Real-World Analysis of Thromboembolic Events and Mortality of COVID-19 Outpatients in the United States

Peacock, W. Frank; Crawford, James M.; Chen, Yen‐Wen; Ashton, Veronica; Campbell, Alicia; Milentijevic, Dejan; Spyropoulos, Alex C.

doi:10.1177/10760296221120421

Cited by 6 publications

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References 25 publications

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“…A lthough the incidence of venous and arterial thrombosis in hospitalized patients with COVID-19 exceeds that of those not requiring hospitalization (16% versus 1.4%), [1][2][3][4] a growing majority of patients infected with SARS-CoV-2 (severe acute respiratory syndrome coronavirus-2) do not require hospital admission. 5 Increased viral infectivity, shifting demographics of infected patients toward younger ages, widespread vaccine availability, and increasing therapies for mitigating disease severity favor a shift in the burden of COVID-19 to the outpatient setting.…”

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confidence: 99%

Rivaroxaban for Prevention of Thrombotic Events, Hospitalization, and Death in Outpatients With COVID-19: A Randomized Clinical Trial

et al. 2023

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Background: COVID-19 (coronavirus disease 2019) is associated with heightened risks of venous and arterial thrombosis and hospitalization due to respiratory failure. To assess whether prophylactic anticoagulation can safely reduce the frequency of venous and arterial thrombosis, hospitalization, and death in nonhospitalized patients with symptomatic COVID-19 and at least one thrombosis risk factor, we conducted the PREVENT-HD double-blind, placebo-controlled randomized trial (A Study of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic COVID-19] Infection). Methods: PREVENT-HD was conducted between August 2020 and April 2022 at 14 US integrated health care delivery networks. A virtual trial design used remote informed consent and clinical monitoring and facilitated data collection through electronic health record integration with a cloud-based research platform. Nonhospitalized patients with symptomatic COVID-19 and at least one thrombosis risk factor were enrolled and randomly assigned to either 10 mg of oral rivaroxaban or placebo daily for 35 days. The primary efficacy outcome was time to first occurrence of a composite of symptomatic venous thromboembolism, myocardial infarction, ischemic stroke, acute limb ischemia, non–central nervous system systemic arterial embolism, hospitalization, or death through day 35. The principal safety end point was International Society on Thrombosis and Hemostasis critical-site or fatal bleeding. The last study visit was on day 49. Results: The study was terminated prematurely because of enrollment challenges and a lower-than-expected blinded pooled event rate. A total of 1284 patients underwent randomization with complete accrual of primary events through May 2022. No patients were lost to follow-up. The primary efficacy outcome occurred in 22 of 641 in the rivaroxaban group and 19 of 643 in the placebo group (3.4% versus 3.0%; hazard ratio, 1.16 [95% CI, 0.63–2.15]; P =0.63). No patient in either group experienced critical-site or fatal bleeding. One patient receiving rivaroxaban had a major bleed. Conclusions: The study was terminated prematurely after enrollment of 32% of planned accrual because of recruitment challenges and lower-than-expected event rate. Rivaroxaban prescribed for 35 days in nonhospitalized patients with symptomatic COVID-19 at risk for thrombosis did not appear to reduce a composite end point of venous and arterial thrombotic events, hospitalization, and death. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04508023.

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Rivaroxaban for Prevention of Thrombotic Events, Hospitalization, and Death in Outpatients With COVID-19: A Randomized Clinical Trial

et al. 2023

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“…Os sintomas mais comuns são anosmia, hipogeusia, tosse, febre, mialgia, dispneia e dor de cabeça (Brann et al, 2020;Burke et al, 2020;Stokes et al, 2020;Butowt and Von Bartheld, 2021). Complicações extrapulmonares também têm sido descritas para a COVID -19, como dano renal (Robbins-Juarez et al, 2020;Yang et al, 2020;Silva et al, 2022), trombose (Bohula et al, 2022;Ns et al, 2022;Peacock et al, 2022) e manifestações neurológicas (Chou et al, 2021;Graham et al, 2021;Macintosh et al, 2021;Song et al, 2021;Olivarria et al, 2022).…”

