Ohm Joel, Jernberg Tomas, Johansson David, Warnqvist Anna, Leosdottir Margrét, Hambraeus Kristina, Svensson Per
Department of Emergency Medicine, Solna, Karolinska University Hospital, Anna Steckséns gata 33, Stockholm SE-171 76, Sweden.
Department of Medicine, Solna, Karolinska Institutet, Stockholm SE-17177, Sweden.
Eur Heart J Open. 2021 Aug 11;1(2):oeab020. doi: 10.1093/ehjopen/oeab020. eCollection 2021 Sep.
To investigate whether participants in clinical trials after myocardial infarction (MI) are representable for the post-MI population concerning characteristics, secondary prevention, and prognosis.
Cohort study on 31 792 attendants to 1-year revisits after MI throughout Sweden ( = 2941 clinical trial participants) between 2008 and 2013 identified in the Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART). Individual-level data on socioeconomic status (SES) (disposable income, educational level, and marital status) and outcomes (first recurrent non-fatal MI, coronary heart disease death, fatal or non-fatal stroke until study end 2018) were linked from other national registries. Trial participants were more likely to be men [risk ratio 1.09; 95% confidence interval (CI) 1.07-1.11], and married (1.07; 1.04-1.10), have a highest-quintile income (1.42; 1.36-1.48), and post-secondary education (1.25; 1.18-1.33), while less likely to have a history of MI (0.88; 0.80-0.97), be persistent smokers (0.83; 0.75-0.92) and have left ventricular dysfunction (0.59; 0.44-0.79) compared to non-participants. During a mean 6.7-year follow-up, 5206 outcome events occurred. Risk was lower in trial participants (hazard ratio 0.80; 95% CI 0.72-0.89), also after adjusting for clinical characteristics and post-MI therapies (0.85; 0.77-0.94) and additionally for SES (0.88; 0.79-0.97).
Clinical trial participants post-MI are more often male, have higher SES, a more advantageous risk profile, and better prognosis. Additional unmeasured participation bias was implied. Questionable external validity of post-MI trials highlights the importance of complementary studies using real-world data.
探讨心肌梗死（MI）后临床试验的参与者在特征、二级预防和预后方面是否能代表MI后的总体人群。
对2008年至2013年期间瑞典全国31792名MI后1年复诊者（n = 2941名临床试验参与者）进行队列研究，这些数据来自瑞典心脏病循证护理增强与发展网络系统（SWEDEHEART）。从其他国家登记处获取了个体层面的社会经济地位（SES）（可支配收入、教育水平和婚姻状况）和结局（至2018年研究结束时首次复发性非致命MI、冠心病死亡、致命或非致命性卒中）数据。与非参与者相比，试验参与者更可能为男性[风险比1.09；95%置信区间（CI）1.（07 - 1.11）]、已婚（1.07；1.04 - 1.10）、收入处于最高五分位数（1.42；1.36 - 1.48）且接受过高等教育（1.25；1.18 - 1.33），而MI病史（0.88；0.80 - 0.97）、持续吸烟者（0.83；0.75 - 0.92）和左心室功能障碍（0.59；0.44 - 0.79）的可能性较小。在平均6.7年的随访期间，发生了5206例结局事件。试验参与者的风险较低（风险比0.80；95% CI 0.72 - 0.89），在调整临床特征和MI后治疗后（0.85；0.77 - 0.94）以及进一步调整SES后（0.88；0.79 - 0.97）也是如此。
MI后临床试验参与者男性比例更高，SES更高，风险状况更有利，预后更好。这意味着存在额外的未测量参与偏倚。MI后试验的外部有效性存疑，凸显了使用真实世界数据进行补充研究的重要性。
