Semenzato Laura, Le Vu Stéphane, Botton Jérémie, Bertrand Marion, Jabagi Marie-Joelle, Drouin Jérôme, Cuenot François, Zores Florian, Dray-Spira Rosemary, Weill Alain, Zureik Mahmoud
EPI-PHARE Scientific Interest Group in Epidemiology of Health Products from the French National Agency for the Safety of Medicines and Health Products and the French National Health Insurance.
University Paris-Saclay, Faculté de pharmacie, Orsay, France.
JAMA. 2024 Aug 26;332(16):1367-77. doi: 10.1001/jama.2024.16380.
IMPORTANCE: Although patients with myocarditis after COVID-19 mRNA vaccination appear to have a good prognosis near hospital discharge, their longer-term prognosis and management remain unknown. OBJECTIVE: To study the cardiovascular complications of post-COVID-19 mRNA vaccination myocarditis and other types of myocarditis during an 18-month follow-up, as well as disease management based on a study of the frequency of medical procedures and drug prescriptions. DESIGN, SETTING, AND PARTICIPANTS: In this cohort study based on the French National Health Data System, all individuals aged 12 to 49 years hospitalized for myocarditis in France between December 27, 2020, and June 30, 2022, were identified. EXPOSURE: Individuals were categorized as having postvaccine myocarditis (within 7 days after COVID-19 mRNA vaccine), post-COVID-19 myocarditis (within 30 days of SARS-CoV-2 infection), or conventional myocarditis. MAIN OUTCOMES AND MEASURES: The occurrence of clinical outcomes (hospital readmission for myopericarditis, other cardiovascular events, all-cause death, and a composite outcome of these events) over the 18 months following hospital admission were analyzed using weighted Cox models to standardize the comparisons with the conventional myocarditis group. Also, medical management after hospital discharge was longitudinally assessed using generalized estimated equation models. RESULTS: In total, 4635 individuals were hospitalized for myocarditis: 558 with postvaccine myocarditis, 298 with post-COVID-19 myocarditis, and 3779 with conventional myocarditis. Patients with postvaccine myocarditis were younger than those with post-COVID-19 and conventional myocarditis (mean [SD] age of 25.9 [8.6], 31.0 [10.9], and 28.3 [9.4] years, respectively) and were more frequently men (84%, 67%, and 79%). Patients with postvaccine myocarditis had a lower standardized incidence of the composite clinical outcome than those with conventional myocarditis (32/558 vs 497/3779 events; weighted hazard ratio, 0.55 [95% CI, 0.36-0.86]), whereas individuals with post-COVID-19 myocarditis had similar results (36/298 events; weighted hazard ratio, 1.04 [95% CI, 0.70-1.52]). The standardized frequency of medical procedures and drugs prescribed in patients with postvaccine myocarditis or post-COVID-19 myocarditis followed a similar trend in the 18 months following hospital discharge to that of patients with conventional myocarditis. CONCLUSIONS AND RELEVANCE: Patients with post-COVID-19 mRNA vaccination myocarditis, contrary to those with post-COVID-19 myocarditis, show a lower frequency of cardiovascular complications than those with conventional myocarditis at 18 months. However, affected patients, mainly healthy young men, may require medical management up to several months after hospital discharge.
重要性:尽管新冠病毒 mRNA 疫苗接种后发生心肌炎的患者在出院时预后似乎良好,但其长期预后和管理仍不明确。 目的:在 18 个月的随访期间,研究新冠病毒 mRNA 疫苗接种后心肌炎及其他类型心肌炎的心血管并发症,以及基于医疗程序频率和药物处方研究的疾病管理情况。 设计、地点和参与者:在这项基于法国国家卫生数据系统的队列研究中,确定了 2020 年 12 月 27 日至 2022 年 6 月 30 日期间在法国因心肌炎住院的所有 12 至 49 岁个体。 暴露因素:个体被分类为接种疫苗后心肌炎(在新冠病毒 mRNA 疫苗接种后 7 天内)、新冠病毒感染后心肌炎(在严重急性呼吸综合征冠状病毒 2 感染后 30 天内)或传统心肌炎。 主要结局和指标:使用加权 Cox 模型分析入院后 18 个月内临床结局(因心肌心包炎再次住院、其他心血管事件、全因死亡以及这些事件的综合结局)的发生情况,以标准化与传统心肌炎组的比较。此外,使用广义估计方程模型对出院后的医疗管理进行纵向评估。 结果:共有 4635 人因心肌炎住院:558 例为接种疫苗后心肌炎,298 例为新冠病毒感染后心肌炎,3779 例为传统心肌炎。接种疫苗后心肌炎患者比新冠病毒感染后心肌炎和传统心肌炎患者更年轻(平均[标准差]年龄分别为 25.9[8.6]岁、31.0[10.9]岁和 28.3[9.4]岁),男性比例更高(分别为 84%、67%和 79%)。接种疫苗后心肌炎患者的综合临床结局标准化发病率低于传统心肌炎患者(32/558 事件与 497/3779 事件;加权风险比,0.55[95%置信区间,0.36 - 0.86]),而新冠病毒感染后心肌炎患者的结果相似(36/298 事件;加权风险比,1.04[95%置信区间,0.70 - 1.52])。接种疫苗后心肌炎或新冠病毒感染后心肌炎患者的医疗程序和药物处方标准化频率在出院后的 18 个月内与传统心肌炎患者遵循相似趋势。 结论和意义:与新冠病毒感染后心肌炎患者不同,新冠病毒 mRNA 疫苗接种后心肌炎患者在 18 个月时心血管并发症的发生率低于传统心肌炎患者。然而,受影响的患者,主要是健康的年轻男性,出院后可能需要长达数月的医疗管理。
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