Rivaroxaban to prevent major clinical outcomes in non-hospitalised patients with COVID-19: the CARE – COALITION VIII randomised clinical trial

Avezum, Álvaro; Oliveira, Haliton Alves de; Neves, Precil Diego Miranda de Menezes; Alves, Lucas Bassolli de Oliveira; Cavalcanti, Alexandre Biasi; Rosa, Régis Goulart; Veiga, Viviane Cordeiro; Azevedo, Luciano César Pontes; Zimmermann, Sérgio Luiz; Silvestre, Odílson Marcos; Prudente, Raphael Cruz Seabra; Kormann, Adrian; Moreira, Frederico Rafael; Boszczowski, Ícaro; Sobrinho, Edgar de Brito; Souza, André da Silva e; Seligman, Renato; Paolino, Bruno de Souza; Razuk, Alvaro; Feitosa, Audes Diógenes de Magalhães; Belmonte, Pedro Luiz  Monteiro; Gonçalves, Priscila Freitas das Neves; Hernandes, Mauro Esteves; Fagundes, Ariovaldo Leal; Esteves, Jose Maria  Sarmet; Tognon, Alexandre Pereira; Eikelboom, John W.; Berwanger, Otávio; Lópes, Renato D.; Oliveira, Gustavo B.F.

doi:10.1016/j.eclinm.2023.102004

Cited by 8 publications

(8 citation statements)

References 21 publications

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“…A total of 25 studies 11 – 13 , 15 – 19 , 22 , 26 – 41 involving, 17 911 patients were included. There were 18 studies comparing different doses of anticoagulants on hospitalized patients.…”

Section: Resultsmentioning

confidence: 99%

“…Moreover, three studies investigated the use of additional antiplatelet therapy, primarily P2Y12 agonists, with one study also including aspirin in the treatment. Furthermore, three studies 19 , 39 , 41 explored postdischarge prophylaxis and four studies 15 , 16 , 18 , 40 explored prophylactic anticoagulation for outpatients, with one study 18 using LMWH (Table 1 ).…”

Section: Resultsmentioning

confidence: 99%

“…Four studies 15 , 16 , 18 , 40 compared the use of prophylactic anticoagulation or no anticoagulation for outpatient. The results showed no statistically significant difference in thromboembolism events (RR, 0.50; 95% CI: 0.19–1.20) (Fig.…”

Section: Resultsmentioning

confidence: 99%

“…Recently, there have been several RCTs 12 , 15 – 19 published regarding thromboembolism prevention in COVID-19 patients, but they have not been incorporated into the latest guidelines or subjected to a meta-analysis. In order to provide better guidance for clinical practice, we conducted a meta-analysis of RCTs to explore the appropriate dose for thromboprophylaxis in hospitalized COVID-19 patients, the necessity of using antiplatelet therapy, and the need for outpatient and postdischarge prophylaxis.…”

Section: Introductionmentioning

confidence: 99%

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Appropriate thromboprophylaxis strategy for COVID-19 patients on dosage, antiplatelet therapy, outpatient, and postdischarge prophylaxis: a meta-analysis of randomized controlled trials

Meng,

Tang,

Xiao

et al. 2024

International Journal of Surgery

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Background: There was controversy surrounding the optimal thromboprophylaxis strategy for COVID-19 patients. This included debates on the dosage of anticoagulants for thromboembolism prophylaxis, the requirement for additional antiplatelet therapy, and the necessity of prophylaxis for outpatients and post-discharge. To explore this, we performed a meta-analysis of randomized controlled trials. Methods: PubMed, Cochrane Library, Embase, and Web of Science were last searched on 26 July 2023 for studies comparing the effect of different dose of anticoagulation, additional antiplatelet and post-discharge prophylaxis for COVID-19 patients. The results of eligible studies were analyzed in terms of thromboembolism events, major bleeding and all-cause mortality during follow-up. Results: Our study included a total of 25 randomized controlled trials, involving 17,911 patients. Our results revealed that, compared to prophylactic dose, therapeutic dose showed lower thrombotic risk (RR, 0.66; 95%CI, 0.45 to 0.96) but had similar major bleeding risk for critically ill patients with COVID-19. On the other hand, intermediate dose and prophylactic dose demonstrated similar thromboembolism risk and major bleeding risk. For non-critically ill patients with COVID-19, therapeutic dose of anticoagulants was associated with lower thrombotic risk (RR, 0.50; 95%CI 0.34 to 0.72) but, at the same time, increased the risk of major bleeding (RR, 2.01; 95%CI 1.22 to 3.33). However, intermediate dose showed lower thromboembolism risk (RR, 0.38; 95%CI 0.21 to 0.69) while maintaining a similar major bleeding risk. In critically ill patients, additional antiplatelet therapy showed similar thromboembolism, major bleeding risk, and mortality when compared to no treatment. For outpatients, additional prophylactic anticoagulation showed similar thromboembolism, major bleeding risk, and mortality when compared to no treatment. For post-discharge patients, post-discharge prophylaxis reduced thromboembolism risk (RR, 0.49; 95%CI 0.31 to 0.76) but increased major bleeding risk (RR, 2.63; 95%CI, 1.13 to 6.14). Conclusion: For non-critically ill patients, therapeutic dose prophylactic anticoagulation significantly reduced venous thromboembolism but increases major bleeding risk. Intermediate dose effectively lowered venous thromboembolism without raising major bleeding risk. The optimal dose and need for additional antiplatelet therapy in critically ill patients, as well as the necessity of prophylactic anticoagulation in outpatient and post-discharge patients, required further investigation and confirmation through rigorous evidence studies.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Appropriate thromboprophylaxis strategy for COVID-19 patients on dosage, antiplatelet therapy, outpatient, and postdischarge prophylaxis: a meta-analysis of randomized controlled trials

