Secondary Stroke Prevention: A Precautionary Tale

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1 Secondary Stroke Prevention: A Precautionary Tale Kirsten George-Phillips, BSP Clinical Practice Leader, AHS Clinical Pharmacist, AHS Owen Stroke Prevention Clinic

2 Learning Objectives! Examine literature available using combined ASA + Clopidogrel in Secondary Stroke Prevention! Discuss extended monitoring for AF and treatments being explored for Embolic Stroke of Unknown Source (ESUS)! Determine what antithrombotic therapy should be used in patients with AF + stroke + stable CAD! Discuss future antithrombotic options in secondary stroke prevention

3 Disclosures! I have no current or past relationships with commercial entities! Speaking Fees for current program: I have received a speaker s fee from CSHP for this learning activity! I have no financial disclosures or conflicts of interest to report

4 Prologue! Stroke is a leading cause of death, disability and hospitalizations! Rates of stroke after TIA/stroke at 3 months is up to 20% 3.7% We are doing at better job at prevention NEJM 2016; 374:

5 Prologue Antiplatelet Blood Pressure Lipids Diabetes Anticoagulant Modifiable Risk Factors Diet Weight Exercise Sleep Apnea Antiplatelet Smoking Alcohol BCP/HRT

6 Chapter 1: Single or Dual? ASA or ASA + Clopidogrel in Secondary Stroke Prevention

7 Dual Antiplatelet Therapy! ASA + clopidogrel inhibit platelet aggregation synergistically! Dual therapy reduces risk of recurrent ischemia in patient with ACS Eur Heart J 1998; 19: ; NEJM 2001; 345: ; JAMA 2002; 288:

8 MATCH (2004) CHARISMA (2006) SPS3 (2012) P: 7599 patients with recent stroke + >1 risk factor 49% of patients were randomized from day 7-31 I: Clopidogrel 75mg + ASA 75mg daily 15,603 patients with CV disease or multiple risk factor Clopidogrel 75 + ASA mg daily 3020 patients with symptomatic lacunar stroke From days of stroke onset Clopidogrel 75mg + ASA 325mg daily C: Clopidogrel 75mg daily ASA mg daily ASA 325mg daily O: 1 0 Efficacy - ischemic event: 16% vs 17% (p=0.244) Safety Life-threatening bleeding: 3% vs 1% (RR,1.26; 95% CI, ; p <0.0001) 1 0 Efficacy - composite of MI, stroke, death from CV: 6.8% vs 7.3% (RR, 0.93; 95% CI, ; p = 0.22) 1 0 Safety - Severe bleeding: 1.7% vs 1.3% (RR,1.25; 95% CI, ; p = 0.09) 1 0 Efficacy - stroke recurrence: 2.5%/yr vs 2.7%/yr (HR 0.92;95% CI ) 1 0 Safety - Major hemorrhage: 2.1% vs 1.1% (HR 1.97; 95% CI, ; p<0.001) Lancet 2004; 364(9431): NEJM 2012; 367: ; NEJM 2006; 354:

9 Is Timing Everything? MATCH Lancet 2004; 364(9431):

10 CARESS (2005) FASTER (2007) CLAIR (2010) P: 107 patients with >50% carotid stenosis with ipsalateral symptoms (stroke/tia) within last 3 months I: Clopidogrel 300mg X 1, 75mg + ASA 75mg daily X 7 days 392 patient within 24 hours of symptom onset of TIA or minor stroke Clopidogrel X 300mg, 75mg daily + ASA 162mg X1 then 81mg daily X 90 days C: ASA 75mg daily X 7 days ASA 162mg X1 then 81mg daily X 90 days O: 1 0 Efficacy microemboli signals (MES) on transcranial doppler (TCD) Day 7: 43.8% vs 72.7% (RRR 39.8%; 95% CI, ; p=0.0013); No stroke, 4 TIAs, vs 4 recurrent stroke, 7 TIAs 1 0 Efficacy stroke within 90 days: 7.1% vs 10.8% (RR 0.7; 95% CI ) 100 patients with acute ischemic stroke/tia with large artery stenosis in cerebral of carotid arteries that had MES on TCD Clopidogrel 300mg X 1, 75mg + ASA mg daily X 7 days ASA mg daily X 7 days 1 0 Efficacy Day 2: 14/45 vs 27/50 had >1 microemboli signals (MES) on transcranial doppler (TCD) (RRR 42.4%, 95% CI, ; p=0.025) 2 patients vs 0 ICH 2 minor vs no hemorrhage Circulation 2005; 111(17): Lancet Neurol 2007; 6(11): Lancet Neurol 2010; 9(5):

