Goals 6/6/2014. Stroke Prevention in Atrial Fibrillation: New Oral Anti-Coagulants No More INRs. Ashkan Babaie, MD

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1 Stroke Prevention in Atrial Fibrillation: New Oral Anti-Coagulants No More INRs Ashkan Babaie, MD Arrhythmia Service Providence Heart Clinic June 8 th, 2014 Goals Discuss the data behind approval of NOACs as an alternative to warfarin Discuss special circumstances involving the usage of these agents Discuss most recent ACC/AHA/HRS recommendations for use of Oral Anticoagulants 1

2 Sites Of Action Of The New Oral Anticoagulants Rivaroxaban Apixaban Edoxaban Dabigatran Eikelboom J W, Weitz J I BMJ 2011;342:bmj.c by British Medical Journal Publishing Group 5 Cumulative Hazard Rates Dabigatran compared to warfarin to prevent strokes. D 150 mg vs. Warfarin RR = % CI = P = 0.03 Dabigatran110 Warfarin Dabigatran Years of Follow-up Connolly et al. NEJM 2009; 361:1139 2

3 RELY Trial - Dabigatran vs Warfarin 1 0 Outcome: Superiority Analysis Stroke or systemic Embolism D 110mg D 150mg warfarin Annual rate Annual rate Annual rate 1.5 % 1.1 % 1.7 % D 150mg vs. Warfarin RR 95% CI P <0.001 Stroke 1.4 % 1.0 % 1.6 % <0.001 Ischemic Stroke 1.34 % 0.92 % 1.20 % 0.03 Connolly et al. NEJM 2009; 361:1139 Bleeding D 110mg Annual rate D 150mg Annual rate warfarin Annual rate Total 14.6% 16.4% 18.2% Major 2.7 % 3.1 % 3.4 % Life-Threatening major 1.2 % 1.5 % 1.8 % GI Major 1.1 % 1.5 % 1.0 % Connolly et al. NEJM 2009; 361:1139 Rocket AF: Rivaroxaban vs Warfarin Patel et al. NEJM 2010; 365:883 3

4 Rocket AF: Rivaroxaban vs Warfarin Patel et al. NEJM 2010; 365:883 Primary Safety Outcomes Rivaroxaban Warfarin Major and non-major Clinically Relevant Event Rate Event Rate HR (95% CI) P- value (0.96, 1.11) Major Bleeding (0.90, 1.20) Non-major Clinically Relevant (0.96, 1.13) Event Rates are per 100 patient-years Based on Safety on Treatment Population Patel et al. NEJM 2010; 365:883 Aristotle Trial: Apixaban vs Warfarin Granger CB et al. N Engl J Med 2011;365:

5 Apixaban proved superior to warfarin in reducing the risk of stroke or systemic embolism 1.60% /year 1.27% /year p=0.01 Granger CB et al. N Engl J Med 2011;365: Apixaban also had a lower risk of bleeding than warfarin. 3.09% /year 2.13% /year p<0.001 Granger CB et al. N EnglJ Med 2011;365: When compared To aspirin monotherapy in the AVERROES trial, Apixaban had a similar risk Of bleeding. Connolly et al. N Engl J Med 2011;364:

6 ENGAGE-AF-TIMI 48 (Study for Evaluation of DU-176b vs Warfarin in Subjects with AF) AF on ECG <12 mos Intended oral A/C CHADS 2 Score >2 R Randomization Strata: 1. CHADS vs Drug clearance Low Dose Edoxaban 30 mg QD (n=7034) High Dose Edoxaban 60 mg QD (n=7035) Active Control Warfarin (n=7036) Median Duration of Followup 24 months 1º EP = Stroke or SEE(Noninferiority Boundary HR 1.38) 2º EP = Stroke or SEE or All-Cause Mortality Safety EP s = Major Bleeding, Hepatic Function High dose Edoxaban had a lower risk of stroke than warfarin. Both doses of Edoxaban also had a lower risk of bleeding than warfarin. 6

7 Dabigatran Summary of Novel Oral Anticoagulants (NOACs) compared Ischemic to Warfarin. ICH Stroke Prevention Better (Reduced Ischemic Strokes) Better Bleeding Risk Same Rivaroxaban Same Better Same Apixaban Same Better Better Edoxaban Same Better Better Cost of Novel Oral Anticoagulants Cost Dabigatran $ Rivaroxaban $ Apixaban $ Dosages of Novel Oral Anticoagulants Dosage Criteria Dabigatran Rivaroxaban Apixaban 150mg BID 75mg BID 20mg Daily 15mg Daily CrCl > 30 CrCl CrCl > 50 CrCl mg BID 2.5 mg BID (2 of 3) Age >80, Body Weight < 60 kg or Cr > 1.5 mg/dl Avoid CrCl <30 7

