Section of Cardiovascular Medicine, Department of Medicine Yale School of Medicine New Haven CT USA.
Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiovascular Medicine Beth Israel Deaconess Medical Center Boston MA USA.
J Am Heart Assoc. 2023 Jul 18;12(14):e029588. doi: 10.1161/JAHA.123.029588. Epub 2023 Jul 14.
Background Frailty is rarely assessed in clinical trials of patients who receive dual antiplatelet therapy (DAPT) after percutaneous coronary intervention. This study investigated whether frailty defined using claims data is associated with outcomes following percutaneous coronary intervention, and if there is a differential association in patients receiving standard versus extended duration DAPT. Methods and Results Patients ≥65 years of age in the DAPT (Dual Antiplatelet Therapy) Study, a randomized trial comparing 30 versus 12 months of DAPT following percutaneous coronary intervention, had data linked to Medicare claims (n=1326), and a previously validated claims-based index was used to define frailty. Net adverse clinical events, a composite of all-cause mortality, myocardial infarction, stroke, and major bleeding, were compared between frail and nonfrail patients. Patients defined as frail using claims data (12.0% of the cohort) had higher incidence of net adverse clinical events (23.1%) compared with nonfrail patients (10.7%; <0.001) at 18-month follow-up and increased risk after multivariable adjustment (adjusted hazard ratio [HR], 2.24 [95% CI, 1.38-3.63]). There were no differences in effects of extended duration DAPT on net adverse clinical events for frail (HR, 1.42 [95% CI, 0.73-2.75]) and nonfrail patients (HR, 1.18 [95% CI, 0.83-1.68]; interaction =0.61), although analyses were underpowered. Bleeding was highest among frail patients who received extended duration DAPT. Conclusions Among older patients in the DAPT Study, claims-defined frailty was associated with higher net adverse clinical events. Effects of extended duration DAPT were not different for frail patients, although comparisons were underpowered. Further investigation of how frailty influences ischemic and bleeding risks with DAPT are warranted. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00977938.
背景 在接受经皮冠状动脉介入治疗（PCI）后接受双联抗血小板治疗（DAPT）的患者的临床试验中，很少评估虚弱。本研究调查了使用索赔数据定义的虚弱是否与 PCI 后的结局相关，以及在接受标准或延长 DAPT 的患者中是否存在差异关联。
方法和结果 在 DAPT（双重抗血小板治疗）研究中，年龄≥65 岁的患者（一项比较 PCI 后 30 与 12 个月 DAPT 的随机试验）的数据与医疗保险索赔相关联（n=1326），并使用先前验证的基于索赔的指数来定义虚弱。在 18 个月的随访中，与非虚弱患者（10.7%；<0.001）相比，使用索赔数据定义为虚弱的患者（队列的 12.0%）发生净不良临床事件（全因死亡率、心肌梗死、卒中和主要出血的复合）的发生率更高（23.1%），并且在多变量调整后风险增加（调整后的危险比[HR]，2.24 [95%CI，1.38-3.63]）。对于虚弱（HR，1.42 [95%CI，0.73-2.75]）和非虚弱患者（HR，1.18 [95%CI，0.83-1.68]；交互作用=0.61），延长 DAPT 对净不良临床事件的影响没有差异，尽管分析的效力不足。虚弱患者的出血风险最高，且接受了延长 DAPT。
结论 在 DAPT 研究中的老年患者中，索赔定义的虚弱与更高的净不良临床事件相关。对于虚弱患者，延长 DAPT 的效果没有差异，尽管比较的效力不足。进一步研究虚弱如何影响 DAPT 的缺血和出血风险是必要的。
