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Accomplishments in Stroke Care

Accomplishments in Stroke Care. Patrick D. Lyden, MD UCSD Stroke Center VAMC San Diego. NIH Guidelines for Stroke Teams. • Door to doctor: 10 min • Door to CT scan: 25 min • Door to CT reading: 45 min • Door to drug: 60 minutes • Door to monitored bed: 3 hours. www.stroke-site.org

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Accomplishments in Stroke Care

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  1. Accomplishments in Stroke Care Patrick D. Lyden, MD UCSD Stroke Center VAMC San Diego

  2. NIH Guidelines for Stroke Teams • Door to doctor: 10 min • Door to CT scan: 25 min • Door to CT reading: 45 min • Door to drug: 60 minutes • Door to monitored bed: 3 hours www.stroke-site.org Proceedings of a National Symposium on Rapid Identification and Treatment of Acute Stroke December 12-13, 1996 NINDS Symposium, 2002

  3. Before Thrombolysis • Thornton Emergency • 120 Minutes after Stroke Start NINDS Symposium, 2002

  4. After Thrombolysis • Clinic Visit • 11 days after stroke NINDS Symposium, 2002

  5. Pivotal Trials NINDS Symposium, 2002

  6. Larger treatment effect = smaller sample size 12% Treatment Effect: 2.6% N=600 N=5000 Sample Size: NINDS Symposium, 2002

  7. Post-Pivotal Trials

  8. Relationship between Protocol Violations and ICH NINDS Symposium, 2002

  9. Current Use of thrombolysis • 1.8% Medicare Stroke patients • Range 2 to 3 % in many community surveys • 20 to 25% if Stroke Team NINDS Symposium, 2002

  10. The Innovation Effect: To Justify Innovation, first Indict the Status Quo • No vascular imaging in ECASS or NINDS • Need better thrombolytics • NINDS, “only 1 of which was +” • 2002, West J Med 176:198-199 • “We suggest randomly allocating patients into –our trial--. Details are available from the author’s web site” • Etc Etc NINDS Symposium, 2002

  11. The Innovation Effect Reduces Treatment • Non-specialists are confused • Does thrombolysis work or not? • Do I need an angiogram or not? • Do I need a PET or MRI scan or not? • Our bona fide disagreements may be magnified for nefarious purposes. • Payers who don’t want to pay • Regulators who don’t want to approve NINDS Symposium, 2002

  12. NINDS TPA Stroke Study: Time to Treatment and Odds Ratio of Favorable Outcome 8 7 6 5 Odds Ratio Favorable Outcome 4 3 2 Benefit for rt-PA 1 m No Benefit for rt-PA 0 60 70 80 90 100 110 120 130 140 150 160 170 180 Minutes Stroke Onset To Start of Treatment

  13. “Only a few stroke patients are eligible” • 27% of all stroke patients present within 3 hours. • Of these, many are excluded for “too mild”, rapidly improving, or CT showing EIC NINDS Symposium, 2002

  14. Mild Patients do Poorly • Of patients excluded from treatment for mild or rapidly improving symptoms, 32% were dead or dependent at discharge. • Of 15 patients excluded for CT abnormalities, only 4 (27%) were confirmed on retrospective review as valid exclusions Barber et al Neurology 2001;56:1015-20 NINDS Symposium, 2002

  15. Did Mild Patients Unbalance the Trial? • Patients NIHSS 0 to 5 were enrolled: • 42 in tPA, 16 in placebo • First NEJM paper was adjusted for this using Multi-variable methods • All subsequent papers likewise adjusted NINDS Symposium, 2002

  16. Favorable 3-month Outcome in NINDS Stroke Trial Odds ratios are adjusted for Age, baseline NIHSS, admission MBP, Diabetes, Early CT findings (Edema, hypodensity or intravascular thrombus), age x NIHSS, age admission MBP and center *Included two patients who were randomizedafter 180 minutes from strokeonset NINDS Symposium, 2002

  17. Is there a significant Effect? • Independent analysis (without data) suggests the imbalance produces 4% of the observed 12% treatment effect (ie 1/3) Wardlaw, Lindley, Lewis. West J. Med May 2002 176;198-199 NINDS Symposium, 2002

  18. NINDS Symposium, 2002

  19. CT Findings Do Not Exclude NINDS Symposium, 2002 Patel, et al JAMA 2001

  20. No EIC (n=46 plac, 38 SK) EIC <1/3 (n=45 plac, 37 SK) EIC >1/3 (n=45 plac, 49 SK) SK* (n=34 heme, 236 no heme) sBP* ‘’ 0 0.1 1.0 10 100 * After multivariate adjustment Cerebral Hemorrhage in the Australian Streptokinase Trial OR (CI) for PH1 and 2 NINDS Symposium, 2002 Stroke 2002;33:2236-2242

  21. NINDS Symposium, 2002

  22. Ethos Stroke Registry • 15,500 Patient Records in Internet Registry • Over 100 hospitals • Represents Hospitals focusing on Acute Stroke Treatment • Average Age: 74 Male: 72 Female: 76 • Gender of Pts: Male: 44% Female: 56% • Ethnicity: White 83%Black 12% Hispanic 1% Asian 0.6% Other 0.8% Unk 2& NINDS Symposium, 2002