8 The newer anticoagulants consistently have a lower risk of intracranial bleeding than warfarin. Drug Warfarin Dabigatran p < Apixaban p < Rivaroxaban p = 0.02 Edoxaban p < Increased bleeding with Pradaxa? December 7, 2011 FDA Drug Safety Communication: Safety review of post-market reports of serious bleeding events with the anticoagulant Pradaxa (dabigatran etexilate mesylate) "FDA is working to determine whether the reports of bleeding in patients taking Pradaxa are occurring more commonly than would be expected, based on observations in the large clinical trial that supported the approval of Pradaxa," Increased bleeding with Pradaxa? New England Journal of Medicine Commentary April 4, 2013 We believe that the large number of reported cases of bleeding associated with dabigatran provides a salient example of stimulated reporting. In this case, such reporting provided a distorted estimate of the comparative bleeding rates associated with dabigatran and warfarin in clinical practice. 8

9 Risk Of Bleeding By Age Group With Newer Anticoagulants Compared To Warfarin Age < 65 Age Age > 75 Age < 65 Age Age > 75 Age < 65 Age Age > 75 Age Possible Rebound Hypercoagulability After Discontinuation of NOACs? Do not stop taking ELIQUIS (apixaban) without talking to the doctor who prescribed it for you. Stopping ELIQUIS increases your risk of having a stroke. Do not stop taking XARELTO without talking to the doctor who prescribes it for you. Stopping XARELTO increases your risk of having a stroke. Do not stop taking PRADAXA without talking to the doctor who prescribes it for you. Stopping PRADAXA increases your risk of having a stroke. There was a higher stroke rate with discontinuation of rivaroxaban at the end of ROCKET-AF. Events per 100 Patient-Yrs (Total Events) Rivaroxaban Warfarin Rivaroxaban: Warfarin HR (95% CI) p Value Stroke or non-cns embolism rates All discontinuations and interruptions (before end of study) (51) (44) 1.21 ( ) 0.35 Temporary interruptions 6.20 (9) 5.05 (8) 1.28 ( ) 0.62 Permanent discontinuations (42) (36) 1.10 ( ) 0.66 After end of study 6.42 (22) 1.73 (6) 3.72 ( ) Patel et al. JACC 2013; 61:

10 Increased embolic events after rivaroxaban discontinuation may partly be due to longer time to reach therapeutic INR with transition to warfarin. Time to Therapeutic International Normalized Ratio Cumulative proportion of patients with international normalized ratio (INR) of 2 or more after the end of the study for those treated with warfarin and rivaroxaban during the ROCKET AF study. Patel et al. JACC 2013; 61: Similar increase in Stroke /embolic events was noted at the end of the Aristotle study. Events 30 days after end of treatment Apixaban Warfarin N Events/100 pt-yr N Events/100 pt-yr 21/ / Patel et al. JACC 2013; 61: An increased Risk of embolism was also noted at the end of Averroes study. Events 30 days after end of treatment Apixaban Aspirin N Events/100 pt-yr N Events/100 pt-yr 9/ / FROM FDA submission for apixaban page

11 Possible Rebound Strokes After Discontinuation of Rivaroxaban and Apixaban? A significant component of the increseased risk of stroke with discontinuation of apixaban/dabigatran may be due to inadequate overlap with warfarin in high risk patients There may still be a small increased risk of thromboembolism with discontinuation of these drugs. The benefits of these drugs outweigh the risks. Simple rule: If you change oral anticoagulants, make sure the patient is always therapeutically anticoagulated. Transition from NOACs to warfarin Dabigatran Rivaroxaban Cr Cl > 50: Overlap with warfarin x 3d Cr Cl 30-50: Overlap with warfarin x 2d Cr Cl 15-30: Overlap with warfarin x 1d FDA: Stop Drug and start parenteral anticoagulant and warfarin. Europe: Overlap Warfarin and NOAC until INR > 2.0 Apixaban *All 3 NOACs can affect INR levels making warfarin effect difficult to measure. Transition from warfarin to NOACs Dabigatran Start when INR < 2.0 Rivaroxaban Start when INR < 3.0 Apixaban Start when INR <

