Univ. Lille, CHU Lille, Département de Médecine Interne et d'Immunologie Clinique, INSERM, UMR 1167, F-59000 Lille, France.
Hospital for Special Surgery, New York, NY, USA.
Semin Arthritis Rheum. 2024 Apr;65:152347. doi: 10.1016/j.semarthrit.2023.152347. Epub 2023 Dec 20.
Long-term anticoagulant therapy is generally recommended for thrombotic antiphospholipid syndrome (TAPS) patients, however it may be withdrawn or not introduced in routine practice.
To prospectively evaluate the risk of thrombosis recurrence and major bleeding in non-anticoagulated TAPS patients, compared to anticoagulated TAPS, and secondly, to identify different features between those two groups.
PATIENTS/METHODS: Using an international registry, we identified non-anticoagulated TAPS patients at baseline, and matched them with anticoagulated TAPS patients based on gender, age, type of previous thrombosis, and associated autoimmune disease. Thrombosis recurrence and major bleeding were prospectively analyzed using Kaplan-Meier method and compared using a marginal Cox's regression model.
As of June 2022, 94 (14 %) of the 662 TAPS patients were not anticoagulated; and 93 of them were matched with 181 anticoagulated TAPS patients (median follow-up 5 years [interquartile range 3 to 8]). The 5-year thrombosis recurrence and major bleeding rates were 12 % versus 10 %, and 6 % versus 7 %, respectively (hazard ratio [HR] 1.38, 95 % confidence interval [CI] 0.53 to 3.56, p = 0.50 and HR 0.53; 95 % CI 0.15 to 1.86; p = 0.32, respectively). Non-anticoagulated patients were more likely to receive antiplatelet therapy (p < 0.001), and less likely to have more than one previous thrombosis (p < 0.001) and lupus anticoagulant positivity (p = 0.01).
Fourteen percent of the TAPS patients were not anticoagulated at recruitment. Their recurrent thrombosis risk did not differ compared to matched anticoagulated TAPS patients, supporting the pressing need for risk-stratified secondary thrombosis prevention trials in APS investigating strategies other than anticoagulation.
长期抗凝治疗通常被推荐用于血栓性抗磷脂综合征（TAPS）患者，但在常规实践中可能会停药或不开始抗凝治疗。
前瞻性评估未抗凝 TAPS 患者与抗凝 TAPS 患者相比血栓复发和大出血的风险，并其次，确定两组之间的不同特征。
患者/方法：使用国际登记处，我们在基线时确定了未抗凝的 TAPS 患者，并根据性别、年龄、先前血栓形成的类型和相关自身免疫性疾病与抗凝的 TAPS 患者进行匹配。使用 Kaplan-Meier 方法前瞻性分析血栓复发和大出血，并使用边缘 Cox 回归模型进行比较。
截至 2022 年 6 月，662 例 TAPS 患者中有 94 例（14%）未抗凝；其中 93 例与 181 例抗凝 TAPS 患者匹配（中位随访 5 年[四分位距 3 至 8]）。5 年血栓复发和大出血发生率分别为 12%和 10%，6%和 7%（风险比[HR] 1.38，95%置信区间[CI] 0.53 至 3.56，p=0.50 和 HR 0.53；95%CI 0.15 至 1.86；p=0.32）。未抗凝患者更有可能接受抗血小板治疗（p<0.001），而不太可能有多次先前血栓形成（p<0.001）和狼疮抗凝剂阳性（p=0.01）。
在招募时，14%的 TAPS 患者未接受抗凝治疗。与匹配的抗凝 TAPS 患者相比，他们的血栓复发风险没有差异，这支持了在 APS 中进行风险分层的二级血栓预防试验的迫切需要，这些试验调查了除抗凝以外的策略。
