44TH ANNUAL RECENT ADVANCES IN NEUROLOGY

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1 Presenter Disclosure Information J. Donald Easton, MD Clinical Professor of Neurology February 17, TH ANNUAL RECENT ADVANCES IN NEUROLOGY TIA: Definition, Evaluation, and Treatment J. Donald Easton, MD TIA: Definition, Evaluation and Treatment FINANCIAL DISCLOSURE None UNLABELED/UNAPPROVED USES DISCLOSURE None 2 The Purpose of the Statement Easton JD, Saver JL, Albers GW, et al. Stroke 2009 (Jun);40: Recent scientific studies have revised our understanding of 3 key aspects of TIA how it is best defined what the early risk of stroke and other vascular outcomes is how it is best evaluated This statement reviews and synthesizes recent scientific advances regarding the definition, urgency, and evaluation of TIA and is designed to aid the clinician in the short- and long-term management of patients with TIA 4 1

2 Traditional Definition of TIA The Rationale for the Statement a sudden, focal neurologic deficit that lasts for less than 24 hours, is presumed to be of vascular origin, and is confined to an area of the brain or eye perfused by a specific artery New data show the 24 hour definition is misleading many <24 hour events cause infarction multiple studies document the 24 hour limit does not reflect the typical duration of transient ischemic events A Classification and Outline of Cerebrovascular Diseases II Stroke 1975;6; Percent Duration of Symptoms and Proportion with DWI Positivity Pooled Data from 10 MRI Studies; N=818 New AHA/ASA Definition for TIA A transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction This is a tissue- rather than time-based definition that harmonizes cerebrovascular nosology with other ischemic conditions and encourages use of neurodiagnostic tests to identify brain injury and vascular pathology Duration of Symptoms (Hours) Easton JD, Saver JL, Albers GW, et al. Stroke 2009 (Jun);40: Easton JD, Saver JL, Albers GW, et al. Stroke 2009 (Jun);40:

3 Features of the Traditional and New Definitions of TIA Traditional, Time-Based Definition Based on an arbitrary 24-hour time limit Suggests transient ischemic symptoms are benign Promotes diagnosis on the basis of the temporal course rather than pathophysiology Fosters delays in interventions for acute cerebral ischemia Inaccurately predicts the presence or absence of ischemic brain injury Diverges from the distinction between angina and myocardial infarction New, Tissue-Based Definition Based on the presence or absence of a biologic end point Indicates that transient ischemic symptoms can cause permanent brain injury Encourages use of neurodiagnostic tests to identify brain injury and its cause Facilitates rapid interventions for acute brain ischemia More accurately reflects the presence or absence of ischemic brain injury Consistent with the distinction between angina and myocardial infarction 9 The Rationale for the Statement New data show the 24 hr definition is misleading many <24 hr events cause infarction multiple studies document the 24 hr limit does not reflect the typical duration of transient ischemic events New data emphasize the high short-term risk of stroke after TIA brief review of clinical (not imaging) data as a prelude to ongoing trials Short-term Prognosis After TIA Northern California Kaiser N= 1707 Outcomes at 90 days Short-term Prognosis After TIA Northern California Kaiser Stroke-Free Survival 10.5% stroke (1/2 <2 days) 14.6% other adverse outcomes 2.6% death 2.6% hospitalization 12.7% recurrent TIAs Johnston SC, Gress DR, Browner WS, Sidney S. JAMA 2000;284: Johnston SC, Gress DR, Browner WS, Sidney S. JAMA 2000;284:

4 Short-term Stroke Risk After TIA Year N Stroke Risk Whisnant, et al (Mayo) %/90d Biller, et al (Iowa) %/6d (exp 4%) Putnam & Adams (Iowa) %/6d (exp 5%) Johnston, et al (Kaiser ED) %/90d Eliasiew, et al (NASCET) %/90d Lovett, et al (Oxfordshire) %/30d Gladstone, et al (Toronto) %/30d (readm) Daffertshofer, et al (Grmy) %/180d Hill, et al (Alberta) %/90d Lisabeth, et al (Texas) %/90d Kleindorfer, et al (Cinc) %/90d Whitehead, et al (Scotld) %/30d Correia, et al (Portugal) %/7d Tsivgoulis, et al (Greece) %/30d Purroy, et al (Spain) %/7d Mielke, et al (Germany) %/11d Prediction Rules California Score Age >60 yrs (1) Diabetes (1) Duration >10 min (1) Any Weakness (1) Speech impairment (1) Final score 0-5 AVERAGE ~12% stroke risk in 90 days after TIA 5% in first 2 days Johnston SC, Gress DR, Browner WS, Sidney S. JAMA 2000;284: Short-term Prognosis After TIA Northern California Kaiser Stroke-Free Survival, stratified by points Prediction Rules California Score Age >60 yrs (1) Diabetes (1) Duration >10 min (1) Any Weakness (1) Speech impairment (1) ABCD Score Age >60 yrs (1) Blood Pressure SBP >140 or DBP>90 (1) Clinical Unilateral weakness (2) Speech disturbance w/o weakness (1) Duration >60 min (2) min (1) Johnston SC, Gress DR, Browner WS, Sidney S. JAMA 2000;284: Final score 0-6 Final score 0-5 Johnston et al JAMA :2901 Rothwell et al Lancet :29 4

