Long term anticoagulant therapy in patients with atrial fibrillation at high risk of stroke: a new scenario after RE-LY trial

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1 Long term anticoagulant therapy in patients with atrial fibrillation at high risk of stroke: a new scenario after RE-LY trial Camillo Autore Università di Roma Sapienza II Facoltà di Medicina e Chirurgia Azienda Ospedaliera Sant Andrea

2 Disclosures: none

3 AF: The Most Common Arrhythmia It has been estimated that 2.2 million people in America and 4.5 million in the European Union have paroxysmal or persistent AF The estimated prevalence of AF is 0.4% to 1% in the general population, increasing with age Accounts for approximately 1/3 of hospitalizations for cardiac rhythm disturbances

4 Prevalence (%) AF Prevalence: Age and Gender Prevalence of atrial fibrillation with age Age, years JAMA 2001; 285: 2370

5 Patient characteristcs Data from Euro Heart Survey on Atrial Fibrillation First detected Paroxymal Persistent Permanent Age (years) Female gender (%) Hypertension (%) CAD (%) Heart failure (%) Valvular heart disease (%) Diabetes (%) Previous tromboembolism (%) Stroke (%) European Heart Journal (2005) 26,

6 Consequences of atrial fibrillation Thromboembolism Risk of stroke 5-fold Mortality Risk 2 fold in CV disease Reduction of quality of life Impaired hemodynamics Heart failure Hospitalization Risk 2-3-fold

7 Hemodynamic stabilization Rate Rhythm control Management of atrial fibrillation Thromboembolism prevention Antithrombotic Therapy

8 Risk stratification

9 Stroke Rate (% per year) Stroke Risk in Atrial Fibrillation Data from Framingham Heart Study Age (years) Stroke 1991;22;

10 Risk Stratification in AF Stroke Risk Factors High-Risk Factors Mitral stenosis Prosthetic heart valve History of stroke or TIA Moderate-Risk Factors Age >75 years Hypertension Diabetes mellitus Heart failure or LV function Less Validated Risk Factors Age years Coronary artery disease Female gender Thyrotoxicosis Dubious Factors Duration of AF Pattern of AF Left atrial diameter AHA/ACC/ESC guidelines on atrial fibrillation 2006

11 Nonvalvular Atrial Fibrillation Stroke Rates Without Anticoagulation According to Isolated Risk Factors 15 12,5 10 7,5 5 2,5 0 Prior Stroke/TIA Age > 75 years Hypertension Diabetes Heart Failure LVEF Hart RG et al. Neurology 2007; 69: 546.

12 The CHADS 2 Index Stroke Risk Score for Atrial Fibrillation Score (points) Prevalence (%) Congestive Heart failure 1 32 Hypertension 1 65 Age >75 years 1 28 Diabetes mellitus 1 18 Stroke or TIA 2 10 Moderate-High risk > Low risk VanWalraven C, et al. Arch Intern Med 2003; 163:936.

13 The CHADS 2 Index Stroke Risk Score for Atrial Fibrillation Approximate Risk threshold for Anticoagulation Score (points) Risk of Stroke (%/year) %/year Van Walraven C, et al. Arch Intern Med 2003; 163:936. Go A, et al. JAMA 2003; 290: Gage BF, et al. Circulation 2004; 110: 2287.

14 Antithrombotic therapy in atrial fibrillation ASA Warfarin ASA Clopidogrel New antithrombotic drugs

15 Antiplatelet therapy vs placebo N Patientevents Year AFASAK ASA Risk Reduction (%) SPAF Relative RR vs. placebo 19% EAFT Absolute risk 130 reduction 838 primary 0.8%/yr Absolute risk reduction secondary 2.5%/yr Combined NNT primary prevention 125 NNT secondary prevention ASA better ASA worse -100 Hart RG et al. Ann Intern Med 2007; 146:

16 Warfarin therapy vs placebo N Patientevents Year AFASAK BAATAF CAFA SPAF SPINAF Combined Warfarin Risk Reduction (%) Relative RR vs. placebo 64% Absolute risk reduction primary 2.7%/yr Absolute risk reduction secondary 8.4%/yr NNT primary prevention 37 NNT secondary prevention Warfarin better Warfarin worse -100 Hart RG et al. Ann Intern Med 2007; 146:

17 ASA + Clopidogrel Documented AF + 1 risk factor for Stroke ACTIVE W ASA + Clopidogrel versus VKA

18 ACTIVE W Failure of clopidogrel/asa to prevent stroke, embolism, MI or vascular death compared to anticoagulant therapy Lancet 2006; 367:

19 Antithrombotic Therapy for Atrial Fibrillation ACC/AHA/ESC Guidelines 2006 No risk factors CHADS 2 = 0 Risk Factor One moderate risk factor CHADS 2 = 1 Any high risk factor or >1 moderate risk factor CHADS 2 >2 or Mitral stenosis Prosthetic valve Recommended Therapy Aspirin, mg qd Aspirin, mg/d or Warfarin (INR , target 2.5) Warfarin (INR , target 2.5) Warfarin (INR , target 3.0)

20 Limitations of Warfarin Limitation Slow onset of action Genetic variation in metabolism Multiple food and drug interactions Narrow therapeutic index Consequence Overlap with a parenteral anticoagulant Variable dose requirements Frequent coagulation monitoring Frequent coagulation monitoring Risk of fatal bleeding (1,5% per year)

21 Adequacy of Anticoagulation in Patients with AF in Primary Care Practice Warfarin 50% Contraindication 25% No compliance 25% Therapeutic range 50% Higher 20% Lower 30% Samsa GP, et al. Arch Intern Med 2000;160:967.

