NEWER ANTICOAGULANTS: FOCUS ON STROKE PREVENTION IN ATRIAL FIBRILLATION AND DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM

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1 NEWER ANTICOAGULANTS: FOCUS ON STROKE PREVENTION IN ATRIAL FIBRILLATION AND DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM Carol Lee, Pharm.D., Jessica C. Song, M.A., Pharm.D. INTRODUCTION For many years, warfarin has been the standard of care and the only available oral anticoagulant to prevent thromboembolic complications associated with atrial fibrillation, as well as venous and pulmonary thrombosis. 1 Despite its long-term use and familiarity among many healthcare providers, warfarin is now up against three new oral anticoagulants, dabigatran, rivaroxaban, and apixaban all of which do not require blood monitoring and frequent dose adjustments. 2-5 These newer agents not only provide options for patients who are difficult to manage, but they also enable healthcare providers to choose the most appropriate drug based on patient-specific circumstances. CURRENT STANDARD OF PRACTICE - STROKE PREVENTION IN ATRIAL FIBRILLATION AND DEEP VEIN THROMBOSIS/PULMONARY EMBOLISM Based on the results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) study, dabigatran has been shown to be superior to warfarin in reducing the risk of stroke or systemic embolism. 6 This open-label study included patients with mean CHADS 2 scores of 2.1, and their INRs were in therapeutic range for 64% of the time. Rivaroxaban has been shown to be noninferior to warfarin with regard to preventing stroke and systemic embolism in nonvalvular atrial fibrillation patients. 7 The patients enrolled in the ROCKET-AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism) study were higher-risk patients as shown by a mean CHADS 2 score of 3.5±0.9 ( 3, 87%). In addition, the patients were not well controlled on warfarin therapy, since their INRs were in therapeutic range for 55% of the time. Rivaroxaban has not been compared against apixaban or dabigatran in head-to-head clinical trials of stroke prevention in atrial fibrillation. Apixaban has been shown to be noninferior to warfarin for preventing stroke and systemic embolism. 8 The ARISTOLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) study featured patients with a mean CHADS 2 score of 2.1±1.1 ( 3, 30%) and INRs of warfarin-treated patients were in therapeutic range for 62.2% of the time. The American Heart Association (AHA)/American Stroke Association (ASA) guidelines for the prevention of first and recurrent stroke in patients with non-valvular AF awarded class I recommendations for using warfarin, apixaban, and dabigatran, but gave a class IIa recommendation for rivaroxaban. 9 Because of the high-risk population enrolled in ROCKET-AF, AHA/ASA recommended rivaroxaban as an alternative to warfarin in patients with non-valvular AF who have a prior history of transient ischemic attack, stroke, or systemic embolism or 2 additional risk factors. Apixaban (5 mg twice daily) was deemed to be a viable alternative to warfarin in patients with non-valvular AF who have 1 additional risk factor and do not exhibit more than 1 of the following characteristics: (1) age 80 years; (2) weight 60 kg; or (3) serum creatinine 1.5 mg/dl. AHA/ASA recommended dabigatran as an efficacious alternative to warfarin in patients with non-valvular AF who have 1 additional risk factor and creatinine clearance above 30 ml/minute. Rivaroxaban has been shown to be noninferior to enoxaparin (1 mg/kg subcutaneously twice daily 5 days)/warfarin with regard to preventing recurrence of symptomatic VTE in patients with acute, symptomatic DVT and in patients with an acute symptomatic PE with or without DVT. 10,11 Dabigatran and apixaban have not received FDA (Food and Drug Administration) approval for the indication of treatment of patients with DVT and PE. 3,5 The American College of Chest Physician s Antithrombotic guidelines awarded a grade 1B recommendation for the use of parenteral anticoagulants (IV unfractionated heparin,

