Translating clinical evidence into real-world outcomes

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1 Annual Swiss Stroke Society Meeting 31st of January 2013 Symposium: From RE-LY to practice: Changing the attitude on stroke prevention in AF Translating clinical evidence into real-world outcomes Unité Cérébrovasculaire Patrik Michel, PD Service de Neurologie, DNC

2 Stroke prevention in AF: Translating clinical evidence into real-world outcomes Menu 1) New oral anticoagulants for 2 prevention in stroke patients 2) Long term safety and efficacy of NOAC 3) European Society of Cardiology guidelines

3 Stroke prevention in AF: Translating clinical evidence into real-world outcomes Menu 1) New oral anticoagulants for 2 prevention in stroke patients 2) Long term safety and efficacy of NOAC 3) European Society of Cardiology guidelines

4 Patients with FA and previous stroke or TIA and rel. effectiveness of NOAC as compared to AVK (N= ) Further event Odds ratio Stroke & systemic embolism 0.85* ( ) Ischemic & haemorrh. stroke 0.87 ( ) Haemorrhagic stroke 0.44* ( ) Major bleeding 0.86* ( ) Gastrointestinal bleeding 1.22 ( ) Myocardial infarct 1.08 ( ) Death from any cause 0.90 ( ) NOA better AVK better Ischemic & intracranial haemorrhage; * Statistically significant Ntaios et al, Stroke 2012

5 Patients with FA and previous stroke or TIA and effectiveness of NOAC NOAC are more efficacious and decrase intracranial haemorrhage rate Relative efficacy and safety are similar as in nonstroke patients Absolute efficacy and safety may be higher in stroke patients Because of higher CHADS 2 VA 2 Sc and HAS-BLED NNT is lower NOAC are more cost effective

6 Acute ischemic stroke and AF CHUV experience June-Dec N = 49 Age (median) : 80.5y Female : 59% History of stroke/tia : 20.4% AF known : 80.0% AF new : 20.0% EF <35%: 6.1% Coronary disase.: 36.7% Antithrombotic at time of stroke Xarelto INR <2.0: 46% INR 2-3: 18% INR >3.0: 36% AVK 23% 4% 49% 24% None Antiplatelets Source: P.Michel /A. Eskandari/M. Cordier

7 Discharge medication for AF After acute ischemic stroke, June-Dec N = 49 Death 27% 16% Clexane 2% Antiplatelets 14% 20% 20% AVK Xarelto Pradaxa NOAC : 22% with discharged on lower dose (age, renal) Source: P.Michel /A. Eskandari/M. Cordier

8 When should we start anticoagulation after an AVC/AIT for 2 prevention? Karolinska recommendation 2012 TIA without significant lesion on imaging : start immediately Minor stroke: wait 3-5 days Moderate stroke: wait 5-7 days Severe stroke: wait 14 days * CHUV: Minor : < 20% of MCA or cerebellar territory Moderate 20-40%. Severe: > 40%

9 Stroke prevention in AF: Translating clinical evidence into real-world outcomes Menu 1) New oral anticoagulants for 2 prevention in stroke patients 2) Long term safety and efficacy of NOAC 3) European Society of Cardiology guidelines

10 Safety of NOAs in trials All NOAC Intracranial haemorrhage Dabigatran GI-bleeds, dyspepsia Rivaroxaban GI bleeds, epistaxis, haematuria RELY/Connolly, N Engl J Med 2010 ROCKET-AF/Patel NEJM 2011 ARISTOTLE/Granger NEJM 2011

11 Safety of NOAs in real life Remember Situations increasing haemorrhage risk Renal failure Very elderly Low body weight Adding antiplatelets* Drug interactions *Dabigatran: Dans Circulation 2012

12 Drug interactions of anti-iia (dabigatran) that could bleeding risk or efficacy CHUV : contra-indicated Haemorrhage risk (Inhibitors P-gp) Thrombosis risk (Inductors P-gp) CHUV : avoid Haemorrhage risk (Inhibitors P-gp) Ketoconazole (sytemic) Rifampicin* Amiodarone Itraconazole (sytemic) St. John's Worth* Propafenone Voriconazole (sytemic) Carbamazepin* Ranolazine Ritonavir Phenytoin* Verapamil Other HIV antiproteases Quinidine Dronedarone Ciclosporine Tacrolimus *Compendium Suisse: prudence, generally avoid

