Low-dose aspirin vs low-dose aspirin plus low-intensity warfarin in thromboprophylaxis: a prospective, multicentre, randomized, open, controlled trial in patients positive for antiphospholipid antibodies (ALIWAPAS)

Cuadrado, María J.; Bertolaccini, Maria Laura; Seed, Paul; Tektonidou, Maria G.; A, Aguirre de Cárcer; Micó, Luisa; Gordon, Caroline; Ruiz‐Irastorza, Guillermo; Egurbide, María Victoria; Gil, Antonio; Espinosa, Gerard; Houssiau, Frédéric; Rahman, Anisur; Martı́n, H; McHugh, Neil; Galindo, María; Akil, Mohammed; Amigo, Mary Carmen; Murru, Veronica; Khamashta, Munther A.

doi:10.1093/rheumatology/ket313

Cited by 74 publications

(49 citation statements)

References 47 publications

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“…Trials with clinical outcomes are ideal; however, when APS trials with clinical outcomes have succeeded, the numbers have been relatively small, e.g. 334 patients in five RCTs on treatment for APS-associated recurrent miscarriage in the meta-analysis by Mak et al [75], and trials with larger recruitment targets have proved challenging [76,77]. The appropriateness or otherwise of the use of surrogate markers in clinical trials was considered in an editorial review by Svennson et al, who, after supporting their use in fatal diseases such as amyotrophic lateral sclerosis, went on to say that they felt this approach was justified: 'in the case of very rare diseases, (where) validation of hard end points may take an unreasonable time to complete' [78].…”

Section: Rcts Of Doacs In Apsmentioning

confidence: 99%

Use of direct oral anticoagulants in antiphospholipid syndrome

Cohen

Efthymiou

Isenberg

2018

Journal of Thrombosis and Haemostasis

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The direct oral anticoagulants (DOACs) are therapeutic alternatives to warfarin and other vitamin K antagonists (VKAs), and constitute the standard of care for many indications. VKAs constitute the conventional therapy for the treatment and secondary thromboprophylaxis of thrombotic antiphospholipid syndrome (APS), but are often problematic, owing to the variable sensitivity of thromboplastins to lupus anticoagulant. Thus, the International Normalized Ratio may not accurately reflect anticoagulation intensity, or be clinically effective. Definition of the current role of DOACs in the treatment of APS is based on limited clinical trial data and information from other sources, including manufacturers' data, case series or cohort studies, and expert consensus. The Rivaroxaban in Antiphospholipid Syndrome (RAPS) randomized controlled trial (RCT), which had a laboratory surrogate primary outcome measure, suggests that rivaroxaban has the potential to be an effective and convenient alternative to warfarin in thrombotic APS patients with a single venous thromboembolism event requiring standard-intensity anticoagulation. However, further studies, in particular to provide better long-term efficacy and safety data, are needed before it can be widely recommended. APS patients are clinically heterogeneous, with the risk of recurrent thrombosis and the intensity of anticoagulation being influenced by their clinical phenotype and risk profile. DOAC trials involving homogeneous thrombotic APS populations, with the antiphospholipid antibody status well defined, will help to optimize the appropriate treatment in APS patient subgroups. Ongoing and emerging DOAC RCTs should provide further information to guide the use of DOACs in APS patients. Optimal identification of APS patients is a key step in working towards improved therapeutic strategies in these individuals.

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Section: Rcts Of Doacs In Apsmentioning

confidence: 99%

Use of direct oral anticoagulants in antiphospholipid syndrome

Cohen

Efthymiou

Isenberg

2018

Journal of Thrombosis and Haemostasis

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“…The adequate strategy for the primary prophylaxis of thrombosis in patients with antiphospholipid antibodies (aPL) remains very controversial [1][2][3][4]. However, experts at the 13th International Congress on antiphospholipid antibodies have advocated the use of low-dose aspirin for primary prophylaxis of thrombosis in aPL carriers with high risk profiles such as lupus anticoagulant (LA) positivity or triple positivity (positivity of LA, anticardiolipin [aCL] and of anti-β2-glycoprotein-I [β2GPI] antibodies) or isolated persistently positive anticardiolipin antibodies aCL at medium-high titers [5].…”

Section: Introductionmentioning

confidence: 99%

Patient-level analysis of five international cohorts further confirms the efficacy of aspirin for the primary prevention of thrombosis in patients with antiphospholipid antibodies

Arnaud

Mathian

Devilliers³

et al. 2015

Autoimmunity Reviews

128

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“…There was no difference in the thrombosis risk between the two groups. However, the risk of bleeding was higher among patients receiving the combination therapy [42]. ANTIPHOSPHOLIPID SYNDROME…”

Section: Anticoagulation In Primary Thromboprophylaxismentioning

confidence: 99%