Objective To assess the comparative effectiveness of computed tomography and invasive coronary angiography in women and men with stable chest pain suspected to be caused by coronary artery disease. Design Prospective, multicentre, randomised pragmatic trial. Setting Hospitals at 26 sites in 16 European countries. Participants 2002 (56.2%) women and 1559 (43.8%) men (total of 3561 patients) with suspected coronary artery disease referred for invasive coronary angiography on the basis of stable chest pain and a pre-test probability of obstructive coronary artery disease of 10-60%. Intervention Both women and men were randomised 1:1 (with stratification by gender and centre) to a strategy of either computed tomography or invasive coronary angiography as the initial diagnostic test (1019 and 983 women, and 789 and 770 men, respectively), and an intention-to-treat analysis was performed. Randomised allocation could not be blinded, but outcomes were assessed by investigators blinded to randomisation group. Main outcome measures The primary endpoint was major adverse cardiovascular events (MACE; cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke). Key secondary endpoints were an expanded MACE composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, transient ischaemic attack, or major procedure related complication) and major procedure related complications. Results Follow-up at a median of 3.5 years was available in 98.9% (1979/2002) of women and in 99.0% (1544/1559) of men. No statistically significant gender interaction was found for MACE (P=0.29), the expanded MACE composite (P=0.45), or major procedure related complications (P=0.11). In both genders, the rate of MACE did not differ between the computed tomography and invasive coronary angiography groups. In men, the expanded MACE composite endpoint occurred less frequently in the computed tomography group than in the invasive coronary angiography group (22 (2.8%) v 41 (5.3%); hazard ratio 0.52, 95% confidence interval 0.31 to 0.87). In women, the risk of having a major procedure related complication was lower in the computed tomography group than in the invasive coronary angiography group (3 (0.3%) v 21 (2.1%); hazard ratio 0.14, 0.04 to 0.46). Conclusion This study found no evidence for a difference between women and men in the benefit of using computed tomography rather than invasive coronary angiography as the initial diagnostic test for the management of stable chest pain in patients with an intermediate pre-test probability of coronary artery disease. An initial computed tomography scan was associated with fewer major procedure related complications in women and a lower frequency of the expanded MACE composite in men. Trial registration NCT02400229ClinicalTrials.gov [NCT02400229][1]. Individual participant data that underlie the results reported in the published article after de-identification will be shared with researchers who provide a sound proposal approved by the Dissemination Committee of the DISCHARGE trial. Proposals should be directed to discharge.eu@charite.de. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02400229&atom=%2Fbmj%2F379%2Fbmj-2022-071133.atom

中文翻译：

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初始计算机断层扫描和侵入性冠状动脉造影对患有稳定胸痛和疑似冠状动脉疾病的女性和男性的有效性比较：多中心随机试验

目的 评估计算机断层扫描和侵入性冠状动脉造影对疑似由冠状动脉疾病引起的稳定胸痛的女性和男性的有效性。设计前瞻性、多中心、随机实用试验。在 16 个欧洲国家的 26 个地点设有医院。参与者 2002 名 (56.2%) 女性和 1559 名 (43.8%) 男性（总共 3561 名患者）疑似冠状动脉疾病，基于稳定的胸痛和阻塞性冠状动脉疾病的预测试概率为 10，转诊进行侵入性冠状动脉造影-60%。干预 女性和男性均按 1:1（按性别和中心分层）随机分配至计算机断层扫描或侵入性冠状动脉造影策略作为初始诊断测试（分别为 1019 名女性和 983 名女性，以及 789 名男性和 770 名男性），进行了意向治疗分析。随机分配不能采用盲法，但结果由对随机分组不知情的研究人员进行评估。主要结局指标 主要终点是主要不良心血管事件（MACE；心血管死亡、非致命性心肌梗死或非致命性中风）。关键的次要终点是扩大的 MACE 复合终点（心血管死亡、非致命性心肌梗塞、非致命性卒中、短暂性脑缺血发作或主要手术相关并发症）和主要手术相关并发症。结果 98.9% (1979/2002) 的女性和 99.0% (1544/1559) 的男性获得了平均 3.5 年的随访。对于 MACE（P=0.29）、扩展的 MACE 复合材料（P=0.45）或主要手术相关并发症（P=0.11），没有发现统计学上显着的性别交互作用。在两种性别中，计算机断层扫描组和侵入性冠状动脉造影组的 MACE 发生率没有差异。在男性中，计算机断层扫描组中扩展的 MACE 复合终点的发生频率低于侵入性冠状动脉造影组（22（2.8%）v 41（5.3%）；风险比 0.52，95% 置信区间 0.31 至 0.87）。在女性中，计算机断层扫描组发生主要手术相关并发症的风险低于侵入性冠状动脉造影组（3 (0.3%) vs 21 (2.1%)；风险比 0.14、0.04 至 0.46）。结论 本研究没有发现证据表明女性和男性在使用计算机断层扫描而不是侵入性冠状动脉造影作为初始诊断测试来治疗冠状动脉疾病中等预检概率的患者的稳定胸痛方面存在差异。 。初次计算机断层扫描与女性中较少的主要手术相关并发症以及男性中扩展的 MACE 复合材料的发生率较低有关。试验注册 NCT02400229ClinicalTrials.gov [NCT02400229][1]。去识别化后发表的文章中报告的结果所依据的个人参与者数据将与提供经 DISCHARGE 试验传播委员会批准的合理提案的研究人员共享。提案应发送至discharge.eu@charite.de。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02400229&atom=%2Fbmj%2F379%2Fbmj-2022-071133.atom