Anticoagulation in Atrial Fibrillation An Asian Perspective. Dr Yap Lok Bin Cardiologist

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1 Anticoagulation in Atrial Fibrillation An Asian Perspective Dr Yap Lok Bin Cardiologist

2 Structure Atrial Fibrillation and OACs among Asians Warfarin Our experience of anticoagulants Risk Scoring

3 Strategies for the management of AF Stroke prevention Risk stratify: CHA2DS2VAS c or CHADS2 scores Anticoagulants (Warfarin or NOACs) Underutilized Rate control Adequate rate control defined as achievement of arbitrary heart rate target at rest and exercise Rhythm control Revert to Sinus Rhythm DCCV or Catheter Ablation Efficacy defined as freedom from AF

4 Stroke Stroke is 5 times more likely in patients with atrial fibrillation compared with those without. A CVA during atrial fibrillation is twice as likely to cause death and disability compared with non embolic strokes 33% of acute strokes in elderly population are related to AF

5 High Baseline ICH Risk in Asian 100% Undetermined SAH 80% Intracerebral hemorrhage 60% Hospital-based study 10 regions in China (Beijing, Shanghai, Guangzhou) 8,268 stroke patients 40% 20% Ischemic stroke Zhang L Stroke 2003 North East 0% Thrift AG Stroke 2001 Melbourne Zhang LF Stroke 2003 China Huang CY Stroke 1990 Hong Kong

6 Ethnic Difference: Risk of Intracranial Hemorrhage with Warfarin for AF Asian vs. White: ~4X risk of ICH with warfarin Shen AY, et al. JACC 2007;50:309-15, n = 18,000 Rate of ICH is 20% in whites and 30% in Asians

7 WARFARIN

8 Atrial Fibrillation and Anticoagulation Prevalence: 5% of people over age 65 10% of people over age 80 Incidence of stroke with afib increases with age: 1.3 %/year in patients %/year in %/year in %/year in 80 89

9 Warfarin vs Aspirin Adjusted dose warfarin and antiplatelet agents have been shown to reduce the risk of stroke compared with control by 64% and 22% Warfarin has been shown to be more effective than aspirin, in reducing stroke by 45%, but increasing the risk of bleeding Warfarin and other oral anticoagulants (OAC) are recommended for patients at increased risk of stroke; and aspirin is recommended for patients at lower risk Risk Reduction in Stroke (%) % -22 % Warfarin Antiplatelets Ann Intern Med 2007; 146:

10 Warfarin Use Older patients less likely to receive anticoagulation Older patients more likely to be underanticoagulated -- even though data is clear that there is no significant stroke protection at an INR of less than 2. Overestimation of Falls Risk

11 Developmental History Current FDA Approved Anticoagulants 1930s 1950s 1970s s 2002 s Heparin Warfarin LMWHs DTIs Factor Xa Enoxaparin Dalteparin Tinzaparin Argatroban Bivalirudin Lepirudin Iprivask inhibitor Fondaparinux DTI and Factor Xa inhibitors Dabigatran Rivaroxaban Apixaban

12 Stroke Prevention in Atrial Fibrillation -Limitations of Warfarin Therapy in Atrial Fibrillation Unpredictable response Narrow therapeutic window (INR range 2-3) Routine coagulation monitoring Frequent dose adjustments Warfarin therapy has several limitations that make it difficult to use in practice Slow onset/offset of action Numerous food-drug interactions Numerous drug-drug interactions Risk of Bleeding Complications Warfarin was #1 in 2003 and 2004 in the number of mentions of deaths for drugs causing adverse effects in therapeutic use Warfarin caused 6% of the 702,000 ADEs treated in the ED/year; 17% required hospitalization J Thromb Thrombolysis 2008; 25:

13 Stroke Prevention in Atrial Fibrillation -Limitations of Warfarin Therapy in Atrial Fibrillation -Narrow Therapeutic Window 80 Target INR ( ) Ischaemic stroke Intracranial haemorrhage Events / 1000 patient years The anticoagulant effect of vitamin K antagonists are optimized when therapeutic doses are maintained within a very narrow range 0 < >4.5 N Engl J Med 2003; 349: International Normalised Ratio (INR)

14 NOACs

15 Advantages NOAC over Warfarin No monitoring of PT/INR Less incidence of intracranial haemorrhage Lower rates of stroke and systemic embolism Disadvantages of NOAC High Cost GI side effects No antidote available (yet) Contraindicated in severe renal impairment