5 ABCD 2 Score Score points for each of the following Age >60 (1) Blood pressure >140/90 on initial evaluation (1) Clinical Focal weakness (2) Speech impairment without weakness (1) Duration >60 min (2) min (1) Diabetes (1) Final Score 0-7 Johnston, Rothwell, et al, Lancet, 369:283, 2007 ABCD2I collaboration: an analysis of unpublished data on 4574 patients. Giles MF, Albers GW, Amarenco P, Arsava MM, Asimos A, Ay H, Calvet D, Coutts S, Cucchiara BL, Demchuk AM, Johnston SC, Kelly PJ, Kim AS, Labreuche J, Lavallee PC, Mas JL, Merwick A, Olivot JM, Purroy F, Rosamond WD, Sciolla R, Rothwell. Neurology, under review, 2011 TIAs Treatment of TIA Definition Short-term prognosis Diagnosis of high-risk TIA Evaluation Implications for treatment Conventional Carotid intervention (endarterectomy or A/Stent) Anticoagulation for cardioembolism Antiplatelet therapy Hyeracute Antiplatelet therapy The POINT Trial (CHANCE Trial in China) 5

6 Conventional Antiplatelet Treatment to Prevent Stroke What we know ASA reduces ischemic stroke risk (Antithrombotic Trialists) Clopidogrel (CAPRIE), ASA + dipyridamole (ESPS-2, ESPRIT), Ticlopidine (TASS) & Cilostazol (CSPS-2) are more effective than ASA Clopidogrel is at least as effective as ASA + dipyridamole with less serious bleeding (PRoFESS) Clopidogrel + ASA not more effective than clopidogrel alone (MATCH) N= 20,333 End point ASA+DP, n (%) CPL, n (%) Hazard Ratio (95% CI) Stroke recurrence Sacco RL, et al. N Engl J Med, 2008;359:1-14 P-value 916 (9.0) 898 (8.8) 1.01 ( ) % more bleeding on DP + ASA than on clopidogrel Conventional Antiplatelet Treatment to Prevent Stroke What we also know Clopidogrel + ASA, ticlopidine + ASA & cilostazol + ASA vs. ASA alone have not been studied adequately in cerebrovascular patients Clopidogrel + ASA very effective in several coronary artery conditions Clopidogrel + ASA Shows Major Benefits Over ASA alone, primarily in ACS & A/S CLASSICS (Clopidogrel Aspirin Stent International Cooperative Study) CURE (Clopidogrel in Unstable Angina to Prevent Recurrent Events) CREDO (Clopidogrel for the Reduction of Events During Observation) in PCI CLARITY (Clopidogrel as Adjunctive Reperfusion Therapy) Addition of clopidogrel to ASA & fibrinolysis in ST-segment elevation MI) COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) CARESS (Clopidogrel & Aspirin for Reduction of Emboli in Symptomatic carotid Stenosis) CHARISMA (Stroke subgroup; n= 4320)- controversial 6

7 Let s Talk About Hyper-acute TIA Time is brain Recovery after Ischemia FASTER Pilot Trial Stroke Neurologic Deficit TIA Time Stroke? Johnston SC, Easton JD. Are patients with acutely recovered cerebral ischemia more unstable? Stroke. 2003;34: N= 396 Stroke Risk at 90 days 10.8% placebo vs. 7.1% clopidogrel 34% RRR Composite outcome (stroke, MI, vascular death) 11.9% placebo vs. 8.6% clopidogrel 28% RRR A trend toward efficacy 7

