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Outcomes of Temporary Interruption of Rivaroxaban Compared with Warfarin in Patients with Nonvalvular Atrial Fibrillation.

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  1. Outcomes of Temporary Interruption of RivaroxabanCompared with Warfarin in Patients with Nonvalvular Atrial Fibrillation Matthew W. Sherwood, Anne Hellkamp, Manesh R. Patel, Jonathan P. Piccini, YuliyaLokhnygina, James Douketis, Richard C. Becker, Kenneth W. Mahaffey, Keith A. A. Fox, and Robert M. Califf on behalf of the ROCKET AF Investigators

  2. Disclosures • Matthew W. Sherwood – ACCF/BMS travel award

  3. Background • Oral anticoagulation (OAC) attenuates the risk of stroke in atrial fibrillation (AF) • Interruption of OAC is common in clinical practice • In ROCKET AF, rivaroxaban was non-inferior to warfarin for the prevention of stroke and systemic embolism • There are very few data on the management and outcomes of temporary interruption (TI) in the current era of oral anticoagulation Patel MR. N Engl J Med. 2011; 365:883-891

  4. Objectives • To describe the population who required temporary interruption of anticoagulation for any reason • To describe patterns of bridging therapy used in these patients • To describe the clinical outcomes of patients with TI

  5. Risk factors • CHF • Hypertension • Age 75 • Diabetes • OR • Stroke, TIA, or systemic embolism Study Design At least 2 or 3 required* Atrial fibrillation Rivaroxaban Warfarin Randomize Double Blind / Double Dummy (n ~ 14,000) 20 mg daily 15 mg for CrCl 30–49 ml/min INR target: 2.5 (2.0–3.0 inclusive) Monthly monitoring Adherence to standard of care guidelines Primary endpoint: Stroke or non-CNS systemic embolism *Enrollment of patients without prior stroke, TIA, or systemic embolism and only 2 factors capped at 10% Rationale and design of the rocket af study. Am Heart J. 2010;159:340-347

  6. Outcomes and definitions • Temporary Interruption (TI) – Defined as ≥3 days ending with resumption of study drug • Median TI duration 5 days • At risk period – 3 days after interruption until 3 days after resumption • Outcomes: • Composite of all stroke (ischemic & hemorrhagic) and non-central nervous system (CNS) embolism • Death and MI • ISTH major bleeding (fatal, involving a critical site, Hb drop 2 g/dL or more, or transfusion ≥2 units RBC) • Clinically relevant non-major (CRNM) bleeding • All events were adjudicated by a blinded multispecialty adjudication committee

  7. Methods and Analyses • TI Study population  4693/14236 patients (33%) • Included  All patients randomized who received at least 1 dose of study drug • Excluded  interruptions with (1) transition to open-label warfarin or (2) permanent cessation of study drug • Baseline characteristics of TI patients and bridging therapy described • Clinical outcomes analyzed as events/# patients • Stratified by treatment group • Stratified by use of bridging therapy

  8. Patient Characteristics

  9. Reasons for Temporary Interruption

  10. Distribution of procedures causing TI

  11. Clinical Outcomes by Treatment Arm

  12. Patterns of bridging anticoagulation

  13. Patients characteristics of those bridged

  14. Clinical Outcomes and Bridging

  15. Limitations • Post-hoc analysis • Fairly small number of events in the setting of temporary interruption • Granularity of data not available for all TIs, including urgency and relationship of study drug restart to events

  16. Conclusions • In a moderate to high risk population of patients with atrial fibrillation, temporary interruption of anticoagulation is common • Use of bridging therapy was infrequent despite the high risk population • Rates of stroke/embolism and clinically significant bleeding were moderate but comparable between rivaroxaban and warfarin

  17. Clinical Implications • Temporary Interruptions of oral anticoagulation are associated with increased risk and should be minimized if possible • More investigation is needed to determine the optimal management of temporary interruption and bridging for warfarin and new oral anticoagulants

  18. Freedom from TI by treatment group

  19. Stroke or non-CNS embolism after any interruption or discontinuation Rivaroxaban better Warfarinbetter

  20. Cumulative proportion of subjects with INR ≥2 who completed the study 81.3 Warfarin 48.8 Rivaroxaban Safety/Days 3 to 30 after the last dose

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