11 Take a CHANCE? P: 5170 patients with acute minor stroke (NIHSS <3) or high risk TIA and able to start study drug within 24 hours of symptom onset Day 1 Days 2 21 Days I: Clopidogrel 300mg Clopidogrel 75mg R ASA mg ASA 75mg ASA 75mg Placebo ASA C: Placebo Clopidogrel Wang Y et al. N Engl J Med 2013;369:11-19.

12 Take a CHANCE? O: 1 0 Efficacy and Safety:! new stroke (ischemic or hemorrhagic) confirmed by imaging at 90 days! moderate to severe bleeding event as per GUSTO definition 2 0 Efficacy:! Composite and individual outcomes: ischemic stroke, hemorrhagic stroke, MI, or vascular death Wang Y et al. N Engl J Med 2013;369:11-19.

13

14 Wang Y et al. N Engl J Med 2013;369:11-19.

15 Can We Take a CHANCE? Applicability?! Different population Rate of stroke Large vs small vessel Access to care Polymorphism! ASA more common Patient population?! High risk TIAs and low risk stroke (NIHSS <3)! Low bleeding risk! Early presentation that can have ASA and clopidogrel initiated <24 hours Significant benefit with low risk of adverse effects Wang Y et al. N Engl J Med 2013;369:11-19.; Int J Stroke 2006; 1:158-9.

16 Secondary Prevention Guidelines Canadian Best Practice Guidelines:! Short-term concurrent use of ASA and clopidogrel (up to 90 days) has not shown an increased risk of bleeding (Evidence Level A); longer-term use of ASA and clopidogrel is not recommended, unless there is an alternate indication (e.g. drug-eluting stent requiring dual antiplatelet therapy) (Evidence Level A) AHA/ASA Executive Guidelines:! For patients with recent stroke or TIA (within 30 days) attributable to severe stenosis (70% 99%) of a major intracranial artery, the addition of clopidogrel 75 mg/d to aspirin for 90 days might be reasonable (Class IIb; Level of Evidence B). Int J Stroke (2): Stroke (4): 1-96.

17 Practice Tips What are we seeing in practice?! Everything! Inappropriate and appropriate indication and duration What do we need to do as pharmacists?! Initiate therapy in the acute phase (<24 hours) when indicated (minor stroke or TIA, low bleed risk patient)! Ensure clopidogrel discontinued within days! Monitor for adverse effects! Counsel patient on proper administration and importance of compliance! Communicate with community providers

18 Get to the POINT (2020?) Population CHANCE POINT High risk TIA or stroke Multicentre in China 210 sites worldwide Intervention Treat within 24 hours Clopidogrel load: 300mg 21 day treatment with dual Comparator Clopidogrel ASA Treat within 12 hours Clopidogrel load: 600mg 90 day treatment with dual Outcomes 1 0 efficacy: Stroke 1 0 efficacy: Stroke Wang Y et al. N Engl J Med 2013;369:

19 Chapter 2: Who s the Villian? Antithrombotic Treatment Based on Cause of Stroke

20 Ischemic Stroke:! The Usual Suspects Cerebrovascular Atherosclerosis Atrial Fibrillation Carotid Atherosclerosis Are we able to identify all patients with AF using a 24 hour holter? 24 hour Holter Monitor Carotid Doppler or CT Angiogram

21 Extended Monitoring for AF Study Investigation Group n Duration (days) EMBRACE Usual * % AF Detected (%) Intensive % (NNT/screen = 8; 95% CI, ; p<0.001) CRYSTAL-AF Usual * 220 ~ % Intensive % (HR = 6.4; 95% CI, ; p<0.001) * 12 lead ECG and Holter ECG monitoring for hours Event-triggered loop recorder attached Subcutaneous ECG monitoring with an implanted device for up to 3 years NEJM 2014; 370: NEJM 2014; 370: Nat Rev Cardiology 2014; 11:

22 Embolic Strokes of Undetermined Source (ESUS)! Cryptogenic stroke have been reported to account for 25-32% of all strokes! Events now thought to be embolic originating from cardiac, veins via paradoxical embolism, nonocclusive atherosclerotic plaques! Although outcomes are similar to strokes from large and small vessel stenosis, patients have fewer risk factors! Secondary prevention efforts are now focused on antithrombotic therapy Lancet Neuro (4):

23 Let the Punishment Fit the Crime! Cause: Clot Type: Treatment: Carotid atherosclerosis Cerebrovascular atherosclerosis Atrial Fibrillation White clot White clot Red clot Antiplatelet Antiplatelet Anticoagulant ESUS Red clot???? TBD

24 Coming Soon. NAVIGATE and RESPECT ESUS Population RESPECT - ESUS NAVIGATE - ESUS Patients with ESUS; No AF detected Intervention Dabigatran 110mg po bid or 150mg po bid Rivaroxaban 15mg po daily Comparator ASA 100mg po daily ASA 100mg po daily Outcomes Time to recurrent stroke Time to first occurrence of stroke or systemic embolism =NAVIGATE&rank=4;

25 Secondary Prevention Guidelines Canadian Best Practice Guidelines:! In cases where the ECG or initial 24 or 48 hr holter does not show AF but a cardioembolic mechanism is suspected, prolonged ECG monitoring is recommended (Evidence Level B). Canadian AF Guidelines:! For patients being investigated for an acute embolic ischemic stroke or TIA, we recommend at least 24 hours of ECG monitoring to identify paroxysmal AF (Strong Recommendation, Moderate-Quality Evidence)! For selected older patients with ESUS for which AF is suspected but unproven, we suggest additional ambulatory monitoring (beyond 24 hours) for AF detection (Conditional Recommendation, Moderate-Quality Evidence). Int J Stroke (2): ; CJC (10):

26 Practice Tips What are we seeing in practice?! Extended monitoring of stroke/tia patients suspected of AF or ESUS (when available)! Extended holters (up to 30 days), implantable loop recorders What do we need to do as pharmacists?! Initiate anticoagulation therapy when AF detected individualizing therapy to each patient! Counsel patient on benefits of therapy, potential adverse effects, proper administration, and importance of compliance! Ensure appropriate monitor for adverse effects! Communicate with community providers! Stay tuned for new possible new treatment options for ESUS

27 Chapter 3: Cow or Beans? Difficult Decision Stroke + AF + CAD Should ASA be continued with OAC?

28 Once Upon a Time! Jack was admitted to Faraway Kingdom Hospital with a leg fracture after an incident involving a beanstalk and a giant! Jack s PMH included ACS with PCI (2013), AF and stroke (2015)! The orthopedics pharmacist noted postoperatively that prior to admission Jack was receiving both ASA and DOAC therapy

29 CJC 2014; 30(10): * We suggest NOAC be used in preference to warfarin in patients with NVAF

30 Combined Warfarin + ASA! Systematic review of RCTs comparing OAC + ASA versus OAC alone: No reduction in thromboembolic risk in AF (OR, 0.99; 95% CI, ) or CAD (OR, 0.69; 95% CI, ) Risk of major bleeding higher in OAC + ASA (OR, 1.43; 95% CI, )! Post-hoc analysis NVAF patients in SPORTIF III and IV receiving warfarin + ASA vs warfarin alone: No reduction in stroke or systemic embolism (1.55% vs 1.7%; p=0.78) Major bleeding increased (3.9% vs 2.3%; p<0.01) Arch Intern Med 2007; 167(2): Am Heart J 2006; 152(5):

31 Bleed Risk - Single, Dual, or Triple! Cohort trial of Danish patients hospitalized with AF! Followed 82,854 patients for 3.3 years! 11.4% (13,573) had bleeding events (fatal and non) Agents HR 95% CI Warfarin ASA Clopidogrel ASA + Clopidogrel Warfarin + ASA Warfarin + Clopidogrel Warfarin + ASA + Clopidogrel Arch Intern Med 2010; 170(16):

