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209 Figure 1Kaplan-Meier curves displaying cumulative all-cause mortality[Figure omitted. See PDF]Conflict of InterestNo conflicts of interest
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BACKGROUND: Patients hospitalized with COVID-19 suffer thrombotic complications. Risk factors for poor outcomes are shared with coronary artery disease. OBJECTIVES: To investigate the efficacy of an acute coronary syndrome regimen in patients hospitalized with COVID-19 and coronary disease risk factors. METHODS: A randomized controlled, open-label trial across acute hospitals (United Kingdom and Brazil) added aspirin, clopidogrel, low-dose rivaroxaban, atorvastatin, and omeprazole to standard care for 28 days. Primary efficacy and safety outcomes were 30-day mortality and bleeding. The key secondary outcome was a daily clinical status (at home, in hospital, on intensive therapy unit admission, or death). RESULTS: Three hundred twenty patients from 9 centers were randomized. The trial terminated early due to low recruitment. At 30 days, there was no significant difference in mortality (intervention vs control, 11.5% vs 15%; unadjusted odds ratio [OR], 0.73; 95% CI, 0.38-1.41; p = .355). Significant bleeds were infrequent and were not significantly different between the arms (intervention vs control, 1.9% vs 1.9%; p > .999). Using a Bayesian Markov longitudinal ordinal model, it was 93% probable that intervention arm participants were more likely to transition to a better clinical state each day (OR, 1.46; 95% credible interval [CrI], 0.88-2.37; Pr [beta > 0], 93%; adjusted OR, 1.50; 95% CrI, 0.91-2.45; Pr [beta > 0], 95%) and median time to discharge to home was 2 days shorter (95% CrI, -4 to 0; 2% probability that it was worse). CONCLUSION: Acute coronary syndrome treatment regimen was associated with a reduction in the length of hospital stay without an excess in major bleeding. A larger trial is needed to evaluate mortality.
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Background: A single dose strategy may be adequate to confer population level immunity and protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, especially in low- and middle-income countries where vaccine supply remains limited. We compared the effectiveness of a single dose strategy of the Oxford-AstraZeneca or Pfizer-BioNTech vaccines against SARS-CoV-2 infection across all age groups and over an extended follow-up period. Methods: Individuals vaccinated in North-West London, UK, with either the first dose of the Oxford-AstraZeneca or Pfizer-BioNTech vaccines between January 12, 2021 and March 09, 2021, were matched to each other by demographic and clinical characteristics. Each vaccinated individual was additionally matched to an unvaccinated control. Study outcomes included SARS-CoV-2 infection of any severity, COVID-19 hospitalisation, COVID-19 death, and all-cause mortality. Findings: Amongst matched individuals, 63,608 were in each of the vaccine groups and 127,216 were unvaccinated. Between 14 and 84 days of follow-up after matching, there were 534 SARS-CoV-2 infections, 65 COVID-19 hospitalisations, and 190 deaths, of which 29 were categorized as due to COVID-19. The incidence rate ratio (IRR) for SARS-CoV-2 infection was 0.85 (95% confidence interval [CI], 0.69 to 1.05) for Oxford-Astra-Zeneca, and 0.69 (0.55 to 0.86) for Pfizer-BioNTech. The IRR for both vaccines was the same at 0.25 (0.09 to 0.55) and 0.14 (0.02 to 0.58) for reducing COVID-19 hospitalization and COVID-19 mortality, respectively. The IRR for all-cause mortality was 0.25 (0.15 to 0.39) and 0.18 (0.10 to 0.30) for the Oxford-Astra-Zeneca and Pfizer-BioNTech vaccines, respectively. Age was an effect modifier of the association between vaccination and SARS-CoV-2 infection of any severity; lower hazard ratios for increasing age. Interpretation: A single dose strategy, for both vaccines, was effective at reducing COVID-19 mortality and hospitalization rates. The magnitude of vaccine effectiveness was comparatively lower for SARS-CoV-2 infection, although this was variable across the age range, with higher effectiveness seen with older adults. Our results have important implications for health system planning -especially in low resource settings where vaccine supply remains constrained.
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BACKGROUND: On March 11, 2020, the World Health Organization declared SARS-CoV-2, causing COVID-19, as a pandemic. The UK mass vaccination program commenced on December 8, 2020, vaccinating groups of the population deemed to be most vulnerable to severe COVID-19 infection. OBJECTIVE: This study aims to assess the early vaccine administration coverage and outcome data across an integrated care system in North West London, leveraging a unique population-level care data set. Vaccine effectiveness of a single dose of the Oxford/AstraZeneca and Pfizer/BioNTech vaccines were compared. METHODS: A retrospective cohort study identified 2,183,939 individuals eligible for COVID-19 vaccination between December 8, 2020, and February 24, 2021, within a primary, secondary, and community care integrated care data set. These data were used to assess vaccination hesitancy across ethnicity, gender, and socioeconomic deprivation measures (Pearson product-moment correlations); investigate COVID-19 transmission related to vaccination hubs; and assess the early effectiveness of COVID-19 vaccination (after a single dose) using time-to-event analyses with multivariable Cox regression analysis to investigate if vaccination independently predicted positive SARS-CoV-2 in those vaccinated compared to those unvaccinated. RESULTS: In this study, 5.88% (24,332/413,919) of individuals declined and did not receive a vaccination. Black or Black British individuals had the highest rate of declining a vaccine at 16.14% (4337/26,870). There was a strong negative association between socioeconomic deprivation and rate of declining vaccination (r=-0.94; P=.002) with 13.5% (1980/14,571) of individuals declining vaccination in the most deprived areas compared to 0.98% (869/9609) in the least. In the first 6 days after vaccination, 344 of 389,587 (0.09%) individuals tested positive for SARS-CoV-2. The rate increased to 0.13% (525/389,243) between days 7 and 13, before then gradually falling week on week. At 28 days post vaccination, there was a 74% (hazard ratio 0.26, 95% CI 0.19-0.35) and 78% (hazard ratio 0.22, 95% CI 0.18-0.27) reduction in risk of testing positive for SARS-CoV-2 for individuals that received the Oxford/AstraZeneca and Pfizer/BioNTech vaccines, respectively, when compared with unvaccinated individuals. A very low proportion of hospital admissions were seen in vaccinated individuals who tested positive for SARS-CoV-2 (288/389,587, 0.07% of all patients vaccinated) providing evidence for vaccination effectiveness after a single dose. CONCLUSIONS: There was no definitive evidence to suggest COVID-19 was transmitted as a result of vaccination hubs during the vaccine administration rollout in North West London, and the risk of contracting COVID-19 or becoming hospitalized after vaccination has been demonstrated to be low in the vaccinated population. This study provides further evidence that a single dose of either the Pfizer/BioNTech vaccine or the Oxford/AstraZeneca vaccine is effective at reducing the risk of testing positive for COVID-19 up to 60 days across all age groups, ethnic groups, and risk categories in an urban UK population.