Zuily Stéphane, Lefèvre Benjamin, Sanchez Olivier, Empis de Vendin Ombeline, de Ciancio Guillaume, Arlet Jean-Benoît, Khider Lina, Terriat Béatrice, Greigert Hélène, Robert Céline S, Louis Guillaume, Trinh-Duc Albert, Rispal Patrick, Accassat Sandrine, Thiery Guillaume, Montani David, Azarian Réza, Meneveau Nicolas, Soudet Simon, Le Mao Raphaël, Maurier François, Le Moing Vincent, Quéré Isabelle, Yelnik Cécile M, Lefebvre Nicolas, Martinot Martin, Delrue Maxime, Benhamou Ygal, Parent Florence, Roy Pierre-Marie, Presles Emilie, Goehringer François, Mismetti Patrick, Bertoletti Laurent, Rossignol Patrick, Couturaud Francis, Wahl Denis, Thilly Nathalie, Laporte Silvy
Vascular Medicine Division, Université de Lorraine, CHRU-Nancy, Rare Vascular and Systemic Autoimmune Diseases Regional Referral Center, France.
Inserm, UMR 1116 DCAC, F-54000 Nancy, France.
EClinicalMedicine. 2023 Jun;60:102031. doi: 10.1016/j.eclinm.2023.102031. Epub 2023 Jun 9.
Venous thromboembolism is a major complication of coronavirus disease 2019 (COVID-19). We hypothesized that a weight-adjusted intermediate dose of anticoagulation may decrease the risk of venous thromboembolism COVID-19 patients.
In this multicenter, randomised, open-label, phase 4, superiority trial with blinded adjudication of outcomes, we randomly assigned adult patients hospitalised in 20 French centers and presenting with acute respiratory SARS-CoV-2. Eligible patients were randomly assigned (1:1 ratio) to receive an intermediate weight-adjusted prophylactic dose or a fixed-dose of subcutaneous low-molecular-weight heparin during the hospital stay. The primary outcome corresponded to symptomatic deep-vein thrombosis (fatal) pulmonary embolism during hospitalization (COVI-DOSE ClinicalTrials.gov number: NCT04373707).
Between May 2020, and April 2021, 1000 patients underwent randomisation in medical wards (noncritically ill) (80.1%) and intensive care units (critically ill) (19.9%); 502 patients were assigned to receive a weight-adjusted intermediate dose, and 498 received fixed-dose thromboprophylaxis. Symptomatic venous thromboembolism occurred in 6 of 502 patients (1.2%) in the weight-adjusted dose group and in 10 of 498 patients (2.1%) in the fixed-dose group (subdistribution hazard ratio, 0.59; 95% CI, 0.22-1.63; P = 0.31). There was a twofold increased risk of major or clinically relevant nonmajor bleeding: 5.9% in the weight-adjusted dose group and 3.1% in the fixed-dose group (P = 0.034).
In the COVI-DOSE trial, the observed rate of thromboembolic events was lower than expected in patients hospitalized for COVID-19 infection, and the study was unable to show a significant difference in the risk of venous thromboembolism between the two low-molecular-weight-heparin regimens.
French Ministry of Health, CAPNET, Grand-Est Region, Grand-Nancy Métropole.
静脉血栓栓塞是2019冠状病毒病（COVID-19）的主要并发症。我们假设，根据体重调整的中等剂量抗凝治疗可能会降低COVID-19患者发生静脉血栓栓塞的风险。
在这项多中心、随机、开放标签、4期优效性试验中，对结局进行盲法判定，我们将在20个法国中心住院的成年急性呼吸道SARS-CoV-2患者进行随机分组。符合条件的患者被随机分配（1:1比例）在住院期间接受根据体重调整的中等预防剂量或固定剂量的皮下低分子肝素。主要结局为住院期间出现症状性深静脉血栓形成（致死性）肺栓塞（COVI-DOSE临床试验注册号：NCT04373707）。
2020年5月至2021年4月期间，1000例患者在普通病房（非危重症）（80.1%）和重症监护病房（危重症）（19.9%）进行了随机分组；502例患者被分配接受根据体重调整的中等剂量，498例接受固定剂量的血栓预防治疗。根据体重调整剂量组的502例患者中有6例（1.2%）发生了症状性静脉血栓栓塞，固定剂量组的498例患者中有10例（2.1%）发生了症状性静脉血栓栓塞（亚组分布风险比，0.59；95%CI，0.22-1.63；P=0.31）。严重或具有临床意义的非严重出血风险增加了两倍：根据体重调整剂量组为5.9%，固定剂量组为3.1%（P=0.034）。
在COVI-DOSE试验中，因COVID-19感染住院的患者中观察到的血栓栓塞事件发生率低于预期，且该研究未能显示两种低分子肝素方案在静脉血栓栓塞风险上存在显著差异。
法国卫生部、CAPNET、大东部地区、大南锡都市圈。
Zotero 插件
