updates in intracranial intervention - metro · pdf filewhat went wrong • variety of...
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UPDATES IN INTRACRANIAL INTERVENTION Jordan Taylor DO
Metro Health Neurology
2015
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NEW STUDIES FOR 2015
• MR CLEAN
• ESCAPE
• EXTEND-IA
• REVASCAT
• SWIFT PRIME
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RECOGNIZED LIMITATIONS
• IV Alteplase proven benefit up to 4.5 hours • Less effective in proximal occlusions
• Internal carotid artery terminus occlusion reperfusion in only about 1/3 of patients • Proximal occlusion patients who often have a high NIH tend to have poor outcomes
• Limited time frame • Many contraindications
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TRIALS FAILING TO SHOW BENEFIT
• IMS III
• SYNTHESIS EXPANSION TRIAL
• MR RESCUE
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IMS III
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SYNTHESIS EXPANSION
TRIAL
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MR RESCUE
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WHAT WENT WRONG
• Variety of catheters used (Solitaire, Penumbra, Merci, Trevo) • May limit learning curve • Variable ability to recanulize (older devices-lower rates)
• Relatively long time to intra-arterial treatment • 3.45 hrs vs 2.45 hrs TPA (median time) in Synthesis expansion trial • +/- 5.5 hrs in MR RESCUE
• Variable pre- endovascular imaging to confirm proximal occlusion
• Wide range of NIH stoke scales at randomization • Higher NIH trended toward more significant benefit
• Relatively low rates of reperfusion
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MR CLEAN
• A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke • Conducted in the Netherlands • Randomized to either intraarterial treatment plus usual care and usual care
alone • Confirmed proximal anterior circulation arterial occlusion on CTA, MRA, or DSA
• Distal internal carotid artery, • Middle cerebral artery (M1 or M2) • Anterior cerebral artery (A1 or A2)
• Treatment needed to be initiated within 6 hours of stroke symptom onset • Goal of lower modified Rankin score in endovascular group • Third generation devices only
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OUTCOMES
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OUTCOMES
• Absence of residual occlusion • Endovascular: 75.4%, control: 32.9%
• Infarct volume (median) • Endovascular: 49 mL, control: 79 mL
• Modified Rankin scale at 90 days (median) • Endovascular: 3, control: 4
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LIMITATIONS
• Low relative proportion of patients in the control group ended with a modified Rankin of 0-2. • May indicate a collection of patients with a poor prognosis from the beginning
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ESCAPE
• Randomized Assessment of Rapid Endovascular Treatment of Ischemic Stroke • Intended to identify and treat patients with a large vessel infarct with a small
infarct core and moderate to good collateral circulation • Used CT (ASPECTS) , CTA (multiphase) • Included occlusion of MCA and intermediate branches, with or without
occlusion of ICA • Identify candidates within 4.5 hours of onset • ASPECTS of 6-10 • Filling of 50% or more of MCA circulation on CTA
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ESCAPE
• Retrievable stent devices preferred but available devices allowed
• All patients treated with IV t-PA within 4.5 hours
• Goal of CT to groin puncture of 60 min and CT to repurfusion of 90 min or less
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OUTCOMES
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OUTCOMES
• Study was halted early due to efficacy
• Proportion of patients with a modified Rankin at 90 days of 0-2 • Endovascular: 53%, control 29.3%
• Modified Rankin scale at 90 days (median) • Endovascular: 2, control: 4
• Mortality at 90 days: • Endovascular: 10.4%, control 19%
• Major success in achieving shorter interval (onset, CT to repurfusion) compared to earlier studies
• Imaging may be helpful in selecting candidates
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LIMITATIONS
• Only 1.44 (average) participants per center per month were enrolled
• Device-related or procedural complications were observed in 18 patients
• Fairly narrow treatment group selected
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EXTEND-IA
• Endovascular Therapy for Ischemic Stroke with Perfusion-Imaging Selection • Test whether using advance imaging selection, recently developed devices, and
earlier intervention improves outcomes • Use of CT perfusion imaging to determine penumbra (salvageable tissue with
low ischemic core volume) • Occlusion in the internal carotid or middle cerebral artery • Use of Solitaire FR stent retriever device • Primary goal of reperfusion rather than clinical outcomes
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EXTEND-IA
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OUTCOMES
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OUTCOMES
• Terminated early due to efficacy
• Patients with acute ischemic stroke from major vessel occlusion and salvageable tissue on CT perfusion imaging showed faster and more complete reperfusion with early mechanical thrombectomy after alteplase
• Substantial benefit in early neurologic outcomes and functional outcome at 3 months
• Managed statistically significant benefit despite small sample size
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LIMITATIONS
• Small sample size • Unable to perform subgroup analysis
• Patients with large ischemic core volume who may have benefited were excluded
• Early termination may overestimate effect
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REVASCAT
• Thrombectomy within 8 hours after Symptom Onset in Ischemic Stroke • Assess the safety and efficacy of thrombectomy for the treatment of stroke • Used a population-based stroke repurfusion registry • Confirmed proximal anterior circulation occlusion (MCA M1 w or w/o ICA) • Absence of large ischemic core on CT (ASPECTS) or MRI • Used Solitaire FR device • Used ongoing quality improvement to reduce time to perfusion
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REVASCAT
• Control: IV Alteplase within 4.5 hours or NO Alteplase in patients who had a contraindication
• Endovascular group then went on to have reperfusion with mechanical thrombectomy • Only patients with residual occlusion 30 min after Alteplase were included
• As trial continued inclusion ASPECTS was increased (excluding more patients with a higher stroke burden)
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OUTCOMES
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OUTCOMES
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OUTCOMES
• Stopped early due to emerging results from other endovascular studies
• Results consistent with the other studies confirming benefit of stent retriever devices
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SWIFT PRIME
• Stent-Retriever Thrombectomy after Intravenous t-PA vs. t-PA Alone in Stroke • Establish efficacy and safety of rapid neurovascular thrombectomy with a stent
retriever and IV t-PA in acute ischemic stroke • Solitaire FR or Solitaire 2 device alone without any cervical stenting • Confirmed occlusion of intracranial internal carotid artery, MCA M1 segment or
both • Absence of large ischemic core (pnenumbra measured with RAPID (image post-
processing system)) • Required history of experience with 40 or more mechanical thrombectomies • Target of imaging to groin puncture within 70 minutes
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OUTCOMES
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OUTCOMES
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LIMITATIONS
• Very narrow treatment group selected
• Continuous quality improvement measures where implemented through out the study and would have to be reproduced to show the same results
• All study sites were tertiary care centers and results may not generalize to other institutions
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WHAT HAVE WE LEARNED?
• Patients with acute ischemic stroke and confirmed occlusion of either the ICA or proximal MCA benefit from rapid assessment and treatment with IV t-PA combined with new generation stent retrieval devices.
• The experience of the operator likely improves outcomes
• Patients with high initial NIH but low infarct core volume benefit the most.
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LIMITATIONS GOING INTO THE FUTURE
• Low numbers of appropriate patients. (may be as low as 1-2 per month even in large centers) • All studies had fairly restrictive inclusion criteria • Many ischemic strokes will either involve other distributions (lacunar, etc) or have
no residual occlusion in a large vessel at presentation
• Rapid assessment and treatment produces the most robust results so current policies and procedures will likely need to be modified to meet match the benefit.
• About 1/3 of patients in these studies will reperfuse with IV t-PA alone and may or may not need further treatment