Update on Antiplatelet Therapy for Non-Cardioembolic Ischemic Stroke

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1 Update on Antiplatelet Therapy for Non-Cardioembolic Ischemic Stroke Eric M. Bershad, M.D. Assistant Professor of Neurology Vascular Neurologist and Neurointensivist Baylor College of Medicine Houston, Texas, USA

2 Oral antiplatelet agents Salicylates Aspirin (ASA)(Acetylsalicyclic( acid) Trifusal Thienopyridines Ticlopidine (Ticlid( ) Clopidogrel (Plavix ) Phosphodiesterase inhibitors Dipyridamole (Persantine( ) Cilostazol (Pletal( )

3 Acetylsalicylic acid (ASA)(aspirin( ASA)(aspirin) Class: salicylate Mechanism: Irreversible inhibitor of cyclooxygenase, which produces thromboxane and prostaglandins. Thromboxane A2 is potent stimulator of platelet aggregation and vasoconstriction.

4 Trifusal Class: salicylate Mechanism: inhibits platelet cyclooxygenase, increases platelet and endothelial camp, increases neutrophil nitric oxide synthase.

5 Clopidogrel (plavix ) Class: thienopyridine Mechanism: prodrug converted to active form by liver cytochrome P450 system (CYP2C19) Irreversible inhibition of adenosine diphosphate (ADP) receptor, subtype P2Y12

6 Ticlopidine (ticlid( ) Class: thienopyridine Mechanism: inhibits ADP/P2Y12 receptor

7 Dipyridamole (persantine( ) Mechanism: inhibits thromboxane synthase, inhibits reuptake of adenosine, inhibits adenosine deaminase,, inhibits phosphodiesterase

8 ASA +extended-release dipyridamole (aggrenox ) Class: combination Mechanism: see ASA and dipyridamole

9 Cilostazol (pletal( ) Class: phosphodiesterase (PDE) inhibitor Mechanism: selective inhibitor of PDE-3, resulting in vasodilation and camp mediated inhibition of platelet aggregation.

10 Large clinical trials of antiplatelet agents for non-cardioembolic stroke Aspirin versus placebo CAST Chinese Acute Ischemic Stroke Trial IST International Stroke Trial Clopidogrel versus Aspirin CAPRIE Clopidogrel versus Aspirin in Patients at Risk for Ischemic Events Warfarin versus Aspirin WARSS - Warfarin-Aspirin Recurrent Stroke Study Clopidogrel + Aspirin versus Clopidogrel MATCH Management of ATherothrombosis with Clopidogrel in High risk Patients Aspirin + ER dipyridamole versus Aspirin ESPRIT European/Australasian Stroke Prevention in Reversible Ischemia Trial Aspirin + ER dipyridamole versus Clopidogrel PRoFESS Prevention Regimen for Effectively Avoiding Second Strokes

11 N = 21,106 patients from 413 Chinese hospitals Design: Randomized, double-blind, blind, placebo-controlled controlled Qualifying Event: Suspected ischemic stroke within 48 hours Intervention: aspirin 160 mg or placebo within 48 hours, and continued for up to 4 weeks. Primary endpoint: Death from any cause within 4 weeks, or death or dependency at discharge. Follow up: 4 weeks Results: Relative risk reduction of 14% in mortality with aspirin versus placebo (3.3 vs 3.9%, p=0.04) No significant reduction in death or dependency at discharge in ASA versus placebo (30.5 vs 31.6, p=0.08) Fewer recurrent strokes in ASA versus placebo during treatment period p (1.6 vs 2.1%, p=0.01), but trend toward higher hemorrhage stroke (1.1 vs 0.9, p=0.10) Relative risk reduction of 12% in death or non-fatal stroke vs. placebo (5.3 vs 5.9%, p=0.03) at 4 weeks.

12 N = 19,435 from 467 sites in 36 countries Design: Randomized, placebo-controlled, controlled, open-label, factorial design Qualifying event: acute ischemic stroke (< 48 hours) Intervention: heparin ( units bid) or no heparin, aspirin 300 mg or no aspirin, within 48 hours of stroke onset continued for up to 14 days. Primary outcome: death within 14 days, or death or dependency at 30 days Follow up: 6 months Results: Significantly fewer recurrent stroke at 14 days in aspirin vs placebo (2.8 vs 3.9%, p=0.001) No significant increase in hemorrhagic stroke (0.9 vs 0.8%) No significant decrease in death or dependency at 30 days in ASA vs. placebo (62.2 vs 63.5%, p=0.07)

13 CAST + IST pooled data N=~40,000 Results: 9 fewer deaths or non-fatal strokes per 1000 patients in first few weeks (p=0.001) 13 fewer dead or dependent in first few weeks to months (p<0.01)

