紫杉醇药物洗脱支架在复杂病变中的临床近、远期疗效评价

Evaluation of Clinical Outcomes of TAXUS Stent in Patients With Complicated Lesions-DES in Real World

目的 :评价紫杉醇药物洗脱支架 (TAXUS)应用的临床疗效。方法 :对 2 0 0 3年 4月～ 12月间 2 41例置入 3 0 8个TAXUS支架的临床疗效进行统计学分析。在 2 41例 2 82处病变中弥漫性病变 86处 ( 3 0 5 % ) ,分叉病变 5 6处 ( 19 9% ) ,慢性完全闭塞病变 41处 ( 14 5 % ) ,支架内再狭窄 3 3处 ( 11 7% ) ,开口部病变 2 4处 ( 8 5 % ) ,左冠状动脉主干病变 7处 ( 2 5 % )以及小血管病变或其它病变 3 5处 ( 12 4% )。结果 :支架置入成功率为 99 0 % ,术中无死亡 ,无急性血栓形成和急性血管闭塞发生 ,支架置入后分支血管发生闭塞12例 ( 2 1 4% ) ,住院期间死亡 1例 (死于出血性休克 ) ,发生急性心肌梗死 2例 (均由分支闭塞所致 ) ,住院期间心脏事件发生率为 1 2 % ,199例患者随访超过 6个月 ,1例院外猝死 ,2例发生急性心肌梗死 ,7例靶血管重建 ,心脏事件发生率为4 5 % ,靶病变重建率为 3 0 %。结论 :与TAXUSI～Ⅳ研究相比 ,本研究放宽病变的适应证后其再狭窄发生率仅轻度升高 ,提示对于复杂病变应用TAXUS仍是安全和有效的。

Objective:To evaluation clinical outcomes of paclitaxel-eluting stent (TAXUS stent) in patients with complicated lesions.Methods:From April 2003 to December 2003,241 CAD patients with 282 lesions were treated with 308 TAXUS stents.Of 241 patients,139 had single vessel disease,89 had double vessel disease and 13 had triple vessel disease.Among 282 lesions,86(30.5%) manifested as diffuse disease,56(19.9%) as bifurcation lesions,41(14.5%) as chronic total occlusion lesions,33(11.7%) as in-stent restenosis,24(8.5%) as ostial lesions and 7(2.5%) as unprotection left main disease etc.Results:The success rate of TAXUS Stent implantation was 99.0% (308/311).There were no death,acute thrombosis or acute occlusion during the procedure.Side breach (diam>2.0 mm) occlusion occurred after implanting TAXUS stents in 12 patients.AMI caused by side breach closure in two patients.One patient died of bleeding shock during hospitalization.The incidence of main cardiac events (death,AMI & revascularization,MACE) was 1.2% during hospitalization.Six-month follow-up was performed in 199 patients.One patient had sudden death on the first day after discharge from hospital.AMI occurred in two patient.Target vessel revascularization was performed in 12 patients.Target lesion revascularization (TLR) was performed in 7 patients.TLR rate was 3.0% MACE rate during follow-up was 4.5%.Angiographic follow-up at 6-8 months showed that in stent restenosis (ISR) rate was 15.2% (restenosis in stent was 13.0%).Conclusions:After extending entry criteria as compared with that of TAXUS Ⅳtrial,in-stent restenosis rate of TAXUS stent was only slightly increased,which indicating that TAXUS stent was saft and effective in patients with complicated lesions.