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PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants September 2012 - June 2013.

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Presentation on theme: "PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants September 2012 - June 2013."— Presentation transcript:

1 PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants September June 2013

2 2 PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants Disclosure of Commercial Support This activity is supported by educational grants from Boehringer Ingelheim Pharmaceuticals, Inc. and Bristol-Myers Squibb and Pfizer Inc. This slide presentation and artwork was independently developed by Boston University School of Medicine’s Powerpoint designer. Boston University School of Medicine’s Disclosure Policy Boston University School of Medicine asks all individuals involved in the development and presentation of Continuing Medical Education (CME) activities to disclose all relationships with commercial interests. This information is disclosed to CME activity participants. Boston University School of Medicine has procedures to resolve any apparent conflicts of interest. In addition, faculty members are asked to disclose when any unapproved use of pharmaceuticals and devices is being discussed.

3 3 PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants Accreditation Information This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Boston University School of Medicine and Anticoagulation Forum. Boston University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians. Boston University School of Medicine designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Continuing Nursing Education Provider Unit, Boston University School of Medicine is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. CNE Contact Hours: 1.00 Nurses will receive contact hours for those sessions attended, after completion of an evaluation and claim for credit form. Continuing Pharmacy Education Credits The University of Rhode Island College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Attendance and completion of program evaluations at the conclusion of the program are required for a statement of credit. This knowledge-based activity is approved for 1.0 Contact Hours (0.1 CEUs). UAN: L01-P. Expiration date: September 5, 2013.

4 4 : PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants Learning Objectives At the conclusion of this activity participants will be able to: Describe benefits of oral anticoagulants for stroke prevention in atrial fibrillation Identify the population of patients who would be at risk of stroke with atrial fibrillation Compare current and new oral anticoagulants with regards to safety, efficacy, pharmacology, cost and convenience Compare the benefits and risks of oral anticoagulant therapy for reducing the risk of stroke in atrial fibrillation patients Utilize available decision making tools to stratify the risks and benefits of anticoagulation therapy in patients with atrial fibrillation

5 Prevalence and incidence of AF Risk stratification for stroke and bleeding New oral anticoagulants Guidelines Practical considerations for choosing an anticoagulant PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants Highlights

6 Prevalence and incidence of AF Risk stratification for stroke and bleeding New oral anticoagulants Guidelines Practical considerations for choosing an anticoagulant Highlights PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants

7 7 Question #1 An 82 year old man is in your office for an annual Medicare physical. What is the chance he has atrial fibrillation? 1. 1% 2. 5% 3. 10% 4. 25%

8 8 Prevalence of Diagnosed AF Go AS, JAMA May 9;285(18): Pub Med PMID: # Women # Men Men surpass women in every age range Stratified by Age and Sex x-axis = % y-axis = # of men/women

9 9 A 46 year old male patient is in for an annual physical exam. What is his lifetime risk of developing AF? 1. 1% 2. 5% 3. 10% 4. 25% Question #2

10 10 Incidence of AF Index Age, yrs MenWomen % (24.0 – 27.0)23.0% (21.0 – 24.0) % (23.9 – 27.0)23.2% (21.3 – 24.3) % (23.7 – 26.9)23.4% (21.4 – 24.4) % (22.1 – 25.5)23.0% (20.9 – 24.1) % (20.1 – 24.1)21.6% (19.3 – 22.7) Lifetime Risk for AF at Selected Index Ages by Sex Lloyd-Jones DM, et al. Circulation Aug 31;110(9): Pub Med PMID: in 4 Men & women >40 Years will develop AF Lifetime risk if currently free of AF

11 Prevalence and incidence of AF Risk stratification for stroke and bleeding New oral anticoagulants Guidelines Practical considerations for choosing an anticoagulant PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants Highlights

12 12 Question #3 68 year old female with atrial fibrillation and no other co- morbidities. How would you classify her stroke risk? 1. Low 2. Moderate 3. High

