{"id":20337,"date":"2021-06-14T04:08:00","date_gmt":"2021-06-13T20:08:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=20337"},"modified":"2021-06-15T05:58:58","modified_gmt":"2021-06-14T21:58:58","slug":"20337","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=20337","title":{"rendered":"[Lancet\u53d1\u8868\u8bba\u6587]\uff1a\u4f34\u968fD-\u4e8c\u805a\u4f53\u5347\u9ad8\u7684\u65b0\u51a0\u80ba\u708e\u4f4f\u9662\u60a3\u8005\u4f7f\u7528\u6cbb\u7597\u6027\u6216\u9884\u9632\u6027\u6297\u51dd"},"content":{"rendered":"\n

ARTICLES| VOLUME 397, ISSUE 10291<\/a>, P2253-2263, JUNE 12, 2021<\/p>\n\n\n\n

Therapeutic versus prophylactic anticoagulation for patients admitted to hospital with COVID-19 and elevated D-dimer concentration (ACTION): an open-label, multicentre, randomised, controlled trial<\/h1>\n\n\n\n

Renato D Lopes, Pedro Gabriel Melo de Barros e Silva, Remo H M Furtado, et al<\/h3>\n\n\n\n

Lancet 2021; 397: 2253-2263<\/h3>\n\n\n\n

DOI:https:\/\/doi.org\/10.1016\/S0140-6736(21)01203-4<\/a><\/h3>\n\n\n\n

Summary<\/h2>\n\n\n\n

Background<\/h3>\n\n\n\n

COVID-19 is associated with a prothrombotic state leading to adverse clinical outcomes. Whether therapeutic anticoagulation improves outcomes in patients hospitalised with COVID-19 is unknown. We aimed to compare the efficacy and safety of therapeutic versus prophylactic anticoagulation in this population.<\/p>\n\n\n\n

Methods<\/h3>\n\n\n\n

We did a pragmatic, open-label (with blinded adjudication), multicentre, randomised, controlled trial, at 31 sites in Brazil. Patients (aged \u226518 years) hospitalised with COVID-19 and elevated D-dimer concentration, and who had COVID-19 symptoms for up to 14 days before randomisation, were randomly assigned (1:1) to receive either therapeutic or prophylactic anticoagulation. Therapeutic anticoagulation was in-hospital oral rivaroxaban (20 mg or 15 mg daily) for stable patients, or initial subcutaneous enoxaparin (1 mg\/kg twice per day) or intravenous unfractionated heparin (to achieve a 0\u00b73\u20130\u00b77 IU\/mL anti-Xa concentration) for clinically unstable patients, followed by rivaroxaban to day 30. Prophylactic anticoagulation was standard in-hospital enoxaparin or unfractionated heparin. The primary efficacy outcome was a hierarchical analysis of time to death, duration of hospitalisation, or duration of supplemental oxygen to day 30, analysed with the win ratio method (a ratio >1 reflects a better outcome in the therapeutic anticoagulation group) in the intention-to-treat population. The primary safety outcome was major or clinically relevant non-major bleeding through 30 days. This study is registered with ClinicalTrials.gov<\/a> (NCT04394377<\/a>) and is completed.<\/p>\n\n\n\n

Findings<\/h3>\n\n\n\n

From June 24, 2020, to Feb 26, 2021, 3331 patients were screened and 615 were randomly allocated (311 [50%] to the therapeutic anticoagulation group and 304 [50%] to the prophylactic anticoagulation group). 576 (94%) were clinically stable and 39 (6%) clinically unstable. One patient, in the therapeutic group, was lost to follow-up because of withdrawal of consent and was not included in the primary analysis. The primary efficacy outcome was not different between patients assigned therapeutic or prophylactic anticoagulation, with 28\u2008899 (34\u00b78%) wins in the therapeutic group and 34\u2008288 (41\u00b73%) in the prophylactic group (win ratio 0\u00b786 [95% CI 0\u00b759\u20131\u00b722], p=0\u00b740). Consistent results were seen in clinically stable and clinically unstable patients. The primary safety outcome of major or clinically relevant non-major bleeding occurred in 26 (8%) patients assigned therapeutic anticoagulation and seven (2%) assigned prophylactic anticoagulation (relative risk 3\u00b764 [95% CI 1\u00b761\u20138\u00b727], p=0\u00b70010). Allergic reaction to the study medication occurred in two (1%) patients in the therapeutic anticoagulation group and three (1%) in the prophylactic anticoagulation group.<\/p>\n\n\n\n

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Interpretation<\/h3>\n\n\n\n

In patients hospitalised with COVID-19 and elevated D-dimer concentration, in-hospital therapeutic anticoagulation with rivaroxaban or enoxaparin followed by rivaroxaban to day 30 did not improve clinical outcomes and increased bleeding compared with prophylactic anticoagulation. Therefore, use of therapeutic-dose rivaroxaban, and other direct oral anticoagulants, should be avoided in these patients in the absence of an evidence-based indication for oral anticoagulation.<\/p>\n\n\n\n

Funding<\/h3>\n\n\n\n

Coalition COVID-19 Brazil, Bayer SA<\/p>\n","protected":false},"excerpt":{"rendered":"

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