Prevenzione secondaria dell ischemia cerebrale di origine arteriosa. Marco Cattaneo. Ospedale San Paolo Università degli Studi di Milano

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1 Prevenzione secondaria dell ischemia cerebrale di origine arteriosa Marco Cattaneo Ospedale San Paolo Università degli Studi di Milano

2 Cerebral Ischemia of Arterial Origin (CIAO)

3 Cumulative meta-analysis of aspirin efficacy after cerebral ischaemia of arterial origin OVERALL RRR: 13% No difference in relative risk reduction for doses of ASA: low (<100 mg/day), medium ( mg/day), high (>900 mg/day) ALGRA A, VAN GIJN J J Neurol Neurosurg Psychiatry 1999;66:

4 Vitamin K antagonists

5 Vitamin K antagonists (VKA) vs ASA in patients with Cerebral Ischemia of Arterial Origin Year Trial INR Outcome HR AC vs. ASA 1997 SPIRIT VE + MB 2.3 ( ) 2001 WARSS IS + D 1.13 ( ) 2007 ESPRIT VE + MB 1.02 ( ) VE, vascular event; MB, major bleeding; IS, ischaemic stroke; D, death Major/fatal bleedings: SPIRIT = 53 (VKA) vs 6 (ASA); WARSS = 44 (VKA) vs 30 (ASA); ESPRIT = 55 (VKA) vs 22 (ASA) SPIRIT, Ann Neurol 1997;42: WARSS, N Engl J Med 2001;345: ESPRIT, Lancet Neurol 2007;6:115-24

6 THIENOPYRIDINES ACTIVE METABOLITES S N Cl HOOC HS N Cl Ticlopidine S O N Cl CH 3 HOOC HS O N Cl CH 3 Clopidogrel

7 1072 pts with previous TE stroke End point = Stroke, AMI, Death RRR=23.3%, p=0.02 Gent, CATS trial, Lancet 1989

8 Ticlopidine vs Aspirin in stroke (TASS Study): main results End point Ticlopidine ASA RRR (95% CI) Non-fatal stroke or death 17% 19% 12% (-2/26) Fatal and non-fatal stroke 10% 13% 21% (4/38) Hass et al, NEJM 1989

9 CAPRIE Steering Committee, Lancet 1996

10 Kaplan-Meier curves for cumulative rates of primary endpoint events (composite of ischaemic stroke, myocardial infarction, vascular death, or rehospitalisation for acute ischaemia) Diener et al (MATCH Trial), 2004

11 Kaplan-Meier curves for cumulative rates of primary intracranial haemorrhage in the MATCH trial Diener et al (MATCH Trial), 2004

12 The CHARISMA Trial Background. Dual antiplatelet therapy with clopidogrel plus low-dose aspirin has not been studied in a broad population of patients at high risk for atherothrombotic events. Methods. 15,603 patients with either clinically evident cardiovascular disease or multiple risk factors were randomly assigned to receive clopidogrel (75 mg per day) plus low-dose aspirin (75 to 162 mg per day) or placebo plus low-dose aspirin Follow up. a median of 28 months Primary efficacy end point. A composite of myocardial infarction, stroke, or death from cardiovascular causes Secondary efficacy end points included hospitalization Bhatt, D. L. et al. N Engl J Med 2006;354:

13 Composite and Individual Primary and Secondary End Points. Bhatt, D. L. et al. N Engl J Med 2006;354:

14 A+C conclusion (MATCH, CHARISMA) (Somewhat) higher efficacy (to be on the optimistic side) More bleeding complications Overall balance: not better

15

16 Probability of primary outcome SPS3 TRIAL, NEJM 2012

17 Safety outcomes SPS3 TRIAL, NEJM 2012

18

19 modified from Morrow et al (TRA 2P trial), Stroke 2013

20 Effect of vorapaxar, added to antiplatelet therapy, on CV death, AMI or stroke in patients who experienced a stroke 2weeks-1year before Morrow et al (TRA-2P), Stroke 2013

21 Effect of vorapaxar, added to antiplatelet therapy, on moderate/severe bleeding in patients who experienced a stroke 2weeks-1year before Morrow et al (TRA-2P), Stroke 2013

22 Effect of vorapaxar, added to antiplatelet therapy, on intracranial bleeding in patients who experienced a stroke 2weeks-1year before Morrow et al (TRA-2P), Stroke 2013