8 Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) ABCD 2 Score and Stroke Risks Randomized, double-blind, placebo controlled trial of acute TIA (ABCD 2 score >4) or minor ischemic stroke (NIHSS <3) Clopidogrel (600 mg load then 75/day) vs. placebo Background aspirin at dose mg/day Event onset <12 hours, no low-yield TIAs Primary outcome (the cluster of ischemic stroke, MI, ischemic vascular death) at 90 days 4150 patients at 150 U.S. centers Partner with NINDS NETT and POINT Clinical Research Collaboration NINDS/NIH: PI is S. Claiborne Johnston Johnston, Rothwell, et al, Lancet, 369:283, 2007 Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Rationale for dual antiplatelet therapy Cerebrovascular patients bleed on dual therapy MATCH- clopidogrel & aspirin ACTIVE A- clopidogrel & aspirin PRoFESS- dipyridamole & aspirin TRITON- clopidogrel/prasugrel & aspirin TRA 2 P TIMI 50- clopidogrel & aspirin & vorapaxar Stopped early for cerebrovascular patients POINT patients are different High-risk for thrombosis, low-risk for bleeding Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Group 1 N=2075 Patients with TIA or minor ischemic stroke within 12 h of sx onset Group 2 N=2075 R Loading Dose Clopid 600 mg ASA mg Placebo ASA mg Clopidogrel 75 mg from Day 2 to Day 90 ASA mg from Day 2 to Day 90 Day 7 Phone F/U (7+2 days) Day 7 Open label ASA- dose at discretion of investigator Placebo from Day 2 to Day 90 ASA mg from Day 2 to Day 90 ClinicalTrials.gov identifier: NCT Final Visit (90+14 days) 8

9 POINT Enrollment- 31-Dec Conclusions Recent scientific studies have revised our understanding of 3 key aspects of TIA How it is best defined The early risk of stroke & other vascular outcomes How it is best evaluated 150 The clinical implications Q Q Q Q Q Projected Actual High-risk TIAs and minor strokes lead to stroke quickly not all TIAs are high risk TIAs require early evaluation by experts High-risk TIAs require early treatment Carotid endarterectomy Warfarin for AF Optimal antithrombotic therapy (?) AHA/ASA Recommendations Antiplatelet Therapy Class I Recommendations Thank you for your attention! For patients with non-cardioembolic ischemic stroke or TIA, Aspirin (50 to 325 mg/d) monotherapy, the combination of aspirin and extended-release dipyridamole, and clopidogrel monotherapy are all acceptable options for initial therapy (Class I, Level of Evidence A) The combination of aspirin & extended-release dipyridamole is recommended over aspirin alone (Class I, Level of Evidence B) Update American Stroke Assoc Guidelines for Stroke Prevention in Stroke and TIA patients. Stroke. 2008:39;

10 AHA/ASA Recommendations Antiplatelet Therapy Class I Recommendations For patients with non-cardioembolic ischemic stroke or TIA, Aspirin (50 to 325 mg/d) monotherapy, the combination of aspirin and extended-release dipyridamole, and clopidogrel monotherapy are all acceptable options for initial therapy (Class I, Level of Evidence A) The combination of aspirin & extended-release dipyridamole is recommended over aspirin alone (Class I, Level of Evidence B) PRoFESS-aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke Furie KL, Kasner SE, Adams RJ, et al. Guidelines for the Prevention of Stroke in Patients With Stroke or Transient Ischemic Attack. 2011;42: SPS-3 (clopidogrel vs. placebo in lacunar stroke patients receiving aspirin; n=3,000 [2738 now]) POINT (clopidogrel vs. placebo in TIA or mild ischemic stroke; n=4,150 [156 now]) CHANCE (clopidogrel in High-risk Patients With Acute Nondisabling Cerebrovascular Event; n=5,100 [>3000 now]) FASTER 2 (clopidogrel vs. placebo in TIA or mild ischemic stroke) CATHARSIS (Cilostazol-Aspirin Therapy Against Recurrent Stroke With Intracranial Artery Stenosis; cilostazol v. placebo, n=200) TOSS-2 (Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis II; cilostazol v. clopidogrel, n=480 [completed]) 37 Conclusions: TIA and Minor Stroke The Implications High-risk TIAs and minor strokes lead to stroke quickly Not all TIAs are high risk TIAs require early evaluation by experts High-risk TIAs & minor strokes require early treatment Carotid endarterectomy/stent Anticoagulation for AF Optimal antithrombotic therapy (?) 10

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