Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville.
Center for Drug Evaluation and Safety, University of Florida, Gainesville.
JAMA Netw Open. 2023 Apr 3;6(4):e238585. doi: 10.1001/jamanetworkopen.2023.8585.
A platelet ADP P2Y12 receptor (P2Y12) inhibitor plus aspirin is standard therapy for patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). Compared with clopidogrel, prasugrel and ticagrelor are associated with superior antiatherothrombotic effects but increased bleeding risk; with recent guideline updates, it is important to describe current treatment patterns and the role of bleeding risk in treatment choice.
To describe secular trends and determinants of initial P2Y12 inhibitor choice and switching, including deescalation (switch from prasugrel or ticagrelor to clopidogrel).
DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used MarketScan Commercial Claims Data from 2010 to 2019 for patients aged 18 years or older who underwent PCI for ACS, had no P2Y12 inhibitor use in the past year, and filled a P2Y12 inhibitor prescription within 30 days after PCI hospitalization discharge. Data were analyzed from February to May 2022.
Clopidogrel, prasugrel, and ticagrelor, with determinants including bleeding risk measured using Academic Research Consortium for High Bleeding Risk criteria, sociodemographic characteristics, P2Y12 inhibitor copays, and bleeding events during follow-up.
The prevalence of each P2Y12 inhibitor among patients who initiated the drugs and the prevalence of switching within 12 months after PCI were evaluated. The association between baseline bleeding risk and bleeding manifestations during follow-up and initial treatment and deescalation were calculated using multivariable logistic and Cox proportional hazards regression models.
Between 2010 and 2019, 62 423 patients were identified who initiated P2Y12 inhibitors (females, 22.4%; males, 77.6%; mean [SD] age, 54.32 [7.13] years). The prevalence of clopidogrel as initial therapy decreased from 77.5% in 2010 to 29.6% in 2019, while initial use of prasugrel or ticagrelor increased from 22.5% to 60.4%. Within 1 year after PCI, 11.0% of patients switched therapy, mostly for deescalation. Deescalation prevalence increased from 1.8% in 2010 to 12.6% in 2018. Between 2016 and 2018, 8588 of 22 886 (37.5%) patients had major baseline bleeding risk, which decreased the selection of prasugrel or ticagrelor as initial therapy (adjusted odds ratio, 0.78; 95% CI, 0.74-0.84). Among 11 285 patients who initiated prasugrel or ticagrelor, major bleeding risk at baseline (adjusted hazard ratio, 1.11; 95% CI, 1.00-1.23) and the occurrence of bleeding during follow-up (adjusted hazard ratio, 4.42; 95% CI, 3.62-5.93) were associated with deescalation.
A strong shift in preference for prasugrel and ticagrelor as initial therapy following PCI for ACS was observed. Deescalation increased over the study period. Major bleeding risk at baseline was moderately associated with initial treatment choice but had a limited association with deescalation. The increasing use of more potent P2Y12 inhibitors emphasizes opportunities to enhance preemptive patient-centered treatment strategies to maintain optimal antiplatelet activity while reducing bleeding risk during the subacute period following PCI for ACS.
对于接受经皮冠状动脉介入治疗(PCI)治疗急性冠状动脉综合征(ACS)的患者,血小板 ADP P2Y12 受体(P2Y12)抑制剂加阿司匹林是标准治疗方法。与氯吡格雷相比,普拉格雷和替格瑞洛与更好的抗动脉粥样硬化作用相关,但出血风险增加;随着最近指南的更新,描述当前的治疗模式和出血风险在治疗选择中的作用非常重要。
描述初始 P2Y12 抑制剂选择和转换(包括降级,即从普拉格雷或替格瑞洛转换为氯吡格雷)的趋势和决定因素。
设计、设置和参与者:本回顾性队列研究使用 MarketScan 商业索赔数据,从 2010 年至 2019 年,纳入年龄在 18 岁或以上、过去一年未使用 P2Y12 抑制剂且在 PCI 住院出院后 30 天内开具 P2Y12 抑制剂处方的患者。数据分析于 2022 年 2 月至 5 月进行。
氯吡格雷、普拉格雷和替格瑞洛,包括使用学术研究联合会高出血风险标准衡量的出血风险、社会人口统计学特征、P2Y12 抑制剂共付额和随访期间的出血事件。
评估了患者开始使用每种 P2Y12 抑制剂的患病率以及 PCI 后 12 个月内转换的患病率。使用多变量逻辑和 Cox 比例风险回归模型计算基线出血风险与随访期间出血表现之间以及初始治疗和降级之间的关联。
在 2010 年至 2019 年期间,确定了 62423 名开始使用 P2Y12 抑制剂的患者(女性,22.4%;男性,77.6%;平均[标准差]年龄,54.32[7.13]岁)。氯吡格雷作为初始治疗的患病率从 2010 年的 77.5%降至 2019 年的 29.6%,而普拉格雷或替格瑞洛的初始使用率从 22.5%升至 60.4%。在 PCI 后 1 年内,有 11.0%的患者进行了治疗转换,主要是降级。降级的患病率从 2010 年的 1.8%增加到 2018 年的 12.6%。在 2016 年至 2018 年期间,22886 名患者中有 8588 名(37.5%)有主要的基线出血风险,这降低了选择普拉格雷或替格瑞洛作为初始治疗的可能性(调整后的优势比,0.78;95%CI,0.74-0.84)。在 11285 名开始使用普拉格雷或替格瑞洛的患者中,基线时主要出血风险(调整后的危险比,1.11;95%CI,1.00-1.23)和随访期间出血(调整后的危险比,4.42;95%CI,3.62-5.93)与降级相关。
观察到 PCI 治疗 ACS 后普拉格雷和替格瑞洛作为初始治疗的偏好发生了强烈转变。在此期间,降级的比例有所增加。基线时的主要出血风险与初始治疗选择中度相关,但与降级的相关性有限。更有效的 P2Y12 抑制剂的使用增加强调了增强以患者为中心的治疗策略的机会,以在 ACS 患者 PCI 后亚急性期保持最佳抗血小板活性,同时降低出血风险。