Section: Apresentação Clínica Da Covid-19unclassified

Ativação do inflamassoma: a importância na leishmaniose, na influenza e na COVID-19

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Gostaria de, inicialmente, agradecer a Deus por ter me amparado em todos os momentos difíceis e me dado forças para continuar mesmo quando tudo parecia desabar ao meu redor. Agradeço ao professor Dr. Dario Simões Zamboni por ter me dado a oportunidade de fazer o doutorado no laboratório de Patogenicidade Microbiana e Imunidade Inata. O meu aprendizado e amadurecimento foram enormes durante todo período, e nossas conversas e seus conselhos permitiram-me enxergar e trilhar um caminho para novas possibilidades que antes pareciam tão distantes da minha realidade. Agradeço ao professor Dr. Alexandre Todorovic Fabro por todos os ensinamentos, orientações e enorme disponibilidade para ajudar. O seu trabalho durante a pandemia com a coleta das autópsias e depois com todos os ensinamentos, permitiram-me desbravar um novo horizonte no conhecimento.A todos os colegas que passaram pelo laboratório durante todos esses anos, pela harmoniosa convivência e por estarem sempre dispostos a ajudar. Gostaria de agradecer de forma especial à Luana Alexandrina Amaral por ter me acompanhado durante todos esses anos e ter trabalhado de forma incansável ao meu lado.

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Incidence and individual risk prediction of post-COVID-19 cardiovascular disease in the general population: a multivariable prediction model development and validation study

la Roi-Teeuw,

van Smeden,

Geersing

et al. 2023

European Heart Journal Open

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Background and Aims Previous studies suggest relatively increased cardiovascular risk after Covid-19 infection. This study assessed incidence and explored individual risk and timing of cardiovascular disease occurring post-Covid-19 in a large primary care database. Methods Data were extracted from the United Kingdom’s Clinical Practice Research Datalink. Incidence rates within 180 days post-infection were estimated for arterial or venous events, inflammatory heart disease, and new-onset atrial fibrillation or heart failure. Next, multivariable logistic regression models were developed on 220,751 adults with Covid-19 infection before December 1st 2020 using age, sex and traditional cardiovascular risk factors. All models were externally validated in (1) 138,034 vaccinated and (2) 503,404 unvaccinated adults with a first Covid-19 infection after December 1st 2020. Discriminative performance and calibration were evaluated with internal and external validation. Results Increased incidence rates were observed up to 60 days after Covid-19 infection for venous and arterial cardiovascular events, and new-onset atrial fibrillation, but not for inflammatory heart disease or heart failure, with the highest rate for venous events (13 per 1000 person-years). The best prediction models had c-statistics of 0.90 or higher. However, less than 5% of adults had a predicted 180-day outcome-specific risk larger than 1%. These rare outcomes complicated calibration. Conclusions Risks of arterial and venous cardiovascular events, and new-onset atrial fibrillation are increased within the first 60 days after Covid-19 infection in the general population. Models’ c-statistics suggest high discrimination, but because of the very low absolute risks they are insufficient to inform individual risk management.

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Real-World Analysis of Thromboembolic Events and Mortality of COVID-19 Outpatients in the United States

Cited by 6 publications

References 25 publications

Rivaroxaban for Prevention of Thrombotic Events, Hospitalization, and Death in Outpatients With COVID-19: A Randomized Clinical Trial

Rivaroxaban for Prevention of Thrombotic Events, Hospitalization, and Death in Outpatients With COVID-19: A Randomized Clinical Trial

Ativação do inflamassoma: a importância na leishmaniose, na influenza e na COVID-19

Incidence and individual risk prediction of post-COVID-19 cardiovascular disease in the general population: a multivariable prediction model development and validation study

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