Acute Stroke Treatment: Current Trends 2010
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1 Acute Stroke Treatment: Current Trends 2010 Helmi L. Lutsep, MD Oregon Stroke Center Oregon Health & Science University Overview Ischemic Stroke Neuroprotectant trials to watch for IV tpa longer treatment window Intra-arterial treatments present and future Imaging to optimize therapy
2 Acute Stroke Treatment Approaches Neuroprotective agents Help injured brain cells live Thrombolytics Dissolve the clot using medication Mechanical devices Remove the clot with a catheter device put into the blocked artery in the brain Ongoing Neuroprotectant Trials Mg++ FAST-MAG trial: IV magnesium vs. placebo given by paramedics within 2 hrs n=1298 by June 2011 ALIAS albumin trial: Albumin vs. placebo in 5 hrs n=1600 by June 2014 ClinicalTrials.gov
3 NeuroFlo Device Trial ClinicalTrials.gov Randomized trial of 500 patients Time window 14 hours Temporary balloon occlusion of aorta increases cerebral blood flow Will be reported at the World Stroke Congress in Seoul Oct and at ISC in L.A. Feb Sphenopalatine Ganglion (SPG) Stimulation Stimulation of SPG hypothesized to augment blood flow: vasodilating, parasympathetic ti Implantable neurostimulator inserted into the palatine canal through the greater palatine foramen near the third molar Stimulation 3-4 hrs daily over 5-7 days BrainsGate.com
4 SPG Stimulation Pivotal Trial ImPact-24 initiated January 2009 Multinational, randomized, double blind, sham controlled (2:1) Treated 8-24 hours post stroke No tpa or mechanical embolectomy N=480 by October 2010 ClinicalTrials.gov, BrainsGate.com IV tpa
5 NINDS IV tpa 0-3 Hr Study Results Favorable outcome at 3 mos tpa (%) Placebo (%) Barthel Rankin Glasgow NIHSS Symptomatic hemorrhage Mortality NEJM 1995;333: Can tpa Be Given Later? ECASS 3 study showed a small benefit when tpa given between hrs from symptom onset mrs 0-1: 52.4% tpa vs 45.2% control (p=0.04) AHA/ASA Science Advisory supports expansion of the tpa treatment window NEJM 2008;359: ; Stroke 2009; 40
6 Time to Treatment: Pooled Analysis of ECASS, ATLANTIS, NINDS, EPITHET Trials Favorable outcome decreased as onset to start of treatment increased No benefit of alteplase after about 270 min (4.5 hrs) The Lancet 2010;375: Time to Treatment: Pooled Analysis of ECASS, ATLANTIS, NINDS, EPITHET Trials Large parenchymal hemorrhage seen in 5.2% of alteplase group ICH had no clear relation to onset to start of treatment The Lancet 2010;375:
7 STS-ISTR: IV tpa Treatment Over Years Lancet Neurology, published online July 27, 2010 STS-ISTR: IV tpa Treatment Thrombolysis within hrs was implemented without cost to <3 hr patients Simultaneous increase in number of patients treated within 3 hours Admission to treatment time was not increased Lancet Neurology, published online July 27, 2010
8 STS-ISTR: IV tpa hrs vs <3 hrs: Mortality Higher, Independence Lower Lancet Neurology, published online July 27, 2010 Patient presents between hrs after symptom onset with a moderate stroke
9 Patient Case: 52 y/o Man Presented 3 hrs 15 min after symptom onset No diabetes, no warfarin use Right sided weakness with 2+ drift arm and leg, dysarthria but no aphasia NIHSS score = 8 Cause of the stroke? Is IA treatment an option? Patient Case: 52 y/o NIHSS=8 at 3.25 hrs Would you treat this patient with IV tpa? a) Yes b) No
10 Patient Case: What if patient is 82 y/o NIHSS=8 at 3.25 hrs? Would you treat this patient with IV tpa? a) Yes b) No Older Than 80 yrs hrs from Onset following additional exclusion criteria: Patients t older than 80 years, those taking oral anticoagulants with an INR 1.7, those with a baseline NIHSS score >25, or those with both a history of stroke and diabetes. Therefore, for the 3-to-4.5-hour window, all patients receiving oral anticoagulant are excluded regardless of the INR. AHA/ASA Science Advisory Stroke 2009; 40
