Jara-Palomares Luis, Bikdeli Behnood, Jiménez David, Muriel Alfonso, Demelo-Rodríguez Pablo, Moustafa Farès, Villalobos Aurora, López-Miguel Patricia, López-Jiménez Luciano, Otálora Sonia, Peris María Luisa, Amado Cristina, Chopard Romain, Rivera-Cívico Francisco, Monreal Manuel
Respiratory Department, Virgen del Rocio Hospital and Instituto de Biomedicina, Sevilla, CIBER de Enfermedades Respiratorias (CIBERES), Instituto de Salud Carlos III, Madrid, Spain.
Cardiovascular Medicine Division, Brigham and Women's Hospital, Harvard Medical School, USA.
EClinicalMedicine. 2024 May 25;73:102659. doi: 10.1016/j.eclinm.2024.102659. eCollection 2024 Jul.
The clinical relevance of recurrent venous thromboembolism (VTE) after discontinuing anticoagulation in patients with COVID-19-associated VTE remains uncertain. We estimated the incidence rates and mortality of VTE recurrences developing after discontinuing anticoagulation in patients with COVID-19-associated VTE.
A prospective, multicenter, non-interventional study was conducted between March 25, 2020, and July 26, 2023, including patients who had discontinued anticoagulation after at least 3 months of therapy. All patients from the registry were analyzed during the study period to verify inclusion criteria. Patients with superficial vein thrombosis, those who did not receive at least 3 months of anticoagulant therapy, and those who were followed for less than 15 days after discontinuing anticoagulation were excluded. Outcomes were: 1) Incidence rates of symptomatic VTE recurrences, and 2) fatal PE. The rate of VTE recurrences was defined as the number of patients with recurrent VTE divided by the patient-years at risk of recurrent VTE during the period when anticoagulation was discontinued.
Among 1106 patients with COVID-19-associated VTE (age 62.3 ± 14.4 years; 62.9% male) followed-up for 12.5 months (p25-75, 6.3-20.1) after discontinuing anticoagulation, there were 38 VTE recurrences (3.5%, 95% confidence interval [CI]: 2.5-4.7%), with a rate of 3.1 per 100 patient-years (95% CI: 2.2-4.2). No patient died of recurrent PE (0%, 95% CI: 0-7.6%). Subgroup analyses showed that patients with diagnosis in 2021-2022 (vs. 2020) (Hazard ratio [HR] 2.86; 95% CI 1.45-5.68) or those with isolated deep vein thrombosis (vs. pulmonary embolism) (HR 2.31; 95% CI 1.19-4.49) had significantly higher rates of VTE recurrences.
In patients with COVID-19-associated VTE who discontinued anticoagulation after at least 3 months of treatment, the incidence rate of recurrent VTE and the case-fatality rate was low. Therefore, it conceivable that long-term anticoagulation may not be required for many patients with COVID-19-associated VTE, although further research is needed to confirm these findings.
Sanofi and Rovi, Sanofi Spain.
新冠病毒相关静脉血栓栓塞症（VTE）患者停用抗凝治疗后复发性静脉血栓栓塞症的临床相关性仍不确定。我们估计了新冠病毒相关VTE患者停用抗凝治疗后发生VTE复发的发病率和死亡率。
于2020年3月25日至2023年7月26日进行了一项前瞻性、多中心、非干预性研究，纳入至少接受3个月抗凝治疗后停用抗凝药物的患者。研究期间对登记处的所有患者进行分析以核实纳入标准。排除患有浅静脉血栓形成的患者、未接受至少3个月抗凝治疗的患者以及停用抗凝治疗后随访少于15天的患者。观察指标为：1）有症状的VTE复发的发病率，以及2）致命性肺栓塞。VTE复发率定义为复发性VTE患者数除以停用抗凝治疗期间有VTE复发风险的患者人年数。
在1106例新冠病毒相关VTE患者（年龄62.3±14.4岁；62.9%为男性）停用抗凝治疗后随访12.5个月（四分位间距，6.3 - 20.1），发生38例VTE复发（3.5%，95%置信区间[CI]：2.5 - 4.7%），复发率为每100患者年3.1例（95% CI：2.2 - 4.2）。无患者死于复发性肺栓塞（0%，95% CI：0 - 7.6%）。亚组分析显示，2021 - 2022年诊断的患者（与2020年相比）（风险比[HR] 2.86；95% CI 1.45 - 5.68）或孤立性深静脉血栓形成患者（与肺栓塞相比）（HR 2.31；95% CI 1.19 - 4.49）的VTE复发率显著更高。
在至少接受3个月治疗后停用抗凝治疗的新冠病毒相关VTE患者中，VTE复发的发病率和病死率较低。因此，可以设想，许多新冠病毒相关VTE患者可能不需要长期抗凝治疗，不过仍需要进一步研究来证实这些发现。
赛诺菲和罗维公司，赛诺菲西班牙分公司
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