy,circulation dynamics and operation region,the optimal secondary preventive measure to be taken after percutaneous transluminal angioplasty(PTA) of peripheral arteries has not yet been determined.Results of prospective studies in other regions of the circulatory system are not necessarily applicable to the arteries of the leg.The objective of this prospective study is to evaluate the clinical effect and restenosis rate of antiplatelet therapy following peripheral artery angioplasty and stenting so as to provide the dependable basis for the clinical application.Samples:After successful placement of peripheral artery stents to 103 patients with PAOD in Huashan Hospital since January 2003,56 patients were randomized assigned to Antiplatelet Group and 47 patients to Anticoagulation Group.Methods:1.Those patients in Antiplatelet Group receive Clopidogrel 75mg plus Aspirin 100mg per day and those in Anticoagulation Group receive a seven day subcutaneous injection of LWMH plus long-term oral Warfarin therapy.2.The primary endpoint was major bleeding rate and a composite rate of restenosis and reocclusion.The secondary endpoint included cardiovascular events,vascular amputation,death and ADRs of drugs(such as Agranulemia). 3.The Follow-up items include Color Duppler Ultrasound,Blood Routine and Coagulation Funtion examinations,Ankel-Branchial Index 1 day,1,6,12,18 months after the implation of stents.The In-stent Retenosis(ISR) is defined by Color Duppler Ultrasound as Stenosis Degree≥50%.Results:1.In a 18-month follow up,the mean value of ABI rose up to 0.53±0.26 from 0.71±0.22 in antiplatelet group and from 0.60±0.19 to 0.74±0.28,the improvement rate was 85.7%and 78.7%respectively(P＞0.05).2.The reocclusion rate reached 5.4%in antiplatelet group and 10.6%in controlled group and the restenosis rate was 14.3%versus 25.5%.There was no significantly difference in reocclusion and restenosis rate in 18 months follow-up between these two groups(P＞0.05).3.Patency in patients who receied antiplatelet was 84.9%and was not statistically significantly different from 75.0%in patients who received anticoagulation treatment(P=0.183).4.The bleeding complication rate was significantly lower(1.8%) in antiplatelet group than that in anticoagulation group(19.1%),(P=0.009).There was no significant difference in cardiovascular events rate and mortalityConclusion:This trial shows combined antiplatelet therapy with clopidogrel plus aspirin is effective and safe in preventing restenosis following peripheral artery angioplasty and stenting.In addition,the antiplatelet treatment has the advantages of easy handling and better tolerance because there is no need for laboratory monitoring as,in contrast,with oral anticoagulants,e.g.,coumadin,or with subcutaneous UFH.So the clopidogrel plus aspirin treatment is recommended after peripheral artery angioplasty and stenting procesure.