12 Transition between NOACs Start the new NOAC at the next scheduled dose of the previous NOAC. Transition between parenteral Agents and NOACS Start NOAC 2 hours after discontinuation of IV heparin. Start NOAC at next scheduled dose of LMWH. NOACS and cardioversion The safety of NOACs for anticoagulation prior to cardioversion has been evaluated in retrospective analysis of the major studies of each of the available NOACs. Data from all 3 studies support the cardioversion of patients who are on chronic anticoagulations therapy with NOACs. There have not been prospective studies on a 3 week course of NOACs prior to cardioversion Dabigatran and cardioversion The safety of cardioversion using dabigatran was evalauated in subgroup analysis from the RE-LY trial. A total of 1983 cardioversion were performed during the RE-LY trial N Stroke and Sytemic Embolism Dabigatran 110mg (0.8%) Dabigatran 150mg (0.3%) Warfarin (0.6%) 12

13 Dabigatran and cardioversion Transesophageal echos were performed at the discretion of the patients primary physician. N LA thrombus Dabigatran 110mg 165 (25.5%) 1.8% Dabigatran 150mg 162 (24.1%) 1.2% Warfarin 88 (13.3%) 1.1% Apixaban and cardioversion The safety of cardioversion using apixaban was evalauated in subgroup analysis from the ARISTOTLE trial. A total of 743 cardioversion were performed during the ARISTOTLE trial N Apixaban Warfarin Stroke and Sytemic Embolism Average time on treatment --- approximately 250 days NOACS and cardioversion 2014 AHA/ACC/HRS Guidelines for Management of Atrial Fibrillation: Class IIa -- Anticoagulation with apixaban, rivaroxaban or dabigatran is reasonable for at least three weeks prior and 4 weeks after cardioversion. EHRA/ESC Recommendations: it is mandatory to explicitly ask the patient about adherence over the last weeks and to document the answer in the file. If compliancewith NOAC intake can be reliably confirmed, cardioversionseems acceptably safe. However, a prior TEE should be considered if there is doubt about compliance. 13

14 Half-Life Renal Clearance Dabigatran Hours 80% Rivaroxaban 5-9 Hours 36% Apixaban 12 Hours 27% Dabigatran Package Insert Hrs (CrCl >50) 3 to 5 days (CrCl <50) Low Risk Procedure 24 to 36 Hrs 48 Hrs (CrCl < 50) High Risk Procedure 48 to 72 Hrs 96 Hrs (CrCl < 50) Rivaroxaban 24 Hours 24 Hrs 36 Hrs (CrCl < 30) Apixaban 24 Hours (low risk) 48 Hours (high risk) 24 Hrs 36 Hrs (CrCl < 30) 48 Hrs 48 Hrs Reversal Agents? 14

15 Reversal of Oral Anticoagulants There is no well accepted reversal agent for NOACs Some agents may not affect laboratory measures of anticoagulation but do stop bleeding in animal models. There is conflicting data regarding the use of various procoagualants for NOAC induced bleeding and no consensus. The best data is for 4 factor prothrombin complex concentrate (KCENTRA) and activated PCC (FEIBA) although even these have mixed results. Recombinat factor VIIa has even less data Reversal of NOACs for life threatening bleeding Dabigatran FEIBA - Activated PCC 50 IE/kg; max. 200 IE/kg/day) OR 4 factor prothrombin complex concentrate (PCC) 25 U/kg (may be repeated once or twice) Rivaroxaban Apixaban Hemodialysis Activated Charcoal (for recent ingestion) Maintain adequate diuresis FEIBA - Activated PCC 50 IE/kg; max. 200 IE/kg/day) OR 4 factor prothrombin complex concentrate (PCC) 25 U/kg (may be repeated once or twice) Activated Charcoal (for recent ingestion) Reversal of Oral Anticoagulants: The future Monoclonal anitbodies for NOACS Inactive Proteins with binding affinity for Factor Xa inhibitors 15

