Criteri di scelta ed appropriatezza prescrittiva dei nuovi anticoagulanti orali

Transcription

1 Criteri di scelta ed appropriatezza prescrittiva dei nuovi anticoagulanti orali Elisabetta Toso, MD Città della Salute e della Scienza di Torino Università di Torino

2 THE NEW ANTICOAGULANTS HISTORY Oral Inhibitors Edoxaban Apixaban Antistasin (FXa inhibitor) Hirudin (thrombin -I) Rivaroxaban Dabigatran Ximelagatran FDA Approves Dabigatran RELY FDA Approves Rivaroxaban ROCKET-AF FDA Approves Apixaban FDA Approves Edoxaban Xabans i.v. ARISTOTLE ENGAGE AF Years

3 Updated European Heart Rhythm Association practical guide on the use of non-vitamin-k antagonist

4 4 RCT DOACs pts vs AVK pts Annual event per 100 pts/year Intracranial bleeding mortality All cause mortality Other bleeding mortality Vascular mortality Liew A. et al. F Thrombosis and Hemostasis 2014; 12: 1419

5 Efficacy of NOACs: data from Trials Warfarin vs New Oral Anticoagulants 10% % Stroke/y in Warfarin % Stroke/y in New Oral Anticoag 5% 2.4% 1.7% 1.1% 1.7% 1.56% 2.1% 1.6% 1.2% 1.5% 1.18% 1.5% 1.6% 0 Dabigatran 150 RELY Dabigatran 110 RELY Rivaroxaban ROCKET-AF Apixaban ARISTOTLE Edoxaban 60 ENGAGE Edoxaban 30 ENGAGE

6 NON VALVULAR AF: ANNUAL MAJOR BLEEDS RISK Warfarin vs New Oral Anticoagulants % Major bleeds /y in Warfarin 10% % Major bleeds /y in New Oral Anticoag 5% 3.57% 2.87% 3.57% 3.32% 3.40% 3.60% 3.09% 2.13% 3.43% 2.75% 3.43% 1.61% 0 Dabigatran 150 RELY Dabigatran 110 RELY Rivaroxaban ROCKET-AF Apixaban ARISTOTLE Edoxaban 60 ENGAGE Edoxaban 30 ENGAGE

7 NON VALVULAR AF: ANNUAL INTRACRANIAL HEMORRAGE RISK Warfarin vs New Oral Anticoagulants % ICH/y in Warfarin 10% % ICH/y in New Oral Anticoag 5% % 0.75% 0.7% 0.5% 0.3% 0.23% Dabigatran 150 RELY Dabigatran 110 RELY Rivaroxaban ROCKET-AF 0.8% 0.33% Apixaban ARISTOTLE 0.85% 0.85% 0.39% 0.26% Edoxaban 60 ENGAGE Edoxaban 30 ENGAGE

8 The AF Guideline Changes ESC AF Guidelines 2010 ESC AF Guidelines 2016

9 Lip GY et al, JACC 2015

10 Valvular Atrial Fibrillation Hypertrophic CM Biological valve

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12 252 pts with bileaflet mechanical prosthetic valves Mean Euroscore 2.3, mean age 55 y, 70% aortic valve recently implanted ( population A) or implanted more than 3 months prior to enrollment (population B) Dabigatran (150 mg, 220 mg, 300 mg BD) vs Warfarin Death & TE complications Bleedings 5% 27% 3% 2% 2% 2% 12% 1% 4% 2% 4% 2% N Engl J Med 2013

