Thrombosis recurrence and major bleeding in non-anticoagulated thrombotic antiphospholipid syndrome patients: Prospective study from antiphospholipid syndrome alliance for clinical trials and international networking (APS ACTION) clinical database and repository ("Registry")

被引:1
作者
Yelnik, Cecile M. [1 ,36 ]
Erton, Zeynep Belce
Drumez, Elodie [1 ]
Cheildze, Dachi [2 ,3 ]
de Andrade, Danieli [4 ]
Clarke, Ann [5 ]
Tektonidou, Maria G. [6 ]
Sciascia, Savino [7 ]
Pardos-Gea, Jose [8 ]
Pengo, Vittorio [9 ]
Ruiz-Irastorza, Guillermo [10 ]
Belmont, H. Michael [11 ]
Pedrera, Chary Lopez [12 ]
Fortin, Paul R. [13 ]
Wahl, Denis [14 ,15 ]
Gerosa, Maria [16 ]
Kello, Nina [17 ]
Signorelli, Flavio [18 ]
Atsumi, Tatsuya [19 ]
Ji, Lanlan [20 ]
Efthymiou, Maria [21 ]
Branch, D. Ware [22 ,23 ]
Nalli, Cecilia [24 ]
Rodriguez-Almaraz, Esther [25 ]
Petri, Michelle [26 ]
Cervera, Ricard [27 ]
Shi, Hui [28 ]
Zuo, Yu [29 ]
Artim-Esen, Bahar [30 ]
Pons-Estel, Guillermo [31 ]
Willis, Rohan [32 ]
Barber, Megan R. W. [5 ]
Skeith, Leslie [5 ]
Bertolaccini, Maria Laura [33 ]
Cohen, Hannah [21 ]
Roubey, Robert [34 ]
Erkan, Doruk [35 ]
机构
[1] Univ Lille, Dept Med Interne & Immunol Clin, CHU Lille, INSERM,UMR 1167, F-59000 Lille, France
[2] Hosp Special Surg, New York, NY USA
[3] Yale New Haven Hosp, New Haven, CT USA
[4] Univ Sao Paulo, Sao Paulo, Brazil
[5] Univ Calgary, Calgary, AB, Canada
[6] Natl & Kapodistrian Univ Athens, Athens, Greece
[7] Univ Turin, Turin, Italy
[8] Vall dHebron Univ Hosp, Barcelona, Spain
[9] Padova Univ Hosp, Padua, Italy
[10] BioCruces Bizkaia Hlth Res Inst, Baracaldo, Spain
[11] New York Univ, Langone Med Ctr, New York, NY USA
[12] Maimonides Inst Biomed Res Cordoba, Cordoba, Spain
[13] Univ Laval, Ctr ARThrite CHU Quebec, Quebec City, PQ, Canada
[14] Univ Lorraine, Inserm DCAC, Nancy, France
[15] CHRU Nancy, Nancy, France
[16] Univ Milan, Milan, Italy
[17] Northwell Hlth, New Hyde Pk, NY USA
[18] Univ Estado Rio De Janeiro, Rio De Janeiro, Brazil
[19] Hokkaido Univ Hosp, Sapporo, Hokkaido, Japan
[20] Peking Univ First Hosp, Beijing, Peoples R China
[21] UCL, London, England
[22] Univ Utah, Salt Lake City, UT USA
[23] Intermt Healthcare, Salt Lake City, UT USA
[24] Univ Brescia, Brescia, Italy
[25] Hosp Univ 12 Octubre, Madrid, Spain
[26] Johns Hopkins Univ, Sch Med, Baltimore, MD USA
[27] Hosp Clin Barcelona, Barcelona, Catalonia, Spain
[28] Shanghai Jiao Tong Univ, Sch Med, Ruijin Hosp, Dept Rheumatol & Immunol, Shanghai, Peoples R China
[29] Univ Michigan, Ann Arbor, MI USA
[30] Istanbul Univ, Sch Med, Istanbul, Turkiye
[31] Ctr Reg Enfermedades Autoinmunes & Reumat Grp Oron, Rosario, Argentina
[32] Univ Texas Med Branch, Galveston, TX USA
[33] Kings Coll London, Sch Cardiovasc & Metab Med & Sci, London, England
[34] Univ North Carolina Chapel Hill, Chapel Hill, NC USA
[35] Weill Cornell Med, Hosp Special Surg, Barbara Volcker Ctr Women & Rheumat Dis, New York, NY USA
[36] CHU Lille, Hop Huriez, Serv Med Interne & Immunol Clin, Rue Polonovski, F-59037 Lille, France
关键词
Antiphospholipid syndrome; Antiphospholipid antibodies; Anticoagulant therapy; Bleeding; Thrombosis; ANTIBODIES;
D O I
10.1016/j.semarthrit.2023.152347
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background: Long-term anticoagulant therapy is generally recommended for thrombotic antiphospholipid syndrome (TAPS) patients, however it may be withdrawn or not introduced in routine practice. Objectives: 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. Results: 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 5year 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). Conclusion: 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.
