该项研究旨在评价计算机断层扫描和有创冠状动脉造影对怀疑由冠状动脉疾病引起的稳定胸痛的女性和男性的疗效比较。

该项研究纳入3561例患者，数据结果显示在男性中，与有创冠状动脉造影组相比，计算机断层扫描组扩展MACE复合终点发生的频率较低(22 (2.8%)vs 41 (5.3%);风险比0.52,95%置信区间0.31 ~ 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有创冠状动脉造影组(3 (0.3%)vs 21 (2.1%);风险比0.14,0.04到0.46)。

本研究没有发现证据表明，对于冠状动脉疾病中期预试验概率患者的稳定胸痛管理，使用计算机断层扫描(ct)而不是侵入性冠状动脉造影作为初始诊断试验的好处在女性和男性之间存在差异。初次计算机断层扫描与女性较少的主要手术相关并发症和男性较低的扩大MACE复合材料的频率相关。

Abstract

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.

文章连接：

www.bmj.com/content/379/bmj-2022-071133.long

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