Stroke Prevention for Atrial Fibrillation. Joseph A Manfredi, MD, FACC, FHRS AnMed Health Arrhythmia Specialists February 22 nd, 2014

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1 Stroke Prevention for Atrial Fibrillation Joseph A Manfredi, MD, FACC, FHRS AnMed Health Arrhythmia Specialists February 22 nd, 2014

2 Disclosures Speaker honorariums: STJM, BS, Medtronic Stock: Boston Scientific

3 Atrial Fibrillation Epidemiology of Atrial Fibrillation (AF) Review stroke risk associated with AF Review older therapies for SPAF New Anticoagulants for SPAF Future therapies for those with contraindications to oral anticoagulation (OAC)

4 Atrial Fibrillation: Epidemiology Most common sustained arrhythmia Lifetime risk of developing AF: 1 in 4 adults > 40 years old fold increase in mortality fold increase in risk of stroke 2 1.NEJM 1982;306: Lancet 1987;1: Circulation 2004;110:

5 Atrial Fibrillation: Stroke AF is the #1 preventable cause of stroke. 1 out of every 6 strokes occur in patients with AF Non-valvular AF stroke risk is 5% per Year In patients with rheumatic valvular disease the risk is 5X greater

6 Prevalence of Diagnosed AF Stratified by Age and Sex Women Men < > 85 x-axis = % y-axis = # of men/women # Women # Men Go AS, JAMA May 9;285(18): Pub Med PMID: d

7 THE % STROKES ATTRIBUTABLE TO AF 35 FRAMINGHAM HEART STUDY % AF PREVALENCE STROKES ATTRIBUTABLE TO AF AGE RANGE (YEARS) (Wolf et al. Stroke 1991; 22: )

8 CHADS 2 SCORING INDEX CHADS2 Risk Score CHADS2 score Patients (n = 1733) Adjusted stroke rate %/year CHF 1 Hypertension 1 Age > 75 1 Diabetes 1 Stroke or TIA 2 Moderate Risk > 2 Low Risk 0-1 From ESC AF Guidelines:

9 CHADS 2 -> CHA 2 DS 2 VASc CHADS2 Risk Score CHA2DS2-VASc Risk Score CHF 1 Hypertension 1 Age > 75 1 CHF or LVEF < 40% Hypertension 1 Age > 75 2 Diabetes 1 1 Diabetes 1 Stroke/TIA/ Thromboembolism 2 Stroke or TIA 2 Moderate-high Risk > 2 Intermediate Risk 1 Low Risk 0 From ESC AF Guidelines: Vascular Disease (MI,PVD,Aortic Plaque) Age Female 1 1

10 Denmark National Hospital registry of AF patients 73,000 patients CHADS2 defined 32% as intermediate risk, whereas CHADS2Vasc found 91% of these were high risk Similarly CHADS2 defined 22% as low risk CHADS2Vasc classified these as 38% intermediate and 21% as high risk and only 8% were low risk CHADS2 intermediate risk patients had 4.75 strokes/yr compared to CHADS2Vasc patients 2.01 strokes/yr BMJ 2011;342: d124

11 How well are we doing? Canadian registry of patients with known AF admitted for stroke 597 patients were admitted with their first stroke (60% Disabling, 20% Fatal) 40% on Warfarin with 75% having an INR of < 2 on admission 30% on Antiplatelet therapy 29% on no Anticoagulation Stroke. 2009; 40:

12 CHADS 2 -> CHA 2 DS 2 VASc CHADS2 score Patients (n = 1733) Adjusted stroke rate %/year CHA2DS2- VASc score Patients (n = 7329) Adjusted stroke rate (%/year) From ESC AF Guidelines:

13 Bleeding Risk Scores in AF ATRIA HAS-BLED HEMORR 2 HAGES Anemia 1 3 Hypertension 4 1 Hepatic 10 or 1 Renal disease 2 1 Severe renal disease 2 3 Abnormal Renal 5 or 1 Liver function 6 1 Ethanol abuse 1 Age 75 yrs 2 Stroke 1 Malignancy 1 Any prior hemorrhage 1 Bleeding 1 Older Age (>75 yrs) 1 Hypertension 3 1 Labile INR 8 1 Reduced platelet number or function 11 1 Elderly (>65 yrs) 1 Rebleeding 12 2 Drugs 9 or Alcohol 1. Hemoglobin <13 g/dl men; <12 g/dl women 2. Estimated glomerular filtration rate <30 ml/min or dialysis-dependent 3. Diagnosed hypertension 4. Systolic blood pressure >160 mmhg 5. Presence of chronic dialysis or renal transplantation or serum creatinine 200 mmol/l 6. Chronic hepatic disease (eg cirrhosis) or biochemical evidence of significant hepatic derangement (eg bilirubin 2 x upper limit of normal, in association with aspartate aminotransferase/alanine aminotransferase/alkaline phosphatase >3 x upper limit normal, etc.) 8. Unstable/high INRs or poor time in therapeutic range (eg <60%) 9. Concomitant use of drugs, such as antiplatelet agents, non-steroidal anti-inflammatory drugs, or alcohol abuse etc. 10. Cirrhosis, two-fold or greater elevation of AST or APT, or albumin <3.6 g/dl 11. Platelets <75,000, use of antiplatelet therapy (eg daily aspirin) or NSAID therapy; or blood dyscrasia 12. Prior hospitalization for bleeding 13. Most recent hematocrit <30 or hemoglobin <10 g/dl 14. CYP2C9*2 and/or CYP2C9*3 15. Alzheimer's dementia, Parkinson's disease, schizophrenia, or any condition predisposing to repeated falls 1 1 Hypertension 4 1 Anemia 13 1 Genetic factors 14 1 Excessive fall risk 15 1 Stroke 1 Apostolakis S, Lane DA, Guo Y, Buller H, Lip GY. J Am Coll Cardiol 2012;60: Jul 24. [Epub ahead of print] Online Appendix. PMID:

14 HAS-BLED % HAEMORRHAGIC EVENTS 3 4 >5THROMBOTIC EVENTS Gallego P et al. Circ ArrhythmElectrophysiol. 2012;5: Copyright American Heart Association, Inc. All rights reserved.

15 STROKE PREVENTION IN AF 33% 19% (Fuster et al. Circulation 2011; 123: e269-e367)

16 No. of Events Patient- Years AFASAK Warfarin versus Placebo BAATAF CAFA SPAF % SPINAF Combined Atrial Fibrillation Investigators. Arch Intern Med. 1994;154: Warfarin Better Warfarin Worse Risk Reduction, %

17 Warfarin Safety Bleeding risk 1.3% compared to 1% of patients treated with ASA or Placebo

18 ACTIVE W The AF Clopidogrel 1. For patients with Trial ischemic with stroke Irbesartan or TIA for with paroxysmal prevention (intermittent) or permanent of Vascular Events AF, anticoagulation with a vitamin K antagonist (target INR, 2.5; range, Warfarin ) superior is recommended to ASA/Plavix (Class I; Level with patients of Evidence A). having a CHADS2 2. For patients of unable 1 with to take 45% oral less strokes anticoagulants, aspirin and the trial was stopped early alone (Class I; Level of Evidence A) is recommended. TTR of < 58% showed no benefit The combination of clopidogrel plus aspirin carries a risk of bleeding similar to that of ASA vs. ASA/Plavix warfarin in patients who were felt to therefore is not recommended for be non-candidates patients with a for warfarin showed a hemorrhagic contraindication to slight benefit (ARR of < 1%), but increased warfarin(class III; bleeding rates

19 What about following PCI with a Stent? What is the Optimal antiplatelet and anticoagulation therapy in patients with oral anticoagulation and Stenting Trial WOEST Lancet 2013;381:

20 New Anticoagulants FEATURES RIVAROXABAN Xarelto APIXABAN Eliquis DABIGATRAN Pradaxa Target Xa Xa IIa Molecular Weight Prodrug No No Yes Bioavailability (%) Time to peak (h) Half-life (h) Renal exertion (%)

21 Comparison of New Anticoagulants with Warfarin Features Warfarin New Agents Onset Slow Rapid Dosing Variable Fixed Food Effect Yes No Drug Interactions Many Few Monitoring Yes No Half-Life Long Short Antidote Yes No

22 COAGULATION CASCADE De Caterina et al. JACC Vol. 59, No. 16, 2012

23 Comparison of Stroke Prevention in AF Trials RE-LY ROCKET ARISTOTLE Drug Dabigatran Rivaroxaban Apixaban N 18,113 14,266 18,206 Dose (mg) 150, 110 BID 20 (15) QD 5 (2.5) BID Dose adjustment for drug clearance None 20->15 5->2.5 Design Open Double Blind Double Blind Endpoint Stroke/SEE Stroke/SEE Stroke/SEE

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

25 RELY Results: 34% Fewer Strokes (TTR overall was 64%) Connoly S J et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:

26 RELY Trial 16% discontinuation rate: 12% GI distress/dyspepsia 0.2% increase in MI compared to Warfarin GI bleeding 1.5% vs. 1.02% Dabigatran 150 mg BID dosing approved with a 75 mg BID dosing in patients with a CrCl ml/min