引用
收藏
页数:8
相关论文
共 25 条
  • [1] Arterial Thrombosis in Patients with Antiphospholipid Syndrome: A Review and Meta-Analysis
    Aibar, Jesus
    Schulman, Sam
    [J]. SEMINARS IN THROMBOSIS AND HEMOSTASIS, 2021, 47 (06) : 709 - 723
  • [2] Antiplatelet and anticoagulant agents for secondary prevention of stroke and other thromboembolic events in people with antiphospholipid syndrome
    Bala, Malgorzata M.
    Celinska-Lowenho, Magdalena
    Szot, Wojciech
    Padjas, Agnieszka
    Kaczmarczyk, Mateusz
    Swierz, Mateusz J.
    Undas, Anetta
    [J]. COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2020, (10):
  • [3] Predictive value of the adjusted Global Anti-Phospholipid Syndrome Score on clinical recurrence in APS patients: a longitudinal study
    Barilaro, Giuseppe
    Esteves, Alexandra
    Della Rocca, Carlo
    Perez-Isidro, Albert
    Araujo, Olga
    Pires da Rosa, Gilberto
    Ruiz-Ortiz, Estibaliz
    Tassies Penella, Dolors
    Vinas, Odette
    Carles Reverter, Joan
    Cervera, Ricard
    Espinosa, Gerard
    [J]. RHEUMATOLOGY, 2023, 62 (04) : 1576 - 1585
  • [4] Morbidity and mortality in the antiphospholipid syndrome during a 10-year period: a multicentre prospective study of 1000 patients
    Cervera, R.
    Serrano, R.
    Pons-Estel, G. J.
    Ceberio-Hualde, L.
    Shoenfeld, Y.
    de Ramon, E.
    Buonaiuto, V.
    Jacobsen, S.
    Zeher, M. M.
    Tarr, T.
    Tincani, A.
    Taglietti, M.
    Theodossiades, G.
    Nomikou, E.
    Galeazzi, M.
    Bellisai, F.
    Meroni, P. L.
    Derksen, R. H. W. M.
    de Groot, P. G. D.
    Baleva, M.
    Mosca, M.
    Bombardieri, S.
    Houssiau, F.
    Gris, J-C
    Quere, I.
    Hachulla, E.
    Vasconcelos, C.
    Fernandez-Nebro, A.
    Haro, M.
    Amoura, Z.
    Miyara, M.
    Tektonidou, M.
    Espinosa, G.
    Bertolaccini, M. L.
    Khamashta, M. A.
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2015, 74 (06) : 1011 - 1018
  • [5] Cessation of oral anticoagulants in antiphospholipid syndrome
    Comarmond, C.
    Jego, P.
    Veyssier-Belot, C.
    Marie, I.
    Mekinian, A.
    Elmaleh-Sachs, A.
    Leroux, G.
    Saadoun, D.
    Oziol, E.
    Fraisse, T.
    Hyvernat, H.
    Thiercein-Legrand, M-F
    Sarrot-Reynauld, F.
    Ferreira-Maldent, N.
    de Menthon, M.
    Goujard, C.
    Khau, D.
    Nguen, Y.
    Monnier, S.
    Michon, A.
    Castel, B.
    Decaux, O.
    Piette, J-C
    Cacoub, P.
    [J]. LUPUS, 2017, 26 (12) : 1291 - 1296
  • [6] Importance of events per independent variable in proportional hazards analysis .1. Background, goals, and general strategy
    Concato, J
    Peduzzi, P
    Holford, TR
    Feinstein, AR
    [J]. JOURNAL OF CLINICAL EPIDEMIOLOGY, 1995, 48 (12) : 1495 - 1501
  • [7] Crowther M, 2017, Antiphospholipid syndrome: current research highlights and clinical insights, P223
  • [8] Risk Assessment of Recurrence in Patients With Unprovoked Deep Vein Thrombosis or Pulmonary Embolism The Vienna Prediction Model
    Eichinger, Sabine
    Heinze, Georg
    Jandeck, Lisanne M.
    Kyrle, Paul A.
    [J]. CIRCULATION, 2010, 121 (14) : 1630 - 1636
  • [9] APS ACTION - AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking
    Erkan, D.
    Lockshin, M. D.
    [J]. LUPUS, 2012, 21 (07) : 695 - 698
  • [10] The emerging role of multiple antiphospholipid antibodies positivity in patients with antiphospholipid syndrome
    Forastiero, Ricardo
    Martinuzzo, Marta
    [J]. EXPERT REVIEW OF CLINICAL IMMUNOLOGY, 2015, 11 (11) : 1255 - 1263