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CT在稳定型胸痛和疑似冠脉疾病患者的初始诊断方面不存在性别差异
作者:小柯机器人 发布时间:2022/10/24 15:52:35

德国柏林大学M Dewey团队比较了初步计算机断层扫描和有创冠状动脉造影在稳定型胸痛和疑似冠状动脉疾病的女性和男性中的有效性。这一研究成果于2022年10月19日发表在《英国医学杂志》上。

该研究旨在评估比较计算机断层扫描和有创冠状动脉造影在疑似由冠状动脉疾病引起的稳定胸痛患者中的有效性。研究组在16个欧洲国家的26个机构医院进行了一项前瞻性、多中心、随机实用试验。

共招募了2002(56.2%)名女性和1559(43.8%)名男性(共3561名患者),根据稳定的胸痛和10-60%的阻塞性冠状动脉疾病的预测试概率,将疑似冠心病患者转诊为有创性冠状动脉造影。将女性和男性以1:1随机分组(按性别和中心分层),以计算机断层扫描或有创冠状动脉造影作为初始诊断测试(分别为1019和983名女性,789和770名男性),并进行意向治疗分析。

随机分配非盲,但结果由对随机分组盲的研究人员进行评估。主要终点是重大心血管不良事件(MACE;心血管死亡、非致命性心肌梗死或非致命性中风)。关键次要终点是扩大的MACE综合结局(心血管死亡、非致命性心肌梗死、非致命中风、短暂性缺血发作或重大手术相关并发症)和重大手术相关的并发症。

98.9%(1979/2002)的女性和99.0%(1544/1559)的男性患者中位随访时间为3.5年。MACE(P=0.29)、扩大的MACE综合结局(P=0.45)或重大手术相关并发症(P=0.11)均未发现有统计学意义的性别交互作用。

在两种性别中,计算机断层扫描组和有创冠状动脉造影组的MACE发生率没有差异。在男性中,计算机断层扫描组的MACE综合结局发生率低于有创冠状动脉造影组(分别为22名(2.8%)与41名(5.3%))。在女性中,计算机断层扫描组发生重大手术相关并发症的风险低于有创冠状动脉造影组(分别为3名(0.3%)与21名(2.1%))。

研究结果表明,对于冠状动脉疾病预试验中等概率患者的稳定性胸痛的处理,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试验方面,没有证据表明女性和男性有差异。初次计算机断层扫描与女性较少的重大手术相关并发症和男性较低的扩大MACE综合结局发生率相关。

附:英文原文

Title: Comparative effectiveness of initial computed tomography and invasive coronary angiography in women and men with stable chest pain and suspected coronary artery disease: multicentre randomised trial

Author: DISCHARGE Trial Group

Issue&Volume: 2022/10/19

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.

DOI: 10.1136/bmj-2022-071133

Source: https://www.bmj.com/content/379/bmj-2022-071133

 

期刊信息

BMJ-British Medical Journal:《英国医学杂志》,创刊于1840年。隶属于BMJ出版集团,最新IF:27.604
官方网址:http://www.bmj.com/
投稿链接:https://mc.manuscriptcentral.com/bmj