Use of direct oral anticoagulants in patients with thrombotic antiphospholipid syndrome: Guidance from the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis.
antiphospholipid antibodies
antiphospholipid syndrome
arterial thrombosis
direct oral anticoagulants
triple positivity
venous thromboembolism
vitamin K antagonists
Journal
Journal of thrombosis and haemostasis : JTH
ISSN: 1538-7836
Titre abrégé: J Thromb Haemost
Pays: England
ID NLM: 101170508
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
04
03
2020
revised:
20
04
2020
accepted:
18
05
2020
entrez:
4
9
2020
pubmed:
4
9
2020
medline:
20
5
2021
Statut:
ppublish
Résumé
Clarity and guidance is required with regard to the use of direct oral anticoagulants in antiphospholipid syndrome (APS) patients, within the confines of the recent European Medicines Agency recommendations, discrepant recommendations in other international guidelines and the limited evidence base. To address this, the Lupus Anticoagulant/Antiphospholipid Antibodies Scientific and Standardization Committee (SSC) chair and co-chairs together with SSC Control of Anticoagulation members propose guidance for healthcare professionals to help them manage APS patients. Uncertainty in this field will be addressed. This guidance will also serve as a call and focus for research.
Identifiants
pubmed: 32881337
doi: 10.1111/jth.14935
pii: S1538-7836(22)01647-6
doi:
Substances chimiques
Anticoagulants
0
Lupus Coagulation Inhibitor
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2126-2137Informations de copyright
© 2020 International Society on Thrombosis and Haemostasis.
Références
Holbrook A, Schulman S, Witt DM, et al. American College of Chest Physicians. Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:e152S-e184.
Ruiz-Irastorza G, Cuadrado MJ, Ruiz-Arruza I, et al. Evidence-based recommendations for the prevention and long-term management of thrombosis in antiphospholipid antibody-positive patients: report of a task force at the 13th International Congress on antiphospholipid antibodies. Lupus. 2011;20:206-218.
Crowther M, Legault KJ, Garcia DA, et al. Antiphospholipid syndrome. Current Research Highlights and Clinical Insights. Prevention and Treatment of Thrombotic Antiphospholipid Syndrome. Page 223-233. Editor: Springer Nature. 2017.
Tektonidou MG, Andreoli L, Limper M, et al. EULAR recommendations for the management of antiphospholipid syndrome in adults. Ann Rheum Dis. 2019;78:1296-1304.
Miyakis S, Lockshin MD, Atsumi T, et al. International consensus statement on an update of the classification criteria for definite antiphospholipid syndrome (APS). J Thromb Haemost. 2006;4:295-306.
Schwarb H, Tsakiris DA. New Direct Oral Anticoagulants (DOAC) and Their Use Today. Dentistry Journal. 2016;4(1).
Tripodi A, de Laat B, Wahl D, Ageno W, Cosmi B, Crowther M. Subcommittees on Control of Anticoagulation and Lupus Anticoagulant/Antiphospholipid Antibodies. Monitoring patients with the lupus anticoagulant while treated with vitamin K antagonists: communication from the SSC of the ISTH. J Thromb Haemost. 2016;14:2304-2307.
Pengo V, Denas G, Zoppellaro G, et al. Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome. Blood. 2018;132:1365-1371.
Pharmacovigilance Risk Assessment Committee (PRAC). EMA/PRAC/219985/2019. https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-8-11-april-2019-prac-meeting_en.pdf. 2019;.
Konstantinides SV, Meyer G, Becattini C, et al. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2019.
Arachchillage DRJ, Gomez K, Alikhan R, Anderson JAM, Lester W, Laffan M. British Society for Haematology Haemostasis and Thrombosis Taskforce. Addendum to British Society for Haematology Guidelines on Investigation and Management of Antiphospholipid syndrome, 2012 (Br. J. Haematol. 2012; 157: 47-58): use of direct acting oral anticoagulants. Br J Haematol 2020.
Fazili M, Stevens SM, Woller SM. Direct oral anticoagulants in antiphospholipid syndrome with venous thromboembolism: Impact of the European Medicines Agency guidance. Research and Practice in Thrombosis and Haemostasis. 2020;4(1):9-12.
Baglin T, Bauer K, Douketis J, Buller H, Srivastava A, Johnson G. SSC of the ISTH. Duration of anticoagulant therapy after a first episode of an unprovoked pulmonary embolus or deep vein thrombosis: guidance from the SSC of the ISTH. J Thromb Haemost. 2012;10:698-702.
Douketis JD, Weitz JI. Guidance, guidelines, and communications. J Thromb Haemost. 2014;12:1744-1745.
