@article{357ef32df8144f23b8d34d65d117c138,
title = "Noncontrast Computed Tomography Alberta Stroke Program Early CT Score May Modify Intra-Arterial Treatment Effect in DAWN",
abstract = "Background and Purpose - It is unknown whether noncontrast computed tomography (NCCT) can identify patients who will benefit from intra-arterial treatment (IAT) in the extended time window. We sought to characterize baseline Alberta Stroke Program Early CT Score (ASPECTS) in DAWN (DWI or CTP Assessment With Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention With Trevo) and to assess whether ASPECTS modified IAT effect. Methods - Core lab adjudicated ASPECTS scores were analyzed. The trial cohort was divided into 2 groups by qualifying imaging (computed tomography versus magnetic resonance imaging). ASPECTS-by-treatment interaction was tested for the trial coprimary end points (90-day utility-weighted modified Rankin Scale (mRS) score and mRS, 0-2), mRS 0 to 3, and ordinal mRS. ASPECTS was evaluated separately as an ordinal and a dichotomized (0-6 versus 7-10) variable. Results - Of 205 DAWN subjects, 123 (60%) had NCCT ASPECTS, and 82 (40%) had diffusion weighted imaging ASPECTS. There was a significant ordinal NCCT ASPECTS-by-treatment interaction for 90-day utility-weighted mRS (interaction P=0.04) and mRS 0 to 2 (interaction P=0.02). For both end points, IAT effect was more pronounced at higher NCCT ASPECTS. The dichotomized NCCT ASPECTS-by-treatment interaction was significant only for mRS 0 to 2 (interaction P=0.04), where greater treatment benefit was seen in the ASPECTS 7 to 10 group (odds ratio, 7.50 [2.71-20.77] versus odds ratio, 0.48 [0.04-5.40]). A bidirectional treatment effect was observed in the NCCT ASPECTS 0 to 6 group, with treatment associated with not only more mRS 0 to 3 outcomes (50% versus 25%) but also more mRS 5 to 6 outcomes (40% versus 25%). There was no significant modification of IAT effect by diffusion weighted imaging ASPECTS. Conclusions - Baseline NCCT ASPECTS appears to modify IAT effect in DAWN. Higher NCCT ASPECTS was associated with greater benefit from IAT. No treatment interaction was observed for diffusion weighted imaging ASPECTS.",
keywords = "Infarction, Magnetic resonance imaging, Prognosis, Thrombectomy, Tomography",
author = "Parita Bhuva and Yoo, {Albert J.} and Jadhav, {Ashutosh P.} and Jovin, {Tudor G.} and Haussen, {Diogo C.} and Alain Bonafe and Budzik, {Ronald J.} and Yavagal, {Dileep R.} and Hanel, {Ricardo A.} and Hassan, {Ameer E.} and Marc Ribo and Christophe Cognard and Sila, {Cathy A.} and Morgan, {Patricia M.} and Yanchang Zhang and Ryan Shields and Wade Smith and Saver, {Jeffrey L.} and Liebeskind, {David S.} and Nogueira, {Raul G.}",
note = "Funding Information: The DAWN trial (DWI or CTP Assessment With Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention With Trevo) was funded by Stryker Neurovascular, Inc. Funding Information: Dr Yoo receives research grant support from Stryker, Medtronic, Neuravi/Cerenovus, Genentech, and Penumbra, is a consultant for Cerenovus and Genentech, and has equity ownership interest in Insera Therapeutics, Inc. Dr Jovin has the following disclosures: Consultant at Cerenovus (steering committee/data safety monitoring board–modest), Stryker Neurovascular (Principal Investigator DAWN [DWI or CTP Assessment With Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention With Trevo]-unpaid), holds Stock at Anaconda, Blockade Medical, Route 92, Corindus, FreeOx Biotech, Viz.ai, Silk Road, Imperative Care. Dr Nogueira reports potential conflicts with Stryker Neurovascular (DAWN Trial Principal Investigator–no compensation, Trevo Retriever Registry Steering Committee–no compensation, Trevo-2 Trial Principal Investigator–modest; Consultant–modest), Medtronic (SWIFT [SOLITAIRE FR With the Intention for Thrombectomy] Trial Steering Committee–modest; SWIFT-Prime Trial Steering Committee–no compensation; STAR [Solitaire Flow Restoration Thrombectomy for Acute Revascularization] Trial Angiographic Core Lab–significant), Penumbra (3D Separator Trial Executive Committee–no compensation), Cerenovus/ Neuravi (ENDOLOW Trial Principal Investigator, EXCELLENT Registry Principal Investigator, Analysis of Revascularization in Ischemic Stroke with EmboTrap (ARISE-2)-2 trial Steering Committee–no compensation, Physician Advisory Board, modest), Phenox (Physician Advisory Board, modest), Anaconda (Physician Advisory Board, modest), Genentech (Physician Advisory Board–modest), Biogen (Physician Advisory Board–modest), Prolong Pharmaceuticals (Physician Advisory Board–modest), Allm Inc. (Physician Advisory Board– no compensation), IschemaView (Speaker, modest), Brainomix (Research Software Use–no compensation), Sensome (Research Device Use–no compensation), Viz-AI (Physician Advisory Board, stock options), Philips (Research Software Use–no compensation, Speaker–modest), and Corindus Vascular Robotics (Physician Advisory Board, stock options). Dr Haussen is a consultant for Stryker and Vesalio. Dr Bonafe is a consultant for Stryker, Medtronic, and Phenox. Dr Yavagal is a consultant for Medtronic, Neural Analytics, Cerenovus, Rapid Medical (Steering Committee Member of TIGER [Treatment With Intent to Generate Reperfusion] Clinical Trial & Consultant); Stryker (funding for patient enrollment in DAWN trial as sponsor of the trial). Dr Ribo is a consultant for Cerenovus, Medtronic, Stryker, Apta Targets, Anaconda Biomed and has equity ownership interest in Anaconda Biomed. Dr Cognard is a consultant for Stryker, Microvention, Medtronic, and Cerenovus. A.E. Hassan is a consultant, speaker and proctor for Medtronic, Stryker, and Microvention and a consultant/speaker for Penumbra, Balt, and GE Heathcare. Dr Saver is an employee of the University of California. The University of California has patent rights in retrieval devices for stroke. Dr Saver has served as an unpaid site investigator in multicenter trials sponsored by Medtronic, Stryker, and Neuravia/ Cerenovus for which the University of California Regents received payments on the basis of clinical trial contracts for the number of subjects enrolled. Dr Saver has received contracted hourly payments from Medtronic, Stryker, and Neuravia/Cerenovus and contracted stock options from Rapid Medical for services as a scientific consultant advising on rigorous trial design and conduct. Dr Liebeskind receives support as a consultant as imaging core lab for Stryker, Medtronic, Cerenovus, Vesalio, Neurvana, and Rapid Medical. The other authors report no conflicts.",
year = "2019",
month = sep,
day = "1",
doi = "10.1161/STROKEAHA.118.024583",
language = "English (US)",
volume = "50",
pages = "2404--2412",
journal = "Stroke",
issn = "0039-2499",
publisher = "Lippincott Williams and Wilkins",
number = "9",
}