Meng,

Tang,

Xiao

et al. 2024

International Journal of Surgery

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“…1 2 Several randomized trials have been conducted to assess the role of antithrombotic prophylaxis to reduce the risk of hospitalization, death, and thrombotic events such as venous thromboembolism (VTE), myocardial infarction (MI), and ischemic stroke in those who did not require hospitalization at the time of COVID-19 diagnosis, termed “prehospital” patients. 3 4 5 6 7 8 9 10 All the trials were stopped ahead of plan due to recruitment challenges, lower than expected clinical event rates or futility, leading to inconclusive results.…”

Section: Introductionmentioning

confidence: 99%

Antithrombotic Prophylaxis with Rivaroxaban in Patients with Prehospital COVID-19: A Meta-analysis of Two Placebo-Controlled Trials

Hsia,

Spyropoulos,

Piazza

et al. 2023

Thromb Haemost

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Background We conducted a prespecified meta-analysis of two randomized, placebo-controlled trials of rivaroxaban 10 mg daily in prehospital patients with acute coronavirus disease 2019 (COVID-19). Individually, the trials had limited power to detect a treatment effect due to recruitment stopping ahead of plan. Material and Methods The statistical analysis plan for the meta-analysis was finalized before unblinding of PREVENT-HD, the larger of the two trials. Pooled risk ratios and pooled risk differences along with the two-sided 95% confidence intervals were calculated using random-effect models. Results Rivaroxaban did not reduce the occurrence of either the primary prespecified endpoint, a composite of symptomatic arterial and venous thromboembolism, myocardial infarction, ischemic stroke, acute limb ischemia, all-cause hospitalization, and all-cause mortality (risk difference: 0.0044; 95% confidence interval: −0.0263, 0.0175; p = 0.69 for pooled risk difference) or the secondary endpoint of all-cause hospitalization (p = 0.76). Although thrombotic events were infrequent, pooled analysis did reveal that rivaroxaban reduced arterial and venous thrombotic events (placebo 6 events, rivaroxaban 0 events; pooled risk difference: −0.0068; 95% confidence interval: −0.0132, −0.0006; p = 0.03). In the pooled studies, only one major bleeding event was observed in a rivaroxaban-allocated patient with no critical site or fatal bleeding events. Conclusion Although this meta-analysis does not support antithrombotic prophylaxis with rivaroxaban in a broad prehospital population with acute COVID-19, the prevention of arterial and venous thrombotic events among rivaroxaban-allocated patients is consistent with the known thromboprophylactic effect of the drug in medically ill patients.

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Thromboprophylaxis for outpatients with COVID-19: a Systematic Review and Meta-analysis

Chiang,

Ahmed,

Liu

et al. 2024

J Thromb Thrombolysis

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Rivaroxaban to prevent major clinical outcomes in non-hospitalised patients with COVID-19: the CARE – COALITION VIII randomised clinical trial

Cited by 8 publications

References 21 publications

Appropriate thromboprophylaxis strategy for COVID-19 patients on dosage, antiplatelet therapy, outpatient, and postdischarge prophylaxis: a meta-analysis of randomized controlled trials

Appropriate thromboprophylaxis strategy for COVID-19 patients on dosage, antiplatelet therapy, outpatient, and postdischarge prophylaxis: a meta-analysis of randomized controlled trials

Antithrombotic Prophylaxis with Rivaroxaban in Patients with Prehospital COVID-19: A Meta-analysis of Two Placebo-Controlled Trials

Thromboprophylaxis for outpatients with COVID-19: a Systematic Review and Meta-analysis

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