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

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Presentation on theme: "Accomplishments in Stroke Care Patrick D. Lyden, MD UCSD Stroke Center VAMC San Diego."— Presentation transcript:

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

3 NINDS Symposium, 2002 NIH Guidelines for Stroke Teams Proceedings of a National Symposium on Rapid Identification and Treatment of Acute Stroke December 12-13, 1996 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

4 NINDS Symposium, 2002 Before Thrombolysis Thornton Emergency 120 Minutes after Stroke Start

5 NINDS Symposium, 2002 After Thrombolysis Clinic Visit 11 days after stroke

6 NINDS Symposium, 2002 Pivotal Trials YearSeriesN (tPA)SICHOutcome 1995ECASS620 (313)29.3% (35.7%) 1995NINDS Parts (312)0.6% (6.4%) 26% (39%) 1997ECASS II800 (409)3.4% (8.8%) 36.6% (40.3%) 2000STAT500 (248)2% (5%)34.4% (42.2%) 1988Asset4975 (2516) 0.4% (1.4%) (7.2%) 9.8% mortality

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

8 Post-Pivotal Trials YearSeriesNSICHOutcome 1998Cologne1005%40% 1999Oregon % 2000Lyon2004%45% 2000STARS3893.3%11.5% 2000Vancouver462.2%43% 2001Berlin752.7%40% 2001Barber847.1%54% 2001Houston2695.6%Impr NIHSS 2002CASES %46%

9 NINDS Symposium, 2002 Relationship between Protocol Violations and ICH StudyTimeRxBPCoagICHP STARS 41%33%25%18%3%NS Cleveland 27%74%14%16%? Houston 10%7%NS Calgary 9% <0.05 USA8%15%3%4%6%NS Indianapolis 25%13%25%10%<0.02

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

11 NINDS Symposium, 2002 The Innovation Effect 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: –“ We suggest randomly allocating patients into –our trial--. Details are available from the author’s web site”  Etc Etc

12 NINDS Symposium, 2002 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

13 NINDS TPA Stroke Study: Time to Treatment and Odds Ratio of Favorable Outcome Minutes Stroke Onset To Start of Treatment Odds Ratio Favorable Outcome  Benefit for rt-PA No Benefit for rt-PA

14 NINDS Symposium, 2002 “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

15 NINDS Symposium, 2002 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:

16 NINDS Symposium, 2002 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

17 NINDS Symposium, 2002 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 randomized after 180 minutes from stroke onset

18 NINDS Symposium, 2002 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 ;

19 NINDS Symposium, 2002

20 CT Findings Do Not Exclude Patel, et al JAMA 2001

21 NINDS Symposium, 2002 Stroke 2002;33: Cerebral Hemorrhage in the Australian Streptokinase Trial OR (CI) for PH1 and 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* ‘’ * After multivariate adjustment

22 NINDS Symposium, 2002

23 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&

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

25 NINDS Symposium, 2002 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

26 NINDS Symposium, 2002 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

27 NINDS Symposium, 2002 Ethos—Time to Treatment NINDS 0-3 hr arrival 3-6 hr Onset to ED N/A st Seen by MD Image Initiated Results Rcvd TX Given N/A (times are in minutes and are Median times)

28 NINDS Symposium, 2002 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

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

30 NINDS Symposium, 2002 Volume improves outcome: Trauma Experience

31 NINDS Symposium, 2002 Some General Management Issues  Oxygen  Hyperthermia  Glucose  Blood Pressure  Heparin

32 NINDS Symposium, 2002

33 NINDS Symposium, 2002 Shall We Implement What We Have?  It seems reasonable to proceed with what we have recognizing: innovation  1. The need for innovation further  2. The need for further studies: 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.

34 Placebo T-PA Placebo T-PA NIHSS Barthel > 8 Death 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): , 1997

35 NINDS Symposium, 2002 tPA >1/3 ECASS 1 % Patients with mRankin Scale 0 to 5 tPA <1/3 Placebo >1/3 tPA Placebo Placebo >1/3

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

37 NINDS Symposium, 2002 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: , Albers et al

38 NINDS Symposium, 2002 Questions

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

40 NINDS Symposium, 2002 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%

41 NINDS Symposium, 2002 Further Experience in Houston

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

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

44 Atlantis Study - Results

45 NINDS Symposium, 2002 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:

46 NINDS Symposium, 2002 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%

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

48 NINDS Symposium, 2002 TNK: A New Clot-Buster

49 NINDS Symposium, 2002 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.

50 NINDS Symposium, 2002 Studies Prior to Pivotal YearSeriesN (tPA)SICHOutcome 1992NIH 0-90(74)4%(46%)* 1992Haley 0-180(20)10%(15%) 1992Mori 6h31 (19)8% (11%) Incr scores HSS 1993Bridging27 (14)0%15% (47%) *  NIHSS >=4 points at 24 hours

51 NINDS Symposium, 2002 NIH Guidelines for Stroke Teams Proceedings of a National Symposium on Rapid Identification and Treatment of Acute Stroke December 12-13, 1996 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

52 NINDS Symposium, 2002 A Patient

53 NINDS Symposium, 2002 Early Improvement Annals of Emergency Medicine 30 (5): , 1997.

54 NINDS Symposium, 2002 Before We Innovate, Shall We Implement What Works?  Patients who arrive within 2 hours  Patients who fit NINDS criteria  Patients without acute hypodensity on CT

55 NINDS Symposium, 2002 The imbalance at baseline does not explain the overall study effect:  Rankin (0,1) at 3 months –0-90 min RR 1.4 (1.0,2.0) – RR 1.8 (1.3,2.5  Without NIHSS 0-5 Patients – (1.0, 2.1) – (1.1, 2.4) –(about 25%)


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