7 th Munich Vascular Conference

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1 7 th Munich Vascular Conference Secondary prevention of major cardiovascular events in patients with CHD or PAD - What can we learn from EUCLID and COMPASS, evaluating Clopidogrel, Ticagrelor and Univ.-Prof. Dr. med. Christine Espinola-Klein Department of Angiology Center of Cardiology / Cardiology I University Medical Center Mainz

2 Potential conflicts of interest Scientific support: Berlin Chemie-Menarini, Abbott Vascular GmbH Advisory board, speaker fee: Amgen GmbH, Bayer Health Care, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Leo Pharma, MSD Sharp & Dohme, Pfizer Pharma GmbH, Sanofi-Aventis GmbH

3 Prognosis with atherosclerosis 1-year outcomes in patients with atherosclerotic disease Steg P et al. JAMA 2007;297:

4 Therapeutic options vorapaxar Lüscher T.F. Hämostaseologie 2016; 36: 26-32

5 Antithrombotic Trialists Collaboration Risk for cardiovascular events (myocardial infarction, stroke, cardiovascular death) Disease Acute myocardial infarction Acute stroke Previous myocardial infarction Previous stroke High risik patients CAD PAD* High embolic risk Diabetes Total % Risk reduction 22% ±2 (P<0.004) Antithrombotic better Placebo better * 9214 PAD patients from 43 studies Antithrombotic Trialists Collaboration. BMJ 2002; 324:

6 Cummulative event rate [%] Clopidogrel CAPRIE (Efficacy of Clopidogrel vs. ASA in MI, stroke or vascular death) ASS Clopidogrel 8 4 p = n = 19, Follow-up [months] CAPRIE Lancet 1996; 348:

7 Clopidogrel CAPRIE (Efficacy of Clopidogrel vs. ASA in MI, stroke or vascular death) CAPRIE risik reduction in subgroups: CVD (N=6.431) 7,3 % CAD (N=6.302) -3,7% PAD (N=6.452) 23,8 % All patients (N=19.185) 8,7 % Aspirin better Clopidogrel better CAPRIE Lancet 1996; 348:

8 Ticagrelor PEGASUS Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin Thrombolysis In Myocardial Infarction Long-term therapy with Ticagrelor (90 or 60 mg) vs. placebo + ASS 100 after myocardial infaction (Total: N=21,162; subgroup LEAD: N=1,143) Bonaca MP et al., J Am Coll Cardiol 2016; 67:

9 Ticagrelor EUCLID Effects of Ticagrelor and Clopidogrel in patients with LEAD - 13,885 patients with LEAD (previous revascularisation or ankle-brachial index <=0,8 at screening - Clopidogrel 75 mg od versus ticagrelor 90 mg od - Primary endpoint: cv death, MI, stroke Hiatt WR et al., N Engl J Med. 2017; 376:

10 Ticagrelor EUCLID Effects of Ticagrelor and Clopidogrel in patients with LEAD Primary endpoint: cv death, MI, stroke Hiatt WR et al., N Engl J Med. 2017; 376:

11 Ticagrelor EUCLID Effects of Ticagrelor and Clopidogrel in patients with LEAD Hiatt WR et al., N Engl J Med. 2017; 376:

12 Ticagrelor EUCLID Effects of Ticagrelor and Clopidogrel in patients with LEAD Hiatt WR et al., N Engl J Med. 2017; 376:

13 Conclusion: EUCLID Trial In patients with symptomatic PAD, ticagrelor was not shown to be superior to clopidogrel for the reduction of cardiovascular events. Major bleeding occurred at similar rates among the patients in the two trial groups but ticagrelor causes more often dyspnoea as side effect.

14 Therapeutic options vorapaxar Lüscher T.F. Hämostaseologie 2016; 36: 26-32

15 2-year Kaplan Meier estimate (%) ATLAS ACS 2 TIMI 51: Vascular Dose Reduced CV Events and Death in Patients with acute coronary syndrome (exclusion: prior stroke / TIA) CV death, MI or stroke CV death All-cause death HR=0.80 (95% CI ); p=0.007 Placebo HR=0.55 (95% CI ); p<0.001 NNT=50 Placebo HR=0.58 (95% CI ); p<0.001 NNT=49 Placebo mg bid mg bid mg bid Days Days Days 720 CI, confidence interval; HR, hazard ratio; NNT, number needed to treat Patients also received antiplatelet standard of care: ASA + thienopyridine (~93%) or ASA alone (~7%) Mega JL et al, Eur Heart J 2014;35(Suppl.):992. Abstract P5518 (poster presentation)

