Practical everyday use of NOACs. Dr. Elisabetta Toso SOC Cardiologia Ospedale Cardinal Massaia - Asti

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1 Practical everyday use of NOACs Dr. Elisabetta Toso SOC Cardiologia Ospedale Cardinal Massaia - Asti

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

3 The AF Guideline Changes ESC AF Guidelines Update of the ESC AF Guidelines

4 DABIGATRAN 150 bid or 110 bid APIXABAN 5 bid or 2.5 bid RIVAROXABAN 20 or 15 od EDOXABAN 30 or 60 od Practical everyday use of NOACs Name Pradaxa Eliquis Xarelto Lixiana Target Direct IIa inhibitor Factor Xa inhibitor Factor Xa inhibitor Factor Xa inhibitor Bioavailability 7% 80% 60-80% 40% Half-life (T ½) h 12 h 7-11 h 8-10 T max h 2-4 h 3-4 h 2-4 h 1-5 h Clearence 80% renal 25% renal 75% biliary 60% renal 33% biliary 40% renal Drug interaction P-gp competition CYP3A4 inhibition Amiodarone ( ) Quinidine ( ) Verapamil ( ) Diltiazem ( ) Ketoconazolo( ) Ritonavir( ) Ketokonazole( ) Quinidine( ) Quinidine( ) Verapamil( )

5 DABIGATRAN APIXABAN RIVAROXABAN EDOXABAN % Stroke/y D 150mg: 1.11% D 110 mg: 1.56% 1.27% 2.1% E 60mg: 1.18% E 30mg: 1.61% % Major Bleeds/ y D 150mg: 3.31% D 110 mg: 2.71% 2.13% 3.6% E 60mg: 2.75% E 30mg: 1.61% Coagulation tests aptt ECT Anti-Fxa chromogenic assays PT Anti-Fxa chromogenic assays PT Anti-Fxa chromogenic assays Deborah Cohen BMJ 2014;349

6 DABIGATRAN APIXABAN RIVAROXABAN EDOXABAN % Stroke/y D 150mg: 1.11% D 110 mg: 1.56% 1.27% 2.1% E 60mg: 1.18% E 30mg: 1.61% % Major Bleeds/ y D 150mg: 3.31% D 110 mg: 2.71% 2.13% 3.6% E 60mg: 2.75% E 30mg: 1.61% Coagulation tests aptt ECT Anti-Fxa chromogenic assays PT Anti-Fxa chromogenic assays PT Anti-Fxa chromogenic assays Bleedings management Antidote IDARUCIZIMAB (Boehringer Ing.) RE-Verse AD study PCC 25 U/Kg apcc 50 IE/Kg rfviia 90 mcg/kg ANDEXANET ALFA (Portola) ANNEXA- A study

7 The pratical everyday use of ORAL ANTICOAGULANT VALVULAR HEART DISEASE HYPERTROPHIC CARDIOMYOPATHY ELECTRICAL CARDIOVERSION What about NEW oral anticoagulants?

8 NOACs for VALVULAR HD ESC AF Guidelines European Heart Journal 2012 Patients with prosthetic heart valves should not take dabigatran/rivaroxaban/apixaban nor should pts with AF that is caused by a heart valve problem.

9

10 252 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 5% 3% 27% Bleedings 2% 2% 2% 12% 1% 4% 2% 4% 2% N Engl J Med 2013

11 Exclusion criteria regarding valvular disease in NOACs trials 3950/18113 pts (22%) Ezekowitz et al. Poster contributions JACC /18201 (26%) pts Oral presentation ESC Congress 2013 Breithardt G. et al Eur Heart Journal 2014

12 Valvular Heart Disease 1992 pts (14%) 90% mitral regurgitation (only 3% post-rheumatic) Stroke or SE Major Bleedings % Events/100 pts/y P 0,76 2,01 2,43 Rivaroxaban Warfarin % Events/100 pts/y 6,14 P 0,01 4,20 Breithardt G. et al Eur Heart Journal 2014