16

17 SPAF trials Re-LY ROCKET- AF ARISTO TLE ENGAGE AF-TIMI 48 Drug Dabigatran Rivaroxaban Apixaban Edoxaban Dose (mg) 150, (15*) 5 (2.5*) 60*, 30* Freq BID QD BID QD N 18,113 14,266 18,206 >21,000 Design PROBE 2x blind 2x blind 2x blind AF criteria AF x 1 < 6 mths AF x 2 (>1 in <30d) AF or AFl x 2 <12 mths AF x 1 < 12 mths % VKA naive 50% 38% 43% 40% goal *Dose adjusted in patients with drug clearance. **Max of 10% with CHADS-2 score = 2 and no stroke/tia/see PROBE = prospective, randomized, open-label, blinded end point evaluation VKA = Vitamin K antagonist

18 There is less haemorrhagic stroke for NOACs Efficacy outcomes (Asia vs. non-asia) Stroke or SEE Asia Non-Asia Ischemic stroke Asia Non-Asia Hemorrhagic stroke Asia Non-Asia Myocardial infarction Asia Non-Asia Death from any cause Asia Non-Asia 150mg bid Rate (%/year) Dabigatran Warfarin 110mg bid Dabigatran 150mg bid vs. Warfarin RE-LY Asia Masatsugu Hori et al. Stroke. 2013;44: HR (95%CI) Interaction p value Dabigatran 110mg bid vs. Warfarin HR (95%CI) Interaction p value Dabigatran better Warfarin better n = 15,000 non Asians and n = 2700 in Asians

19 Summary of NOACs Mode of Action Warfarin Dabigatran Rivaroxaban Apixaban Edoxaban Vitamin K antagonist Direct thrombin inhibitor Factor Xa inhibitor Factor Xa inhibitor Factor Xa inhibitor Half-life 40 h 14 h 5-9 h 8-13 h 5-13 h Dose Once daily 110 mg twice daily 150mg twice daily 15 mg once daily 20mg once daily 2.5 mg twice daily 5 mg twice daily 30mg once daily 60mg once daily Stroke Prevention (vs warfarin) - Non-inferior (110mg) Superior (150mg) Non-inferior (20mg) Superior (5mg) Non-inferior (30mg) Non-inferior (60mg)

20 Our Experience of NOAC vs Warfarin

21 IJN Study

22 IJN Study

23 What is our Experience of NOAC compared to Warfarin? Study of 1000 Clinical records 500 patients prescribed dabigatran vs 500 patients prescribed warfarin at IJN from January 2009 to December Examined for stroke rates, adverse effects, bleeding risks with NOACs compared to warfarin

24 500 IJN Patients on Warfarin Time in Therapeutic Range Mean TTR for warfarin is 50% Median TTR 53%

25 TTR subgroup analysis: mean TTR by country Mean TTR (%) Malaysia Taiwan Mexico Peru Romania India Colombia Russia Brazil China Korea Greece Thailand Malaysia Poland South Africa Japan France Slovakia Portugal Czech Republic Israel Philippines Bulgaria Hungary Hong Kong Turkey Belgium United States Austria Spain Germany Switzerland Singapore Argentina Netherlands Norway Canada United Kingdom Italy Ukraine Denmark Australia Finland Sweden TTR = time in therapeutic range Country Wallentin L et al. Lancet 2010;376:

26 Adverse Effects Analysis Dabigatran Warfarin P value Dyspepsia 20 (3.9%) 2 (0.4%) <0.01 Shortness of 6 (1.2%) Breath Leg oedema 5 (1%) Palpitations 3 (0.6%) Dizziness 3 (0.6%) Chest pain 2 (0.4%) headache 2 (0.4%) Allergy 2 (0.4%) 2 (0.4%) 0.50 Flushing 0 2 (0.4%) 0.16

27 Bleeding Risk Analysis Dabigatran Warfarin P value Minor Bleeding Haematuria 5 (1%) 3 (0.6%) 0.23 Gum bleeding 5 (1%) 1 (0.2%) 0.11 Gastrointestinal 0 3 (0.6%) 0.50 bleed Subconjunctival 2 (0.4%) 2 (0.4%) 0.69 haemorrhage Retinal haemorrhage 1 (0.2%) Epistaxis 1 (0.2%) Major Bleeding Gastrointestinal 2 (0.4%) 2 (0.4%) 0.69 bleed Haematuria 1 (0.2%)

28 Clinical Outcome CVA Events Warfarin Dabigatran P value CVA ischemic 4 (0.8%) CVA haemorrhagic 1 (0.2%) 1 (0.2%) 0.92 Follow-up Period Warfarin Average follow up 355 days (11.7 months) Dabigatran Average follow up 315 days (10.4 months)