16 COMPASS Cardiovascular OutcoMes for People Using Anticoagulation StrategieS N= patients with stable CAD or PAD with primary endpoint 2.5 mg bid + Aspirin 100 mg od Run-in (Aspirin) R 5 mg bid Aspirin 100 mg od Eikelboom JW et al. N Engl J Med 2017; DOI: /NEJMoa ; Anand SS et al. Lancet

17 COMPASS Cardiovascular OutcoMes for People Using Anticoagulation StrategieS Key inclusion criteria* PAD CAD with 1 of: Age 65 years Age <65 years plus atherosclerosis in 2 vascular beds or 2 additional risk factors Current smoker Diabetes mellitus Renal dysfunction (egfr<60 ml/min) Heart failure Non-lacunar ischemic stroke 1 month ago Key exclusion criteria Stroke 1 month or any haemorrhagic or lacunar stroke Severe HF with known ejection fraction <30% or NYHA class III or IV symptoms Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy egfr <15 ml/min Eikelboom JW et al. N Engl J Med 2017; DOI: /NEJMoa ; Anand SS et al. Lancet

18 COMPASS Cardiovascular OutcoMes for People Using Anticoagulation StrategieS Combined endpoint: CV Death, Stroke and MI Eikelboom JW et al. N Engl J Med 2017; DOI: /NEJMoa

19 COMPASS Cardiovascular OutcoMes for People Using Anticoagulation StrategieS Endpoints: CV Death, Stroke and MI Outcomes, n (%) CV death, stroke, or MI 2.5 mg bid + aspirin 100 mg N=9152 Aspirin 100 mg N= mg bid + aspirin 100 mg vs aspirin 100 mg HR (95% CI) p-value 379 (4.1) 496 (5.4) 0.76 ( ) <0.001 CV death 160 (1.7) 203 (2.2) 0.78 ( ) 0.02 Stroke 83 (0.9) 142 (1.6) 0.58 ( ) <0.001 MI 178 (1.9) 205 (2.2) 0.86 ( ) 0.14 Eikelboom JW et al. N Engl J Med 2017; DOI: /NEJMoa

20 COMPASS Cardiovascular OutcoMes for People Using Anticoagulation StrategieS Safety events Crude incidence over mean follow-up of 23 months Aspirin n (%) Riva 2.5mg BID + Aspirin n (%) HR (95% CI) p-value Primary Safety: Major bleeding 170 (1.9) 288 (3.1) 1.70 ( ) <0.001 Fatal bleeding 10 (0.1) 15 (0.2) 1.49 ( ) 0.32 Non-fatal symptomatic ICH 21 (0.2) 19 (0.2) 1.10 ( ) 0.77 Nonfatal, non-ich, symptomatic bleeding into a critical organ Other major bleeding leading to hospitalisation 29 (0.3) 42 (0.5) 1.43 ( ) (1.2) 210 (2.3) 1.88 ( ) <0.001 Eikelboom JW et al. N Engl J Med 2017; DOI: /NEJMoa

21 COMPASS Cardiovascular OutcoMes for People Using Anticoagulation StrategieS Net clinical benefit Outcome Net clinical benefit 2.5 mg bid + aspirin 100 mg N=9152 Aspirin 100 mg N= mg bid + aspirin 100 mg vs aspirin 100 mg HR (95% CI) p-value 431 (4.7%) 534 (5.9%) 0.80 ( ) <0.001 Eikelboom JW et al. N Engl J Med 2017; DOI: /NEJMoa

22 : PAD COMPASS Cardiovascular OutcoMes for People Using Anticoagulation StrategieS Peripheral artery revascularization Limb or foot amputation for arterial vascular disease Intermittent claudication plus: Low ABI (<0.90), or significant peripheral artery stenosis ( 50%) Previous carotid revascularization, asymptomatic carotid artery stenosis 50% CAD + low ABI (<0.90) Number of patients All patients with PAD 7470 Symptomatic PAD limbs 4129 Carotid disease 1919 CAD + low ABI (<0.90) 1422 Anand SS et al. Lancet

23 : PAD COMPASS Cardiovascular OutcoMes for People Using Anticoagulation StrategieS Primary cardiovascular outcome was MACE, defined as: Composite of CV death, stroke, or MI Primary limb outcome was major adverse limb events (MALE), defined as: Severe limb ischaemia leading to an intervention (angioplasty, bypass surgery, amputation, thrombolysis) Major amputation owing to vascular insufficiency above forefoot Anand SS et al. Lancet

24 : PAD COMPASS Cardiovascular OutcoMes for People Using Anticoagulation StrategieS Cardiovascular death/stroke/mi or MALE including major amputation R 2.5 mg bid + A 100 mg vs A 100 mg: HR 0.69 ( ), p= R 5 mg bid vs A 100 mg: HR 0.84 ( ), p=0.08 Anand SS et al. Lancet

