Objective Assessment of generalisability of guideline-informing trials on antithrombotic treatment intensification to real-world patients with cardiovascular disease (CVD). Methods Inclusion and exclusion criteria of the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS), Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management and Avoidance (CHARISMA), Prevention of Cardiovascular events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction (PEGASUS-TIMI) and Dual Antiplatelet Therapy (DAPT) study were applied to coronary artery disease (CAD) and/or peripheral artery disease (PAD) patients from Utrecht Cardiovascular Cohort-Second Manifestations of Arterial Disease (UCC-SMART) to determine real-world eligibility. Eligible and ineligible patients were compared on baseline characteristics, cardiovascular events, major bleeding and mortality. Results Eligibility ranged from 11%–94% for CAD to 75%–90% for patients with PAD. Cardiovascular, bleeding and mortality risks were higher in COMPASS-eligible patients with CAD (rate ratios (RR) 1.98 (95% CI 1.74 to 2.26), 2.02 (95% CI 1.47 to 2.78) and 3.11 (95% CI 2.71 to 3.57), respectively) and CHARISMA-eligible patients (RR 1.51 (95% CI 1.12 to 2.06), 2.25 (95% CI 1.01 to 6.21) and 4.43 (95% CI 2.79 to 7.51), respectively), and lower in COMPASS-eligible patients with PAD (RR 0.45 (95% CI 0.36 to 0.56), 0.29 (95% CI 0.18 to 0.46) and 0.45 (95% CI 0.38 to 0.54), respectively) and DAPT-eligible patients with CAD (RR CVD 0.49 (95% CI 0.34 to 0.69) and mortality 0.67 (95% CI 0.48 to 0.94)) than ineligible patients. After adjustment for trial eligibility criteria, only higher cardiovascular and mortality risks in COMPASS-eligible patients with CAD and lower cardiovascular risks in CHARISMA-eligible and DAPT-eligible patients persisted with CAD. Conclusion A large proportion of contemporary CVD patients would be eligible for intensified antithrombotic treatment trials, with mostly similar adjusted event risks to ineligible patients. Trial-based guideline recommendations are largely applicable to real-world patients. Data are available upon reasonable request. The data underlying this article are available upon reasonable request. Access to the data request module can be applied for via ucc-smart@umcutrecht.nl.

中文翻译：

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心血管疾病患者强化抗血栓治疗试验的普遍性

目的评估强化抗血栓治疗的指南指导试验对现实世界心血管疾病 (CVD) 患者的普遍性。方法 使用抗凝策略 (COMPASS)、氯吡格雷用于高动脉粥样硬化血栓形成风险和缺血稳定、管理和避免 (CHARISMA) 的人群的心血管结局的纳入和排除标准、使用替格瑞洛与安慰剂相比使用替格瑞洛预防既往心脏病发作患者的心血管事件阿司匹林溶栓治疗心肌梗塞 (PEGASUS-TIMI) 和双重抗血小板治疗 (DAPT) 背景研究应用于来自乌得勒支心血管队列第二次动脉表现的冠状动脉疾病 (CAD) 和/或外周动脉疾病 (PAD) 患者疾病 (UCC-SMART) 以确定现实世界的资格。对符合条件和不符合条件的患者的基线特征、心血管事件、大出血和死亡率进行比较。结果 CAD 患者的合格范围为 11%–94%，PAD 患者的合格范围为 75%–90%。符合 COMPASS 资格的 CAD 患者的心血管、出血和死亡风险较高（比率 (RR) 1.98（95% CI 1.74 至 2.26）、2.02（95% CI 1.47 至 2.78）和 3.11（95% CI 2.71 至 3.57） ）和符合 CHARISMA 资格的患者（RR 分别为 1.51（95% CI 1.12 至 2.06）、2.25（95% CI 1.01 至 6.21）和 4.43（95% CI 2.79 至 7.51）），而 COMPASS 符合资格的患者则更低患有 PAD 的患者（RR 分别为 0.45（95% CI 0.36 至 0.56）、0.29（95% CI 0.18 至 0.46）和 0.45（95% CI 0.38 至 0.54））和符合 DAPT 资格的 CAD 患者（RR CVD 0.49（95% CI 0.18 至 0.54））与不符合条件的患者相比，CI 0.34 至 0.69）和死亡率 0.67（95% CI 0.48 至 0.94））。调整试验资格标准后，只有符合 COMPASS 资格的 CAD 患者的心血管和死亡风险较高，而符合 CHARISMA 和 DAPT 资格的 CAD 患者的心血管风险较低。结论 很大一部分当代 CVD 患者有资格接受强化抗血栓治疗试验，调整后的事件风险与不符合资格的患者大多相似。基于试验的指南建议很大程度上适用于现实世界的患者。数据可根据合理要求提供。本文所依据的数据可根据合理请求提供。可以通过 ucc-smart@umcutrecht.nl 申请访问数据请求模块。