27 Dabigatran ISMP Medication Safety Alert: Quarter Watch [ ] 932 serious adverse events for 1 st quarter of deaths 25 cases of permanent disability 543 cases requiring hospitalization 505 cases involved hemorrhage: elderly patients (Median age of 80) 120 cases of hemorrhagic stroke

28 Dabigatran FDA Drug Safety Communication: [ ] FDA investigated the actual rates of gastrointestinal bleeding and intracranial hemorrhage for new users of [dabigatran] compared to new users of warfarin. The results of this Mini Sentinel assessment indicate that bleeding rates associated with new use of [dabigatran] do not appear to be higher than bleeding rates associated with new use of warfarin. 28

29 MECHANICAL VALVES FDA Drug Safety Communication: [ ] A clinical trial in Europe (the RE-ALIGN trial) was recently stopped because [dabigatran] users were more likely to experience strokes, heart attacks, and blood clots forming on the mechanical heart valves than were users of the anticoagulant warfarin. There was also more bleeding after valve surgery in the [dabigatran] users than in the warfarin users [dabigatran] is not approved for patients with AF caused by heart valve problems. 29

30 ROCKET AF TRIAL Stroke and non-cns Embolism 21% reduction Cumulative event rate (%) Event Rate Rivaroxaban Warfarin Warfarin Rivaroxaban HR (95% CI): 0.79 (0.66, 0.96) P-valueNon-Inferiority: <0.001 Days from Randomization No. at risk: Rivaroxaban Warfarin Event Rates are per 100 patient-years Based on Protocol Compliant on Treatment Population (Patel MR et al. NEJM 2011;365: )

31 CONCLUSIONS FROM ROCKET-AF TRIAL Efficacy: Rivaroxaban was non-inferior to warfarin for prevention of stroke and non-cns embolism. Rivaroxaban was superior to warfarin while patients were taking study drug. By intention-to-treat, rivaroxaban was non-inferior to warfarin but did not achieve superiority. Safety: Similar rates of bleeding and adverse events. Less ICH and fatal bleeding with rivaroxaban. Conclusion: Rivaroxaban is a proven alternative to warfarin for moderate or high risk patients with AF.

32 ARISTOTLE TRIAL Stroke or systemic embolism P (non-inferiority)< % RRR Apixaban 212 patients, 1.27% per year Warfarin 265 patients, 1.60% per year HR 0.79 (95% CI, ); P (superiority)=0.011 No. at Risk Apixaban Warfarin Granger CB et. al NEJM 2011 Aug 27

33 ARISTOTLE: Major Bleeding 31% RRR Apixaban 327 patients, 2.13% per year Warfarin 462 patients, 3.09% per year HR 0.69 (95% CI, ); P<0.001 No. at Risk Apixaban Warfarin Granger CB et. al NEJM 2011 Aug 27

34 ARISTOTLE Summary Treatment with apixaban as compared to warfarin in patients with AF and at least one additional risk factor for stroke: Reduces stroke and systemic embolism by 21% (p=0.01) Reduces major bleeding by 31% (p<0.001) Reduces mortality by 11% (p=0.047) with consistent effects across all major subgroups and with fewer study drug discontinuations on apixaban than on warfarin, consistent with good tolerability.

35 Primary Endpoints Stroke or Systemic Embolism Atrial Fibrillation Trials Study NOAC VKA Outcome RE-LY Dabigatran Warfarin RR 0.66 Pradaxa 1.1% 1.7% 95% CI P < superiority ARISTOTLE Apixaban Warfarin HR 0.79 Eliquis 1.3% 1.6% 95% CI P= < Non- I P= 0.01 Superiority ROCKET-AF Rivaroxaban Warfarin HR 0.79 Xarelto 1.7% 2.2% 95% CI P = <0.001 Non-Inferiority

36 Major Bleeding Atrial Fibrillation Trials Study NOAC VKA Outcome RE-LY Dabigatran Warfarin RR 0.93 Pradaxa 3.1% 150 mg 2.7% 110 mg 3.6% 95% CI P = 0.31 ARISTOTLE Apixaban Warfarin HR 0.69 Eliquis 2.1% 3.1% 95% CI P = < ROCKET-AF Rivaroxaban Warfarin HR 1.04 Xarelto 5.6% 5.4% 95% CI P = 0.58 Major Bleeding: Fatal/critical organ bleed, Decrease > 2g/dl Hbg or transfusion of > 2U Blood

37 Intracranial Hemorrhage Atrial Fibrillation Trials Study NOAC VKA Outcome RE-LY Dabigatran Warfarin RR 0.40 Pradaxa 0.3% 0.7% 95% CI P= <0.001 ARISTOTLE Apixaban Warfarin HR 0.42 Eliquis 0.3% 0.8% 95% CI P = <0.001 ROCKET-AF Rivaroxaban Warfarin HR 0.67 Xarelto 0.5% 0.7% 95% CI P = 0.02

