Stacey Moultrie, PharmD ROCKET-AF 1. "Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation" 1

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1 Stacey Moultrie, PharmD ROCKET-AF 1 I. Introduction: (1-4) "Rivaroxaban versus Warfarin in Nonvalvular Atrial Fibrillation" 1 ROCKET-AF: The Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonist for Prevention of Stroke and Embolism Trial in Atrial Fibrillation. Warfarin has been historically the anticoagulant treatment of choice for patients with nonvalvular atrial fibrillation to prevent stroke and embolization. The purpose of this trial was to determine whether or not rivaroxaban is NONINFERIOR to warfarin in prevention of stroke or systemic embolism. Vitamin K is a necessary ingredient for the production of the Vitamin K-dependent clotting factors II, VII, IX and X and Protein C and S. Warfarin is a vitamin K antagonist that affects clot production by depleting systemic vitamin K and thus decreasing clot formation. Excessive dosing/overdose can be treated with omission of doses +/- administration of vitamin k, activated prothrombin complex concentrate, fresh frozen plasma, and/or novoseven (recombinant factor VIIa). Rivaroxaban is a reversible Factor Xa inhibitor with a typical half-life of 5 to 9 hours in healthy subjects (aged 20 to 45) and 11 to 13 hours in the elderly. This drug does not require laboratory monitoring to ensure therapeutic efficacy; however, it does not have an antidote. It will take one to two days to eliminate the drug from the system after discontinuation.. In case of overdose within 8 hours, activated charcoal can be used although the peak effect from a normal dose is within 2 hours of ingestion. In cases of severe bleeding, Novoseven (recombinant factor VIIa) and activated prothrombin complex concentrate can be used. II. Clinical Relevance: (1-11) Although warfarin has been proven to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation, it requires monitoring and dose adjustment based on patient specific variables such as diet, age, new medications/herbals/vitamins added to current therapy, etc. Because of the monitoring and dose adjustments required to maintain a safe and effective dose that reflects the desired goal INR of 2 to 3 in these patients, the authors sought to prove that rivaroxaban is as equally efficacious and as safe as the current gold standard therapy of prevention with warfarin. Rivaroxaban does not require laboratory monitoring and has far "fewer" drug interactions than warfarin. However, patients/physicians on rivaroxaban should avoid concomitant use of drugs that are a P-gp and strong CYP3A4 inducers (ie; St.John's wort, carbamazepine, phenytoin, rifampin, etc.) or strong CYP3A4 inhibitors (ketoconazole, protease inhibitors like ritonavir, erythromycin, fluconazole). 2 Strong CYP 3A4 inducers can decrease rivaroxaban AUC by 50% and thus decrease rivaroxaban efficacy; strong CYP3A4 inhibitors can increase bleeding risk and can increase rivaroxaban AUC by % (ketoconazole and ritonavir increase bleeding risk significantly when co-administered with rivaroxaban). 2

2 Stacey Moultrie, PharmD ROCKET-AF 2 Enoxaparin and rivaroxaban had an additive effect on factor Xa activity when administered concurrently and concurrent use of anticoagulants with rivaroxaban is not advised. Patients on clopidogrel + rivaroxaban have an increase and bleeding time but no change in the pharmacokinetics of either drug; patients on clopidogrel, ASA or NSAID concomitant therapy should be monitored for signs and symptoms of bleeding.2 III. Study Methods: (1,2,5) 14,264 patients with NONVALVULAR atrial fibrillation were randomly assigned to rivaroxaban 20mg po daily with the evening meal (15mg po daily with the evening meal for patients with renal insufficiency/creatinine clearance of 15-50mL/min) OR warfarin at an adjusted dose to maintain INR of 2 to 3 (target: 2.5). The study was double blinded: one group received warfarin + matching rivaroxaban placebo OR rivaroxaban + matching warfarin placebo. ASA up to 100mg/day was permitted in the study. Thienopyridines (ticlopidine, clopidogrel, prasugrel) and fibrinolytic drugs (alteplase, streptokinase) were not permitted for 5 days and 10 days respectively prior to randomization; during intravascular interventions, study patients were permitted to use antiplatelet drugs, ASA, and thienopyridines. Chronic use of NSAIDS was prohibited. Strong CYP3A4 inhibitors and inducers were also prohibited. Prior to surgical interventions, warfarin was suggested to be stopped 4 days prior to the surgical procedure whereas the rivaroxaban patients were suggested to be stop therapy 2 days prior to the procedure. Sham INR values would decrease appropriately as the rivaroxaban+ warfarin placebo was discontinued. Design: (1,5,12) Multicenter, randomized, double-blind (double-dummy), parallel group design. Over 14,000 patients were randomized at 1100 sites across 45 countries. The expected study duration was 40 months from the first patient enrolled to the last event. The non-inferiority design was appropriate for this trial due to nature of the topic. NI trials are used when placebo is considered inappropriate or unethical to use as a comparative agent to determine efficacy. Patients with atrial fibrillation should NOT be placed on a PLACEBO for prevention of stroke or systemic embolism. Warfarin is considered the "gold standard" for stroke and systemic embolism prevention in patients with nonvalvular AF. To estimate the risk ratio of warfarin versus placebo, a meta-analysis of 6 warfarin trials was used. The NI margin was determined to be 1.92; the relative risk ratio was determined to be 0.38 (95% CI ). 5 Patients were seen for follow-up at 1, 2, and 4 weeks and every month thereafter. A standardized questionnaire to screen for stroke symptoms was also used. An independent statistician performed all of the analyses.