23 Mechanisms of action of dipyridamole Chakrabarti & Freedman, Vasc Parpmacol 2008

24 ESPS-2: Results ASA+DP ASA patient years ~3143 ~3092 vascular events event rate (%/year) 8.1% 10.5% Relative risk reduction 23% (10 35) J Neurol Sci 1996;143:1-13

25 ESPS-2: Results ASA+DP ASA patient years ~3143 ~3092 Major bleeds event rate (%/year) 0.88% 0.67% Relative risk 1.32 ( ) J Neurol Sci 1996;143:1-13

26 ESPRIT: Results ASA+DIP ASA patient years vascular events event rate (%/year) 3.31% 4.27% Relative risk reduction 22% (3 37)

27 ESPRIT: Results ASA+DIP ASA patient years major bleeds event rate (%/year) 0.78% 1.18% Relative risk 0.67 ( )

28 Meta-analysis of RCT comparing ASA-Dipyridamole to ASA in Patients with Cerebral Ischemia of Arterial Origin The ESPRIT Study Group, Lancet 2006

29 Verro et al, Stroke 2008

30 Meta-analysis for non-fatal stroke for subsets of trials, based on the type of dipyridamole used Instant release Dipyridamole Extended release Dipyridamole Verro et al, Stroke 2008

31 Verro et al, Stroke 2008

32 Verro et al, Stroke 2008

33 Meta-analysis for non-fatal stroke for subsets of trials, based on the type of dipyridamole used High-dose aspirin Low-dose aspirin Cattaneo, tanto per divertirsi un po, 2011

34 Network of antiplatelet regimens after TIA or stroke Thijs et al, Eur Hear J 2008

35 Network of antiplatelet regimens after TIA or stroke Thijs et al, Eur Hear J 2008

36 Sacco R et al. N Engl J Med 2008

37 Kaplan-Meier Estimates of the Cumulative Probability of Primary and Secondary Outcomes, According to Treatment Group Sacco R et al. N Engl J Med 2008

38 Hazard Ratios for Primary, Secondary, and Key Tertiary Efficacy and Safety Outcomes Sacco R et al. N Engl J Med 2008

39 Other antiplatelet agents tested in Cerebral Ischemia of Arterial Origin Triflusal (COX-1 inhibitor) Cilostazol (PD3 inhibitor) Terutroban (TP receptor antagonist)

40 Triflusal vs. aspirin: vascular events Overall RR 1.03 ( ) Costa J et al. Cochrane Database Syst Rev 2005;3:CD004296

41 Other antiplatelet agents tested in Cerebral Ischemia of Arterial Origin Triflusal (COX-1 inhibitor) Cilostazol (PD3 inhibitor) Terutroban (TP receptor antagonist)

42 Kamal et al, The Cochrane Collaboration 2011

43 Kamal et al, The Cochrane Collaboration 2011

44 Kamal et al, The Cochrane Collaboration 2011

45 Other antiplatelet agents tested in Cerebral Ischemia of Arterial Origin Triflusal (COX-1 inhibitor) Cilostazol (PD3 inhibitor) Terutroban (TP receptor antagonist)

46 PERFORM The PERFORM trial comparing terutroban with 100 mg aspirin daily in 18,000 patients with a history of recent ischaemic stroke or TIA has been halted because interim analyses suggested that continuation of the study would be futile.

47 Guidelines for secondary prevention Cerebral Ischemia of ArterialOrigin It is recommended that patients not requiring anticoagulation should receive antiplatelet therapy (Class I, Level A). Where possible, combined aspirin and dipyridamole, or clopidogrel alone, should be given. Alternatively, aspirin alone, or triflusal alone, may be used (Class I, Level A) European Stroke Organization (ESO). Cerebrovasc Dis 2008;25: Updated: January 2009:

48 Guidelines for secondary prevention Cerebral Ischemia of ArterialOrigin The combination of aspirin and clopidogrel is not recommended in patients with recent ischaemic stroke, except in patients with specific indications (e.g. unstable angina or non-q-wave MI, or recent stenting); treatment should be given for up to 9 months after the event (Class I, Level A) European Stroke Organization (ESO). Cerebrovasc Dis 2008;25: Updated: January 2009:

49 Cerebral Ischemia of Arterial Origin (CIAO)

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