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Abstract：
OBJECTIVE: Clinical practice guidelines (CPGs) are published to guide the management of acute coronary syndrome (ACS). We aimed to critically appraise the representativeness and standard of care of randomised clinical trials (RCTs) supporting CPGs for ACS.
RESULTS: American and European CPGs for ST- and non-ST-elevation ACS were screened to extract all references (n = 2128) and recommendations (n = 600). Among the 407 primary publications of RCTs (19.1%), there were 52.6 and 73.2% recruiting patients in North America and Europe, respectively, whereas other regions were largely under-represented (e.g. 25.3% RCTs recruited in Asia). There was 68.6% RCTs enrolling patient with ACS, whereas the remaining 31.4% did not enrol any patient with ACS. There was under-representation of some important subgroups, including elderly, female (29.9%), and non-white patients (<20%). The incidence and type of reperfusion reported in these RCTs were not reflective of current clinical practice (the percentage of patients who underwent percutaneous coronary intervention (PCI) among all RCTs was 42.7%; whereas for ST-Elevation Myocardial Infarction patients, the number of participants who underwent fibrinolysis was 3.3-fold higher than those who underwent primary PCI). All-cause mortality in these RCTs was 11.9% in RCTs with a follow-up ≤ 1 year.
CONCLUSIONS: Randomised clinical trials supporting CPGs for ACS are not fully representative of the diversity of the ACS population and their current standard of care. While some of these issues with representativeness may be explained by how evidence has been accrued over time, efforts should be made by trialists to ensure that the evidence supporting CPGs is representative of the wider ACS population.
RESULTS: American and European CPGs for ST- and non-ST-elevation ACS were screened to extract all references (n = 2128) and recommendations (n = 600). Among the 407 primary publications of RCTs (19.1%), there were 52.6 and 73.2% recruiting patients in North America and Europe, respectively, whereas other regions were largely under-represented (e.g. 25.3% RCTs recruited in Asia). There was 68.6% RCTs enrolling patient with ACS, whereas the remaining 31.4% did not enrol any patient with ACS. There was under-representation of some important subgroups, including elderly, female (29.9%), and non-white patients (<20%). The incidence and type of reperfusion reported in these RCTs were not reflective of current clinical practice (the percentage of patients who underwent percutaneous coronary intervention (PCI) among all RCTs was 42.7%; whereas for ST-Elevation Myocardial Infarction patients, the number of participants who underwent fibrinolysis was 3.3-fold higher than those who underwent primary PCI). All-cause mortality in these RCTs was 11.9% in RCTs with a follow-up ≤ 1 year.
CONCLUSIONS: Randomised clinical trials supporting CPGs for ACS are not fully representative of the diversity of the ACS population and their current standard of care. While some of these issues with representativeness may be explained by how evidence has been accrued over time, efforts should be made by trialists to ensure that the evidence supporting CPGs is representative of the wider ACS population.
摘要：
目的：发布临床实践指南（CPGs）以指导急性冠脉综合征（ACS）的治疗。我们旨在批判性地评估支持ACSCPG的随机临床试验（RCT）的代表性和护理标准。
结果：对ST和非ST段抬高ACS的美国和欧洲CPG进行筛选，以提取所有参考（n=2128）和建议（n=600）。在RCT的407种主要出版物中（19.1%），在北美和欧洲有52.6%和73.2%的患者正在招募患者，分别,而其他地区在很大程度上代表性不足(例如，25.3%RCT在亚洲招募）。有68.6%的RCT登记ACS患者，而其余31.4%未纳入任何ACS患者.一些重要的分组代表性不足，包括老年人,女性（29.9％）和非白人患者（<20％）。这些随机对照试验中报道的再灌注的发生率和类型不能反映当前的临床实践(在所有随机对照试验中接受经皮冠状动脉介入治疗(PCI)的患者百分比为42.7%;而对于ST段抬高型心肌梗死患者,接受纤维蛋白溶解的参与者数量比接受原发性PCI的参与者高3.3倍).这些随机对照试验的全因死亡率为11.9%，随访≤1年。
结论：支持ACS的CPG的RCT不能完全代表ACS人群的多样性及其当前的护理标准。虽然其中一些具有代表性的问题可以用证据是如何随着时间的推移而积累的来解释的，试验人员应努力确保支持CPG的证据能够代表更广泛的ACS人群.
结果：对ST和非ST段抬高ACS的美国和欧洲CPG进行筛选，以提取所有参考（n=2128）和建议（n=600）。在RCT的407种主要出版物中（19.1%），在北美和欧洲有52.6%和73.2%的患者正在招募患者，分别,而其他地区在很大程度上代表性不足(例如，25.3%RCT在亚洲招募）。有68.6%的RCT登记ACS患者，而其余31.4%未纳入任何ACS患者.一些重要的分组代表性不足，包括老年人,女性（29.9％）和非白人患者（<20％）。这些随机对照试验中报道的再灌注的发生率和类型不能反映当前的临床实践(在所有随机对照试验中接受经皮冠状动脉介入治疗(PCI)的患者百分比为42.7%;而对于ST段抬高型心肌梗死患者,接受纤维蛋白溶解的参与者数量比接受原发性PCI的参与者高3.3倍).这些随机对照试验的全因死亡率为11.9%，随访≤1年。
结论：支持ACS的CPG的RCT不能完全代表ACS人群的多样性及其当前的护理标准。虽然其中一些具有代表性的问题可以用证据是如何随着时间的推移而积累的来解释的，试验人员应努力确保支持CPG的证据能够代表更广泛的ACS人群.