Cohen H, Hunt BJ, Efthymiou M, et al. Rivaroxaban versus warfarin to treat patients with thrombotic antiphospholipid syndrome, with or without systemic lupus erythematosus (RAPS): a randomised, controlled, open-label, phase 2/3, non-inferiority trial. Lancet Haematol. 2016;3:e426-436.
Goldhaber SZ, Eriksson H, Kakkar A, et al. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER(R). Vasc Med. 2016;21:506-514.
Woller SC, Stevens SM, Kaplan DA, Rondina M. Protocol modification of Apixaban for the secondary prevention of thrombosis among patients with antiphospholipid syndrome study. Clin Appl Thromb Hemost. 2018;24:192.
Legault K, Blostein M, Carrier M, et al. Single-arm pilot feasibility cohort Study of Rivaroxaban in antiphospholipid syndrome. Res Pract Thromb Haemost. 2018;2(Suppl. 1):204-205.
Ordi-Ros J, Sáez-Comet L, Pérez-Conesa M, et al. Rivaroxaban versus vitamin K antagonist in antiphospholipid syndrome: a randomized noninferiority trial. Ann Intern Med. 2019;171: 685-694.
Sato T, Nakamura H, Fujieda Y, et al. Factor Xa inhibitors for preventing recurrent thrombosis in patients with antiphospholipid syndrome: a longitudinal cohort study. Lupus. 2019;28:1577-1582.
Malec K, Broniatowska E, Undas A. Direct oral anticoagulants in patients with antiphospholipid syndrome: a cohort study. Lupus. 2019;29: 37-44.
Dufrost V, Risse J, Reshetnyak T, et al. Increased risk of thrombosis in antiphospholipid syndrome patients treated with direct oral anticoagulants. Results from an international patient-level data meta-analysis. Autoimmun Rev. 2018;17:1011-1021.
Sanchez-Redondo J, Espinosa G, Varillas Delgado D, Cervera R. Recurrent thrombosis with direct oral anticoagulants in antiphospholipid syndrome: a systematic literature review and meta-analysis. Clin Ther. 2019;41:1839-1862.
Elsebaie MAT, van Es N, Langston A, Büller HR, Gaddh M. Direct oral anticoagulants in patients with venous thromboembolism and thrombophilia: a systematic review and meta-analysis. J Thromb Haemost. 2019;17:645-656.
Agencia Española de Medicamentos y Productos Sanitarios AEMPS ANTICOAGULANTES ORALES DIRECTOS*: NO RECOMENDADOS EN PACIENTES CON SÍNDROME ANTIFOSFOLÍPIDO Y ANTECEDENTES DE TROMBOSIS https://www.aemps.gob.es/informa/notasInformativas/medicamentosUsoHumano/seguridad/2019/docs/NI_MUH_FV-8-2019-anticoagulantes-orales.pdf.
UK Medicines and Healthcare products (MHRA) regulatory Agency on the Department of Health; Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome advice to healthcare professionals: https://www.gov.uk/drug-safety-update.
ANSM: Lettre aux professionnels de santé. https://ansm.sante.fr/S-informer/Informations-de-securite-Lettres-aux-professionnels-de-sante/Anticoagulants-Oraux-Directs-AODs-apixaban-Eliquis-R-rivaroxaban-Xarelto-R-dabigatran-Pradaxa-R-et-edoxaban-Lixiana-R-Roteas-R-non-recommandes-chez-les-patients-presentant-un-Syndrome-des-Antiphospholipides-SAPL-Lettre-aux-professionnels-de-sante.
Safety-related D.Labeling Changes (SrLC). https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=238.
Sanchez O, Benhamou Y, Bertoletti L, et al. Recommendations of good practice for the management of thromboembolic venous disease in adults. Short version. Rev Mal Respir. 2019;36:249-283.
Bauersachs R, Langer F, Kalka C, et al. Treatment of the antiphospholipid syndrome with direct oral anticoagulantsPosition statement of German societies. Vasa. 2019;48:483-486.
Ruff CT, Giugliano RP, Braunwald E, et al. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014;383:955-962.
Lansberg MG, O’Donnell MJ, Khatri P, et al. Antithrombotic and thrombolytic therapy for ischemic stroke: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:e601S-e636S.
van Es N, Coppens M, Schulman S, Middeldorp S, Büller HR. Direct oral anticoagulants compared with vitamin K antagonists for acute venous thromboembolism: evidence from phase 3 trials. Blood. 2014;124:1968-1975.
Woller SC, Stevens SM, Kaplan DA, et al. Apixaban for the Secondary Prevention of Thrombosis Among Patients With Antiphospholipid Syndrome: Study Rationale and Design (ASTRO-APS). Clin Appl Thromb Hemost. 2016;22:239-247.
