DAWN and DEFUSE 3 trial

sunny_8162 14,917 views 17 slides Jun 11, 2018
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About This Presentation

Diffusion-weighted imaging or computerized tomography perfusion assessment with clinical mismatch in the triage of wake up and late presenting strokes undergoing neurointervention with Trevo (DAWN) trial methods
Int J Stroke. 2017 Aug;12(6):641-652.

Thrombectomy 6 to 24 Hours after Stroke with...


Slide Content

DAWN and DEFUSE 3 trial

Diffusion-weighted imaging or computerized tomography perfusion assessment with clinical mismatch in the triage of wake up and late presenting strokes undergoing neurointervention with Trevo (DAWN) trial methods Int J Stroke. 2017 Aug;12(6):641-652. 2017, Vol. 12(6) 641–652

General inclusion criteria Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups: Subject has failed IV t-PA therapy (defined as a confirmed persistent occlusion 60 min after administration) Subject is contraindicated for IV t-PA administration Age ≥18 Baseline NIHSS ≥10 Subject can be randomized between with 6 to 24 h after time last known well No significant pre-stroke disability (pre-stroke mRS must be 0 or 1 ) Anticipated life expectancy of at least 6 months Subject willing/able to return for protocol required follow-up visits Subject or subject’s legally authorized representative (LAR) has signed the study informed consent form

Imaging inclusion criteria <1/3 MCA territory involved, as evidenced by CT or MRI Occlusion of the intracranial ICA and/or MCA-M1 as evidenced by MRA or CTA Clinical imaging mismatch (CIM) defined as one of the following on MR-DWI or CTP- rCBF maps: ≥ 80 y/o, NIHSS ≥10 + core <21 mL < 80 y/o, NIHSS ≥10 + core <31 mL < 80 y/o, NIHSS ≥20 + core <51 mL

Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct N Engl J Med. 2018 Jan 4;378(1):11-21.

A multicenter randomized controlled trial of endovascular therapy following imaging evaluation for ischemic stroke (DEFUSE 3) Int J Stroke. 2017 Oct;12(8):896-905.

Clinical inclusion criteria Signs and symptoms consistent with the diagnosis of an acute anterior circulation ischemic stroke Age 18–90 years Baseline NIHSS score ≥6 Endovascular treatment can be i nitiated (femoral puncture) between 6 and 16 h of stroke onset. Stroke onset is defined as the time the patient was last known to be at their neurologic baseline (wake-up strokes are eligible if they meet the above time limits) Modified Rankin Scale ≤2 prior to qualifying stroke Patient/Legally authorized representative has signed the informed consent form

Neuroimaging inclusion criteria ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial; with or without tandem MCA lesions) by MRA or CTA Target Mismatch Profile on CT perfusion or MRI (ischemic core volume is <70 ml, mismatch ratio is ≥1.8 and mismatch volume is ≥15 ml)

RAPID mismatch map. The RAPID mismatch summary map allows investigators to quickly, accurately, and easily determine if the patient meets the imaging criteria for enrollment. The case shown here meets the Target Mismatch criteria: core volume is<70 ml, mismatch ratio is ≥1.8 and mismatch volume is ≥15 ml.

Thrombectomy for Stroke at 6 to 16 Hours with Selection by Perfusion Imaging N Engl J Med. 2018 Feb 22;378(8):708-718.

A baseline CT perfusion scan that was obtained with the use of RAPID software shows a region of severely reduced cerebral blood flow (<30% of that in normal tissue), which represents the early infarct (ischemic core), of 23 ml (pink) and a region of perfusion delay of more than 6 seconds, which represents hypoperfused tissue, of 128 ml (green). Volume of Ischemic Core, 23 ml Volume of Perfusion Lesion, 128 ml Mismatch volume, 105 ml Mismatch ratio, 5.6