14 N=6602 patients from 59 centers in 13 European countries Design: randomized, double-blinded, blinded, placebo controlled Qualifying event: recent (<3 months) stroke or TIA Intervention: ASA alone, ER dipyridamole alone, ASA + ER dipyridamole,, or placebo. Primary outcomes: Stroke, death, or stroke and death Follow up: 2 years

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16 N = 19,185 patients from 384 centers in 16 countries Design: randomized, blinded, active-controlled controlled Qualifying event: recent stroke (1 wk to 6 months), MI (<35 days) ) or symptomatic PAD Intervention: aspirin 325 mg daily versus clopidogrel 75 mg daily Primary endpoint: Vascular death, myocardial infarction or ischemic stroke Follow up: 1.9 years Results: Significant reduction in primary endpoint with clopidogrel versus aspirin (5.32 vs. 5.83%, p=0.043) No significant differences in major bleeding

17 N=2206 patients from 48 centers in the United States Design: randomized, double-blind, blind, active-controlled controlled Qualifying event: recent (<30 days) ischemic stroke Intervention: aspirin 325 mg daily vs. warfarin target INR 1.4 to 2.8. Primary endpoint: Recurrent ischemic stroke, or any death Follow up: 2 years Results: No significant difference in primary outcome in ASA versus warfarin group (16.0 vs 17.8, p=0.25) No significant difference in major hemorrhage rates in ASA vs warfarin (1.49 vs 2.22 per 100 patient years, p=0.10)

18 N = 7599 patients from 507 centers in 28 countries Design: randomized, double-blind, blind, active-controlled controlled Qualifying event: recent ischemic stroke / TIA (< 3 months), additional risk factor for atherothrombosis,, and on clopidogrel Intervention: Aspirin and clopidogrel versus clopidogrel 75 mg daily Primary endpoint: ischemic stroke, myocardial infarction, vascular death, or rehospitalization for vascular cause Follow up: 18 months Results: No significant reduction in primary endpoint for combination versus clopidogrel alone (15.7 vs. 16.7%, p=0.244) Significant increase in life-threatening bleeding with combination therapy compared to clopidogrel alone (2.6 vs. 1.3%, p<0.001)

19 N=2739 patients from 79 centers in 14 countries Design: randomized, open-label, active-controlled controlled Qualifying event: recent (< 6 months) TIA or minor stroke Intervention: aspirin ( mg daily) versus ASA + dipyridamole 200 mg twice daily. Primary endpoint: Composite of stroke, MI, vascular death, or major bleeding Follow up: mean 3.5 years Results: Primary outcome was significantly reduced by combination ASA + dipyridamole compared to ASA alone (13 vs 16%, 95% CI ) 0.98) Unexpected finding of reduced major bleeding in ASA + dipyridamole arm, HR 0.67 (95% CI, )

20 N=20,333 patients from 695 centers in 35 countries Design: randomized, double-blind, blind, active-controlled, controlled, factorial design 2x2, non-inferiority trial Qualifying event: recent (<90 days) ischemic stroke Interventions: ASA + ER dipyridamole + telmisartan 80 mg daily ASA + ER dipyridamole + placebo Clopidogrel + telmisartan 80 mg daily Clopidogrel + placebo Primary outcome: Recurrent stroke Follow up: 2.5 years Results: No differences in primary outcome between ASA + ER DP versus clopidogrel. Significantly more major hemorrhages in ASA + ER DP group compared to clopidogrel.

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22 Future trials Cilostazol CSPS II Cilostazol Stroke Prevention Study II. TOSS-II Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II Cilostazol + ASA vs. clopidogrel + ASA CATHARASIS Cilostazol-Aspirin Therapy Against Recurrent Stroke with Intracranial Artery Stenosis ASA + cilostazol versus ASA alone for patients with recent ischemic stroke due to moderate to severe intracranial stenosis,, follow up 2 years. Clopidogrel COMPRESS Combination of Clopidogrel and Aspirin for Prevention of Early Recurrence in Acute Atherothrombotic Stroke ASA + clopidogrel versus ASA alone for 30 days. CLASS-CHINA CHINA Clopidogrel Loading dosage to treat acute ischemic stroke in China Patient with recent (<48 hours) ischemic stroke randomized to clopidogrel 300 mg then 75 mg daily for 27 days, versus clopidogrel 75 mg then 75 mg daily for 27 days. Thromboxane receptor antagonist PERFORM Prevention of cerebrovascular or cardiovascular Events of ischemic origin with terutroban in patients with a history of ischemic stroke or transient ischemic attack. Randomized to aspirin or terutroban (thromboxane receptor antagonist) Thrombin receptor antagonist Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events Patients with recent atherothrombotic event (2 weeks 12 months) randomized to aspirin 81 to 162 mg daily versus SCH

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