Department of Cardiology, National Clinical Research Center for Interventional Medicine, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai 200032, China.
Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
Cardiovasc Res. 2023 Jun 13;119(6):1352-1360. doi: 10.1093/cvr/cvad031.
Publicized adverse events after vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) raised concern among patients with coronary atherosclerosis disease (CAD). We sought to study the association between SARS-CoV-2 vaccines and long-term clinical outcomes including ischaemic and bleeding events among patients with CAD.
Inpatients diagnosed with CAD by coronary angiography, without a history of SARS-CoV-2 infection and vaccination, were included between 1 January and 30 April 2021, and underwent follow-up until 31 January 2022. Two doses of inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac, BBIBPCorV, or WIBP-CorV) were available after discharge, and the group was stratified by vaccination. The primary composite outcomes were cardiovascular death, non-fatal myocardial infarction, stent thrombosis, unplanned revascularization, ischaemic stroke, venous thrombo-embolism, or peripheral arterial thrombosis. The bleeding outcomes were Bleeding Academic Research Consortium (BARC) type 3 or 5 bleeding. Cox regression models with vaccination status as a time-dependent covariate were used to calculate the hazard ratio (HR) for the outcomes. A propensity score matching method was used to reduce confounding biases. This prospective cohort study included 2078 individuals with CAD, 1021 (49.1%) were vaccinated. During a median follow-up of 9.1 months, 45 (4.3%) primary composite outcomes occurred in the unvaccinated group, and 33 (3.2%) in the vaccinated group. In Cox regression, the adjusted HR was 1.13 [95% confidence interval (CI) 0.65-1.93]. The adjusted HR for the bleeding outcomes associated with vaccination was 0.81 [95% CI 0.35-1.19]. After matching, the adjusted HR for the primary composite outcomes associated with vaccination was 1.06 [95% CI 0.57-1.99] and for the bleeding outcomes was 0.91 [95% CI 0.35-2.38]. Similar results were found in the seven prespecified subgroups. No grade 3 adverse reactions after vaccination were recorded.
Our results indicated no evidence of an increased ischaemic or bleeding risk after vaccination with inactivated SARS-CoV-2 vaccine among Chinese patients with CAD, with limited statistical power.
严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）疫苗接种后的不良事件被广泛报道，这引起了冠心病（CAD）患者的担忧。我们旨在研究 SARS-CoV-2 疫苗接种与长期临床结局之间的关联，包括 CAD 患者的缺血和出血事件。
本研究纳入了 2021 年 1 月 1 日至 4 月 30 日期间因冠状动脉造影诊断为 CAD、无 SARS-CoV-2 感染和疫苗接种史的住院患者，并在 2022 年 1 月 31 日前进行了随访。出院后可接种两剂灭活全病毒 SARS-CoV-2 疫苗（科兴中维、BBIBP-CorV 或 WIBP-CorV），根据接种情况对患者进行分层。主要复合结局为心血管死亡、非致死性心肌梗死、支架血栓形成、计划外血运重建、缺血性卒中、静脉血栓栓塞或外周动脉血栓形成。出血结局为 Bleeding Academic Research Consortium（BARC）3 型或 5 型出血。采用以接种状态为时间依赖性协变量的 Cox 回归模型计算结局的风险比（HR）。采用倾向评分匹配法减少混杂偏倚。这项前瞻性队列研究纳入了 2078 例 CAD 患者，其中 1021 例（49.1%）接种了疫苗。中位随访 9.1 个月期间，未接种组发生 45 例（4.3%）主要复合结局，接种组发生 33 例（3.2%）。在 Cox 回归中，调整后的 HR 为 1.13（95%置信区间[CI]：0.65-1.93）。与接种相关的出血结局的调整后 HR 为 0.81（95%CI：0.35-1.19）。匹配后，与接种相关的主要复合结局的调整后 HR 为 1.06（95%CI：0.57-1.99），出血结局的调整后 HR 为 0.91（95%CI：0.35-2.38）。在七个预先指定的亚组中也观察到了相似的结果。接种后未记录到 3 级不良反应。
我们的研究结果表明，在中国 CAD 患者中，接种灭活 SARS-CoV-2 疫苗不会增加缺血或出血风险，但其统计效能有限。
Zotero 插件