29 Reasons for Stopping Warfarin in our Study Reasons for stopping warfarin Switched to Dabigatran 42 Bleeding due to warfarin 10 Patient preference 7 INR subtherapeutic / not in range 6 Poor INR control 5 Doctors preference / recommendation 4 Post watchman device on dual anti-platelets 3 Deaths 3 Hot sensation 2 CVA 2 Poor compliance to warfarin 2 Allergy 2 Gastric upset and pain 2 Vomiting 1 Anxiety 1 Difficulty getting to INR clinic 1 Convenience (blood taking ) 1

30 Malaysian registry study supports the positive efficacy and safety profile of NOACs in Asia Observational cohort study National Health Institute in Malaysia 510 dabigatran users 31% switched from warfarin 60% taking 150 mg BID dose 315 days of follow-up (average) OBSERVATION 1 haemorrhagic stroke 0 ischaemic strokes 2 major bleeding (GI) Dyspepsia 4% Withdrawal 18% 30 The rate of occurrences of adverse effects and bleeding were lower than those seen in the RE-LY trial Yap LB et al. J Thromb Thrombolysis. 2014;38:39 44

31 Current Guidelines

32 Increased risk of thromboembolism when CHA 2 D 2 s-vasc score 2 RISK FACTORS Congestive heart failure 1 Hypertension 1 Age 75 2 Age Diabetes mellitus 1 Stroke/TIA/thromboembolism Vascular disease 1 Sex Female 1 Your score SCORE 2 Add points together CHA2DS2VASc SCORE 0 0% 1 1.3% 2 2.2% 3 3.2% 4 4.0% 5 6.7% 6 9.8% 7 9.6% 8 6.7% % ADJUSTED STROKE RATE (% year) *Or moderate-to-severe left ventricular systolic dysfunction (left ventricular ejection fraction 40%) TIA, transient ischaemic attack; SE, systemic embolism Olesen et al. BMJ

33 HAS-BLED Score CLINICAL CHARACTERISTIC Hypertension 1 Abnormal liver function 1 Abnormal renal function 1 Stroke 1 Tendency to bleed 1 Labile INRs 1 Elderly (Age >65) 1 Drugs 1 Alcohol 1 Your score POINTS AWARDED HAS BLED SCORE NUMBER OF PATIENTS No OF BLEEDS , , , , ,70 BLEEDS PER 100 PATIENT YEARS , Total ,13

34 2012 ESC guidelines for the choice of anticoagulant in AF Antiplatelet therapy with ASA plus clopidogrel, or-less effectively-asa only, should be considered in patients who refuse any OAC, or cannot tolerate anticoagulants for reasons unrelated to bleeding. If there are contraindications to OAC or antiplatelet therapy, left atrial appendage occlusion, closure or excision may be considered. Line: solid=best option; dashed=alternative option NOAC = novel oral anticogulant

35 CPG on Ischaemic Stroke 2012

36 Summary Older Asian Patients have higher risks of stroke Anticoagulation recommended for those with CHADSVASC score 2 Our experience shows that NOACs are effective and safe when compared to warfarin

37 Additional Slides

38 Case 1 Mr Sidek A 67-year-old man presents to the clinic. Past history : hypertension, hyperlipidemia, Type 2 diabetes mellitus. Current Medication: Bisoprolol 5mg daily, lisinopril 5 mg daily, metformin 500mg XR od, atorvastatin 20 mg daily, aspirin 150 mg daily Social History: Mobile, independent, smokes 10/day, no alcohol. Works as a food vendor. BP 120/80 mmhg, irregular pulse HR 70 bpm, egfr > 60 ECG shows atrial fibrillation CHADS2 score = 2 CHA2DS2-VASC score = 3 What drug should be given for stroke prevention?

39 Case 2 Mr Wong A 68-year-old man presents to the clinic with breathlessness. Past history : hypertension, PCI to LAD in 2008, CCF, CVA Current Medication: bisoprolol 2.5mg daily, Perindopril 4 mg daily, rosuvastatin 20 mg daily, spironolactone 12.5mg bd, aspirin 150 mg daily Social History: Unemployed and unable to pay for medication. ECG shows new atrial fibrillation. Rate 80 bpm. egfr > 60 CHADS2 score = 4 CHA2DS2-VASC score = 7 What drug should be given for stroke prevention?

40 Case 3 Mr Jamal A 70-year-old man presents to the clinic with palpitations Past history : Hypertension, PCI to RCA 2013, GI bleed 2012 OGD showed duodenal ulcer. Current Medication: Aspirin 100mg od, Plavix 75 mg od, Omeprazole 20mg od, Atenolol 25mg od, Simvastatin 20mg od, Ramipril 5 mg od Social History: Smoker 20/day, Alcohol 4x a week. Retired Health Professional. ECG and monitoring showed paroxysmal AF CHADS2 score = 1 CHA2DS2-VASC score = 3 HAS-BLED score = 4 What drug should be given for stroke prevention?

41

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