  23. Ethos—tPA Treated • Ischemic Stroke Pts rec’d IV-tpa 6.3% • Systemic Hemorrhage <48hrs/TX 6.6% NINDS Symposium, 2002

  24. Ethos—Reasons for Non-treatment with tPA • Time 39.2% • CT findings 13.1 • Rapid Improvement 13.0 • Stroke Severity 5.3 • Age 3.7 • Uncontrolled Hypertension 2.1 • Unknown 8.8 NINDS Symposium, 2002

  25. Ethos—Onset to ED Arrival • 0-1 hour 12.9% • 1-2 hours 9.9 • 2-3 hours 5.7 • 3-4 hours 3.5 • 4-5 hours 2.5 • 5-6 hours 1.6 • > 6 hours 24.2 • Unknown/ND 39.6 NINDS Symposium, 2002

  26. Ethos—Time to Treatment NINDS 0-3 hr arrival 3-6 hr Onset to ED N/A 69 250 1st Seen by MD 10 10 18 Image Initiated 25 44 63 Results Rcvd 45 72 96 TX Given 60 91 N/A (times are in minutes and are Median times) NINDS Symposium, 2002

  27. Summary • tPA within 3 hours is effective and safe, but underutilized, partly due to the innovation effect • Improvement must follow wider application of routine 3-hour use of IV tPA for acute stroke NINDS Symposium, 2002

  28. ED Physicians can safely use tPA for acute stroke (3-month Rankin scores) NINDS ER Docs Neuro % Patients with mRankin Scale 0 to 5 Akins et al Neurology 2000;55:1801-05 NINDS Symposium, 2002

  29. Volume improves outcome:Trauma Experience NINDS Symposium, 2002

  30. Some General Management Issues • Oxygen • Hyperthermia • Glucose • Blood Pressure • Heparin NINDS Symposium, 2002

  31. www.humanapress.com NINDS Symposium, 2002

  32. Shall We Implement What We Have? • It seems reasonable to proceed with what we have recognizing: • 1. The need for innovation • 2. The need for furtherstudies: especially IST-3, ECASS-3, SITS-MOST, DIAS, etc. • 3. A target of 12% of all strokes has been shown to be feasible with current methods. NINDS Symposium, 2002

  33. NIHSS Placebo T-PA 0-1 2-8 > 8 Death Barthel Placebo T-PA 100-95 90-55 50-0 Death Effect of tPA in the Oldest, Most Severe Patients (49 patients found on admission to have age>75 and NIHSS > 20) Generalized Efficacy of t-PA for Acute Stroke: Subgroup Analysis of the NINDS t-PA Stroke Trial.Stroke 28(11):2119-2124, 1997

  34. ECASS 2 Placebo T-PA ECASS 1 Placebo T-PA % Patients with mRankin Scale 0 to 5 NINDS Symposium, 2002

  35. STARS: Phase 4 Experience • N= 389 • Time to treat 2h 45m • 30 day Mortality 13% • Favorable Outcome 35% • Hemorrhage in 3.3% JAMA 2000, 283:1145-1150, Albers et al NINDS Symposium, 2002

  36. Questions NINDS Symposium, 2002

  37. Intracerebral Hemorrhage Rates After IV t-PA NINDS Symposium, 2002

  38. Community Experience • Houston • 3 hospitals (1 University) • One year after t-PA results published • Followed protocol • Treated 30/267 stroke codes with t-PA • Favorable Outcome in 37% • Symptomatic Hemorrhage in 7% NINDS Symposium, 2002

  39. Further Experience in Houston NINDS Symposium, 2002

  40. Risk of ICH by Deviation from NINDS Protocol p=0.59 p=0.06 NINDS Symposium, 2002

  41. Atlantis Study • Treatment with 0.9 mg/kg over one hour (Total N = 613) • Target population (N=547) - patients treated within 3-5 hours NINDS Symposium, 2002

  42. Atlantis Study - Results

  43. Vancouver Hospital • Stroke Team QA survey • 1996 to 1999 saw n=29 plus transfers n=17 (1.8% of all strokes) • Hemorrhage rate 2.2% • Response rate 43% (Rankin) Chapman et al Stroke 2000;31:2920-24 NINDS Symposium, 2002

  44. Cleveland Area Study • 5000 strokes in one year • 4345 Ischemic • 17% within 3 hours • 70 (1.8%) got tPA • Range 0 to 10.2% • Protocol Deviations in 50% • Anti-coagulants 37% • Hypertension 7% NINDS Symposium, 2002

  45. STAT Study Placebo Ancrod % Patients with Barthel Index Scores NINDS Symposium, 2002

  46. TNK: A New Clot-Buster NINDS Symposium, 2002

  47. NSA Guidelines for Stroke Centers 1. The Center has an established EMS protocol for the emergency treatment and delivery of stroke patients. 2.      All members of the stroke team comply with the availability and response requirements of a 24 hour Stroke Center. 3.      The Center has a written stroke team activation protocol that establishes the criteria for notification of the stroke team and identification of acuity or degree of symptoms of stroke. The protocol should also identify the stroke team members who are to be notified when a stroke patient is enroute or has arrived at the facility. www.stroke.org NINDS Symposium, 2002

  48. Studies Prior to Pivotal * NIHSS >=4 points at 24 hours NINDS Symposium, 2002

  49. NIH Guidelines for Stroke Teams • Door to doctor: 10 min • Door to CT scan: 25 min • Door to CT reading: 45 min • Door to drug: 60 minutes • Door to monitored bed: 3 hours www.stroke-site.org Proceedings of a National Symposium on Rapid Identification and Treatment of Acute Stroke December 12-13, 1996 NINDS Symposium, 2002

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