涂层可降解雷帕霉素洗脱支架术后6个月双联抗血小板治疗的长期疗效与安全性：CREATE研究4年随访结果分析  

Long-term clinical efficacy and safety of six-month dual antiplatelet therapy after biodegradable polymer-based sirolimus eluting stent implantation： results of 4-year follow-up of the CREATE Study

作　　者：李毅[1] 韩雅玲[1] 荆全民[1] 张磊[1] 王效增[1] 马颖艳[1] 王耿[1] 王斌[1] 邓捷[1] 张权宇[1] 

机构地区：[1]沈阳军区总医院全军心血管病研究所,心血管内科,沈阳110016

出　　处：《中华老年多器官疾病杂志》2012年第2期84-88,共5页Chinese Journal of Multiple Organ Diseases in the Elderly

基　　金：“十二五”国家科技支撑计划项目（2011BAlllB07）;军队l临床高新技术重大项目（2010gxjs001）

摘　　要：目的探讨涂层可降解雷帕霉素药物洗脱支架（DES）术后应用6个月双联抗血小板治疗（DAPT）的长期疗效和安全性。方法多中心、前瞻性CREATE研究中术后6个月随访时未发生主要不良心脏事件（MACE）的存活患者共2034例，全部接受Excel涂层可降解雷帕霉素DES治疗，其中1626例（79．9％）于术后6个月内停用氯吡格雷（DAPT≤6个月），408例（20．1％）于6个月后继续服用氯吡格雷（DAPT〉6个月）。对比两组患者在6个月至4年随访期间的MACE和支架内血栓发生率。结果DAPT〉6个月者与≤6个月者相比，心性死亡（2．0％VS2．2％，P：0．753）、心肌梗死（0．2％VSO．4％，P=1．0）和靶病变血运重建（1．7％vs2．4％，P=0．407）发生率差异均无统计学意义。两组总的MACE发生率差异亦无统计学意义（3．7％VS3．4％，P=0．819）。两组总的血栓事件发生率分别为1．5％和0．7％，差异无统计学意义（P=0．128）。两组明确的及很可能的血栓累计发生率差异亦无统计学意义（0．7％VS0．5％，P=0．469）。多因素分析结果表明，陈旧性心肌梗死是支架内血栓的独立危险因素（OR=15-313，95％CI：4．02-58．25，P〈0．001）。DAPT疗程≤6个月与MACE（OR=0．987，95％CI=0．5451．787，P=0．965）及支架血栓事件发生率（OR=0．847，95％CI=0．2083．439，P=0．816）无显著相关性。结论4年临床随访结果表明，冠心病患者置入涂层可降解DES术后使用6个月DAPT安全、有效，但还需随机、对照研究进一步证实。Objective To explore the long-term clinical efficacy and safety of 6-month dual antiplatelet therapy （DAPT） after biodegradable polymer based drug eluting stent （DES） implantation. Methods In the multi-center prospective CREATE Study, a total of 2034 patients who received biodegradable polymer based sirolimus eluting stent （Excel stent） treatment and had no major adverse cardiac events （MACE） at 6-month were included. Among them, 1626 （79.9%） patients discontinued clopidogrel treatment within 6 months （DAPT≤6 months） and 408 （20.1%） prolonged clopidogrel treatment after 6 months （DAPT 〉 6 months）. The incidences of MACE and stent thrombosis through 6 months to 4 years were compared between patients with different DAPT durations. Results There was no statistical difference between the two groups in the incidences of cardiac death （2.0% vs 2.2%, P-0.753）, myocardial infarction （0.2% vs 0.4%, P=I.0）, target lesion revascularization （1.7% vs 2.4%, P=0.407） and MACE （3.7% vs 3.4%, P=0.819）. The overall incidence of stent thrombosis in patients with DAPT 〉 6 months ands〈6 months was 1.5% and 0.7%, respectively （P=0.128）. The incidences of definite or probably stent thrombosis were similar between the two groups （0.7% vs 0.5%, P=0.469）. Multivariate analysis showed that prior myocardial infarction was an independent predictor of stent thrombosis （OR=15.313, 95% CI： 4.02-58.25, P〈 0.001）. However, DAPT duration of≤6 months was neither associated with the risk ofMACE （OR=0.987, 95%CI： 0.545-1.787, P=0.965） nor stent thrombosis （OR=0.847, 95%CI： 0.208-3.439, P=0.816）. Conclusions DAPT for 6 months is safe and effective at four years after biodegradable polymer based DES implantation, which needs further confirmation by randomized controlled studies.

关 键 词：药物洗脱支架 血小板聚集抑制剂 CREATE研究 

分 类 号：R540.46[医药卫生—心血管疾病] R973.2[医药卫生—内科学]