3 Stacey Moultrie, PharmD ROCKET-AF 3 Patients: (1-3,5,6,8,9) Inclusion Criteria: Patients with nonvalvular atrial fibrillation who were at moderate to high risk for stroke (indicated by history of stroke, systemic embolism, TIA or 2+ risk factors: heart failure [left EF <35%], HTN, 75+ years of age, or DM [CHADS 2 score of 2 or more]. The patients were > 18 years old, had persistent or paroxysmal atrial fibrillation documented on 2+episodes (one of which was documented via ECG within 30days of study enrollment) with a risk for future stroke (as mentioned above). Exclusion Criteria 5: 1) Patients with concomitant conditions/therapies: HIV, Pregnancy/breastfeeding, stroke within 14 days of randomization, ASA in excess of 100mg po daily, ASA + thienopyridines within 5 days of study randomization, TIA within 3 days of randomization, IV antiplatelet meds within 5 days before randomization, need for anticoagulant for condition other than atrial fibrillation (like venous thromboembolism), need or use of long-term NSAID treatment, fibrinolytic use within 10 days before randomization, treatment of a CYP3A4 metabolized drugs (inducers or inhibitors) within 4 days during randomization or with planned treatment while participating in study, CrCl<30mL/min during initial screening, anemia as defined as hemoglobin below 10g/dL at initial screening, patients with known hepatic failure/liver disease/hepatitis/cirrhosis/alanine aminotransferase above 3x the UNL. 5 2) Cardiovascular-related conditions: patients with active endocarditis, having a prosthetic heart-valve, atrial fibrillation secondary to a reversible disorder (ie: thyroid condition), preexisting atrial myxoma/left ventricular thrombus, mitral stenosis that is deemed "hemodynamically significant", planned cardioversion. 5 3) Hemorrhage risk-related Criteria: patients with an active internal bleed or a history of a condition that increases bleeding risk (ie: aneurysm, chronic hemorrhagic disorder, intracranial/intraocular/spinal/atraumatic intraarticular bleeding, severe GI bleed within 6months before randomization, majory surgery/trauma within 30 days before randomization, planned major surgery/invasive procedure during the study duration, etc.) 5 **see Table 1 in the Rationale and Design of the rocket AF study 5

4 Stacey Moultrie, PharmD ROCKET-AF 4 Study Treatment: (1-3,5,6,8,9) Rivaroxaban 20mg PO Qday (or 15mg PO Qday in patients with CrCl of 30-49mL/min) + matching warfarin placebo OR Adjusted dose warfarin to a target INR of 2 to 3 + matching rivaroxaban placebo. *all patients (both arms) received a placebo tablet to maintain blinding. INR sent to independent study monitor which provided real or sham INR values depending on the treatment arm. Sham values were based on an algorithm to produce similar characteristics of the study group on warfarin. INR for both groups occurred at a minimum of every 4 weeks (more frequently when necessary). Follow-up: (1-3,5,6,8,9) Median duration of treatment exposure: 590 days; patients were to continue with assigned therapy for the duration of the trial unless discontinuation was clinically indicated. Endpoints: (1-3,5,6,8,9) Efficacy: a) Primary endpoint is composite of stroke and systemic embolism. Stroke was defined as either ischemic or hemorrhagic. Secondary endpoints: a) Composite of stroke, systemic embolism or death from CV events. b) Composite of stroke, embolism, death from CV events, OR MI. c) Individual components of composite end points. Safety: (1-3,5,6,8,9) Composite of major and minor (defined as non-major) bleeding events. Hemorrhagic/ischemic strokes or intracranial bleeds are examples of major bleeds. Bleeding episodes that were considered non-major or minor included GI bleeds (upper, lower or rectal) or drop in hemoglobin (decreases in Hgb of less 2g per deciliter).

