药物洗脱支架治疗冠状动脉疾病的Meta分析

Drug-Eluting Stents in Coronary Artery Disease: A Meta-analysis

目的评价药物洗脱支架用于冠状动脉疾病临床治疗和预防再狭窄的有效性及安全性。方法计算机检索EMBASE、中国生物医学文献光盘数据库、MEDLINE、CENTRAL、SCI及相关临床试验数据库,检索年限为2000～2005年3月。手检已获文献的参考文献、会议及相关网站。评价中、英文发表的有关随机对照试验质量,运用RevMan4.2软件进行Meta分析。结果共纳入25个研究包括5种不同药物洗脱支架的随机对照试验,累计样本量12059例。其中7个试验评价了西罗莫司洗脱支架的有效性和安全性。Meta分析结果提示,试验组术后造影再狭窄率、靶病变血运重建率及不良事件率均低于裸金属支架组。对8个评价紫杉醇洗脱支架的试验数据的合并分析结果提示,紫杉醇洗脱支架的术后造影再狭窄率较裸金属支架低,从而使靶病变血运重建率及不良事件率降低。3个直接比较西罗莫司洗脱支架与紫杉醇洗脱支架的试验肯定了西罗莫司在预防再狭窄方面比紫杉醇具有优势。依维莫司洗脱支架呈现与前述两支架相似的结果,但因样本量过小,未得出明确结论。此外,放线菌素D洗脱支架可使二次血运重建率增加,7hexanoyltaxol洗脱支架组血栓事件率远高于对照组,这两种支架由于初步试验的负性结果,未进行进一步的临床研究。结论现有数据提示,西罗莫司洗脱支架和紫杉醇洗脱支架可降低原位初治单支病变及两支内冠状动脉病变患者(包括糖尿病患者)PCI术后的靶病变血运重建率,但不能改变心肌梗死率及死亡率,也不增加血栓事件发生率。

Objective To evaluate the efficacy and safety of drug-eluting stents in treating patients with coronary artery disease compared with bare metal stents. Methods MEDLINE, EMBASE, CBMdisc and other databases of clinical trials were searched for meta-analysis and randomized controlled trials (RCTs) both in Chinese and English language. Conference Abstracts, personal reference lists, reference lists of retrieved studies and some websites were also searched. Statistical analysis was performed using RevMan 4.2 software. Results Meta-analysis was performed on the results of 25 RCTs with 5 different drug-eluting stents. Seven trials evaluated efficacy and safety of sirolimus-eluting stent, the results of meta-analysis indicated that SES decreased rates in stent restenosis compared with bare metal stent, and therefore the target lesion revascularization and adverse cardiac event rates, no “catch up” were found. Eight trials compared a paclitaxel-eluting stent with bare metal stent, similar results were found, i.e. decreased stent restenosis rate, target lesion revascularization and adverse cardiac event rates in patients receiving paclitaxel-eluting stent compared with bare metal stent. Three trials compared CYPHER TM and TAXUS stents head to head, and the combined analysis showed a superiority of CYPHER TM to TAXUS. But available data can not draw a conclusion with regard to the effect of drug-eluting stents on mortality, occurrence of MI or stent thrombosis. Everolimus-eluting stent had the same performance as these two drug-eluting stents above, but because of a small sample size, no further conclusion can be made. Actinomycin D eluting stents and 7-hexanoyltaxol-eluting stents increased restenosis rate and stent thrombosis rate respectively. Poor performance limited further clinical trials of these two stents. Conclusions Sirolimus-eluting stent and polymetric paclitaxel-eluting stent are efficient and safe in patients with coronary artery atherosclerosis. Sirolimus eluting stent CYPHER TM seems better than paclitaxel eluting stent TAXUS.