13 Interactions of anti-xa (rivaroxaban, apixaban) that could bleeding risk or efficacy CHUV : contra-indicated Haemorrhage risk (Inhibitors CYP3A4) Thrombosis risk (Inductors CYP3A4) Haemorrhage risk (Inhibiteurs CYP3A4) CHUV : avoid Thrombosis risk (Inductors CYP3A4) Ketoconazol (sytemic) Rifampicin Amiodaron Bosentan Itraconazol (sytemic) Phenytoin Boceprevir Dexamethasone Voriconazol (sytemic) Carbamazepine ciclosporin Efavirenz Posaconazol (sytemic) Phenobarbital Dronedarone Felbamate Conivaptan St. John's Worth Grapefruit Oxcarbazepine Ritonavir Quinidine Primidone Other HIV antiproteas. Ranolazine Topiramate Licorice Telaprevir verapamil

14 Long term safety with dabigatran (Pradaxa ) RELY-ABLE, n =5 851, median of 4.3 years Original patients in RELY continued their initial dabigatran dose twice 150 vs. 110 (double blind) Results : Annual ischemic stroke rates 1.13% -1.24% Annual hemorrhagic stroke 0.14 % Long-term effectiveness is similar to RELY results Confirm that 2x 150 mg prevents more strokes but has a slightly higher risk of major haemorrhages compared to 2x110 mg. *Connolly S et al, Scientific Sessions, AHA 2012

15 Long term safety with dabigatran (Pradaxa ) FDA Mini-Sentinel, Results... indicate that bleeding rates associated with new use of Pradaxa do not appear to be higher than... Warfarin Healthcare professionals who prescribe Pradaxa should carefully follow the dosing recommendations in the drug label, especially for patients with renal impairment. Mini-Sentinel pilot of the Sentinel Initiative FDA Drug Safety Communication,

16 Long term safety with dabigatran (Pradaxa ) European Medicines Agency, Data on Pradaxa are consistent with the wellknown risk of bleeding with anticoagulant medicines Updated advice: Patients should seek urgent medical attention if they fall or injure themselves during treatment, especially if they hit their head. Prescribers should follow all the necessary precautions..., including the assessment of kidney function..., as well as dose reductions in certain patients. EMA Q&A on bleeding risk with Pradaxa, May 24th 2012

17 Stroke prevention in AF: Translating clinical evidence into real-world outcomes Menu 1) New oral anticoagulants for 2 prevention in stroke patients 2) Long term safety and efficacy of NOAC 3) European Society of Cardiology guidelines

18 Whom to anticoagulate with lone AF? Prediction of annual stroke risk without antithrombotics C Congestive heart failure 1 H Hypertension : BP consistenly > 140/90 mmhg (or trated hypertension on medication) A2 Age >75 years 2 D Diabetes mellitus 1 S2 V Prior Stroke or TIA or peripheral thromboembolus Vascular disease (prior MI, periph artery disease, aortic plaque) A Age years 1 Sc Sex catergory (i.e. female gender) 1 Camm Eur Heart J 2012, from Lip Chest 2010: Lip Stroke

19 Assessing haemorrhage risk with AVK HAS-BLED score (0-9 points) H Hypertension (SBP > 160 mmhg) 1 A Abnormal renal and liver function (1 point each) 1 or 2 S Stroke 1 B Bleeding tendency or predisposition 1 L Labile INR (si sous anti-vitamin K) 1 E Elderly (ieg, age > 65 years) 1 D Drugs or alcohol (1 point each) 1 or 2 Camm Eur Heart J 2012, from Pisters Chest 2010; validated in Friberg Eur Heart J 2012

20 ESC guidelines for atrial fibrillation 2012 Use CHADS 2 VA 2 Sc, use HAS-BLED NOAC : better efficacy, safety, and convenience NOAC should be considered instead of adjusted-dose VKA (INR 2 3) for most patients with AF in particular if... Difficulties keeping therapeutic INR Side effects of VKAs Inability to attend or undertake INR monitoring Insufficient evidence for superiority of one NOAC, But consider dabigatran 2x150mg if stroke under other OAC Consider patient preferences ESC Guidelines: Camm et al, Eur Heart J 2012

21 Antiplatelets for ACS or electif stenting if chronic anticoagulation indicated (AVK or NOAC) months Oral anticoagulation & SCA or stent + Clopidogrel + Aspirine Always avoid addition of ticagrelor or prasugrel If high haemorrhage risk : - Avoid drug-eluted stent - Consider lower dose of NOAC while on anti-platelet drugs Basé sur: ESO/Cerebrovasc Dis 2008; Camm Eur Heart J 2012; You/ACCP, Chest 2012, Dans Circulation 2012

22 Stroke prevention in AF Summary 1) Stroke patients have absolute benefits from the NOAC All NOAC: intracranial haemorrhage Dabigatran 2x150mg: ischemic strokes 2) Long-term safety and efficacy of NOAC seems as least as good as in the trials Best documented with dabigatran 3) European Society of Cardiology Use scores for risk assessment Consider NOAC as first choice in certain situations Adapt treatment to individual patients

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