Cervera R, Piette J-C, Font J, et al. Antiphospholipid syndrome: clinical and immunologic manifestations and patterns of disease expression in a cohort of 1,000 patients. Arthritis Rheum. 2002;46:1019-1027.
Siddique S, Risse J, Canaud G, Zuily S. Vascular Manifestations in Antiphospholipid Syndrome (APS): Is APS a thrombophilia or a vasculopathy? Curr Rheumatol Rep. 2017;19:64.
Canaud G, Bienaimé F, Tabarin F, et al. Inhibition of the mTORC pathway in the antiphospholipid syndrome. N Engl J Med. 2014;371:303-312.
Zuily S, Regnault V, Selton-Suty C, et al. Increased risk for heart valve disease associated with antiphospholipid antibodies in patients with systemic lupus erythematosus: meta-analysis of echocardiographic studies. Circulation. 2011;124:215-224.
Zuily S, Domingues V, Suty-Selton C, et al. Antiphospholipid antibodies can identify lupus patients at risk of pulmonary hypertension: A systematic review and meta-analysis. Autoimmun Rev. 2017;6:576-586.
Garcia D, Akl EA, Carr R, Kearon C. Antiphospholipid antibodies and the risk of recurrence after a first episode of venous thromboembolism: a systematic review. Blood. 2013;122:817-824.
Kearon C, Parpia S, Spencer FA, et al. Antiphospholipid antibodies and recurrent thrombosis after a first unprovoked venous thromboembolism. Blood. 2018;131:2151-2160.
Keeling D, Mackie I, Moore GW, Greer IA, Greaves M. British Committee for Standards in Haematology. Guidelines on the investigation and management of antiphospholipid syndrome. Br J Haematol. 2012;157:47-58.
Galli M, Luciani D, Bertolini G, Barbui T. Lupus anticoagulants are stronger risk factors for thrombosis than anticardiolipin antibodies in the antiphospholipid syndrome: a systematic review of the literature. Blood. 2003;101:1827-1832.
Gebhart J, Posch F, Koder S, et al. Increased mortality in patients with the lupus anticoagulant: the Vienna Lupus Anticoagulant and Thrombosis Study (LATS). Blood. 2015;125:3477-3483.
Pengo V, Ruffatti A, Legnani C, et al. Incidence of a first thromboembolic event in asymptomatic carriers of high-risk antiphospholipid antibody profile: a multicenter prospective study. Blood. 2011;118:4714-4718.
Andreoli L, Chighizola CB, Banzato A, Pons-Estel GJ, Ramire de Jesus G, Erkan D. Estimated frequency of antiphospholipid antibodies in patients with pregnancy morbidity, stroke, myocardial infarction, and deep vein thrombosis: a critical review of the literature. Arthritis Care Res (Hoboken). 2013;65:1869-1873.
Miranda S, Park J, Le Gal G, et al. Prevalence of confirmed antiphospholipid syndrome in 18-50 years unselected patients with first unprovoked venous thromboembolism. J Thromb Haemost. 2020;18(4):926-930.
Duarte-García A, Pham MM, Crowson CS, et al. The Epidemiology of Antiphospholipid Syndrome: A Population-Based Study. Arthritis & Rheumatology (Hoboken, NJ). 2019;71:1545-1552.
Pengo V, Tripodi A, Reber G, et al. Update of the guidelines for lupus anticoagulant detection. Subcommittee on Lupus Anticoagulant/Antiphospholipid Antibody of the Scientific and Standardisation Committee of the International Society on Thrombosis and Haemostasis. J Thromb Haemost 2009; 7: 1737-1740.
Zuily S, Dufrost V, Devreese K.International Registry of Thrombotic APS patients Treated With Direct Oral Anticoagulants. https://www.isth.org/members/group.aspx?id=100353.
Eikelboom JW, Connolly SJ, Brueckmann M, et al. de Werf F, RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013;369:1206-1214.
Perzborn E, Strassburger J, Wilmen A, et al. In vitro and in vivo studies of the novel antithrombotic agent BAY 59-7939-an oral, direct Factor Xa inhibitor. J Thromb Haemost. 2005;3:514-521.
Bohula EA, Giugliano RP, Ruff CT, et al. Impact of Renal Function on Outcomes With Edoxaban in the ENGAGE AF-TIMI 48 Trial. Circulation. 2016;134:24-36.
Woller SC, Stevens SM, Kaplan DA, et al. Apixaban for the Secondary Prevention of Thrombosis Among Patients With Antiphospholipid Syndrome: Study Rationale and Design (ASTRO-APS). Clin Appl Thromb Hemost. 2016;22:239-247.