摘要
目的比较老年患者置入新型药物洗脱支架(BP-SES)术后,应用6个月与12个月双联抗血小板治疗(DAPT)的疗效和安全性。方法纳入I-LOVE-IT 2研究中置入BP-SES老年患者(≥65岁)627例,其中接受6个月DAPT治疗319例(6个月DAPT组),12个月DAPT治疗308例(12个月DAPT组)。本研究的主要终点为12个月的靶病变失败(TLF,包含心源性死亡、靶血管心肌梗死和临床驱动的靶病变再次血运重建的复合终点),次要终点为12个月净不良临床事件(NACE,包含全因死亡、心肌梗死、缺血性卒中或全部出血的复合终点)以及12个月支架内血栓形成发生率。结果两组患者年龄、性别、体重指数、糖尿病、高血压病等方面比较,差异均无统计学意义(均P>0.05)。基线SYNTAX评分、靶病变个数、靶血管位置等基线造影特征方面比较,差异均无统计学意义(均P>0.05)。随访12个月Kaplan-Meier累积事件,6个月DAPT组主要终点TLF发生率(7.2%比7.1%,P=0.980),次要终点NACE发生率(14.1%比13.0%,P=0.726),支架内血栓形成发生率(2.8%比1.0%,P=0.101)与12个月DAPT组比较,差异均无统计学意义。明确或极可能的支架内血栓形成共5例,其中6个月和12个月DAPT组分别有3例和2例(0.9%比0.6%,P=0.682),差异无统计学意义。界标分析结果显示,在6至12个月随访期间,6个月DAPT组TLF(2.3%比1.7%,P=0.593),NACE事件发生率(4.2%比2.9%,P=0.392),出血发生率(1.0%比1.0%,P=0.961)与12个月DAPT组比较,差异无统计学意义。结论在接受新一代药物洗脱支架置入的老年患者中,术后接受6个月DAPT治疗者,有效性和安全性与接受12个月DAPT的患者差异无统计学意义。
Objective To explore the effi cacy and safety of 6-month and 12-month dual antiplatelet therapy（DAPT）af ter implantation of biodegradable polymer-drug eluting stents（BP-DES） in elderly patients. Methods This study was a subgroup analysis of the I-LOVE-IT 2 trial, which was a prospectively randomized study enrolling 2737 patients receiving either a BP-SES or a DP-SES in a 2：1 ratio. This studied further divided the patients who were randomized to the BP-SES group,whose age ≥ 65 year old, in a 1：1 ratio to receive a 6-month DAPT（n=319） or 12-month DAPT（n=308）randomly before the index PCI. Theprimary end point of this study was 12-month target lesion failure（FhF, including cardiac death,target vessel myocardial infarction and clinically indicated target lesion revascularization）and the secondary end points was 12-month net adverse clinical and cerebral events（including all-cause death, all myocardial infarction, stroke and all bleeding）. Results Rates of TLF at 12 months were 7.1% in the 6-month DAPT group and 7.2% in the 12-month DAPT group（P=0.980）. No diff erences were observed in the occurrence of events in the secondary endpoint at 12 months follow-up between the 6-month DAPT group and 12-months DAPT group（14.1% versus 13.0%, P=0.726）. There were no signifi cant diff erences in stent thrombosis or bleeding complications between the 2 groups. Conclusions This study shorted that 6-month DAPT did not increase the risk of TLF at 12 months after implantation of DES in elderly patients compared with 12-month DAPT. Elderly patients are at high risk of bleeding and ischemic events and study show that 6-month DAPT would be adequate. These results need to be confi rmed with trials of scale in the future.
出处
《中国介入心脏病学杂志》
2018年第1期12-17,共6页
Chinese Journal of Interventional Cardiology
