聚合物涂层可降解钴铬合金西罗莫司(雷帕霉素)洗脱支架(EXCEL2)治疗冠心病合并糖尿病患者的有效性与安全性:CREDIT研究亚组分析Safety and efficacy of the second generation biodegradable polymer Cobalt-Chromium sirolimuseluting stent (EXCEL 2) stent in diabetic patients:A Subgroup analysis of the CREDIT Ⅱ and CREDIT Ⅲ trials
王耿,李根,刘惠亮,柳景华,贾永平,马根山,周旭晨,王守力,浦奎,韩雅玲
摘要(Abstract):
目的通过对CREDITⅡ、Ⅲ研究中的糖尿病亚组资料进行分析,探讨第二代聚合物涂层可降解钴铬合金西罗莫司(雷帕霉素)洗脱支架(EXCEL2)在糖尿病患者中的有效性和安全性。方法入选了CREDITⅡ、Ⅲ研究中置入EXCEL2支架的所有患者。主要终点为24个月的靶病变失败,以心源性死亡、靶血管心肌梗死和临床驱动的靶病变血运重建为复合终点。次要终点为患者相关复合终点,包括全因死亡、心肌梗死和血运重建。结果入选828例患者24个月随访率99.5%,糖尿病组与非糖尿病组比较,主要终点事件发生率(P>0.05)及次要终点发生率[全因死亡(2.5%比1.4%,P=0.290)、心肌梗死(7.5%比5.0%,P=0.215)、任何血运重建(5.0%比3.9%,P=0.533)以及支架内血栓形成(0.6%比0.5%,P=0.577)],差异均无统计学意义。结论 EXCEL2支架可降低糖尿病患者术后支架内再狭窄、靶病变血运重建率及支架内血栓形成风险,且不劣于非糖尿病患者。
关键词(KeyWords): 药物洗脱支架;糖尿病;靶血管再次血运重建
基金项目(Foundation):
作者(Author): 王耿,李根,刘惠亮,柳景华,贾永平,马根山,周旭晨,王守力,浦奎,韩雅玲
参考文献(References):
- [1]de Waha A,King LA,Stefanini GG,et al.Long-term outcomes of biodegradable versus durable polymer drug-eluting stents in patients with acute ST-segment elevation myocardial infarction:a pooled analysis of individual patient data from three randomised trials.Euro Intervention,2015,10(12):1425-1431.
- [2]Lupi A,Gabrio Secco G,Rognoni A,et al.Meta-analysis of bioabsorbable versus durable polymer drug-eluting stents in 20,005 patients with coronary artery disease:an update.Catheter Cardiovasc Interv,2014,83(6):E193-206
- [3]Rodriguez-Granillo A,Rubilar B,Rodriguez-Granillo G,et al.Advantages and disadvantages of biodegradable platforms in drug eluting stents.World J Cardiol,2011,3(3):84-92.
- [4]Stefanini GG,Byrne RA,Serruys PW,et al.Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention:a pooled analysis of individual patient data from the ISAR-TEST 3,ISAR-TEST 4,and LEADERS randomized trials.Eur Heart J,2012,33(10):1214-1222.
- [5]Stefanini GG,Kalesan B,Serruys PW,et al.Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease(LEADERS):4 year follow-up of a randomised non-inferiority trial.Lancet,2011,378(9807):1940-1948.
- [6]Han YL,Zhang L,Yang LX,et al.A new generation of biodegradable polymer-coated sirolimus-eluting stents for the treatment of coronary artery disease:fi nal 5-year clinical outcomes from the CREATE study.Euro Intervention,2012,8(7):815-822.
- [7]Wang G,Sun Z,Jin Q,et al.First-in-man study evaluating the safety and effi cacy of a second generation biodegradable polymer sirolimus-eluting stent in the treatment of patients with de novo coronary lesions:clinical,Angiographic,and OCT outcomes of CREDIT-1.Catheter Cardiovasc Interv,2015,85Suppl 1:744-751.
- [8]Wang G,Wang H,Xu B,et al.Effi cacy and safety of a biodegradable polymer Cobalt-Chromium sirolimus-eluting stent(EXCEL2)in treating de novo coronary artery disease:A pooled analysis of the CREDIT II and CREDIT III trials.Catheter Cardiovasc Interv,2017,89(S1):512-519.
- [9]Introduction:The American Diabetes Association's(ADA)evidence-based practice guidelines,standards,and related recommendations and documents for diabetes care.Diabetes Care,2012,35 Suppl 1:S1-2.
- [10]Applegate RJ,Sacrinty MT,Little WC,et al.Incidence of coronary stent thrombosis based on academic research consortium defi nitions.Am J Cardiol,2008,102(6):683-688.
- [11]洪天配,母义明,纪立农,等.2型糖尿病合并动脉粥样硬化性心血管疾病患者降糖药物应用专家共识.中国介入心脏病学杂志,2017,25(7):481-492.
- [12]江立生,邵琴,卜军,等.冠状动脉造影检查疑似冠心病患者6040例合并传统心血管病危险因素的临床分析.中国介入心脏病学杂志,2016,24(9):497-501.
- [13]Abizaid A,Costa MA,Centemero M,et al.Clinical and economic impact of diabetes mellitus on percutaneous and surgical treatment of multivessel coronary disease patients:insights from the Arterial R evascularization Therapy Study(ARTS)trial.Circulation,2002,11(1):533-538.
- [14]Holmes DR Jr,Leon MB,Moses JW,et al.Analysis of 1-year clinical outcomes in the SIRIUS trial:a randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis.Circulation,2004,109(5):634-640.
- [15]Morice MC,Serruys PW,Sousa JE,et al.A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.N Engl J Med,2002,346(23):1773-1780.
- [16]Stone GW,Ellis SG,Cox DA,et al.A polymer-based,paclitaxel-eluting stent in patients with coronary artery disease.N Engl J Med,2004,350(3):221-231.