atrial fibrillation and stroke prevention - Continuing Medical ...

atrial fibrillation and stroke prevention - Continuing Medical ... atrial fibrillation and stroke prevention - Continuing Medical ...

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Essentials in Primary Care Conference Wednesday, July 31, 2013 ROCKET AF Trial: Rivaroxaban vs Warfarin Nonvalvular AF, history of stroke, TIA, or embolism, or at least 2 of the following: HF, HTN, age 75 years, or diabetes mellitus R Day 1 Treatment period 12-32 months Rivaroxaban 20 mg QD Rivaroxaban 15 mg QD (CrCl 30-49 mL/min at entry) N = 14,269 Warfarin target INR, 2.5 (INR range, 2.0-3.0) End of treatment Follow-up Day 30 after last dose • Primary study endpoint: composite of all-cause stroke and non-CNS systemic embolism • Primary safety endpoint: composite of major and clinically relevant nonmajor bleeding events ROCKET = Rivaroxaban Once-daily, Oral, Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation; CNS = central nervous system. Patel MR, et al. N Engl J Med. 2011;365(10):883-891. Rivaroxiban vs Warfarin Event Rate (%/year) Efficacy Outcomes Rivaroxiban Warfarin Stroke or Systemic Embolism As-treated population 1.7 2.2 Intention-to-treat population 2.1 2.4 Hemorrhagic stroke 0.26 0.44 MI 0.91 1.12 Safety Outcomes Major bleeding (Fatal) 0.2 0.5 ICH 0.5 0.7 0 0.50 1.00 1.50 2.00 Rivaroxiban Better Warfarin Better Patel MR, et al. N Engl J Med. 2011;365(10):883-891. Jan Basile, MD Atrial Fibrillation & Stroke Prevention

Essentials in Primary Care Conference Wednesday, July 31, 2013 Indications for Rivaroxaban in CV Disease • Reduce the risk of stroke and systemic embolism in patients with non-valvular AF • Prophylaxis of DVT, which may lead to PE, in patients undergoing knee or hip replacement surgery • Treatment of DVT and/or PE • To reduce the risk of recurrence of DVT and PE Rivaroxaban Dosing in CV Disease • 20 mg in A Fib if CrCl > 50 cc/min • 15 mg in A Fib if CrCl is 15 – 49 cc/min • Do not use if CrCl

Essentials in Primary Care Conference<br />

Wednesday, July 31, 2013<br />

Indications for Rivaroxaban in CV Disease<br />

• Reduce the risk of <strong>stroke</strong> <strong>and</strong> systemic<br />

embolism in patients with non-valvular AF<br />

• Prophylaxis of DVT, which may lead to<br />

PE, in patients undergoing knee or hip<br />

replacement surgery<br />

• Treatment of DVT <strong>and</strong>/or PE<br />

• To reduce the risk of recurrence of DVT<br />

<strong>and</strong> PE<br />

Rivaroxaban Dosing in CV Disease<br />

• 20 mg in A Fib if CrCl > 50 cc/min<br />

• 15 mg in A Fib if CrCl is 15 – 49 cc/min<br />

• Do not use if CrCl

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