13 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

14 The pratical everyday use of ORAL ANTICOAGULANT VALVULAR HEART DISEASE HYPERTROPHIC CARDIOMYOPATHY ELECTRICAL CARDIOVERSION

15 Electrical Cardioversion on warfarin Sintomatic cerebrovascular complications 0.7% 13/ 5247 pts 0.24% 0.5% 0.4% 0.3% 1841 pts 664 pts 521 pts 275 pts 1946 pts 0

16 Electrical Cardioversion on NOACs Sintomatic cerebrovascular complications CHADS % 9/1708 pts 0,52% 0.8% CHADS % CHADS pts 672 pts 265 pts pts Nagarakanti R et al Circulation 2011 Piccinini et al JACC 2013 Flaker G. et al JACC 2014

17 1504 patients, 141 Centres across 16 countries X-VERT Trial Canada USA Netherlands Belgium Portugal Spain UK Finland Denmark Germany France Greece Singapore China Italy: Botto GL Calò L Cappato R Capucci A Gaita F Grimaldi M Gulizia MM Themistoclakis S South Africa Cappato R. et al. Eur Heart Journal 2014

18 Randomized, open-label, parallel-group, active-controlled multicentre study Inclusion criteria: Age 18 years, non-valvular AF lasting >48 h or unknown duration, scheduled for cardioversion Cardioversion strategy Early # Delayed R 2:1 R 2:1 Rivaroxaban 20 mg od* 1 5 days VKA Rivaroxaban 20 mg od* 21 days (max. 56 days) VKA Cardioversion Cardioversion Rivaroxaban 20 mg od* 42 days VKA Rivaroxaban 20 mg od* 42 days VKA End of study treatment OAC 30-day follow-up *15 mg if CrCl ml/min; VKA with INR ; # protocol recommended only if adequate anticoagulation or immediate TEE Ezekowitz MD et al. Am Heart J 2014;167: ;

19 X-VeRT: clinical characteristics Total (N=1504) Rivaroxaban (n=1002) VKA (n=502) Age, mean SD, years 64.9 ± ± ±10 Male, % Persistent Hypertension, % Renal function/crci, % 80 ml/min Prior OAC use for 6 weeks, % Previous stroke/tia or SE, % CHADS 2 score, mean SD 1.4± ± ±1.1 CHA 2 DS 2 -VASc score, mean SD 2.3± ± ±1.6 Cappato R et al. Eur Heart J 2014

20 X-VeRT: Stroke or TIA 768/872 early CV performed 399/632 delayed CV performed 1,08% 0.7% 0,9% 0.2% 567 pts 277 pts 321 pts 78 pts Cappato R et al. Eur Heart J 2014

21 X-VeRT: LAA Thrombi 628 TEE performed 358 TEE in early CV 270 TEE in delayed CV 8.4% 6.2% 4.1% 0% 240 pts 118 pts 144 pts 126 pts Cappato R et al. Eur Heart J 2014

22 X-VeRT: time to cardioversion Patients cardioverted as scheduled Rivaroxaban: 841/1002 pts (84%) Warfarin: 385/502 pts (77%) Delayed cardioversion Rivaroxaban: 321/417 pts (77%) Warfarin: 78/215 pts (36.3%) Patients (%) p< patient with inadequate anticoagulation 95 patients with inadequate anticoagulation Cappato R et al. Eur Heart J 2014

23 X-VeRT: time to cardioversion The time between randomization and CV was similar or shorter in Rivaroxaban vs Warfarin Early median 1 (1-2 ) vs 1 (1-3) Delayed 22 (21-26) vs 30 (23-42) Days Median time to cardioversion Rivaroxaban VKA p= days p< days 0 Early Delayed Cappato R et al. Eur Heart J 2014

24 For a proper everyday use of NOACs in the clinical practice: Make the right choice (the 5 RIGHT) Avoid the grey zone: Valvular HD, Hypertrophic CM Electrical cardioversion on NOACs is safe, particularly Rivaroxaban may be considered an alternative to VKA

25 Thanks for the attention!

Elisabetta Toso, MD Dipartment of Medical Sciences University of Turin

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