13 13 Scoring Systems in Atrial Fibrillation Given that anticoagulant therapy has both risks (principally bleeding) and benefits (a reduced risk of thrombosis) many authors have attempted to produce scoring systems which estimate the risks of these outcomes No one scoring system is universally accepted or highly predictive (in individual patients)

14 14 Scoring Systems in Stroke Risk A variety of systems have been published –Outlined on next slide All use selected clinical characteristics to predict the risk of stroke Most widely used is the CHADS 2 score All scores provide a rough estimate of risk of thrombosis in a population at similar risk as patient being reviewed

15 15 Atrial Fibrillation Risk Stratification 12 Schemes applied to 1000 patients from SPAF III study Stroke Risk in Atrial Fibrillation Working Group. Stroke Jun;39(6): Pub Med PMID: High Moderate Low

16 16 CHADS 2 : Risk of Stroke CHADS 2 Score # Patients (n = 1733) # Strokes (n = 94) NRAF Crude Stroke Rate per 100 Patient-yrs NRAF Adjusted Stroke Rate (95% CI)† ( ) ( ) ( ) ( ) ( ) ( ) ( ) National Registry of Atrial Fibrillation Participants (NRAF) Scoring: 1 point: Congestive heart failure, HTN, < 75 years, and DM 2 points: Stroke history or transient ischemic attack † Expected stroke rate per 100 pt-yrs from the exponential survival model, assuming aspirin not taken Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. JAMA Jun 13;285(22): Pub Med PMID:

17 17 CHA 2 DS 2 -VASc Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Chest Feb;137(2): Pub Med PMID: Risk Factor Score Congestive heart failure/LV dysfunction1 Hypertension1 Age ≥ 75 y2 Diabetes mellitus1 Stroke/TIA/TE2 Vascular disease (prior myocardial infarction, peripheral artery disease, or aortic plaque) 1 Age y1 Sex category (i.e. female gender) Birmingham Schema Expressed as a Point-Based Scoring System LV = left ventricular; TE = thromboembolism

18 18 CHA 2 DS 2 -VASc CHA 2 DS 2 - VASc Score ##TEEvents TE Rate During 1 yr (95% CI) TE Rate During 1 yr, Adjusted for Aspirin RX % (0-0)0% % ( )0.7% % ( )1.9% % ( )4.7% % ( )2.3% % ( )3.9% % ( )4.5% % ( )10.1% % ( )14.2% % ( )100% Total1,08425 P Value for trend Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Chest Feb;137(2): Pub Med PMID: Stroke or Other TE at One Year

19 19 CHA 2 DS 2 -VASc and CHADS 2 Score 0–1 1 Year Follow-up 12 Years Follow-up Person YrsEventsStroke rate (95%CI)Person YrsEventsStroke rate (95%CI) CHADS 2 score 0–140,2721, (3.31–3.68)187,2004, (2.39–2.53) CHA 2 DS 2 -VASc = 06, (0.65–1.08)39, (0.68–0.85) CHA 2 DS 2 -VASc = 18, (1.53–2.09)45, (1.34–1.56) CHA 2 DS 2 -VASc = 211, (3.34–4.03)51,5951, (2.74–3.04) CHA 2 DS 2 -VASc = 311, (5.33–6.21)45,7991, (4.04–4.41) CHA 2 DS 2 -VASc = 41, (6.68–10.02)4, (4.32–5.64) CHADS 2 score = 017, (1.41–1.79)92, (1.21–1.35) CHA 2 DS 2 -VASc = 06, (0.65–1.08)39, (0.68–0.85) CHA 2 DS 2 -VASc = 16, (1.46–2.09)35, (1.32–1.57) CHA 2 DS 2 -VASc = 23, (2.19–3.31)16, (1.90–2.34) CHA 2 DS 2 -VASc = (1.60–6.40)1, (1.43–3.07) CHADS 2 Score = 122,9451, (4.65–5.22)94, (3.49–3.73) CHA 2 DS 2 -VASc = 12, (1.42–2.64)10, (1.25–1.70) CHA 2 DS 2 -VASc = 28, (3.65–4.50)34, (3.07–3.45) CHA 2 DS 2 -VASc = 311, (5.38–6.27)44, (4.09–4.48) CHA 2 DS 2 -VASc = 41, (6.68–10.02)4, (4.32–5.64) Refines stroke risk stratification in AF patients: nationwide cohort Olesen JB, Torp-Pedersen C, Hansen ML, Lip GY. Thromb Haemost Jun;107(6): Pub Med PMID:

20 20 Question #4 78 year old male with atrial fibrillation and hypertension (CHADS2 score = 2 [4% stroke rate per year]). What is his annual major bleeding rate? 1. 1% 2. 2% 3. 3% 4. 5% 5. 10%

21 21 Bleeding Risk Scores Variety of scoring systems developed to predict risk of bleeding in patients initiating anticoagulants, as with stroke risk Less predictive than stroke risk scores, in general Each score incorporates clinical characteristics and provides estimate of risk of bleeding in a population similar to patients being considered Unclear whether to include risk scores in decision making for individual patients

22 22 Bleeding Risk Scores Widely Used in AF HAEMORRHAGES 1 HASBLED 2 ATRIA Score 3 1. Gage BF, et al. Am Heart J Mar;151(3): PMID: Pub Med PMID: Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. Chest Nov;138(5): PMID: Fang MC, et al. J Am Coll Cardiol Jul 19;58(4): Pub Med PMID:

23 23 Bleeding Risk Scores in AF ATRIAHAS-BLED HEMORR 2 HAGES Anemia 1 3 H ypertension 4 1 H epatic 10 or Renal disease Severe renal disease 2 3 A bnormal Renal 5 or Liver function E thanol abuse 1 Age ≥75 yrs2 S troke 1 M alignancy 1 Any prior hemorrhage1 B leeding 1 O lder Age (>75 yrs) 1 Hypertension 3 1 L abile INR 8 1 R educed platelet number or function 11 1 E lderly (>65 yrs) 1 R ebleeding 12 2 D rugs 9 or Alcohol 1111 H ypertension 4 1 A nemia 13 1 G enetic factors 14 1 E xcessive fall risk 15 1 S troke 1 Apostolakis S, Lane DA, Guo Y, Buller H, Lip GY. J Am Coll Cardiol 2012;60:000– Jul 24. [Epub ahead of print] Online Appendix. PMID: 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

24 AMADEUS Cohort Scheme All Patients Clinically Relevant Bleeding MajorBleeding HEMORR 2 HAGES Low (≤1) Risk1,738 (76.6)182 (10.5)25 (1.4) Intermediate Risk (2–3)517 (22.8)63 (12.2)13 (2.5) High Risk (>3)13 (0.5)3 (23.1)1 (7.7) TOTAL2, (10.9)39 (1.7) HAS-BLED Low Risk (<3)1,739 (75.9)159 (9.1)22 (1.3) High Risk (≥3)553 (24.1)92 (16.6)17 (3.1) TOTAL2, (11.0)39 (1.7) ATRIA Low Risk (<4)2,038 (90)220 (10.8)31 (1.5) Intermediate Risk (4)102 (4.4)13 (12.7)3 (2.9) High Risk (>4)128 (5.6)18 (14.1)5 (3.9) TOTAL2, (10.9)39 (1.7) Stratified by the HEMORR 2 HAGES, HAS-BLED, and ATRIA Schemes 24 Apostolakis S, Lane DA, Guo Y, Buller H, Lip GY. J Am Coll Cardiol 2012;60:000– Jul 24. [Epub ahead of print] Online Appendix. PMID:

25 Risks of Bleeding with Warfarin or Dabigatran in AF Oldgren J, et al. Ann Intern Med Nov 15;155(10):660-7, W204. Pub Med PMID:

