Elisabetta Toso, MD Dipartment of Medical Sciences University of Turin

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1 Security and efficacy of Rivaroxaban in real life in the prevention of the stroke in non valvular AF patients: presentation of the results of the international study Xantus Elisabetta Toso, MD Dipartment of Medical Sciences University of Turin

2 THE FIRST 100 YEARS OF THE HISTORY FDA PROGRESSIVLY APPROVES NOACs Oral Inhibitors Xabans i.v. RELY, ROCKET-AF, ARISTOTLE, ENGAGE-AF Hirudin and Antistasin

3 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

4 SECURITY of NOACs Drug Any bleeding Major bleeding Warfarin (data from NOACs trials) 18,1%/year (mean) 3.4%/year (mean) Dabigatran 16.4%/year 3.11%/year Rivaroxaban 14%/year 3.6%/year Apixaban 18.1%/year 2.13%/year Edoxaban 14.1%/year 2.75%/year

5 Security of NOACs: data from Trials Warfarin vs New Oral Anticoagulants % ICH/y in Warfarin 1% 0.75% 0.75% % ICH/y in New Oral Anticoag 0.7% 0.8% 0.85% 0.85% 0.5% 0.5% 0.3% 0.33% 0.39% 0.23% 0.26% 0 CHADS Dabigatran 150 RELY CHADS Dabigatran 110 RELY CHADS CHADS Rivaroxaban ROCKET-AF Apixaban ARISTOTLE CHADS Edoxaban 60 ENGAGE CHADS Edoxaban 30 ENGAGE

6 THE FIRST 100 YEARS OF THE HISTORY Oral Inhibitors Xabans i.v. FDA PROGRESSIVLY APPROVES NOACs RELY, ROCKET-AF, ARISTOTLE, ENGAGE-AF The real life: REGISTRIES 2015 Hirudin and Antistasin

7 GLORIA-AF 10,675 non valvular AF pts enrolled from 2011 until 2014 in 736 Centers 92% CHA 2 DS 2 VASC score 1 Huisman MV et al. The American Journal of Medicine 2015

8 83898 NVAF pts Using the CHA 2 DS 2 VASC score, % of eligible pts for inclusion into: RE-LY 68% ARISTOTLE 65% ROCKET 51% Using the CHADS score, % of eligible pts for inclusion into: RE-LY 74% ARISTOTLE 72% ROCKET 56% Lee S. et al BMJ Open 2012

9 Security and Efficacy of NOACs: data from Registries ISCHAEMIC STROKE ICH MAJOR BLEEDING GI BLEEDING MI MORTALITY MEDICARE N> Warfarin D150 & D75 BID combined Dabigatran INCIDENCE PER 100 PERSON-YEARS % 1.1% HR: 0.80 P= % 0.2% HR: 0.34 P< % 4.3% HR: 0.97 P= % 3.4% HR: 1.28 P< % 1.6% HR: 0.92 P= % 3.3% HR: 0.86 P=0.006 Graham DJ et al. Circulation 2015;131:157 Preliminary data N pts Apixaban 0.5% 5% 3.1% Tepper et al. ESC 2015 Poster Section ICH MAJOR BLEEDING GI BLEEDING

10 Prospective, single-arm, observational, non-interventional phase IV study 6784 Pts enrolled from June 2012 to December 2013, 311 centres Europe and Canada - Follow up 1 year XANTUS EL study in Eastern EU, Middle East, Africa and Latin XANAP study in Asia Primary outcomes: major bleeding, all-cause mortality, any other adverse events Camm AJ et al, Eur Heart J 2015, I September

11 Clinical Characteristics ROCKET (N=7131) XANTUS (N=6784) Age (years, mean) Gender (male): n (%) 4300 (60.3) 4016 (59.2) AF type, n (%) Paroxysmal 1345 (18.9) 2757 (40.6) Persistent 5786 (81.1) 923 (13.6) Permanent (27.0) Hypertension 6436 (90.3) 5065 (74.7) Diabetes mellitus 2878 (40.4) 1333 (19.6) Prior stroke/non-cns SE/TIA 3916 (54.9) 1291 (19.0) Congestive HF 4467 (62.6) 1265 (18.6) Prior MI 1182 (16.6) 688 (10.1) Mean CHADS 2 score 3.48± ±1.3 Mean CHA 2 DS 2 -VASC score - 3.4±1.7 VKA experienced 4443 (62.3) 3089 (45.5) Camm AJ et al, Eur Heart J 2015, I September

