Natural history of acute stroke from large vessel occlusion: Results from the FIRST trial
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1 Natural history of acute stroke from large vessel occlusion: Results from the FIRST trial Vallabh Janardhan, MD Director, Texas Stroke Institute Director, Comprehensive Stroke Program and Neuro- Interventional Services, HCA North Texas Division
2 Presenter Disclosure FIRST Trial, Penumbra, Inc: Speakers Bureau Principal Investigator Data Safety Monitoring Board Member, Penumbra Pivotal Trial, Penumbra Inc., Consultant Board Member, Insera Therapeutics Inc., Stocks/Stock Options National Science Foundation Grant # Principal Investigator
3 Overview 1 FIRST Trial: Results 2 FIRST Cohort: Comparison with IMS 3 3 FIRST Cohort: Lessons learned about Infarct Core 4 FIRST Trial: Team
4 FIRST Trial: Results
5 FIRST Trial: Purpose Termination of the IMS 3 trial due to futility has led to further controversies surrounding the use of IA endovascular therapy for stroke intervention Objective: To assess the natural history of a stroke cohort eligible for IA intervention and compare its outcome with the IMS 3 results
6 Methods Prospective, single arm, multi-center natural history study of a stroke cohort with the following inclusion criteria: Large vessel occlusion Present within 8 hours from symptom onset Baseline NIHSS score 10 Ineligible or refractory to lytic therapy Untreated with endovascular therapy Interim analysis from 93 patients meeting study criteria Primary endpoint is functional outcome at 90 days as defined by mrs 0-2
7 Participating Centers, Statistical Lab, and Imaging Core Lab Center Medical Center of Plano Plano, TX, USA Plaza Medical Center Plaza, TX, USA Prince of Wales Hospital Hong Kong, China Queen Mary Hospital Hong Kong, China Principal Investigator Vallabh Janardhan, MD Vallabh Janardhan, MD Thomas WH Leung, MD Raymond Cheung, MD, PhD Personnel Nam Nguyen (Statistical Lab) Albert Yoo, MD (Imaging Core Laboratory) Location Chicago, IL MGH/Harvard Medical School, Boston, MA
8 N=1/93 1.1% N=1/93 1.1% N=27/ % N=64/ % MCA ICA ACA Other Target Vessel Location
9 FIRST Baseline Characteristics Patients (N) 93 Age (years) [mean/(sd)] 68.9 ± 14.9 Female 59.1% (55/93) NIHSS [median/(iqr)] 18.0 ( ) TIMI % (93/93) TICI % (93/93) Refractory to IV rtpa 51.6% (48/93)
10 Results: Recanalization BASELINE SPONTANEOUS RECANALIZATION 100% 100% 13.0% (7/54) 11.1% (6/54) 80% 60% 100% (93/93) 100% (93/93) 80% 60% 40% 40% 20% 20% 0% TICI TIMI TICI/TIMI 0-1 TICI 2a-3, TIMI 2-3 0% TICI TIMI TICI/TIMI 0-1 TICI 2a-3, TIMI 2-3
11 Safety Results Event Rate All-Cause Mortality 39.8% (37/93) All SAEs within 24 hrs of stroke onset *29 events in 25 patients 26.9% (25/93) Event Rate Symptomatic ICH 5.4% (5/93) Asymptomatic ICH 16.1% (15/93) Total ICH 21.5% (20/93)
12 Summary of SAEs within 24 hrs of Stroke Onset Event % (n/n) Cerebral Edema 7.5% (7/93) Herniation Syndrome 1.1% (1/93) Sequelae of CVA 4.3% (4/93) Seizures 1.1% (1/93) Respiratory Failure 6.5% (6/93) Other Non-neurologic SAE 10.8% (10/93) *29 events in 25 patients
13 Outcomes Good Outcome at 90 Days % (n/n) mrs % (14/90) Good Neurological Outcome Discharge/7-Day NIHSS 0-1 or 10 point improvement % (n/n) 18.3% (17/93)