25 : PAD COMPASS Cardiovascular OutcoMes for People Using Anticoagulation StrategieS Outcome 2.5 mg bid + aspirin N= mg bid N=2474 Aspirin N=2,504 N (%) N (%) N (%) MACE 126 (5.1) 149 (6.0) 174 (6.9) 2.5 mg bid + aspirin vs. aspirin HR (95% CI) 0.72 ( ) p-value mg bid vs. aspirin HR (95% CI) 0.86 ( ) p-value 0.19 CV death 64 (2.6) 66 (2.7) 78 (3.1) 0.82 ( ) ( ) - Stroke 25 (1.0) 43 (1.7) 47 (1.9) 0.54 ( ) ( ) - MI 51 (2.0) 56 (2.3) 67 (2.7) 0.76 ( ) ( ) - MALE* 30 (1.2) 35 (1.4) 56 (2.2) 0.54 ( ) ( ) 0.03 Major amputation 5 (0.2) 8 (0.3) 17 (0.7) 0.30 ( ) ( ) 0.07 MACE or MALE 157 (6.3) 188 (7.6) 225 (9.0) 0.69 ( ) ( ) 0.08 Anand SS et al. Lancet

26 : PAD COMPASS Cardiovascular OutcoMes for People Using Anticoagulation StrategieS Safety events Outcome 2.5 mg bid + aspirin N= mg bid N=2474 Aspirin N=2504 N (%) N (%) N (%) Major bleeding 77 (3.1) 79 (3.2) 48 (1.9) 2.5 mg bid + aspirin vs. aspirin HR (95% CI) 1.61 ( ) p-value mg bid vs. aspirin HR (95% CI) 1.68 ( ) p-value Fatal 4 (0.2) 5 (0.2) 3 (0.1) Non-fatal ICH* 4 (0.2) 5 (0.2) 8 (0.3) Non-fatal other critical organ* 13 (0.5) 18 (0.7) 8 (0.3) 1.55 ( ) ( ) 0.06 Anand SS et al. Lancet

27 : PAD COMPASS Cardiovascular OutcoMes for People Using Anticoagulation StrategieS Net clinical benefit Outcome Net clinical benefit 2.5 mg bid + aspirin N= mg bid N=2474 Aspirin N=2504 N (%) N (%) N (%) 169 (6.8) 207 (8.4) 234 (9.3) 2.5 mg bid + aspirin vs. aspirin HR (95% CI) 0.72 ( ) p-value mg bid vs. aspirin HR (95% CI) 0.89 ( ) p-value 0.23 For every 1000 patients with PAD treated with rivaroxaban plus ASA, 27 MACE or MALE events would be prevented, and 1 fatal and 1 critical organ would be caused over a 21-month period Anand SS et al. Lancet

28 COMPASS Cardiovascular OutcoMes for People Using Anticoagulation StrategieS Subgroup 2.5 mg bid + aspirin n/n (%) Aspirin alone n/n (%) HR (95% CI) HR (95% CI) p-value All participants 379/9152 (4.1) 496/9126 (5.4) 0.76 ( ) Age 0.20 <65 years 79/2150 (3.7) 126/2184 (5.8) 0.63 ( ) years 179/5078 (3.5) 238/5045 (4.7) 0.74 ( ) 75 years 121/1924 (6.3) 132/1897 (7) 0.89 ( ) Sex 0.75 Male 300/7093 (4.2) 393/7137 (5.5) 0.76 ( ) Female 79/2059 (3.8) 103/1989 (5.2) 0.72 ( ) Body weight kg 41/901 (4.6) 45/836 (5.4) 0.83 ( ) >60 kg 335/8241 (4.1) 448/8285 (5.4) 0.75 ( ) Estimated GFR 0.95 <60 ml/min 132/2054 (6.4) 177/2114 (8.4) 0.75 ( ) 60 ml/min 247/7094 (3.5) 319/7012 (4.5) 0.76 ( ) CAD 0.47 Yes 347/8313 (4.2) 460/8261 (5.6) 0.74 ( ) No 32/839 (3.8) 36/865 (4.2) 0.89 ( ) PAD 0.61 Yes 126/2492 (5.1) 174/2504 (6.9) 0.72 ( ) No 253/6660 (3.8) 322/6622 (4.9) 0.77 ( ) Eikelboom JW et al. N Engl J Med 2017 Favours rivaroxaban 2.5 mg bid + aspirin Favours aspirin alone

29 Conclusion: COMPASS Trial Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone. In addition rivaroxaban 2.5 mg twice daily plus aspirin significantly reduced MALE in patients with PAD compared with aspirin alone.

30 Thank you for your attention!

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