置入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-IT 2亚组研究  

Clinical observation of 6-month versus 12-month oral dual-antiplatelet therapy on patients after implantation of biodegradable polymer-coated and drug-eluted long coronary stents--insight from the I-LOVE-IT 2 trial

作　　者：齐静[1,2] 李毅[2] 李晶[2] 荆全民[2] 徐凯[2] 黄鑫 陶贵周 于红 梁健球[6] 孙英贤[7] 韩雅玲[2] 

机构地区：[1]辽宁中医药大学第一临床学院,沈阳110032 [2]沈阳军区总医院心血管内科,沈阳110016 [3]本溪市中心医院心血管内科,辽宁本溪117000 [4]锦州医科大学附属医院心血管内科,辽宁锦州121000 [5]盘锦市中心医院心血管内科,辽宁盘锦124000 [6]佛山市第二人民医院心血管内科,广东佛山528000 [7]中国医科大学附属第一医院心血管内科,沈阳110001

出　　处：《解放军医学杂志》2017年第5期420-426,共7页Medical Journal of Chinese People's Liberation Army

基　　金：国家十二五科技支撑计划课题(2011BAI11B07);军队临床高新技术重大项目(2010gxjs001)~~

摘　　要：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 6-month and 12-month oral dual-antiplatelet therapy （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 non- target 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 i〉 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 r

关 键 词：长支架 支架总长度 血小板聚集抑制剂 药物洗脱支架 

分 类 号：R654.33[医药卫生—外科学]