置人生物涂层可降解药物洗脱长支架后口服6个月和12个月双联抗血小板药物治疗临床观察——I-LOVE-IT2亚组研究

摘要

目的 探讨置人生物涂层可降解药物洗脱长支架(BP-DES)患者术后6个月和12个月双联抗血小板药物治疗(DAPT)的有效性和安全性.方法 回顾性分析I-LOVE-IT 2研究中,574例置人生物涂层可降解西罗莫司药物洗脱长支架(BP-SES)(总支架长度≥50mm)患者的临床终点结果发生情况,其中270例患者接受6个月DAPT,304例患者接受12个月DAPT.研究主要终点是12个月靶病变失败率(TLF),包括心源性死亡、靶血管心肌梗死、临床驱动的靶病变血运重建(CI-TLR).研究次要终点是12个月净不良临床事件(NACE),包括死亡、心肌梗死、卒中、全部血运重建(包括CI-TLR和非靶病变血运重建)以及全部出血.结果 在置入总支架长度≥50mm的BP-SES患者中,6个月DAPT组和12个月DAPT组总支架长度分别是73.0±22.5mm和69.8±19.4mm,差别无统计学意义(P=0.07).两组在12个月TLF的发生率上差异无统计学意义(11.1％ vs.9.2％,P=0.47),NACE的发生率两组相似(21.9％vs.19.7％,P=0.57).12个月DAPT组总的全部血运重建发生率(5.6％)低于6个月DAPT组(11.1％,P=0.01).12个月全部出血及主要出血两组差异无统计学意义(5.2％vs.6.3％,P=0.60;1.1％ vs.0.3％,P=0.24).6个月界标分析显示,与6个月DAPT组对比,12个月DAPT组经皮冠状动脉支架植入术(PCI)后6～12个月TLF发生率明显降低(2.6％ vs.6.3％,P=0.03),同时全部出血的发生率略有增加趋势,但差异无统计学意义(1.6％ vs.0.7％,P=0.32).结论 对于置入总长度≥50mm的新型BP-SES患者,除全部血运重建这个指标以外其他临床终点结果是相似的.12个月DAPT可降低PCI术后6～12个月的TLF和全部血运重建的发生率.%Objective To investigate the efficacy and safety of 6-month and 12-month oral dual-antiplatelet therapy This work was supported by the National Key Technology Research and Development Program in the "Twelfth Five-year" Plan of China (2011BAIl1B07) and the Military Clinical Key Technology and Development Program (2010gxjs001)(DAPT) on patients implanted with biodegradable polymer-coated and drug-eluted long stents (BP-DES).Methods In the I-LOVE-IT 2 trial,574 patients implanted with biodegradable polymer-coated and sirolimus-eluted long stent (BP-SES) (total stent length ≥50mm) were randomized to accepting either 6-month (n=270) or 12-month (n=304) DAPT.The primary endpoint of present study was 12-month target lesion failure (TLF),including cardiac death,target vessel myocardial infarction and clinically indicated target lesion revascularization (CI-TLR).The major secondary endpoint was 12-month net adverse clinical events (NACE),including all-causes of death,myocardial infarction,stroke,all revascularization (CI-TLR plus clinically indicated nontarget lesion revascularization) and bleeding.Results For the patients implanted with BP-SES of total stent length≥ 50mm,the total stent length was 73.0 ± 22.5mm and 69.8 ± 19.4mm in the 6-month DAPT group and 12-month group,respectively (P=0.07).No significant difference existed in the incidence of 12-month TLF between 6-month DAPT group and 12-month DAPT group (11.1％ vs.9.2％,P=0.47).The incidence of NACE was similar between the 2 groups (21.9％ vs.19.7％,P=0.57).The incidence of revascularization was lower in 12-month DAPT group (5.6％) than in 6-month DAPT group (11.1％,P=0.01).Furthermore,6-month landmark analysis showed that 12-month DAPT was associated with significantly lower risk of TLF (2.6％ vs.6.3％,P=0.03) at a cost of slightly increased risk of all bleeding events (1.6％ vs.0.7％,Log-rank P=0.32) between 6 and 12-months compared to 6-month DAPT.Conclusions In patients treated with BP-SES of total stent length ≥ 50mm,12-month DAPT have similar impacts on 12-month clinical outcomes except for all revascularization.However,12 months DAPT decreased the incidence of TLF and total revascularization between 6 months to 12 months after PCI.