16 Anticoagulation take home Points All the newer anticoagulants are at least equivalent to warfarin in stroke prevention. Caution should be used when using these agents in patients older than 75 and patients with renal insufficiency. Avoid these agents in patients with a previous history of bleeding or at high risk of bleeding. When transitioning to alternate agents, ensure adequate anticoagulation coverage. NOACs in ACS There is minimal data on the use of NOACs in triple therapy When combined with asa/plavix the relative risk of bleeding is at least doubled. There is no data on the use of NOACs with prasugrel or ticagrelor. Minimize the length of time on triple therapy including bare metal stents. Consider ASA/Plavix alone for patients with a CHADS-VASC score of 1. There may be a slightly higher risk of MI in patients taking Dabigatran which has not been noted in Factor Xa inhibitors. WE NEED MORE DATA ON DOUBLE THERAPY WITH AN OAC?PLAVIX VS TRIPLE THERAPY. WOEST: Comparison of Warfarin/Plavix therapy vs triple therapy after stenting Double therapy group: OAC + 75mg Clopidogrel qd Triple therapy group OAC + 75mg Clopidogrel qd+ 80mg Aspirinqd 1 monthminimum afterbms 1 yearafterdes Primary Endpoint: The occurence of all bleeding events (TIMI criteria) Secondary Endpoints: - Combination of stroke, death, myocardial infarction, stent thrombosis and target vessel revascularisation - All individual components of primary and secondary endpoints 16

17 WOEST Primary Endpoint: Total number of TIMI bleeding events Cumulative incidence of bleeding 50 % 40 % 30 % 20 % Triple therapy group Double therapy group 44.9% 19.5% 10 % 0 % p<0.001 HR= %CI[ ] Days n at risk: WOEST Secondary Endpoint(Death, MI,TVR, Stroke, ST) 20 % Triple therapy group Double therapy group 17.7% Cumulative incidence 15 % 10 % 11.3% 5 % 0 % p=0.025 HR= %CI[ ] Days No significant difference in stent thrombosis 263 was 258 noted between 24 the two groups. However, study was not powered to show a difference in stent thrombosis, Update on risk stratification for stroke The newest ACC/AHA/HRS guidelines released in March transitioned from using the CHADS 2 score for risk stratification to use of CHA 2 DS 2 -VASC score. 17

18 The CHADS 2 score was previously the preferred method for risk stratification of stroke. Points Congestive Heart Failure C 1 H Hypertension 1 Age > 75 A 1 D Diabetes 1 Previous stroke or TIA S 2 2 Gage et al. JAMA 2001;285:2864 A higher CHADS 2 score means a higher risk of stroke Stroke Rate Per Year (%) CHADS 2 score Gage et al. JAMA 2001;285:2864 Limitations of CHADS 2 A large percentage of patients are categorized in the intermediate stroke risk category (39.2%) Intermediate risk of stroke can still be fairly high. Low Risk % Intermediate Risk % High Risk % 18

19 The CHA 2 DS 2 VASc score helps further identify patients at Intermediate risk of stroke. Points C Congestive Heart Failure 1 H Hypertension 1 A 2 Age > 75 2 D Diabetes 1 S 2 Previous stroke or TIA 2 V Vascular Disease 1 A Age SC Sex Category (Female) 1 Lip et al. CHEST 2010;137:263 A higher CHA 2 DS 2 VASc score means a higher risk of stroke Stroke Rate Per Year (%) CHA 2 DS 2 VASc score Lip et al. CHEST 2010;137:263 The CHA 2 DS 2 VASc score allows better identication of a true intermediate risk category CHA 2 DS 2 VASc > 1 Start oral anticoagulants CHA 2 DS 2 VASc = 1 ASA or oral anticoagulants CHA 2 DS 2 VASc = 0 ASA or no treatment 19

20 Comparison of CHADS and CHADSVASc scores All patients in Denmark were followed in a registry from 1997 to ,538 patients with non-valvular atrial fibrillation were not treated with warfarin Primary Outcome was occurrence of thromboembolism 58 An intermediate CHADS indicated significant risk of stroke. Stroke Rate Per Year (%) 68% RR 3.3% ARR NNT = 30 CHADS 2 score Olesen et al. BMJ 2011;342:124 A higher CHA 2 DS 2 VASc score means a higher risk of stroke Stroke Rate Per Year (%) 68% RR 1.3% ARR NNT = 73.5 CHA 2 DS 2 VASc score Olesen et al. BMJ 2011;342:124 20

21 Goals Discuss the data behind approval of NOACs as an alternative to warfarin Discuss special circumstances involving the usage of these agents Discuss most recent ACC/AHA/HRS recommendations for use of Oral Anticoagulants 21

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