Baumann Kreuziger Lisa, Kwon Taeim, Kasthuri Raj S, Wahid Lana, Miller Peter J, Enders Kimberly, Wahed Abdus S, Anstrom Kevin J, Wang Tracy Y, Ortel Thomas L
Versiti Blood Research Institute, Milwaukee, Wisconsin, USA.
Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Res Pract Thromb Haemost. 2024 Apr 24;8(4):102417. doi: 10.1016/j.rpth.2024.102417. eCollection 2024 May.
The Accelerating COVID-19 Therapeutic Interventions and Vaccines-4c (ACTIV-4c) trial investigated prophylactic apixaban for 30 days following hospitalization for COVID-19. The overall incidence of early postdischarge death or thromboembolism was low, and the trial was closed early.
To identify a high-risk patient population who might benefit from postdischarge thromboprophylaxis through subgroup analyses stratified by age, race/ethnicity, obesity, D-dimer elevation, World Health Organization score, and modified International Medical Prevention Registry on Venous Thromboembolism score on 30-day composite outcome of all-cause death, arterial thromboembolism (ATE), and venous thromboembolism (VTE).
Cumulative incidences of all-cause death, ATE, and VTE within 30 days were described for each subgroup. Time to death, ATE, or VTE by 30 days was analyzed using Cox proportional hazard models with interaction testing for each subgroup.
Among 1217 patients randomized to apixaban or placebo group, 32% were >60 years old. Modified International Medical Prevention Registry on Venous Thromboembolism score was ≥4 in 2% and 2 or 3 with an elevated D-dimer in an additional 9% of participants. The overall incidence of the primary endpoint was 2.13% in the apixaban group and 2.31% in the placebo group. At day 30, similar rates of the primary endpoint occurred within subgroups, except for participants aged >60 years. No benefit of thromboprophylaxis was seen in any subgroup.
The combined incidence of 30-day death, ATE, and VTE was low in patients who survived COVID-19 hospitalization, except in patients over age 60 years. Due to the limited number of events, the findings remain inconclusive; nonetheless, the study did not identify a high-risk subgroup that would derive benefits from extended thromboprophylaxis.
加速COVID-19治疗干预和疫苗-4c（ACTIV-4c）试验研究了COVID-19住院治疗后30天的预防性阿哌沙班治疗。出院后早期死亡或血栓栓塞的总体发生率较低，该试验提前终止。
通过按年龄、种族/民族、肥胖、D-二聚体升高、世界卫生组织评分以及改良的国际静脉血栓栓塞症医学预防登记评分对全因死亡、动脉血栓栓塞（ATE）和静脉血栓栓塞（VTE）的30天综合结局进行分层的亚组分析，确定可能从出院后血栓预防中获益的高危患者群体。
描述每个亚组30天内全因死亡、ATE和VTE的累积发生率。使用Cox比例风险模型分析30天内死亡、ATE或VTE的时间，并对每个亚组进行交互检验。
在随机分为阿哌沙班组或安慰剂组的1217例患者中，32%年龄>60岁。2%的参与者改良国际静脉血栓栓塞症医学预防登记评分≥4，另外9%的参与者D-二聚体升高且评分为2或3。阿哌沙班组主要终点的总体发生率为2.13%，安慰剂组为2.31%。在第30天，除年龄>60岁的参与者外，各亚组内主要终点的发生率相似。在任何亚组中均未观察到血栓预防的益处。
COVID-19住院幸存者中，30天死亡、ATE和VTE的综合发生率较低，但60岁以上患者除外。由于事件数量有限，研究结果仍无定论；尽管如此，该研究未确定能从延长血栓预防中获益的高危亚组。