32 Apixaban + ASA Warfarin + ASA Apixaban with concomitant ASA! 24% of patients in ARISTOTLE received ASA in addition to randomized therapy! Post-hoc analysis examined efficacy and safety with and without ASA Rate of Stroke/SE (%) HR (95% CI) 1.12% 0.58 ( ) 1.91% 3.92 Rate of Major Bleed Eur Heart J 2014; 35: HR (95% CI) ( ) Apixaban 1.11% 0.84 ( (0.55- Warfarin 1.32% 1.07) )

33 Dabigatran with concomitant ASA! 27% of patients in RE-LY received ASA in addition to randomized therapy! Post-hoc analysis examined efficacy and safety +/- ASA Dabi 150mg bid + ASA Warfarin + ASA Dabi 150mg bid Rate of Stroke/SE HR (95% CI) 1.68 %/yr 0.80 ( ) 2.1%/yr 0.77 %/yr 0.52 ( ) Rate of Major Bleed HR (95% CI) 4.4 %/yr 0.93 ( ) 4.8 %/yr Warfarin 1.47 %/yr 2.8 %/yr 2.6 %/yr 0.94 ( )

34 Dabigatran with concomitant ASA CV Death HR (95% CI) Dabi 150mg bid + ASA 2.63 %/yr 0.78 Warfarin + ASA 3.36%/yr ( ) Dabi 150mg bid 2.07 %/yr 0.91 Warfarin 2.28 %/yr ( ) Addition of ASA to Dabigatran 150mg bid: Increased rate of Stroke/ SE Increased risk of major bleeding Increased risk of CV Death

35 Guidelines: AF + CAD CHEST AF Guidelines (2012):! Stable CAD: presence (or absence) of angina but no revascularization or hospitalizations for ACS in the past year! For patients with AF and stable coronary artery disease (eg, no acute coronary syndrome within the previous year) and who choose oral anticoagulation, we suggest adjusted-dose VKA therapy alone (target INR range, ) rather than the combination of adjusted-dose VKA therapy and aspirin (Grade 2C). CHEST 2012; 141(2 suppl):e531s-575s.

36 Guidelines: OAC + Antiplatelet AHA/ASA Secondary Stroke Prevention Guidelines (2014):! The combination of oral anticoagulation (ie, warfarin or one of the newer agents) with antiplatelet therapy is not recommended for all patients after ischemic stroke or TIA! Combination is reasonable in patients with clinically apparent CAD, particularly an acute coronary syndrome or stent placement. (Class IIb; Level of Evidence C).! Unstable angina and coronary artery stenting represent special circumstances in which management may warrant DAPT/VKA therapy. (New recommendation) Stroke :

37 CCS: AF with Stable CAD/ Vascular Disease CJC :

38 What are the possible options in AF + ACS? C. Michael Gibson JACC 2017;69: American College of Cardiology Foundation

39 CCS: AF with NSTEACS or STEMI CJC :

40 Practice Tips What are we seeing in practice?! Clinicians hesitant to reassess ASA as it was ordered by a specialist! Patients with ~2X higher bleed risk due to unnecessary ASA therapy What do we need to do as pharmacists?! Reassess ongoing need for ASA in addition to OAC! When necessary contact specialists to discuss discontinuation of ASA! If decision is made to discontinue ASA, take necessary actions to ensure discontinuation including patient education and communication with community providers! Document the intervention including rationale and any collaboration during decision making

41 Chapter 4: Travel to the Next Dimension The Future of Antithrombotic Therapy

42 Coming Soon. TARDIS (Date TBA) CHANCE and POINT TARDIS Population High risk TIA or stroke High risk TIA or Stroke Intervention Treat within 24 or 12 hours Clopidogrel load followed by 21 or 90 days with Clopidogrel + ASA Triple therapy with Clopidogrel + ASA + dipyridamole 200mg bid for days Comparator Clopidogrel or ASA Clopidogrel or ASA + dipyridamole Outcomes 1 0 efficacy: Stroke 1 0 efficacy: Stroke Wang Y et al. N Engl J Med 2013;369:

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