在接受依维莫司洗脱支架血管重建术的老年患者中前瞻性应用出血和缺血风险调整后的抗栓方案：EPIC05-Sierra75研究
Prospective application of a bleeding and ischemic risks-adjusted antithrombotic protocol in elderly patients revascularized with everolimus-eluting stents: EPIC05-Sierra75 study.
作者信息
de la Torre Hernandez Jose M, Palop Ramon Lopez, Jimenez Mazuecos Jesus M, Sáez Pilar Carrillo, Gutierez-Barrios Alejandro, Pinar Eduardo, Cid Belen, Fernandez Luis, Camarero Tamara Garcia, Urbano-Carrillo Cristóbal, Oteo Dominguez Juan F, Jimenez Diaz Victor A, Gomez Menchero Antonio E, Fernández Eladio Galindo, Córdoba Soriano Juan G, Ocaranza Raymundo, Úcar Eduardo Arroyo, Roman Koldobika Garcia San, Leal Silvio, Cáceres Ginés Martínez, Linares Vicente Jose A, Ferre Georgina Fuertes, Carrillo Xavier, Rama Merchán Juan C, Costa Catia, Sanchis Juan, Fernandes Renato, Rodrigues Alberto, Vegas Valle Jose M, Pereira Hélder, de Prado Armando Perez
机构信息
Cardiology Department, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.
Cardiology Department, Hospital Universitario San Juan, Alicante, Spain.
出版信息
J Geriatr Cardiol. 2022 May 28;19(5):354-366. doi: 10.11909/j.issn.1671-5411.2022.05.009.
OBJECTIVES
Elderly patients show a higher incidence of ischemic and bleeding events after percutaneous transluminal coronary intervention (PCI). We sought to investigate outcomes in elderly patients treated with antithrombotic strategy guided by bleeding and ischemic risks after revascularization with last generation everolimus-eluting stent (EES).
METHODS
Prospective multicenter registry including patients over 75 years revascularized with EES and antithrombotic therapy guided by clinical presentation, PCI complexity and PRECISE DAPT score. Co-primary safety endpoints were: (1) composite of cardiac death, myocardial infarction and stent thrombosis and; (2) bleeding (BARC 2-5). Primary efficacy endpoint was target lesion revascularization. A matched group of patients revascularized with current drug-eluting stents and no such tailored antithrombotic therapy was used as control.
RESULTS
Finally, 1064 patients were included in SIERRA-75 cohort, 80.8 ± 4.2 years, 36.6% women, 71% acute coronary syndromes (ACS) and 53.6% complex PCI. Co-primary safety endpoint of major adverse cardiovascular events was met in 6.2%, co-primary safety endpoint of bleeding in 7.8% and primary efficacy endpoint of TKLR in 1.5%. The multivariable adjusted model showed no significant association of the prescribed short/long dual antiplatelet therapy (DAPT) durations with any endpoint suggesting a well tailored therapy. No stent thrombosis reported in the subgroup with 1-3 months DAPT duration. As compared to control group, bleeding BARC 2-5 was significantly lower in SIERRA-75 group (7.4% . 10.2%, = 0.04) as well as the net safety-efficacy endpoint (14.3% . 18.5%, = 0.02).
CONCLUSIONS
In elderly population, the application of this risks-adjusted antithrombotic protocol after revascularization with last generation EES seems to be associated with an improved prognosis in terms of ischemic and bleeding outcomes.
目的
老年患者经皮冠状动脉介入治疗（PCI）后缺血和出血事件的发生率较高。我们试图研究使用新一代依维莫司洗脱支架（EES）进行血运重建后，根据出血和缺血风险指导抗栓策略治疗的老年患者的预后情况。
方法
前瞻性多中心注册研究，纳入年龄超过75岁、接受EES血运重建并根据临床表现、PCI复杂性和PRECISE DAPT评分进行抗栓治疗的患者。共同主要安全终点为：（1）心源性死亡、心肌梗死和支架血栓形成的复合终点；（2）出血（BARC 2-5级）。主要疗效终点为靶病变血运重建。一组接受当前药物洗脱支架血运重建且未进行此类针对性抗栓治疗的匹配患者作为对照。
结果
最终，1064例患者纳入SIERRA-75队列，年龄80.8±4.2岁，女性占36.6%，71%为急性冠状动脉综合征（ACS），53.6%为复杂PCI。主要不良心血管事件的共同主要安全终点发生率为6.2%，出血的共同主要安全终点发生率为7.8%，靶病变血运重建的主要疗效终点发生率为1.5%。多变量调整模型显示，规定的短期/长期双联抗血小板治疗（DAPT）持续时间与任何终点均无显著关联，表明治疗方案针对性良好。DAPT持续时间为1-3个月的亚组中未报告支架血栓形成。与对照组相比，SIERRA-75组出血BARC 2-5级显著更低（7.4%对10.2%，P=0.04），净安全-疗效终点也更低（14.3%对18.5%，P=0.02）。
结论
在老年人群中，使用新一代EES进行血运重建后应用这种风险调整后的抗栓方案，在缺血和出血结局方面似乎与预后改善相关。
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