14 Outcome: Patients refractory to IV tpa vs. Patients ineligible for IV tpa Refractory to IV tpa N=48 Ineligible for IV tpa N=45 Recanalization 20.0% (6/30) 4.2% (1/24) ICH (within 24 hrs) 16.7% (8/48) 15.6% (7/45) Mortality 33.3% (16/48) 46.7% (21/45) Discharge/7-Day NIHSS 0-1 or 10 point improvement 22.9% (11/48) 13.3% (6/45) 90-day mrs % (10/46) 9.1% (4/44)
15 FIRST Cohort: Comparison with IMS 3
16 FIRST, IMS III, and Penumbra Study Entry Criteria FIRST IMS III Penumbra Time from Onset 8 hours 3 hours 8 hours IV rtpa Eligible? Ineligible or refractory Yes Yes Age * Baseline NIHSS 10 10** 8 CTA Defined Large Vessel Occlusion Required Optional Required IA Therapy None Other IA devices/ia tpa *Pivotal>18, START 18-85, RetroSTART, PICS, and POST no age criteria **Or NIHSS score 8-9 with CTA evidence of occlusion in M1, ICA, or BA Penumbra System only
17 FIRST, IMS 3, and Penumbra Baseline Characteristics FIRST IMS 3 IV IMS 3 IV/IA Penumbra Patients (N) Age (years) [mean] Female 59.1% 45.0% 49.8% 50.9% NIHSS [median/iqr] 18 (14-23) 16 (8-30) 17 (7-40) 17 (13-21) ASPECTS % 59.0% 56.9% 55.1%
18 FIRST, IMS 3, and Penumbra Outcomes FIRST (N=93) IMS 3 IV (N=222) 1 IMS 3 IV/IA (N=434) 1,2 Penumbra (N=942) TICI % 34.8%** 76.0%** 83.2%** sich 5.4% 5.9% 6.2% 12.6%* Mortality 39.8% 21.6%** 19.1%** 21.7%** 90-Day mrs % 38.7%** 40.7%** 38.3%** 1 Broderick JP, Palesch YY, Demchuk AM, et al. Endovascular Therapy after Intravenous t-pa versus t- PA Alone for Stroke. N Engl J Med 2013;368: Tomsick TA, IMS III Investigators. IMS III: Comparison of Outcome by IA Approach and Interpretation in Light of Comparative Trials. In: International Stroke Conference; Honolulu, Hawaii; *P<0.05; **P<0.01 compared to FIRST, Fisher s Exact two-sided test
19 Discussion Large vessel acute ischemic stroke is a malignant disease wherein 81.7% of patients will either die or suffer long-term disabilities if untreated (81.7% at 7 days; 84.4% at 90 days). Endovascular therapy for large vessel occlusion is safe and effective when compared to medical therapy in an appropriate stroke cohort ineligible or refractory to IV rtpa
20 FIRST Cohort: Lessons learned about Infarct Core
21 Importance of Core Infarct Volume in the Number Needed to Treat Infarct core has been theorized to be an important indicator for treatment success from endovascular intervention in acute ischemic stroke from large vessel proximal occlusion. Objective: To determine the extent to which it contributes to the number of patients needed to treat (NNT) to achieve long-term functional independence. Zaidat O, Yoo A, Janardhan V, Frei D, Ammar L, Meyer D, To C, Kuo SS, Buell H, Barraza L, Bose A, Sit SP. The Importance of Core Infarct Volume in the Number Needed to Treat in Endovascular Therapy for Acute Ischemic Stroke. Presented at SNIS, Colorado Springs, CO, July 2014.
22 N=110/ % N=83/ % N=96/ % N=174/ % PICS RetroSTART START Pivotal Patients pooled from various trials Patients treated by the Penumbra System with acute stroke not eligible and/or refractory to IV rtpa were pooled from numerous trials (N=463) and compared with 93 control patients who were eligible for but not treated by endovascular therapy.
