1 Department of Epidemiology, School of Public Health, Rutgers University, Piscataway, New Jersey.
2 Merck & Co., Kenilworth, New Jersey.
J Manag Care Spec Pharm. 2017 Sep;23(9):947-956. doi: 10.18553/jmcp.2017.23.9.947.
P2Y12 antiplatelet therapy (APT) is highly efficacious in reducing the incidence of ischemic events in patients with acute coronary syndrome (ACS); however, it is associated with several adverse complications. Data on P2Y12-associated complications and adherence to APT are sparse.
To describe the characteristics, frequency of P2Y12-associated complications, adherence and persistence to P2Y12 APT, and health care utilization among ACS patients on P2Y12 APT.
This retrospective observational study of the MarketScan Commercial Claims and Encounters Database identified patients aged ≥ 18 years who were discharged from an ACS hospitalization in 2012-2014 and initiated P2Y12 APT (ticagrelor, prasugrel, or clopidogrel). The proportion of patients within each treatment group who experienced P2Y12-associated complications within 1 year and who were adherent to APT were determined. Frequencies of all-cause health care utilization (i.e., hospitalization, length of stay, emergency room [ER] visits, outpatient visits, cardiac events, and transfusions) were evaluated for each treatment group. Poisson regressions were conducted to evaluate the association between nonad-herence with P2Y12 APT and health care utilization, after adjusting for demographics (age and gender), health insurance type, and comorbidities.
Among 11,629 ACS patients, most were male; 44.6% had hypertension; 20.6% had diabetes; and 53.4% had hyperlipidemia. Clopidogrel use was common (62.6%), with ticagrelor use less common (9.0%). Among all groups, approximately one third experienced P2Y12-associated complications. One-year adherence to APT was suboptimal (68% overall), with 73.3% adherence among prasugrel users, followed by 71.4% adherence among ticagrelor users and 65.6% adherence among clopidogrel users. Switching was most common with ticagrelor users. Inpatient hospitalizations, cardiac events, and transfusions were more common in clopidogrel users compared with prasugrel and ticagrelor users. Nonadherent patients experienced significantly more hospitalizations, ER visits, and transfusions (1.34, 1.09, and 1.85 [P < 0.05], respectively) compared with adherent patients. These trends of association remained consistent across all treatment groups. Also, patients not adherent to ticagrelor experienced 1.9 times as many cardiac events as adherent patients. However, this association was not significant for clopidogrel and prasugrel users. Patients not adherent to P2Y12 APT experienced significantly lower outpatient visits compared with adherent patients.
Complications associated with P2Y12 in ACS patients treated with P2Y12 APT were common, with dyspnea, heart block, and major or life-threatening bleeding as the most common. Adherence was significantly associated with lower health care utilization. Increased adherence to secondary prevention therapy among these very high-risk patients is crucial. Disease management strategies to improve adherence and reduce treatment-associated adverse events through individualized patient care, alternative secondary treatment options, and physician awareness should be designed, implemented, and sustained.
Data analysis was conducted by Merck & Co., the manufacturer of vorapaxar (ZONTIVITY). At the time of this study, Vyas was an employee of Rutgers University, which received grant funding from Merck & Co. for this study, and is now employed with the University of Rhode Island. Patel was employed by Symphony Solutions and the University of North Carolina during the drafting and revising of the manuscript. Bash is employed by Merck & Co. Simpson received consulting fees from Merck & Co. for work on this study and has received fees for research from Amgen and Pfizer. Study concept and design were contributed by Vyas, Bash, Patel, and Simpson. Patel took the lead in data collection, assisted by the other authors. All the authors contributed equally to data analysis and manuscript preparation. The abstract for this study was presented as a poster at the American Heart Association Scientific Sessions 2016; November 12-16, 2016; New Orleans, Louisiana.
在急性冠状动脉综合征（ACS）患者中，P2Y12 抗血小板治疗（APT）在降低缺血事件发生率方面非常有效；然而，它也与一些不良并发症有关。关于 P2Y12 相关并发症和 APT 依从性的数据很少。
描述 ACS 患者接受 P2Y12 APT 治疗时 P2Y12 相关并发症的特征、频率、对 P2Y12 APT 的依从性和持续性，以及医疗保健的利用情况。
本研究回顾性观察了 MarketScan 商业索赔和就诊数据库中的数据，确定了 2012-2014 年因 ACS 住院并开始接受 P2Y12 APT（替格瑞洛、普拉格雷或氯吡格雷）治疗的年龄≥18 岁的患者。确定了每个治疗组在 1 年内发生 P2Y12 相关并发症的患者比例和对 APT 依从的患者比例。评估了每个治疗组的所有原因医疗保健利用情况（即住院、住院时间、急诊室[ER]就诊、门诊就诊、心脏事件和输血）。在调整了人口统计学因素（年龄和性别）、医疗保险类型和合并症后，进行泊松回归评估非依从性与医疗保健利用之间的关联。
在 11629 例 ACS 患者中，大多数为男性；44.6%有高血压；20.6%有糖尿病；53.4%有高脂血症。氯吡格雷的使用率较高（62.6%），替格瑞洛的使用率较低（9.0%）。在所有组中，大约三分之一的患者发生了 P2Y12 相关并发症。APT 的 1 年依从性不理想（总体 68%），普拉格雷使用者的依从率为 73.3%，其次是替格瑞洛使用者的依从率为 71.4%，氯吡格雷使用者的依从率为 65.6%。替格瑞洛使用者最常见的是换药。与普拉格雷和替格瑞洛使用者相比，氯吡格雷使用者的住院治疗、心脏事件和输血更为常见。与依从性患者相比，不依从性患者的住院治疗、急诊就诊和输血次数明显更多（分别为 1.34、1.09 和 1.85[P<0.05]）。这些关联趋势在所有治疗组中都保持一致。此外，不依从替格瑞洛的患者发生心脏事件的几率是依从性患者的 1.9 倍。然而，氯吡格雷和普拉格雷使用者的这种关联并不显著。不依从 P2Y12 APT 的患者的门诊就诊次数明显低于依从性患者。
接受 P2Y12 APT 治疗的 ACS 患者中与 P2Y12 相关的并发症很常见，最常见的是呼吸困难、心脏阻滞和主要或危及生命的出血。依从性与较低的医疗保健利用率显著相关。对于这些极高风险的患者，增加二级预防治疗的依从性至关重要。应设计、实施和维持旨在通过个体化患者护理、替代二级治疗选择和提高医生认识来改善依从性和减少治疗相关不良事件的疾病管理策略。
数据分析由默克公司（ZONTIVITY 的制造商）进行。在这项研究时，Vyas 是罗格斯大学的一名员工，默克公司为此项研究提供了赠款，他现在是罗德岛大学的员工。Patel 在起草和修订稿件期间受雇于 Symphony Solutions 和北卡罗来纳大学。Bash 受雇于默克公司。Simpson 因这项研究获得了默克公司的咨询费，并从安进和辉瑞获得了研究费。Vyas、Bash、Patel 和 Simpson 为研究概念和设计做出了贡献。Patel 主导了数据收集工作，其他作者也提供了协助。所有作者都对数据分析和手稿准备做出了同等贡献。这项研究的摘要作为海报在美国心脏协会科学会议 2016 年会上展出；2016 年 11 月 12-16 日；新奥尔良，路易斯安那州。
