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Inactivated whole-virion SARS-CoV-2 vaccines and long-term clinical outcomes in patients with coronary atherosclerosis disease in China: a prospective cohort study.
Xu, Huajie; Zheng, Jiaojiao; Zhao, Xin; Zhou, Qi; Fan, Bing; Wu, Hongyi; Zhang, Si; Ge, Junbo.
  • Xu H; Department of Cardiology, National Clinical Research Center for Interventional Medicine, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai 200032, China.
  • Zheng J; Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.
  • Zhao X; Department of Cardiology, National Clinical Research Center for Interventional Medicine, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai 200032, China.
  • Zhou Q; Department of Biostatistics, School of Public Health, Fudan University, Shanghai, China.
  • Fan B; Department of Cardiology, National Clinical Research Center for Interventional Medicine, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai 200032, China.
  • Wu H; Department of Cardiology, National Clinical Research Center for Interventional Medicine, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai 200032, China.
  • Zhang S; NHC Key Laboratory of Glycoconjugate Research, Department of Biochemistry and Molecular Biology, School of Basic Medical Sciences, Fudan University, Shanghai 200032, China.
  • Ge J; Department of Cardiology, National Clinical Research Center for Interventional Medicine, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai 200032, China.
Cardiovasc Res ; 119(6): 1352-1360, 2023 06 13.
Article in English | MEDLINE | ID: covidwho-2237149
ABSTRACT

AIMS:

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. METHODS AND

RESULTS:

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.

CONCLUSION:

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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Coronary Artery Disease / Brain Ischemia / Stroke / Atherosclerosis / COVID-19 Type of study: Cohort study / Observational study / Prognostic study Topics: Vaccines Limits: Humans Country/Region as subject: Asia Language: English Journal: Cardiovasc Res Year: 2023 Document Type: Article Affiliation country: Cvr

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Coronary Artery Disease / Brain Ischemia / Stroke / Atherosclerosis / COVID-19 Type of study: Cohort study / Observational study / Prognostic study Topics: Vaccines Limits: Humans Country/Region as subject: Asia Language: English Journal: Cardiovasc Res Year: 2023 Document Type: Article Affiliation country: Cvr