Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19.
Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19.
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DOI：
10.1016/j.jacc.2023.02.041
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发表时间：
2023-05-09
影响因子：
24
通讯作者：
Fuster, Valentin
中科院分区：
文献类型：
--
作者：
Stone, Gregg W.;Farkouh, Michael E.;Lala, Anuradha;Tinuoye, Elizabeth;Dressler, Ovidiu;Moreno, Pedro R.;Palacios, Igor F.;Goodman, Shaun G.;Esper, Rodrigo B.;Abizaid, Alexandre;Varade, Deepak;Betancur, Juan F.;Ricalde, Alejandro;Payro, Gerardo;Castellano, Jose Maria;Hung, Ivan F. N.;Nadkarni, Girish N.;Giustino, Gennaro;Godoy, Lucas C.;Feinman, Jason;Camaj, Anton;Bienstock, Solomon W.;Furtado, Remo H. M.;Granada, Carlos;Bustamante, Jessica;Peyra, Carlos;Contreras, Johanna;Owen, Ruth;Bhatt, Deepak L.;Pocock, Stuart J.;Fuster, Valentin
关键词：
先前在COVID-19患者中进行的治疗剂量抗凝治疗研究报告了相互矛盾的结果。我们试图确定治疗剂量抗凝治疗在非危重COVID-19患者中的安全性和有效性。不需要重症监护室治疗的COVID-19住院患者被随机分配至单剂量依诺肝素、治疗剂量依诺肝素或治疗剂量阿哌沙班。主要结局是联合治疗剂量组与单药治疗剂量组相比的30天全因死亡率、重症监护室水平护理需求、全身血栓栓塞或缺血性卒中的复合终点。在2020年8月26日至2022年9月19日期间，3，398名因COVID-19住院的非危重患者在10个国家的76个中心随机接受单剂量依诺肝素（n = 1，141），治疗剂量依诺肝素（n = 1，136）或治疗剂量阿哌沙班（n = 1，121）。单剂量组和联合治疗剂量组分别有13.2%和11.3%的患者发生30天主要结局（HR：0.85; 95% CI：0.69-1.04; P = 0.11）。全因死亡发生率在接受低剂量依诺肝素治疗的患者中为7.0%，在接受治疗剂量抗凝治疗的患者中为4.9（HR：0.70; 95% CI：0.52-0.93; P = 0.01），分别有8.4%和6.4%的患者需要插管（HR：0.75; 95% CI：0.58-0.98; P = 0.03）。2个治疗剂量组的结果相似，所有3个组的大出血均不常见。在因COVID-19住院的非危重症患者中，治疗剂量抗凝治疗组的30天主要复合结局与非治疗剂量抗凝治疗组相比没有显著降低。然而，接受治疗剂量抗凝治疗的患者需要插管的人数较少，死亡人数较少（FREEDOM COVID [FREEDOM COVID抗凝策略]; NCT 04512079）
Prior studies of therapeutic-dose anticoagulation in patients with COVID-19 have reported conflicting results. We sought to determine the safety and effectiveness of therapeutic-dose anticoagulation in noncritically ill patients with COVID-19. Patients hospitalized with COVID-19 not requiring intensive care unit treatment were randomized to prophylactic-dose enoxaparin, therapeutic-dose enoxaparin, or therapeutic-dose apixaban. The primary outcome was the 30-day composite of all-cause mortality, requirement for intensive care unit–level of care, systemic thromboembolism, or ischemic stroke assessed in the combined therapeutic-dose groups compared with the prophylactic-dose group. Between August 26, 2020, and September 19, 2022, 3,398 noncritically ill patients hospitalized with COVID-19 were randomized to prophylactic-dose enoxaparin (n = 1,141), therapeutic-dose enoxaparin (n = 1,136), or therapeutic-dose apixaban (n = 1,121) at 76 centers in 10 countries. The 30-day primary outcome occurred in 13.2% of patients in the prophylactic-dose group and 11.3% of patients in the combined therapeutic-dose groups (HR: 0.85; 95% CI: 0.69-1.04; P = 0.11). All-cause mortality occurred in 7.0% of patients treated with prophylactic-dose enoxaparin and 4.9% of patients treated with therapeutic-dose anticoagulation (HR: 0.70; 95% CI: 0.52-0.93; P = 0.01), and intubation was required in 8.4% vs 6.4% of patients, respectively (HR: 0.75; 95% CI: 0.58-0.98; P = 0.03). Results were similar in the 2 therapeutic-dose groups, and major bleeding in all 3 groups was infrequent. Among noncritically ill patients hospitalized with COVID-19, the 30-day primary composite outcome was not significantly reduced with therapeutic-dose anticoagulation compared with prophylactic-dose anticoagulation. However, fewer patients who were treated with therapeutic-dose anticoagulation required intubation and fewer died (FREEDOM COVID [FREEDOM COVID Anticoagulation Strategy]; NCT04512079)
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DOI：
10.1136/bmj.n2400
发表时间：
2021-10-14
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Sholzberg M;Tang GH;Rahhal H;AlHamzah M;Kreuziger LB;Áinle FN;Alomran F;Alayed K;Alsheef M;AlSumait F;Pompilio CE;Sperlich C;Tangri S;Tang T;Jaksa P;Suryanarayan D;Almarshoodi M;Castellucci LA;James PD;Lillicrap D;Carrier M;Beckett A;Colovos C;Jayakar J;Arsenault MP;Wu C;Doyon K;Andreou ER;Dounaevskaia V;Tseng EK;Lim G;Fralick M;Middeldorp S;Lee AYY;Zuo F;da Costa BR;Thorpe KE;Negri EM;Cushman M;Jüni P;RAPID trial investigators
通讯作者：
RAPID trial investigators
影响因子：
2.2
作者：
Laino ME;Ammirabile A;Lofino L;Lundon DJ;Chiti A;Francone M;Savevski V
通讯作者：
Savevski V
影响因子：
50.3
作者：
Cordon-Cardo C;Pujadas E;Wajnberg A;Sebra R;Patel G;Firpo-Betancourt A;Fowkes M;Sordillo E;Paniz-Mondolfi A;Gregory J;Krammer F;Simon V;Isola L;Soon-Shiong P;Aberg JA;Fuster V;Reich DL
通讯作者：
Reich DL
影响因子：
158.5
作者：
Ackermann, Maximilian;Verleden, Stijn E.;Jonigk, Danny
通讯作者：
Jonigk, Danny
影响因子：
9.6
作者：
Jiménez D;García-Sanchez A;Rali P;Muriel A;Bikdeli B;Ruiz-Artacho P;Le Mao R;Rodríguez C;Hunt BJ;Monreal M
通讯作者：
Monreal M