26 26 Adjusted HR for Death After Stroke, MI, or Major Hemorrhage Event Pts With Event, n Subsequent Deaths, n (Adjusted Rate) HR for Death (95% CI)† Relative Weights‡ Ischemic stroke (36.4) 5.74 (5.10 – 6.47) 1.00 (reference) Hemorrhage stroke5948 (81.4) (13.15 – 23.75) 3.08 Subdural hemorrhage 4215 (32.4) 3.44 (2.06 – 5.74) 0.60 Major extracranial bleeding event (31.6) 3.82 (3.24 – 4.51) 0.67 Myocardial infarction (38.9) 5.44 (4.51 – 6.56) 0.95 In Patients Who Received Antiplatelet Therapy in the ACTIVE Trials Connolly SJ, et al. Ann Intern Med Nov 1;155(9): Pub Med PMID: † Compared to no event ‡ ratio of hazard ratios

27 Prevalence and incidence of AF Risk stratification for stroke and bleeding New oral anticoagulants Guidelines Practical considerations for choosing an anticoagulant PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants Highlights

28 28 Pharmacokinetics of NOACs Kaatz S, et al. Am J Hematol May;87 Suppl 1:S Pub Med PMID: ApixabanDabigatranRivaroxaban Direct factor inhibitionXaIIaXa Bioavailability (F rel )80%6%80% Peak action (t max )1–3 hr Protein binding84%35%92–95% Renal clearance25%80%33% Elimination half life with creatinine clearance > 80 ml/min 15.1 hr13.8 hr8.3 hr Elimination half life with creatinine clearance 50–79 ml/min 14.6 hr16.6 hr8.7 hr Elimination half life with creatinine clearance 30–49 ml/min 17.6 hr18.7 hr9.0 hr Elimination half life with creatinine clearance < 30 ml/min 17.3 hr27.5 hr9.5 hr

29 29 Coagulation Assays ApixabanRivaroxabanDabigatran PT -dilute PT -modified PT Not useful Data n/a Qualitative Data n/a Not useful Data n/a aPTTNot useful Qualitative TT -dTT/HEMOCLOT No effect Qualitative Quantitative Chromogenic Assays -Anti-Xa -Anti-Iia Quantitative No effect Quantitative No Effect No effect Quantitative Garcia DA, et al. In review. Measuring the Effect of NOACs n/a = not available

30 30 Kaatz S, et al. Am J Hematol May;87 Suppl 1:S Pub Med PMID: ApixabanDabigatranRivaroxaban Oral activated charcoal No dataIn vitroNo data HemodialysisNo dataHuman volunteersNo data Hemoperfusion with activated charcoal No dataIn vitroNo data Fresh frozen plasmaNo dataMouse modelNo data Activated factor VIIaNo dataRat model Rat and baboon model 3-factor PCCNo data 4-factor PCCNo data Human volunteers and rat model Human volunteers Types of Studies Evaluating Reversal of New Oral Anticoagulants Reversal of NOACs

31 31 ApixabanDabigatranRivaroxaban Oral activated charcoal Yes HemodialysisNoYesNo Hemoperfusion with activated charcoal PossibleYesPossible Fresh frozen plasmaNo Activated factor VIIaUnclear 3-factor PCCUnclear 4-factor PCCPossible Reversal of NOACs Suggestions for Reversal of New Oral Anticoagulants Kaatz S, et al. Am J Hematol May;87 Suppl 1:S Pub Med PMID:

32 32 Meta-analysis of Efficacy and Safety of New Oral Anticoagulants Miller CS, Grandi SM, Shimony A, Filion KB, Eisenberg MJ. Am J Cardiol Aug 1;110(3): Pub Med PMID: Dabigatran, Rivaroxaban, Apixaban vs. Warfarin in AF patients All cause stroke/SEE Ischemic and unspecified stroke Hemorrhagic stroke

33 33 GI Bleeding Meta-analysis of Efficacy and Safety of New Oral Anticoagulants Dabigatran, Rivaroxaban, Apixaban vs. Warfarin in AF patients Major bleeding Intracranial bleeding Miller CS, Grandi SM, Shimony A, Filion KB, Eisenberg MJ. Am J Cardiol Aug 1;110(3): Pub Med PMID:

34 Prevalence and incidence of AF Risk stratification for stroke and bleeding New oral anticoagulants Guidelines Practical considerations for choosing an anticoagulant PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants Highlights