11 Intravenous tpa Limitations Exclusions, such as: Time > 4.5 hrs from symptom onset Major surgery within last 14 days Hemorrhage (GI or GU) within 21 days Coagulopathy (INR, platelets < 100,000) Less efficacy in severe strokes In NINDS trial only 8% had favorable outcomes if NIHSS > 20 Stroke 1997;28: ; Stroke 2007;38: Patient presents with more severe stroke
12 Patient Case: 70 y/o Woman Patient presented to outside ED with left hemiparesis and hemianopsia, right gaze preference Previous small left MCA infarct 1 year ago At outside ED 2 hrs post stroke NIHSS=21 Likely cause of stroke? Patient Case: 70 y/o Woman at 2 hrs, NIHSS=21 Would you recommend IV tpa (+/- embolectomy)? a) Yes b) No
13 Merci Registry and IV tpa Interim Results, n=623 Revascularization was not associated with IV tpa pretreatment Positively associated with IA tpa, negatively associated with hypertension and current smoking May underestimate IV tpa effects since only those with residual occlusions studied Lutsep HL, ISC, San Antonio, Feb. 26, 2010 Patient received IV tpa but still has significant findings
14 Patient Case: 70 y/o Woman Received IV tpa for right MCA stroke Transferred for embolectomy, arriving 3.5 hours post symptom onset NIHSS = 24 AHA Database Drip and Ship by Year AHA Get with the Guidelines Database, letter to CMS, June 10, 2008
15 Drip and Ship Can patients be transferred safely? Studies thus far report no complications during transfer or differences in mortality or ICH in locally treated and shipped patients Stroke 2010;41:e18-e24; J Emer Med 2009, epub Patient Case: 70 y/o Woman Post tpa Presented to outside ED with left hemiparesis, right gaze preference
16 Patient Case: 70 y/o Woman Post IV tpa, preembolectomy Post-embolectomy with Merci Retriever Patient Case: 70 y/o Woman CT at 24 hrs
17 IA Occlusion Treatment Approaches Mechanical devices Remove the clot with a catheter device put into the blocked artery in the brain Current IA Therapy Data
18 IA Mechanical Devices Approved for removing thrombus in stroke Merci Retriever Penumbra System MERCI Trials: Single Arm, Multi-center MERCI 1 st pass within 8 hrs of onset NIHSS 8 Age 18 M1, M2, ICA-T, vertebrobasilar INR 3 Multi MERCI Allowed failed IV tpa Incorporated L5 device Stroke 2005;36: ; Stroke 2008;39:
19 Penumbra: Single Arm Multi-center Trial Inclusions Time window 8 hrs NIHSS 8-30 Age years INR 3 Allowed failed IV tpa Occlusion of a treatable intracranial vessel Penumbra aspiration Penumbra extraction Stroke 2009:40: Revascularization in Intra-Arterial Treatment PROACT II n=121 IMS 2 n=81 MERCI n=141 Multi- MERCI n=164 Penumbra n=125 Time to tx (hrs) Baseline NIHSS Median Revasc device + adjuvant % at 1 0 occlusion Controls 18% JAMA 1999;282: ; Stroke 2007;38: ; Stroke 2005;36: ; Stroke 2008;39: ; Stroke 2009:40:
20 Outcomes in Intra-Arterial Treatment Trials PROACT II n=121 IMS 2 n=81 MERCI n=141 Multi- MERCI n=164 Penumbra n=125 Baseline Time to tx NIHSS (hrs) Median Revasc device + adjuvant % Mortality % mrs 2 at 90 days % at 1 0 occlusion Controls 25% JAMA 1999;282: ; Stroke 2007;38: ; Stroke 2005;36: ; Stroke 2008;39: ; Stroke 2009:40: MERCI Trial Predictors of Outcome Variable mrs 2 Odds Ratio (95% CI) P Value Mortality Odds Ratio (95% CI) P Value Revascularization ( ) < ( ) Age, y, decade 0.94 ( ) ( ) Baseline NIHSS 0.78 ( ) ( ) Procedure time 0.36 ( ) 0.78) Right brain infarct 0.14 ( ) Revascularization is the strongest predictor of favorable outcome Stroke 2005; 36:
21 Multi MERCI 90-Day Clinical Outcomes By Revascularization Status 100% Revascularized Non-Revascularized 80% p< % 49.1% p< % 40% 24.8% 20% 9.6% 0% Good Outcome (mrs 0-2) Mortality Stroke 2008;39: ICH in Intra-Arterial Treatment Trials PROACT II n=121 IMS 2 n=81 MERCI n=141 Multi- MERCI n=164 Penumbra n=125 Baseline Time to tx NIHSS (hrs) Median Revasc device + adjuvant % Mortality % mrs 2 at 90 days % sich % (PH2 8.8) (PH2 2.4) at 1 0 occlusion (PH2 1.6) JAMA 1999;282: ; Stroke 2007;38: ; Stroke 2005;36: ; Stroke 2008;39: ; Stroke 2009:40:
22 Ongoing and Future Mechanical Embolectomy Trials Stent Deployment in Acute Stroke Deployment of stent, trapping the occlusion Recanalization AJNR 2007;28:
23 New Devices SWIFT Trial Compares SOLITAIRE device to Merci device Primary outcome Recanalization (TIMI 2-3) and no symptomatic ICH Secondary outcomes Time to recanalization, mortality, neurologic outcomes, symptomatic ICH ClinicalTrials.gov
24 Primary inclusions Age SWIFT Trial NIHSS 8-30 Able to be treated within 8 hours TIMI 0-1 flow in M1, M2, ICA, vertebral or basilar artery Ineligible for IV tpa or failed IV tpa INR 3 No dissection ClinicalTrials.gov 66 y/o Man Slumped at Lunch, 1 hr Ago NIHSS=18 CT: hyperdense MCA, ICA
25 66 y/o Man Slumped at Lunch NIHSS=18 Pre: carotid T occlusion Solitaire in place, 2nd pass Post: vessels patent 3.5 hrs 66 y/o Man: Carotid T Clot and Solitaire Device
26 New Devices Continued (Partial List?) Concentric Trevo System Trial in Europe, expected to start in US soon Main component is a stentriever MindFrame IRIIS Device Trial in Europe, awaiting start in US Micrus Endovascular Now acquired by Johnson & Johnson Using Imaging To Optimize Treatment, Extend IA Treatment Time Windows
27 MRI Mismatch to Identify Best Treatment (IV tpa 3-6 hrs) Responders DEFUSE Early reperfusion associated with best odds of favorable clinical response if mismatch and no malignant profile Ann Neurol 2006;60: DEFUSE: Mismatch vs. No Mismatch Before IV t-pa 5:50 after onset 3 cc 95 cc Occluded vessel 4.5 hrs After IV t-pa 6 cc 0 cc Vessel open Ann Neurol 2006;60:
28 DEFUSE 2 Protocol MRI baseline Intra-arterial Therapy MRI Post-procedure (reperfusion) MRI Day 5 (infarct volume) Favorable clinical response: NIHSS score of 0-1 at day 30 or improvement of NIHSS score by 8 points between baseline and day 30 Preliminary Data for the DAWN Trial (DWI and CTP Assessment in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention): Results of Imaging-Based Endovascular Therapy for Proximal Anterior Circulation Occlusions beyond 8 Hours from Last Seen Well Jovin T et al, AAN, Seattle, April 2009
29 Patients and Methods Retrospective, multicenter, consecutive case series Prospectively acquired databases at 12 academic stroke centers Inclusion Criteria: Anterior circulation proximal arterial occlusion (ICA, MCA-M1, MCA-M2) 1st angiography confirming occlusion performed >8 hours from last seen well CTP or MRI imaging selection (limited infarct core) Results 208 patients treated from March 1998 to April 2009 NIHSS median, 15; IQR, Time from last seen well to treatment (hours): Mean +/- SD: 16+/-13 Median, 12.2; IQR, Range, hours
30 Occlusion sites: MCA-M1: 49% (102/208) MCA-M2: 10.1% (21/208) ICA-T or tandem: 41% (85/208) Results Treatment modalities IA thrombolytics: 98/205 (48%) MERCI device: 120/205 (58.5%) Other mechanical modalities: 68/204 (33%) Successful (TIMI 2-3) recanalization: 74% (154/208) Good outcomes, mrs 2: 47.5% (77/162 available) SICH rate: 9.6% (20/208) Mortality: 22.2% (42/189) Results: Predictors of Outcomes Predictors of Good Outcome at 90-Days on Multivariate Analysis Variable 90-Day mrs 2 Odds Ratio (95% CI) P Value Age 0.96 ( ) TIMI 2-3 Flow 3.44 ( ) Time to Treatment 1.07 ( ) A prospective randomized trial is planned to assess the benefit of this approach as compared to standard medical therapy
31 Imaging to Extend Treatment: Other EXTEND IV tpa versus placebo 3-9 hours post onset in patients with penumbra by MRI (Melbourne) DIAS-3 and DIAS-4 IV desmoteplase versus placebo 3-9 hours post onset in patients with MCA occlusion or high grade stenosis ClinicalTrials.gov Summary of Approved Treatments
32 Summary: Approved/Cleared Acute Stroke Treatments IV tpa up to 3 hrs (4.5?) after symptom onset Merci Retrievers and Penumbra System in large vessel occlusions up to 8 hrs after symptom onset Can treat patients that are not IV tpa eligible Can treat patients with residual clot after IV tpa Current Time Windows Time From Stroke Onset hrs hrs Merci or Penumbra IV tpa IA tpa Other * ** >6 hrs *Patients who are contraindicated for IV tpa or who fail IV tpa therapy **IA lytic is not an FDA-approved therapy
33
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