5 Stacey Moultrie, PharmD ROCKET-AF 5 IV. Results: (1-3,5,6,8,9) Rivaroxaban (N=7131) Stroke/systemic embolism:188 (1.7%/yr) Primary endpoint: 269 (2.1%/ yr) Major and non-major bleeding events: 1475 (14.9%/yr) ICH: 55 (0.5%/yr % p=0.02) Fatal bleeding: 27 (0.2%/yr p=0.003) GI bleeds: 224 (3.2%/yr) Decrease in Hgb > 2g/dL: 305 (4.3%/yr) Warfarin (N=7133) Stroke/systemic embolism: 241(2.2%/yr) Primary endpoint: 306 (2.4%/ yr) Major and non-major bleeding events: 1449 (14.5%/yr) ICH: 85 (0.7%/yr) Fatal bleeding: 55 (0.5%/yr) GI bleeds: 154 (2.2%/yr) Decrease in Hgb > 2g/dL: 254 (3.6%/yr) V. Limitations: (1-3,5,6,8,9,12) NI margin calculation is based on clinical judgment, guidelines, and other studies of similar patients. Management of warfarin was suboptimal; INR was on 55% in therapeutic range. The researchers claim that when the INR values were in therapeutic range, the effect versus rivaroxaban did not differ. However, it has been suggested that the risks of systemic embolism or stroke is higher when the INR is below the therapeutic range of 2 to 3. GI bleed incidence was higher in the rivaroxaban group (in text not listed directly in Table 2 of study). Hgb drop was also higher in the rivaroxaban group. Johnson & Johnson and Bayer Health Care supported/funded this study. Rivaroxaban is a product of Janssen pharmaceuticals. Janssen is a pharmaceutical company of Johnson & Johnson. Many of the researchers in the study accepted consulting fees or were employees of the companies funding the study. However, there was full disclosure of conflict of interest. External Validity: Although not a true "limitation" to the study since it mimics real life, it is worth mentioning that patients were not in a "controlled environment" so compliance with therapy, diet consistency or use of herbal/otc avoidance was not guaranteed. VI. Conclusions: (1-3,5,6,8,9) Rivaroxaban has been determined to be NONINFERIOR to warfarin for the prevention of stroke or systemic embolism in patients with nonvalvular atrial fibrillation. Intracranial hemorrhage and fatal bleeding incidences were reduced in the rivaroxaban group but the major and nonmajor bleeding incidences were deemed not clinically significantly different.

6 Stacey Moultrie, PharmD ROCKET-AF 6 References 1.) Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med Sep 8;365(10): ) Xarelto (rivaroxaban) [package insert]. Janssen Pharmaceuticals; New Jersey: December ) O'Dell KM, Igawa D, Hsin J. New Oral Anticoagulants for Atrial Fibrillation: A Review of Clinical Trials. Clin Ther Apr;34(4): ) PL Detail-Document, Reversing Dabigatran and Rivaroxaban. Pharmacist's letter/prescriber's Letter. September ) ROCKET AF Study Investigators. Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study. Am Heart J Mar;159(3): e1. 6) Hankey GJ, Patel MR, Stevens SR, et. al (ROCKET AF Steering Committee Investigators). Rivaroxaban compared with warfarin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a subgroup analysis of ROCKET AF. Lancet Neurol Apr;11(4): ) Weitz JI, Eikelboom JW, Samama MM. New Antithrombotic Drugs: Antithrombotic Therapy for Prevention of Thrombosis: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (9th Edition). Chest Feb;141 (2 suppl):e120s-e-151s. 8) Ahrens I, Lip GY, Peter K. What do the RE-LY, AVERROES and ROCKET-AF trials tell us for stroke prevention in atrial fibrillation? Thromb Haemost Apr;105(4): ) Cleland JG, Coletta AP, Buga L, et. al. Clinical trials update from the American Heart Association meeting 2010: EMPHASIS-HF, RAFT, TIM-HF, Tele-HF, ASCEND-HF, ROCKET-AF, and PROTECT. Eur J Heart Fail Apr;13(4): ) PL Detail-Document, Comparison of Oral Antithrombotics. Pharmacist's Letter/Prescriber's Letter. October ) Summary of 2006 recommendations for primary and secondary prevention of stroke. Pharmacist's Letter/Prescriber's Letter 2006; 22(7): ) Rodriguez, R. Dare to Compare: Answering Healthcare Questions with Comparative Effectiveness Research (CER). Powerpoint lecture presented at Shands Hospital at the University of FL. Gainesville, FL. 8 Feb 2012.

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