35 35 Question #5 78 year old female with atrial fibrillation, hypertension and CHF. CHADS 2 = 3 CHA 2 DS 2 -VASc = 5 HAS-BLED = 2 What would you use for stroke prevention? 1. No anti-thrombotics 2. Aspirin 3. Aspirin + clopidogrel 4. VKA antagonist 5. Dabigatran or Rivaroxaban

36 36 European Society of Cardiology Guidelines Camm AJ. Europace Oct;12(10): Pub Med PMID: Risk Factors For Stroke and Thrombo-embolism in Non-valvular For Stroke and Thrombo-embolism in Non-valvular AF Risk Factor Score Congestive heart failure/LV dysfunction*1 Hypertension*1 Age >75**2 Diabetes Mellitus*1 Stroke / TIA / Thrombo-embolism**2 Vascular Disease*1 Age 65-74*1 Sex category (i.e. female sex)*1 Maximum Score9 Note: maximum score is 9 since age may contribute 0,1, or 2 points * ‘Clinically relevant non-major’ risk factor ** “Major” risk factor CHA 2 DS 2 -VASc and Stroke Rate

37 37 European Society of Cardiology Guidelines Approach to Thromboprophylaxis in Patients with AF RiskCategory Risk Category CHA 2 DS 2 -VASc ScoreRecommended Antithrombotic Therapy 1 One ‘major’ risk factor or > 2 ‘clinically relevant non-major’ risk factors > 2OAC One ‘clinically relevant non-major’ risk factor’ 1 Either OAC or aspirin mg daily Preferred: OAC rather than aspirin No risk factors0 Either aspirin mg daily or no antithrombotic therapy Preferred: no antithrombotic therapy rather than aspirin 1.Camm AJ. Europace Oct;12(10): Pub Med PMID: Connolly SJ, et al. N Engl J Med 2009;361:1139–1151. PMID: Risk of Bleeding HAS-BLED Score Dabigatran Dosage 2 Low risk0–2150 mg b.i.d. Measurable risk, or 1 clinically- relevant non-major risk factor ≥3110 mg b.i.d.

38 ACCF/AHA/HRS Guidelines Risk Category 1 Recommended Therapy No risk factorsAspirin, 81 to 325 mg daily One moderate risk factorAspirin, 81 to 325 mg daily, or warfarin (INR 2.0 to 3.0, target 2.5) Any high risk factor or > 1 moderate-risk factor Warfarin (INR 2.0 to 3.0, target 2.5)* Antithrombotic Therapy for Patients with Atrial Fibrillation 1.Fuster V. Circulation Mar 15;123(10): Pub Med PMID: Wann LS, et al. J Am Coll Cardiol Mar 15;57(11): Pub Med PMID: Focused Update Recommendation Class I 2 Comments Dabigatran is useful as an alternative to warfarin for the prevention of stroke and systemic thromboembolism in patients with paroxysmal to permanent AF and risk factors for stroke or systemic embolization who do not have a prosthetic heart valve or hemodynamically significant valve disease, severe renal failure (creatinine clearance <15 mL/min) or advanced liver disease (impaired baseline clotting function). (Level of Evidence: B) New Recommendation Less Validated / Weaker Risk Factors 1 Moderate Risk FactorsHigh Risk Factors Female genderAge >75 yearsPrevious stroke, TIA or embolism Age 65 to 74 yearsHypertensionMitral stenosis Coronary artery diseaseHeart failure Prosthetic heart valve* * If mechanical valve, target international normalized ratio (INR) > 2.5 Thyrotoxicosis LV ejection fraction <35% Diabetes mellitus