12 Thromboembolic events according to dosing (events/100 pts/year) 5% 2.1% 2.3% 1.6% 0% CHADS Rivaroxaban 20 or 15 ROCKET AF CHADS CHADS Rivaroxaban 15 mg XANTUS (1410 pts) Rivaroxaban 20 mg XANTUS (5336 pts) Patel MR et al, NEJM Camm AJ et al, Eur Heart J 2015

13 5% Thromboembolic events according to age (events/100 pts/year) 2.1% 2.3% 1.8% 0.8% 0% Median 73 y < 65 y y > 75 y Rivaroxaban ROCKET AF Rivaroxaban XANTUS Patel MR et al, NEJM Camm AJ et al, Eur Heart J 2015

14 Thromboembolic events and major bleedings according to dosing (events/100 pts/year) 5% 3.6% 3.1% 2.1% 2.3% 1.6% 1.8% 0% CHADS Rivaroxaban ROCKET AF CHADS CHADS Rivaroxaban 15 mg XANTUS (1410 pts) Rivaroxaban 20 mg XANTUS (5336 pts) Patel MR et al, NEJM Camm AJ et al, Eur Heart J 2015

15 5% Thromboembolic events and major bleedings according to age (events/100 pts/year) 3.6% 2.1% 0.8% 0.9% 1.8% 1.7% 2.3% 3.2% 0% Median 73 y Rivaroxaban ROCKET AF < 65 y y > 75 y Rivaroxaban XANTUS Patel MR et al, NEJM Camm AJ et al, Eur Heart J 2015

16 Major bleedings (events/100 pts/year): Intracranial (ICH) and Gastrointestinal (GI) 2% 2.0% 0.9% 0.5% 0.4% 0% ICH GI ICH GI Rivaroxaban ROCKET AF Rivaroxaban XANTUS Patel MR et al, NEJM Camm AJ et al, Eur Heart J 2015

17 BLEEDINGS MANAGEMENT ROCKET AF Major bleeding was mostly treated using conservative methods: 2.6% of patients (n=184) received transfusions of 2 units of packed RBCs or whole blood The use of non-specific reversal agents was low: PCC in 4 patients Tranexamic acid in 2 patients XANTUS Major bleeding was mostly treated using conservative methods: 0.8% of patients (n=53) received transfusions of 2 units of packed RBCs or whole blood The use of non-specific reversal agents was low: PCC in 2 patients Tranexamic acid in 3 patients Piccini J et al, Eur Heart J 2014 Camm AJ et al, Eur Heart J 2015

18 All-cause mortality Endpoints ROCKET AF (N=7,061) n (% per year) XANTUS (N=6,784) n (% per year) All-cause mortality 208 (1.9) 118 (1.7) Vascular death 170 (1.5) 49 (0.7) Non-vascular death 21 (0.2) 60 (0.9) Unknown cause 17 (0.2) 9 (0.1) Patel MR et al, NEJM Camm AJ et al, Eur Heart J 2015

19 Thromboembolic events, major bleedings and all-cause death according to risk scores (events/100 pts/year) CHADS 2 score 703 pts 2061 pts 2035 pts 1111 pts 618 pts 222 pts 34 pts CHA 2 DS 2- -VASC score 174 pts 685 pts 1313 pts 1578 pts 1405 pts 837 pts 789 pts Camm AJ et al, Eur Heart J 2015

20 Conclusions In a real world population, rivaroxaban demonstrated low rates of stroke and major bleeding, including intracranial and GI bleeding for both dosages Incidences of these outcomes increased with age and generally with higher risk scores Major bleeding was mostly treated conservatively; reversal agents were rarely used

21 Thank You for your Attention!

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