Inactivated whole-virion SARS-CoV-2 vaccines and long-term clinical outcomes in patients with coronary atherosclerosis disease in China: a prospective cohort study
Inactivated whole-virion SARS-CoV-2 vaccines and long-term clinical outcomes in patients with coronary atherosclerosis disease in China: a prospective cohort study
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DOI：
10.1093/cvr/cvad031
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发表时间：
2023
期刊：
影响因子：
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通讯作者：
Junbo Ge
中科院分区：
文献类型：
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作者：
Huajie Xu;Jiaojiao Zheng;Xin Zhao;Qi Zhou;Bing Fan;Hongyi Wu;Si Zhang;Junbo Ge
Abstract. Aims. Publicized adverse events after vaccination agianst 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 ischemic and bleeding events among patients with CAD.. Methods and Results. Inpatients diagnosed with CAD by coronary angiography, without a history of SARS-CoV-2 infection and vaccination were included between January 1 and April 30, 2021, and underwent follow-up until January 31, 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, nonfatal myocardial infarction, stent thrombosis, unplanned revascularization, ischemic stroke, venous thromboembolism 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 time-dependent covariate were used to calculate the hazard ratio (HR) for the outcomes. 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% 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.. Conclusions. Our results indicated no evidence of an increased ischemic or bleeding risk after vaccination with inactivated SARS-CoV-2 vaccine among Chinese patients with CAD, with limited statistical power.