39 39 ACCP Guidelines Level of Risk ACCP Recommendation Alternative* Not Recommended Low Risk (CHADS 2 = 0) No TherapyAspirinOral anticoagulation or combination therapy with aspirin and clopidogrel Intermediate Risk (CHADS 2 = 1) Oral anticoagulationAspirin with clopidogrel Aspirin High Risk (CHADS 2 = 2) Oral anticoagulation (dabigatran 150 mg b.i.d. vs. VKA**) Aspirin with clopidogrel Aspirin You JJ, et al. Chest Feb;141(2 Suppl):e531S-75S. Pub Med PMID: *For patients with AF unsuitable for, or who refuse, oral anticoagulant (for reasons other than concerns about major bleeding) **VKA = adjusted-dose vitamin K antagonist For patients with Nonrheumatic AF, including those with Paroxysmal AF

40 40 Canadian Cardiovascular Society Guidelines OAC* CHADS 2 = 1 Assess Thromboembolic Risk (CHADS 2 ) Skanes AC, et al. Can J Cardiol Mar-Apr;28(2): Pub Med PMID: OAC CHADS 2 = 2 *ASA is a reasonable alternative for some as indicated by risk/benefit No anti- thrombotic ASAASAOAC*OAC* No additional risk factors for stroke Either female sex or or vascular disease Age > 65 yrs or combination female sex and vascular disease CHADS 2 = 0 *ASA is a reasonable alternative for some as indicated by risk/benefit No anti- thrombotic ASA OAC* No additional risk factors for stroke Either female sex or vascular disease Age > 65 yrs or combination female sex and vascular disease CHADS 2 = 0 When OAC therapy is indicated, most patients receive: Dabigatran, rivaroxaban, or apixaban (after Health Canada approval) In preference to warfarin Conditional Recommendation, High-Quality Evidence Increasing stroke risk

41 Prevalence and incidence of AF Risk stratification for stroke and bleeding New oral anticoagulants Guidelines Practical considerations for choosing an anticoagulant PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants Highlights

42 42 Optimal Candidates for New Drugs Patients who: Find INR testing burdensome Despite adherence to provider recommendations, have low ‘time-in-range’ Can afford (or arrange to get) the new drugs Have normal renal function

43 43 Optimal Candidates for Warfarin Patients who: Have (borderline) renal insufficiency Are taking stable dose of warfarin and do not find INR testing burdensome Have access to self-testing machine Are concerned about the lack of an evidence-based reversal strategy

44 44 TTR per Country in RELY Wallentin L, et al. Lancet Sep 18;376(9745): PMID: USA: Improvement Needed

45 45 Stroke and Systemic Embolism TTR=optimum therapeutic range cTTR=center's mean TTR By Center TTR in RELY Wallentin L, et al. Lancet Sep 18;376(9745): Pub Med PMID:

46 46 Wallentin L, et al. Lancet Sep 18;376(9745): PMID: Major Bleeding By Center TTR in RELY TTR=optimum therapeutic range cTTR=center's mean TTR

47 47 Stroke and Systemic Embolization by Center Proportion of INR in Therapeutic Range in ROCKET AF RivaroxabanWarfarin Rivaroxaban vs. Warfarin Center TTR‡ Total Event Rate (100 Pt Yrs)§ Total Event Rate (100 Pt Yrs)§ Hazard Ratio (95% CI)II %45/1735 (2.59)1.7762/1689 (3.67) (0.48, 1.03) 50.7%-58.5%53/1746 (3.04)1.9463/1807 (3.49) (0.62, 1.29) %54/1734 (3.11)1.9062/1758 (3.53) (0.62, 1.28) %37/1676 (2.21)1.3355/1826 (3.01) (0.49, 1.12) N=7061 rivaroxaban N=7082 warfarin P value for interaction=0.736 Time in therapeutic range-2-3 inclusive ‡Center TTR calculated using total INR values in target range from all warfarin subjects within center, divided by total INR values from all warfarin subjects within center §Number of events per 100 patient-years of follow-up II Hazard ratio from Cox proportional hazard model with treatment as a covariate Patel MR, et al. N Engl J Med Sep 8;365(10): Pub Med PMID:

48 48 Prevalence and incidence of AF Risk stratification for stroke and bleeding New oral anticoagulants Guidelines Practical considerations for choosing an anticoagulant PREVENTING Atrial Fibrillation Related STROKES with Anticoagulants Summary


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