2 low-molecular weight heparin, fondaparinux, subcutaneous unfractionated heparin) or rivaroxaban in patients with VTE. 1 However, because of the limited number of publications on the efficacy and tolerability of rivaroxaban for VTE treatment at the time the recommendations were drafted (October 2011), the panel gave a weak recommendation for low molecular weight heparin/warfarin over rivaroxaban. KEY POINTS FOR NEWER ANTICOAGULANTS Dabigatran (Pradaxa ) 3 Since its FDA approval in 2010, dabigatran has been marketed for stroke prevention and systemic embolism in patients with nonvalvular atrial fibrillation. This direct thrombin inhibitor comes as a 75mg or 150mg tablet and is dosed at 150mg twice daily (half-life is approximately hours). A dose adjustment of 75mg twice daily may be necessary for patients with renal impairment (serum creatinine of 15-30mL/min). No consistent change has been noted in dabigatran pharmacodynamics or exposure in patients with moderate hepatic impairment (Child-Pugh Class B). The conversion from warfarin to dabigatran is simple - warfarin is discontinued and dabigatran is started when the International Normalized Ratio (INR) falls below 2. On the other hand, the number of days to convert dabigatran to warfarin depends on the patient s creatinine clearance (CrCl). Dabigatran should be discontinued 3 days after the start of warfarin therapy if a patient has a CrCl of 50 ml/min or higher, 2 days after if the patient has a CrCl ranging from 30 to 50 ml/min, and 1 day after if the patient has a CrCl ranging from ml/min. Patients on dabigatran usually do not require laboratory monitoring with the exception of testing the aptt (Activated Partial Thromboplastin Time) for patients with life-threatening bleeding or need for emergent reversal. In terms of drug interactions, avoid concomitant use of dabigatran with strong p- glycoprotein inhibitors (e.g. ketoconazole, dronedarone) or reduce the dose of dabigatran to 75mg twice daily; avoid coadministration with drugs that induce p-glycoprotein (e.g. rifampin). Capsules should be used within four months of opening the bottle, assuming appropriate storage conditions (25 0 C in original package). Rivaroxaban (Xarelto ) 4 This oral direct factor Xa inhibitor was developed and first approved by the FDA in 2011 for preventing venous thromboembolism in adults undergoing hip or knee replacement surgery. Shortly after its approval, the FDA accepted its indication for stroke prophylaxis in patients with nonvalvular atrial fibrillation. Finally in 2012, the FDA approved rivaroxaban for the prevention and treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), thereby decreasing the recurrence of venous thromboembolism. Rivaroxaban is available in 10mg, 15mg, and 20mg tablets and has a half-life of approximately 5-9 hours. This agent offers the convenience of once daily dosing for 2 indications: (1) 20mg daily for nonvalvular atrial fibrillation; and (2)10mg daily for days for knee replacement, 35 days for hip replacement patients requiring DVT/PE prophylaxis. During the first 3 weeks of treatment, DVT/PE patients should receive rivaroxaban 15mg twice daily with food. After the initial loading phase, patients should receive rivaroxaban 20mg daily for the remaining treatment duration. Rivaroxaban is available in 10mg, 15mg, and 20mg tablets and has a half-life of approximately 5-9 hours. Renally impaired patients may require dose adjustments when considering rivaroxaban - patients with CrCl ranging from 15 to 50 ml/min should receive 15 mg daily. No dose adjustments are needed for the prevention of DVT/PE. However, use of rivaroxaban in patients with CrCl < 15mL/min should be avoided for nonvalvular atrial fibrillation. Similarly, use of rivaroxaban in patients with CrCl < 30 ml/min should be avoided for DVT/PE treatment and prophylaxis. No adjustments are needed for patients with mild hepatic impairment, but should be avoided in patients with moderate to severe hepatic impairment (Child-Pugh classes B and C) and in patients with any hepatic disease associated with coagulopathy. The conversion from warfarin to rivaroxaban begins by stopping warfarin and starting rivaroxaban when the INR falls

3 below 3. Conversely, discontinue rivaroxaban and begin both parenteral anticoagulant and warfarin at the same time of the next dose when rivaroxaban would have been taken. Routine laboratory monitoring for rivaroxaban is not required but the prothrombin time (PT)/INR may be used prior to invasive procedures or for life-threatening bleeding. Avoid concomitant use of drugs that inhibit CYP3A4 and p- glycoprotein (e.g. ketoconazole, itraconazole, ritonavir (alone, or in combination with lopinavir or indinavir), conivaptan) and CYP3A4/p-glycoprotein inducers (e.g. carbamazepine, phenytoin, rifampin, St. John s Wort). Apixaban (Eliquis ) 5 This agent is FDA-approved for use in prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation; tablet strengths include 2.5 mg and 5 mg. In patients presenting with 2 or more of the following characteristics: (1) 80 years of age or older; (2) weighing 60kg; (3) presenting with serum creatinine 1.5mg/dL, apixaban should be dosed at 2.5mg twice daily. Otherwise, most patients start at 5mg twice daily. No dose adjustment is needed for mild hepatic impairment, but patients with severe hepatic impairment should avoid taking this drug. The conversion from warfarin to apixaban begins with discontinuing warfarin and starting apixaban when the INR falls below 2. If switching from apixaban to warfarin, stop apixaban and start both parenteral anticoagulant and warfarin when the next dose of apixaban would have been given. Similar to dabigatran and rivaroxaban recipients, apixaban recipients generally do not require laboratory monitoring. However, PT/INR may be analyzed in the event of life-threatening bleeding or if emergent reversal is needed. Patients taking strong dual inhibitors of CYP3A4 and p-glycoprotein should receive apixaban 2.5 mg twice daily. Patients taking drugs that induce CYP3A4 and p-glycoprotein (carbamazepine, phenytoin, rifampin, St. John s Wort) should avoid taking apixaban. BLEEDING RISK In stroke prevention trials that included non-valvular atrial fibrillation patients, major bleeding rates did not differ between dabigatran and rivaroxaban compared with warfarin; lower rates occurred in apixaban recipients relative to warfarin recipients. 6-8 Lower rates of intracranial hemorrhage have been reported in patients with non-valvular atrial fibrillation who received rivaroxaban, apixaban, and dabigatran, relative to warfarin-treated patients. Gastrointestinal bleeding occurred more frequently in dabigatran-treated patients and rivaroxaban-treated patients relative to warfarin, whereas there was no difference between apixaban and warfarin. Rivaroxaban therapy resulted in comparable major bleeding rates compared to enoxaparin/warfarin therapy in a phase 3 acute DVT study 10, whereas major bleeding rates were 50% lower in rivaroxaban recipients compared with the enoxaparin/warfarin treatment group in a phase 3 acute PE clinical trial 11. REVERSAL OF NEWER ANTICOAGULANTS At present, no antidote is available for the newer anticoagulants. However, participants of the Thrombosis and Hemostasis Summit of North America recommended the following measures for reversing the effect of these agents 12 : (1) Supportive Care: Patients treated with apixaban, dabigatran, or rivaroxaban who present with significant bleeding or the need for emergent surgery should receive routine usual supportive care including fluid resuscitation, red blood cell transfusions, maintenance of renal function, identification of bleeding source, and surgical intervention as needed. (2) Discontinuation of drug: Given the relatively short half-lives of the new oral anticoagulants, withholding further doses and supportive care is likely to be sufficient for many patients. In patients with normal renal function, most of the anticoagulant effect of new medications should dissipate within a day or two.

