Devang M. Desai, MD, FACC, FSCAI Chief of Interventional Cardiology Director of Cardiac Catheterization Lab St. Mary s Hospital and Regional Medical

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1 Devang M. Desai, MD, FACC, FSCAI Chief of Interventional Cardiology Director of Cardiac Catheterization Lab St. Mary s Hospital and Regional Medical Center

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4 A.Fib affects 2.2 million Americans. The lifetime risk for AF for men and women over age 40 is approximately 25% Increasing life expectancy is certain to lead to an increased prevalence of AF. Current estimates suggest that the prevalence of AF will reach 4 million by 2030 and climb to 5.6 million by 2050

5 Atrial fibrillation increases the risk of stroke approximately 5 fold Atrial fibrillation accounts for 36% of strokes in individuals years of age Strokes in individuals with atrial fibrillation are more disabling and more likely to recur than in individuals with stroke without atrial fibrillation

6 Stroke kills almost 130,000 Americans each year that s 1 out of every 19 deaths. On average, one American dies from stroke every 4 minutes. Every year, more than 795,000 people in the United States have a stroke. About 610,000 of these are first or new strokes. About 185,00 strokes (1/4) are in people who have had a previous stroke. About 87% of all strokes are ischemic strokes. Stroke costs the United States an estimated $36.5 billion each year. This total includes the cost of health care services, medications to treat stroke, and missed days of work. Stroke is a leading cause of serious long-term disability

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16 Heparin / Lovenox Aspirin, Plavix Warfarin NOACs Dabigatran Pradaxa Rivaroxaban Xarelto Apixaban - Eliquis

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19 Mayo Clinic

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25 Dabigatran etexilate (Pradaxa) is the first oral direct thrombin inhibitor to be approved by the US Food and Drug Administration (FDA).

26 Dabigatran etexilate is a prodrug that is rapidly converted to its active compound, dabigatran, by nonspecific esterases in the plasma and liver. This active compound competitively & reversibly binds to the active site of free and clot-bound thrombin, thereby blocking its procoagulant activity

27 An oral direct thrombin inhibitor approved for : 1. Stroke prevention in atrial fibrillation 2. Treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for 5-10 days 3. Long term prevention of recurrent DVT/PE in patients who have been previously treated for DVT/PE

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41 FOR ATRIAL FIBRILLATION P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided. P-gp inhibitors (e.g. dronedarone or systemic ketoconazole) increases the exposure to dabigatran. In patients with moderate renal impairment (CrCl ml/min), consider reducing the dose of PRADAXA to 75 mg twice daily when administered concomitantly with these agents. The use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromycin, ticagrelor does not require a dose adjustment of PRADAXA. The concomitant use of PRADAXA and P-gp inhibitors in patients with severe renal impairment (CrCl ml/min) should be avoided. FOR DVT / PE - Avoid use of PRADAXA and P-gp inhibitors in patients with CrCl <50 ml/min

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46 Rivaroxaban (Xarelto) is the second novel oral anticoagulant and the first oral direct coagulation factor Xa inhibitor approved for clinical use in the United States.

47 Rivaroxaban (Xarelto) reversibly binds to the active site of coagulation factor Xa without antithrombin mediation affecting free and platelet-bound factor Xa.

48 An oral direct factor Xa inhibitor approved for: 1. Stroke prevention in atrial fibrillation (20mg daily, or 15mg daily in patients with CrCl 15-50) 2. Treatment of DVT/PE (15mg bid for 21 days, then 20mg daily) 3. Prevention of DVT/PE following total hip or knee replacement (10mg daily)

49 Rivaroxaban is approved by the FDA, EMA, and HPFB for use in the primary prevention of VTE in adult patients who have undergone elective THA or TKA, the prevention of stroke and systemic embolism in patients with nonvalvular AF, the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE after initial treatment.

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51 Large double-blind, double-dummy, noninferiority study versus dose-adjusted warfarin in 14,264 patients with nonvalvular atrial fibrillation (AF) Patients had multiple comorbidities with CHADS 2 scores 2 reflecting an increased risk of stroke. 87% had CHADS 2 score 3, reflecting an elevated risk for stroke. The primary efficacy outcome was the composite of stroke and non-cns systemic embolism.

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58 The average duration of treatment during the extended trial was 190 days.

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66 A oral direct factor Xa inhibitor approved for stroke and systemic embolism prevention in non-valvular atrial fibrillation, treatment of DVT/PE and prophylaxis of VTE post knee and hip surgery.

67 Apixaban (Eliquis) the third novel oral anticoagulant and second direct coagulation factor Xa inhibitor approved for clinical use in the United States.

68 Apixaban selectively and reversibly inhibits free and clot-bound factor Xa as well as prothrombinase activity.

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79 Trial RE-LY ARISTOTLE ROCKET-AF Design Randomized Open Label N=18,113 Randomized Double blind N=18,209 Randomized double blind & dummy N=14,000 Treatment Dabigatran Apixaban Rivaroxaban 150 mg, BID 5 mg, BID 20 mg, Qday 110 mg, BID Comparator Warfarin 2-3 (67% TTR) Warfarin 2-3 (66% TTR) Warfarin 2-3 (57.8% TTR) Mean CHADS Time Therapeutic Range = TTR Modified Ahrens I, et al Thromb Haemost 2011;105

80 Study NOAC VKA Outcome RE-LY Dabigatran Warfarin RR % 1.7% 95% CI P < superiority ARISTOTLE Apixaban Warfarin HR % 1.6% 95% CI P= < Non- I P= 0.01 Superiority ROCKET-AF Rivaroxaban Warfarin HR % 2.2% 95% CI P = <0.001 Non-Inferiority

81 Study NOAC VKA Outcome RE-LY Dabigatran Warfarin RR % 3.6% 95% CI P = 0.31 ARISTOTLE Apixaban Warfarin HR % 3.1% 95% CI P = < ROCKET-AF Rivaroxaban Warfarin HR % 5.4% 95% CI P = 0.58

82 Study NOAC VKA Outcome RE-LY Dabigatran Warfarin RR % 0.7% 95% CI P= <0.001 ARISTOTLE Apixaban Warfarin HR % 0.8% 95% CI P = <0.001 ROCKET-AF Rivaroxaban Warfarin HR % 0.7% 95% CI P = 0.02

83 Agent Dabigatran 75mg, 150mg Apixaban 2.5mg, 5mg Rivaroxaban 10mg, 15mg, 20mg Dosing Recommendations CrCl > 30 cc/min: 150 mg, BID CrCl 15 to 30 cc/min: 75 mg, BID Avoid < 15 cc/min CrCl > 15 cc/min: 5 mg, BID Any 2 ( > 80 yrs, < 60 kg, SCr > 1.5mg/dL: 2.5 mg, BID) Avoid < 15 cc/min CrCl > 50 cc/min: 20 mg, Qday CrCl cc/min: 15 mg, Qday Avoid CrCl < 15 cc/min

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