在英国，接受经皮冠状动脉介入治疗 (PCI) 的急性冠状动脉综合征 (ACS) 患者的真实世界出血情况：一项基于人群的队列研究模拟“目标试验”。
Real-world bleeding in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) and prescribed different combinations of dual antiplatelet therapy (DAPT) in England: a population-based cohort study emulating a 'target trial'.
机构信息
Bristol Trials Centre, Bristol Medical School, University of Bristol, Bristol, UK
Bristol Heart Institute, University of Bristol, Bristol, UK.
出版信息
Open Heart. 2022 Aug;9(2). doi: 10.1136/openhrt-2022-001999.
OBJECTIVE
To estimate the incidence and HRs for bleeding for different dual antiplatelet therapies (DAPT) in a real-world population with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) in England.
DESIGN
A retrospective, population-based cohort study emulating a target randomised controlled trial (tRCT).
DATA SOURCES
Linked Clinical Practice Research Datalink (CPRD) and Hospital Episode Statistics (HES).
SETTING
Primary and secondary care.
PARTICIPANTS
Patients ≥18 years old with ACS undergoing emergency PCI.
INTERVENTIONS
Aspirin and clopidogrel (AC, reference) versus aspirin and prasugrel (AP) or aspirin and ticagrelor (AT); AP evaluated only in patients with ST-elevation myocardial infarction (STEMI).
MAIN OUTCOME MEASURES
Primary: any bleeding up to 12 months after the index event (HES- or CPRD- recorded). Secondary: HES-recorded bleeding, CPRD-recorded bleeding, all-cause and cardiovascular mortality, mortality from bleeding, myocardial infarction, stroke, additional coronary intervention and major adverse cardiovascular and cerebrovascular events (MACCE).
RESULTS
In ACS, the rates of any bleeding for AC and AT were 89 per 1000 person years and 134 per 1000 person years, respectively. In STEMI, rates for AC, AP and AT were 93 per 1000 person years, 138 per 1000 person years and 143 per 100 person years, respectively. In ACS, compared with AC, AT increased the hazard of any bleeding (HR: 1.47, 95% CI 1.19 to 1.82) but did not reduce MACCE (HR: 1.06, 95% CI 0.89 to 1.27). In STEMI, compared with AC, AP and AT increased the hazard of any bleeding (HR: 1.77, 95% CI 1.21 to 2.59 and HR: 1.50, 95% CI 1.10 to 2.05, respectively) but did not reduce MACCE (HR: 1.10, 95% CI 0.80 to 1.51 and HR: 1.21, 95% CI 0.94 to 1.51, respectively). Non-adherence to the prescribed DAPT regimen was 28% in AC (29% in STEMI only), 31% in AP (STEMI only) and 33% in AT (32% in STEMI only).
CONCLUSIONS
In a real-world population with ACS, DAPT with ticagrelor or prasugrel are associated with increased bleeding compared with DAPT with clopidogrel.
TRIAL REGISTRATION NUMBER
ISRCTN76607611.
目的
在英国接受经皮冠状动脉介入治疗（PCI）的急性冠状动脉综合征（ACS）患者中，估计不同双联抗血小板治疗（DAPT）的出血发生率和 HR。
设计
一项回顾性、基于人群的队列研究，模拟目标随机对照试验（tRCT）。
数据来源
临床实践研究数据链接（CPRD）和医院入院统计（HES）的链接。
设置
初级和二级保健。
参与者
年龄≥18 岁，因 ACS 行紧急 PCI 的患者。
干预措施
阿司匹林加氯吡格雷（AC，参照）与阿司匹林加普拉格雷（AP）或阿司匹林加替格瑞洛（AT）；仅在 ST 段抬高型心肌梗死（STEMI）患者中评估 AP。
主要观察指标
主要终点：索引事件后 12 个月内的任何出血（HES 或 CPRD 记录）。次要终点：HES 记录的出血、CPRD 记录的出血、全因和心血管死亡率、出血死亡率、心肌梗死、卒中和其他冠状动脉介入治疗以及主要不良心血管和脑血管事件（MACCE）。
结果
在 ACS 中，AC 和 AT 的任何出血率分别为 89/1000 人年和 134/1000 人年。在 STEMI 中，AC、AP 和 AT 的出血率分别为 93/1000 人年、138/1000 人年和 143/100 人年。在 ACS 中，与 AC 相比，AT 增加了任何出血的风险（HR：1.47，95%CI 1.19 至 1.82），但未降低 MACCE（HR：1.06，95%CI 0.89 至 1.27）。在 STEMI 中，与 AC 相比，AP 和 AT 增加了任何出血的风险（HR：1.77，95%CI 1.21 至 2.59 和 HR：1.50，95%CI 1.10 至 2.05），但未降低 MACCE（HR：1.10，95%CI 0.80 至 1.51 和 HR：1.21，95%CI 0.94 至 1.51）。AC 的不依从性处方 DAPT 方案为 28%（仅在 STEMI 中为 29%），AP（仅在 STEMI 中）为 31%，AT（仅在 STEMI 中）为 33%。
结论
在 ACS 真实世界人群中，与氯吡格雷相比，替格瑞洛或普拉格雷的 DAPT 治疗与出血增加相关。
试验注册
ISRCTN76607611。
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