4 (3) Activated charcoal: If oral drug intake was within a couple hours of presentation, oral activated charcoal offers a low side effect treatment option. (4) Hemodialysis and hemoperfusion: This should be considered for dabigatran recipients, as 2/3 of the drug will be removed in a few hours. Use of dialysis is unlikely to be effective for apixaban or dabigatran, as they are highly protein-bound. (5) The use of factor VIIa in nonhemophiliac patients is associated with an increase in arterial thrombosis. Human rviia decreases the bleeding time in rats that have been given dabigatran or rivaroxaban, however, it does not reverse the anticoagulation effect as measured by most laboratory tests in this model. There have been no human studies to date and it is unclear if this therapy will be useful for emergent anticoagulation reversal. (6) Prothrombin complex concentrate (PCC): The use of either 3-factor or 4-factor PCCs have the potential to increase the risk of thrombosis. One nonactivated 4-factor PCC has been shown to normalize PT in human volunteers that received rivaroxaban, but did not normalize the aptt or thrombin time in dabigatran recipients. There have been no studies evaluating the effect of PCCs on bleeding in humans receiving the new oral anticoagulants. Whether use of PCCs will be effective to stop critical bleeding or reverse the anticoagulant effects of the new agents enough to safely proceed with emergent surgery is not established, but seems, given the current state of information, to be a reasonable approach in dire clinical situations in the opinion of several of the authors. Importantly, however, consensus was not reached regarding PCC, as two authors felt that PCC cannot be recommended at this time due to absence of data. All authors agreed that an equally justifiable approach, based on the current level of information, is to continue supportive care and local measures to arrest bleeding. Of note, the University of Washington Anticoagulation Clinic uses the following guideline for emergent reversal for life-threatening bleeding 13 : Drug Apixaban Dabigatran Rivaroxaban Emergent Reversal for Life-Threatening Bleeding Monitor PT/INR and anti-factor Xa assay to confirm reversal Monitor aptt and/or DTI assay to confirm reversal Monitor PT/INR and anti-factor Xa assay to confirm reversal

5 REFERENCES 1. Ageno WA, Gallus Wittkowsky AS, et al. Oral Anticoagulant Therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9 th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (Suppl): e44s-e88s. 2. Phillips KW, Ansell J. The clinical implications of new oral anticoagulants: will the potential advantages be achieved? Thromb Haemost 2010; 103: Dabigatran (Pradaxa ) prescribing information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; December Rivaroxaban (Xarelto ) prescribing information. Titusville, NJ: Janssen Pharmaceuticals; November Apixaban (Eliquis ) prescribing information. Princeton, NJ: Bristol-Myers Squibb Company; December Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009; 361: Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011; 365: Granger CB, Alexander JH, McMurray JJV, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011; 365: Furie KL, Goldstein LB, Albers GW, et al. Oral anti-thrombotic agents for the prevention of stroke in nonvalvular atrial fibrillation: a Science Advisory for Healthcare Professionals from the American Heart Association/American Stroke Association. Stroke 2012; 43: The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010; 363: The EINSTEIN PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med 2012; 366: Kaatz S, Kouides PA, Garcia DA, et al. Guidance on the emergent reversal of oral thrombin and factor Xa inhibitors. Am J Hematol 2012; 87: S141-S University of Washington Medicine Anticoagulation Services: suggestions for reversal and management of bleeding. Accessed June 21, 2013.

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