38 Dosing Schedules Atrial Fibrillation 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

39 Stroke reductions from randomized trials Circulation. 2012;125:

40 Conclusions and Take Home Points for Novel Anticoagulants Though expensive, these drugs provide more choices and convenience. SPAF with better efficacy than warfarin, with less ICH. Warfarin s low price, efficacy, and track record will prolong its use. It may decrease, but will not likely go away. None of these are FDA approved for treatment of AF in valvular heart disease Xarelto is the only approved new anticoagulant for the treatment of DVT/PE N Engl J Med Aug 29;369(9): ]. Antidotes are being looked at but not yet studied in randomized trials

41 Black Box Warning Rivaroxaban & Apixaban

42 Switching agents NOA to Warfarin, concomitantly till INR therapeutic, and should be measured just before the next dose of NOA and retested 24 hours after the last dose of NOA Attempt to emphasize compliance due to the short half lives of these agents and assure protection

43 MINOR BLEEDING MANAGEMENT Estimate time to normalization of haemostasis Roughly 24 hours from last dose with normal renal function (CrCl> 50) and 48 hours for CrCl< 50 with Pradaxa, 24 hours for Xarelto and Eliquis regardless of renal function Local haemostatic measures Transfusion and fluids as haemodynamically indicated FFP as a plasma expander not reversal Platelet transfusion if thrombocytopenia TIME

44 MAJOR BLEED MANAGEMENT Prothrombin complex concentrate (PCC) 25 U/kg and can be repeated twice Activated factor VII but only animal evidence Consider HD (preliminary evidence 65% after 4 hours)

45 PERIOPERATIVE MANGEMENT Hold NOA s for hours prior to the planned procedure depending on renal function Can resume for minor surgery 6-8 hours (Dental, Cataract, and Glaucoma) hours after most other surgical interventions

46 CONTRAINDICATION FOR ORAL ANTICOAGULATION AF-associated ischemic strokes generally occlude large intracranial arteries depriving a more extensive region of the brain of blood flow 1 Relative or absolute contraindications to long-term anticoagulation are present in up to 40% of AF patients, usually due to a history of bleeding or an elevated risk of falls and trauma. In fact, anticoagulation is not currently utilized in up to 50% of eligible AF patients 2 91% of strokes that occur in AF is caused by thrombus formed in the LAA 3 1 Tu HT et al, Cerebrovascular Disease. 2010;30(4): Patel et al, CardiolResPract. 2012; 2012:

47 The WATCHMAN product is a device for percutaneous closure of the left atrial appendage WATCHMAN is a self-expanding nitinol frame with fixation anchors and a permeable fabric cover It is designed to be permanently implanted at or slightly distal to the opening of the LAA to trap potential emboli before they exit the LAA WATCHMAN LAA Closure Device Images on file at Boston Scientific Corporation Five sizes of device (21, 24, 27, 30 and 33 mm) allow for precise fit within ostium It is implanted via a transseptal approach by use of a catheterbased delivery system The delivery catheter is capable of recapturing the device if necessary Received CE mark in 2005

48 PROTECT AF Primary Efficacy Results Stroke, Cardiovascular death and systemic embolism Device Control Posterior Probabilities Observed rate (events per 100 pt-yrs) (95% CrI) Observed rate (events per 100 pt-yrs) (95% CrI) Rate Ratio Intervention/Control (95% CrI) Non-inferiority Superiority Primary Efficacy 3.0 (2.1, 4.3) 4.3 (2.6, 5.9) 0.71 (0.44, 1.30) > Reddy, VY et al. Circulation. 2013;127: ;.

49 PROTECT AF Primary Safety Results Device Control Observed rate (events per 100 pt-yrs) (95% CrI) Observed rate (events per 100 pt-yrs (95% CrI) Rate Ratio Intervention/Control (95% CrI) Primary Safety 5.5 ( 4.2, 7.1) 3.6 (2.2, 5.3) 1.53 (0.95, 2.70) Reddy, VY et al. Circulation. 2013;127: ;.

50 DECEMBER 11 th 2013 Following the PREVAIL TRIAL that showed noninferiority to warfarin for prevention of ischemic stroke or systemic embolism And 50% Reduction in procedural complication rate compared to the PROTECT AF Trial Watchman AF Device Won the FDA Panels approval

51 LARIAT PROCEDURE

52

53 Conclusions Patients with AF are at high risk for debilitating strokes Several anticoagulation options are now available Stroke prevention should include a risk/benefit discussion with each patient individually Other options should soon be available for those with contraindications

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