23 ASPECTS Distribution CONTROL (N=93) PENUMBRA (N=463) N=51/ % N=14/ % N=29/ % N=41/ % Small Medium Large N=155/ % N=257/ % Note: 9 control patients did not have ASPECTS score.
24 Outcomes Control (N=93) and Penumbra System (N=463) TIMI 2-3 % (n/n) sich % (n/n) Mortality % (n/n) 90-Day mrs 0-2 % (n/n) Control Penumbra Control Penumbra Control Penumbra Control Penumbra Overall 12.0% (6/50) 81.7%*** (376/460) 6.5% (6/93) 14.0% (65/463) 36.6% (34/93) 25.9%* (120/463) 12.9% (9/70) 38.4%*** (178/463) ASP % (2/24) 79.2%*** (202/255) 0.0% (0/41) 11.7%* (30/257) 41.5% (17/41) 21.4%** (55/257) 20.0% (7/35) 42.8%** (110/257) ASP % (2/18) 86.4%*** (133/154) 10.3% (3/29) 16.1% (25/155) 41.4% (12/29) 24.5% (38/155) 7.4% (2/27) 41.3%*** (64/155) ASP % (1/8) 80.4%*** (41/51) 14.3% (2/14) 19.6% (10/51) 28.6% (4/14) 52.9% (27/51) 0.0% (0/8) 7.8% (4/51) *P-value<0.05 **P-value<0.01 ***P-value<0.001 for Penumbra treatment as compared to control using Fishers Exact Test
25 ASPECTS Group Outcome: 90-Day mrs 0-2 Control (N=70) and Penumbra System (N=463) Overall 12.9% (9/70) 38.4%(178/463)*** Small (8-10) 20.0% (7/35) 42.8% (110/257)** Medium (5-7) Large (0-4) 7.4% (2/27) 7.8% (4/51) 0.0% (0/8) 41.3% (64/155)*** Penumbra Control Day Good Outcome % *P-value<0.05 **P-value<0.01 ***P-value<0.001 for Penumbra treatment as compared to control using Fishers Exact Test
26 Number of Patients Number of Patients Needed to Treat (NNT) for Good Outcome ASPECTS Group 95% CI Small (8-10) 4.38 [2.68, 12.15] Medium (5-7) 2.95 [2.15, 4.69] Large (0-4) 12.8 [6.60, 227.3] Overall Small (8-10) Medium (5-7) Large (0-4) ASPECTS Group 3 13
27 Discussion Data confirms that endovascular therapy may not be as successful in patients with large infarct core Leads to high NNT Excluding this group may lower overall NNT and improve response rate of this therapy
28 FIRST Trial: The Team
29 FIRST Trial: Texas Stroke Institute Physician Team TSI Stroke Intervention Physicians Vallabh Janardhan, MD Director, TSI Parita Bhuva, MD Ryan Gianatasio, MD Paul A. Hansen, MD TSI Stroke & Neuro-critical Care Physicians TSI Research Fellow Alex Venizelos, MD Keyur Patel, MD Suman Nalluri, MD Chandril Chugh, MD Tanzila Shams, MD
30 Texas Stroke Institute Administrative Team Mark Whitley Sr. VP Bus. Dev. Kathy Sheets VP, HCAPS Will Smitham VP, HCAPS Operations Anita Guthmann Director, Comprehensive Stroke Josh Canfield TSI Practice Manager Helen Hare Program Coordinator Rubina Muzina, MD MPH, Supervisor, Research Office, Plaza Medical Center of Fort Worth Dana Davis TSI Clinical Coordinator
31 Queen Mary Hospital Prof. Raymond Cheung Rosalind Ge Prince Wales Hospital Dr. Thomas Leung Roxanna Liu Core Lab Dr. Albert Yoo Penumbra, Inc. Siu Po Sit Lynne Ammar Denise Meyer Leticia Barraza Jessica Harpel Susana S. Hak Yosephine Lumintang Sophia S. Kuo Nam Nguyen Hope Buell Dawn Ueda Synapse Therapeutics (CRO) Clinton Wong Irene Hung Karen Chan
32 Q&A
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