13 doi: /europace/euv309 Downloaded from by guest on November 8, 2015 Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation Hein Heidbuchel 1 *, Peter Verhamme 2, Marco Alings 3, Matthias Antz 4, Hans-Christoph Diener 5, W erner Hacke 6, Jonas Oldgren 7, Peter Sinnaeve 2, A. John Camm 8, and Paulus Kirchhof 9, Advisors:, Azhar Ahmad, M.D. (Boehringer Ingelheim Pharma), Jutt a Heinrich-Nols, M.D. (Boehringer Ingelheim Pharma), Susanne Hess, M.D. (Bayer Healthcare Pharmaceuticals), Markus Müller, M.D., Ph.D. (Pfizer Pharma), Felix Münzel, Ph.D. (Daiichi-Sankyo Eur ope), Mar kus Schwer t feger, M.D. (Daiichi-Sankyo Eur ope), Martin Van Eickels, M.D. (Bayer Healthcare Pharmaceut icals), and Isabelle Richard-Lordereau, M.D. (Bristol Myers Squibb/Pfizer) Document reviewers:, Gregory Y.H. Lip, (Reviewer Coordinator; UK), Chern-En Chiang, (Taiwan), Jonathan Piccini, (USA), Tatjana Potpara, (Serbia), Laurent Fauchier, (France), Deirdre Lane, (UK), Alvaro Avezum, (Brazil), Torben Bjerr egaard Larsen, (Denmark), Guiseppe Boriani, (Italy), Vanessa Roldan-Schilling, (Spain), Bulent Gor enek, (T ur key), and Ir ene Savelieva, (U K, on behalf of EP-Eur opace) 1 Department of Cardiology Arrhythmology, Hasselt University and Heart Center, JessaHospital, Stadsomvaart 11, 3500 Hasselt,Belgium; 2 Department of Cardiovascular Sciences, University of Leuven, Belgium; 3 Department of Cardiology, Amphia Ziekenhuis, Breda, Netherlands; 4 Department of Cardiology, Klinikum Oldenburg, Oldenburg, Germany; 5 Department of Neurology, University Hospital Essen, University Duisburg-Essen, Germany; 6 Department of Neurology, Ruprecht Karls Universität,Heidelberg, Germany; 7 Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden; 8 Clinical Cardiology, St George s University, London, UK; 9 University of Birmingham Centre for Cardiovascular Sciences, Birmingham, UK; and 10 Department of Cardiology and Angiology, University of Münster, Germany The current manuscript is an update of the original Practical Guide, published in June 2013[Heidbuchel H, Verhamme P, Alings M, Antz M, Hacke W, Oldgren J, et al. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with nonvalvular atrial fibrillation. Europace 2013;15:625 51; Heidbuchel H, Verhamme P, Alings M, Antz M, Hacke W, Oldgren J, et al. EHRA practical guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation: executive summary. Eur Heart J2013;34: ]. Non-vitamin K antagonist oral anticoagulants (NOACs) are an alternative for vitamin K antagonists(vkas) to prevent stroke in patients with non-valvular atrial fibrillation (AF). Both physicians and patients have to learn how to use these drugs effectively and safely in clinical practice. Many unresolved questions on how to optimally use these drugsin specific clinical situations remain. The European Heart Rhythm Association

14 In HCM pts CHA 2 DS 2 VASC score to calculate stroke risk is not recommended There are no data on the use of NOACs in HCM pts

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16 Valvular Atrial Fibrillation Other conditions Hypertrophic CM Biological valve CHADS 2 CHA 2 DS 2 VASC HASBLED RENAL IMPAIREMENT CONCOMITANT DRUGS COMPLIANCE

17 CHADS 2 score patient distribution in trials 13% 36% 32% 36% 34% 47% 53% 87% 32% 30% CHADS 2 score

18 Efficacy of NOACs: data from Trials Warfarin vs New Oral Anticoagulants 10% % Stroke/y in Warfarin % Stroke/y in New Oral Anticoag 5% 2.4% 1.7% 1.1% 1.7% 1.56% 2.1% 1.6% 1.2% 1.5% 1.18% 1.5% 1.6% 0 CHADS Dabigatran 150 RELY CHADS Dabigatran 110 RELY CHADS CHADS Rivaroxaban ROCKET-AF Apixaban ARISTOTLE CHADS Edoxaban 60 ENGAGE CHADS Edoxaban 30 ENGAGE

19 CHA 2 DS 2 VASC a) Congestive heart failure, Hypertension,Age 75 years (2 points), Diabetes, prior Sstroke/TIA/embolus (2 points),vascular disease, age years, female Sex. b) Includes women without other stroke risk factors. c) IIaB for women with only one additional stroke risk factor.

20 HASBLED % Modified from Lopes et al Lancet 2012; Jones el al EHJ in press

21 RENAL IMPAIREMENT Updated European Heart Rhythm Association practical guide on the use of non-vitamin-k antagonist

22 CONCOMITANT DRUGS Updated European Heart Rhythm Association practical guide on the use of non-vitamin-k antagonist

23 AF Patients Strongly Prefer Once-Daily Dosing for Anticoagulation European survey: 1507 patients with AF od bid Not sure/declined to answer Patient preference for anticoagulant dosing regimen (%) % 11.9% 13.8% % 10.8% 8.7% % 5.4% 12.6% % 3.7% 15.9% % 7% 7.4% TOTAL 80.7% 7.6% 11.7% Overall, 81% preferred once-daily anticoagulation Zamorano JL et al, presented at ESC 2012; Bakhai A et al, BMC Cardiovasc Disord 2013;13:

24 One-Third of Twice-Daily Prescribed Medications Were Being Taken Once Daily Therapy adherence Self-reported patient survey (N=266) Taking OAC once daily Taking OAC twice daily 94% Rivaroxaban 6% 27% Dabigatran 73% 30% Apixaban 70% 86% Warfarin 14% Andrade JG et al, Can J Cardiol 2015;doi:0.1016/j.cjca

25 CONCLUSIONS Warfarin for valvular AF, biological valve and HCM CHADSVASC, HASBLED, Compliance Renal function, Drugs interaction