A recently published secondary analysis sought to evaluate the risk of MACE in those patients who received one or two doses of the COVID-19 following acute coronary syndromes.
Is there an increased risk for a major adverse cardiovascular event (MACE) if you’ve received a COVID-19 vaccine after an acute coronary syndrome? The short answer is no. A recently published secondary analysis in JAMA Network Open sought to evaluate the risk of MACE in those patients who received one or two doses of the COVID-19 following acute coronary syndromes (ACS).
This evaluation and research journey actually started in 2019, when researchers were evaluating the efficacy of influenza vaccines after an ACS. The influenza analysis was a randomized, multicenter trial occurred between July 19, 2019 and November 30, 2020, and the secondary research compared the incidence of cardiopulmonary events in those patients who had received (versus those who did not) one or two doses of a COVID-19 vaccination in Brazil. While not randomized to COVID-19 vaccines, they were studied to primary and secondary endpoints.
The primary end points were all-cause death, myocardial infarction, stroke, hospitalization for heart failure or other respiratory infections, urgent coronary revascularization, or unstable angina leading to hospitalization. The secondary endpoint was MACE. Patients who presented with the study end points or had died within 90 days after randomization as a means of minimizing ascertainment bias.
A study found there was no significant increase in the risk of major adverse cardiovascular events (MACE) in patients who received COVID-19 vaccines.
These findings suggest that vaccination is at least neutral or potentially beneficial in terms of preventing severe outcomes after ACS.
The study supports the safety of COVID-19 vaccines for patients with a history of ACS, as there was no evidence of increased adverse cardiovascular events among vaccinated individuals.
The researchers noted that they performed an analysis for a 90-day event-free period in which vaccinated participants were compared to unvaccinated participants. The COVID-19 vaccine was utilized as a time-dependent covariable, adjusting for age. First, let’s look at the study participants. 1801 were involved in the study, the median age was 56.7 years, 30.3% female, 35.7% were active smokers, and 16.2% (or 292) individuals had a prior myocardial infarction.1665 did not have any cardiopulmonary events during the initial 90-days and among those, 835 (50.2%) had at least one COVID-19 vaccine dose. 63.9% of those who did receive at least one dose, had received a viral vector vaccine (Oxford/AstraZeneca) during the follow-up period.
What did they find? That in the 90-day event-free follow-up analysis the incidence of the primary endpoint per 100 patient-years was 9.37 in unvaccinated individuals versus 4.81 in those who had at least one vaccine dose. The authors noted that “Vaccination did not significantly reduce incidence of MACE (aHR, 0.32; 95% CI, 0.07-1.53; P = .60), all-cause death (aHR, 0.29; 95% CI, 0.09-0.91; P = .12) ,or cardiovascular death (aHR, 0.42; 95% CI, 0.04-4.02; P > .99). A sensitivity analysis of all participants revealed similar findings for the adjusted incidence of the primary composite end point (aHR, 0.43; 95% CI, 0.02-0.94; P = .12) and all-cause death (aHR, 0.30; 95% CI, 0.10-0.89; P = .12).” The authors highlighted that this secondary analysis points to the similar rates of the primary composite endpoint and MACE in those vaccinated participants, versus those who were unvaccinated.
Future analysis they noted, should include randomization for COVID-19 vaccines and more flexibility in terms of analysis design. While vaccination did not lower the rate of MACE, cardiovascular death, or all-cause death, these findings do underscore that rates of poor outcomes weren’t higher in vaccinated individuals after ACS. Such information further strengthens vaccination and education campaigns in terms of vaccination safety and addressing misinformation that is too frequently spread.