22 New Oral Anticoagulants for Stroke Prevention in AF

23 Factor X Otamixaban Rivaroxaban Apixaban Factor Xa AT III Fondaparinux AT III LMWH Heparin Pro-thrombin Thrombin Bivalirudina (ev) Ximelagatran (os) Dabigatran (os)

24 PHASE III TRIALS IN PATIENTS WITH AF Direct inhibitors of Xa Direct inhibitors of thrombin Rivaroxaban ROCKET-AF (ongoing) Apixaban ARISTOTLE (ongoing) Dabigatran RE-LY Ximelagatran SPORTIF

25 Dabigatran etexilate is approved as Pradaxa in over 28 countries for the primary prevention of venous thromboembolic events (blood clots) in adults who have undergone elective total hip or elective total knee replacement surgery. Dabigatran etexilate (Boeringher Ingelheim) is not approved by the FDA.

26

27 Comparison of Features of Dabigatran With Those of Warfarin Features Warfarin Dabigatran Onset Slow Rapid Dosing Variable Fixed Food effect Yes No Drug interactions Many Few Monitoring Yes No Half-life Long Short Antidote Yes No

28 New treatment superior Standard treatment superior SUPERIORITY NON INFERIORITY EQUIVALENCE - % 1 + %

29 Dabigatran versus Warfarin in Patients with Atrial Fibrillation Follow up (median): 2 years Dabigatran 110 mg patients with atrial fibrillation and a risk for stroke Dabigatran 150 mg Warfarin sec INR NEJM 2009; 12(361):139

30 RE-LY: Baseline Characteristics Characteristic Dabigatran 110 mg Dabigatran 150 mg Warfarin Randomized Mean age (years) Male (%) CHADS2 score (mean) 0-1 (%) 2 (%) 3+ (%) Prior stroke/tia (%) Prior MI (%) CHF (%) Baseline ASA (%) Warfarin Naïve (%) Connolly et al., NEJM, 2009

31 Time in Therapeutic Range (TTR) with Warfarin in the RE-LY Trial 64% As in other trials...

32 % event/year Dabigatran versus Warfarin in Patients with AF PRIMARY OUTCOME 1,8 Efficacy end-point 1,5 1,2 0,9 0,6 0,3 0 Systemic embolism Stroke or stroke Warfarin - adjusted dose 1,69 1,2 Dabigatran mg 1,53 1,34 Dabigatran mg 1,11 0,92

33 RE-LY: Systemic embolism or stroke Dabigatran 110 vs. Warfarin HR 0.91 Non-inf p-value <0.001 Sup p-value 0.34 Dabigatran 150 vs. Warfarin HR 0.66 <0.001 <0.001 Margin = 1.46 Connolly et al., NEJM, 2009 Dabigatran better HR (95% CI) Warfarin better

34 RELY: results by CHADS2 Score Dabigatran 110 vs. Warfarin Dabigatran 150 vs. Warfarin CHADS2 1 CHADS2 2 CHADS2 3+ p=0.41 p= HR (95% CI) Dabigatran better Warfarin better HR (95% CI) Dabigatran better Warfarin better

35 RE-LY: Secondary Efficacy Outcomes According to Treatment Group Event (% per year) Warfarin Dabigatran 110 mg Dabigatran 150 mg All-cause mortality Vascular death Myocardial infarction Connolly, et al. N Engl J Med 2009;361: Increased myocardial infarction: Dabigatran harmful or Warfarin protective?

36 % event/ year Dabigatran versus Warfarin in Patients with AF BLEEDINGS Safety end-point 3,5 3 2,5 Dabigatran 150 mg increased G-I bleeding RR = ,5 1 0,5 0 Major bleeding Hemorrhagic Gastrointestinal stroke Warfarin - adjusted dose 3,36 0,38 1,02 Dabigatran mg 2,71 0,1 1,12 Dabigatran mg 3,11 0,12 1,51

37 % event/year Net clinical benefit 7,8 7,64 7,6 Major vascular events Major bleeding 7,4 7,2 7 7,09 6,91 Warfarin - adjusted dose Dabigatran mg Death 6,8 6,6 Dabigatran mg 6,4 Net clinical benefit

38 Concerns with dabigatran Dyspepsia: 12% in dabigatran group Renal function Elderly Low weight Drug interaction: P-glycoprotein inhibitors Amiodarone Verapamil Quinidine Hepatotossicity: 2% in dabigatran group

39 Differences in price Warfarin (1 month): $ 35 (including cost of monitoring) Dabigatran 110 mg (1 month): $ 339 Can we afford RE-LY? N Engl J Med 2009;361:2674-5

40 Possible dabigatran scenarios in AF Lower-dose regimen Elderly Renal insufficiency Lower stroke risk (CHADS 2 score of 1) Higher-dose regimen Higher stroke risk (CHADS 2 score 2)

41 Conclusions The past twenty years have led to a considerable improvement in the antithrombotic prophylaxis of AF Warfarin has demonstrated his superiority compared with treatment with both ASA alone and ASA plus clopidogrel

42 Conclusions Dabigatran (as other new drugs) may represent a therapeutic revolution that will likely overcome conventional therapy offering both patients and clinicians a better tolerability and manageability. In this way, we hope this new drug(s) will bring effective anticoagulation to a wider segment of the population at risk and help to prevent strokes.

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