Efficacy and safety of rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome: Rationale and design of the Trial on Rivaroxaban in AntiPhospholipid Syndrome (TRAPS) trial

Pengo, Vittorio; Banzato, Alessandra; Bison, Elisa; Zoppellaro, Giacomo; Jose, S. Padayattil; Denas, Gentian

doi:10.1177/0961203315611495

Cited by 79 publications

(58 citation statements)

References 25 publications

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“…Ongoing clinical trials to determine the safety and efficacy of NOACs in APS may lead to additional clarity. 14,18 This uncertainty should be discussed with the patients who should also be involved in the decisionmaking process.…”

Section: Resultsmentioning

confidence: 99%

Recurrent Thrombosis in Patients with Antiphospholipid Syndrome Receiving Newer Oral Anticoagulants: A Case Report and Review of Literature

2017

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We present the case of a patient with primary APS who had a recurrence of thrombotic event while on treatment with rivaroxaban and had to be restarted on warfarin. The current literature on recurrence of thrombotic events in patients with antiphospholipid syndrome (APS) treated with newer oral anticoagulants (NOAC) is also reviewed. Relevant case reports and case series were identified by searching the Medline database using the key words antiphospholipid syndrome, anticoagulants and names of the NOACs, and data on individual patients was abstracted. We identified several reports on the failure of newer anticoagulants in APS, as well as cases and clinical trial results reporting efficacy. We conclude that treatment strategies for APS should be tailored cautiously when using NOACs.

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Section: Resultsmentioning

confidence: 99%

Recurrent Thrombosis in Patients with Antiphospholipid Syndrome Receiving Newer Oral Anticoagulants: A Case Report and Review of Literature

2017

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“…[26][27][28] Methodology of the TRAPS clinical trial will target a higher risk population and should therefore provide more meaningful guidance on appropriate therapy across the APS spectrum. 30 The literature shows that there is an increased risk of thrombotic events associated with a history of arterial occlusions and/or triple antibody positivity APS regardless of treatment with warfarin or the NOACs. In previous trials related to DVT and atrial fibrillation, NOACs were compared to warfarin with a target INR 2 to 3.…”

Section: Discussionmentioning

confidence: 99%

“…The moderate renal impairment group will be dosed with rivaroxaban 15 mg once daily based on the recommendation by the American College of Cardiology/American Heart Association Task Force related to dosing in the trials associated with nonvalvular atrial fibrillation. 22,30 A feasibility pilot study is currently in progress with Apixaban for Secondary Prevention of Thrombosis among Patients with APS (ASTRO-APS). Patients will be enrolled from 2 health care systems comprising more than 160 outpatient clinics and Volume 51, October 2016 22 hospitals within the United States.…”

Section: Controlled Clinical Trialsmentioning

confidence: 99%

Role of Novel Oral Anticoagulants in the Treatment of Antiphospholipid Syndrome

2016

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Background Antiphospholipid syndrome (APS) is an autoimmune disease characterized by thrombosis or pregnancy loss with persistent positive antibodies. Standard treatment for APS with history of thromboembolism is heparin or low-molecular-weight heparin followed by a vitamin K antagonist (VKA). Novel oral anticoagulants (NOACs) could be effective in patients with APS, but none carry indications for treatment related to APS. Clinical Evidence Five case reports or series with rivaroxaban and dabigatran suggest thrombotic events occur most often in the higher risk population (arterial thrombosis and/or triple positive antibodies) or in patients who had recurrent VTEs on warfarin therapy. An observational cohort in 26 APS patients using dabigatran or rivaroxaban described a recurrent thrombotic event in only 1 patient after 8 months of treatment. The event-free survival rate was 87.9% at 12 months. Three controlled clinical trials are underway to evaluate the thrombotic risk of NOACs (RAPS, TRAPS, and ASTRO-APS). Discussion There are no completed studies that evaluate the use of NOACs in APS compared to VKAs. One major disadvantage of the NOACs is the limited availability of reversal agents for patients with a major bleeding episode. An increased risk of thrombotic events is associated with arterial occlusions and triple antibody positivity APS with both warfarin and NOACs; this is currently being researched in the TRAPS study. Conclusion Based on current available evidence, VKAs remain the standard of care in the treatment of APS. Results of ongoing trials may offer more guidance on how to appropriately use NOACs for patients with APS.

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“…Third, direct oral anticoagulants (DOAC), which do not require dose‐adjustment based on laboratory tests , could be used to treat LA‐positive patients instead of VKA. However, presently there are no indications in this respect and clinical trials (currently in progress ) are warranted to prove whether DOAC are effective and safe.…”

Section: Alternative Systems Of Monitoringmentioning

confidence: 99%

Monitoring patients with the lupus anticoagulant while treated with vitamin K antagonists: communication from the SSC of the ISTH

Tripodi

Laat

Wahl

et al. 2016

Journal of Thrombosis and Haemostasis

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Efficacy and safety of rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome: Rationale and design of the Trial on Rivaroxaban in AntiPhospholipid Syndrome (TRAPS) trial

Abstract: The methods and the study design should be appropriate to achieve study results that are both scientifically valid and relevant to clinical practice.

Cited by 79 publications

References 25 publications

Recurrent Thrombosis in Patients with Antiphospholipid Syndrome Receiving Newer Oral Anticoagulants: A Case Report and Review of Literature

Recurrent Thrombosis in Patients with Antiphospholipid Syndrome Receiving Newer Oral Anticoagulants: A Case Report and Review of Literature

Role of Novel Oral Anticoagulants in the Treatment of Antiphospholipid Syndrome

Monitoring patients with the lupus anticoagulant while treated with vitamin K antagonists: communication from the SSC of the ISTH

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