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目的探讨置入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例置入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CITLR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 dual antiplatelet drug therapy (DAPT) at 6 months and 12 months post biofilm biodegradable drug eluting stent (BP-DES). Methods A retrospective analysis of the clinical endpoint outcome of 574 patients with biodegradable sirolimus-eluting long stent (BP-SES) (total stent length ≥50 mm) was performed in the I-LOVE-IT 2 study , 270 patients received 6 months DAPT, 304 patients received 12 months DAPT. The primary endpoint of the study was a 12-month target lesion failure rate (TLF), including cardiac death, target-vessel MI, and clinically-driven target lesion revascularization (CI-TLR). The study’s secondary endpoint was a 12-month net adverse clinical event (NACE), including death, myocardial infarction, stroke, total revascularization (including revascularization of CITLR and non-target lesions), and complete bleeding. Results The total length of stent in 6-month DAPT group and 12-month DAPT group was 73.0 ± 22.5mm and 69.8 ± 19.4mm, respectively, in BP-SES patients with a total stent length ≥50mm, with no significant difference (P = 0.07). There was no significant difference in the incidence of TLF at 12 months between the two groups (11.1% vs.9.2%, P = 0.47). The incidence of NACE was similar between the two groups (21.9% vs.19.7%, P = 0.57). The overall rate of total revascularization at 5.6 months in the DAPT group at 12 months was lower than in the 6-month DAPT group (11.1%, P = 0.01). There was no significant difference between the two groups in overall bleeding and major bleeding at 12 months (5.2% vs.6.3%, P = .60; 1.1% vs.0.3%, P = .24). Six-month landmark analysis showed that compared with 6-month DAPT group, the incidence of TLF was significantly decreased 6 to 12 months after percutaneous coronary artery stent implantation (PCI) in 12-month DAPT group (2.6% vs. 6.3% P = 0.03). At the same time, the incidence of all bleeding increased slightly, but the difference was not statistically significant (1.6% vs.0.7%, P = 0.32). Conclusions For all new BP-SES patients with a total length of ≥50 mm, all clinical outcomes were similar except for total revascularization. DAPT at 12 months reduced the incidence of TLF and total revascularization 6 to 12 months after PCI.