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Original research
Safety of full-dose intravenous recombinant tissue plasminogen activator followed by multimodal endovascular therapy for acute ischemic stroke
  1. Raul G Nogueira1,2,
  2. Albert J Yoo3,
  3. Shihab Masrur1,
  4. Leonardo M Batista1,
  5. Reza Hakimelahi3,
  6. Joshua A Hirsch3,
  7. Lee H Schwamm1
  1. 1Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
  2. 2Departments of Neurology, Neurosurgery, and Radiology, Emory University School of Medicine, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Atlanta, GA
  3. 3Department of Radiology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
  1. Correspondence to Dr Raul G Nogueira, Emory Faculty Office Building, 80 Jesse Hill Dr. SE, Room 398, Atlanta, GA 30303, USA; rnoguei{at}emory.edu

Abstract

Background and purpose The optimal management of stroke patients who fail treatment with intravenous recombinant tissue plasminogen activator (rt-PA) remains unknown. A study was undertaken to establish whether treatment with a standard intravenous t-PA dose (0.9 mg/kg) followed by multimodal endovascular therapy would have a similar safety profile to reduced dose (0.6 mg/kg) bridging therapy.

Methods A retrospective analysis was performed of a prospectively collected database. All patients treated with full-dose t-PA and endovascular therapy were included. The primary safety endpoints included ECASS-III symptomatic intracranial hemorrhage (sICH) and ECASS parenchymal hematomas (PH). Secondary safety endpoints included severe systemic bleeding and 90-day mortality. Clinical efficacy endpoints included rates of recanalization (TICI 2–3), ambulation at hospital discharge and 90-day independent outcomes (mRS 0–2).

Results 106 consecutive patients (mean age 69±17 years; mean baseline NIH Stroke Scale 17.8±4.8; 55% women; occlusion sites: MCA-M1 60.4%; MCA-M2 6.6%; ICA-T 19.8%; tandem cervical ICA+MCA-M1 7.5%; basilar artery 5.7%) were identified over a 10-year period. The sICH rate was 8.5% and the PH-1, PH-2 and subarachnoid hemorrhage rates were 2.8%, 8.5% and 2.8%, respectively. There were two (1.9%) severe groin hematomas. The recanalization rate was 66%. At hospital discharge, 41.4% of the patients were ambulatory. The rate of independent functional outcomes at 90 days was 24%; however, this sample is biased since nearly all deaths were captured but detailed 90-day functional outcomes were missing in 27 patients. The 90-day death rate was 32.4%.

Conclusion Combined treatment with full-dose intravenous rt-PA followed by multimodal endovascular therapy seems to be associated with similar rates of sICH to that of bridging therapy with reduced rt-PA dosage.

  • Stroke
  • intravenous thrombolysis
  • rt-PA
  • thrombectomy
  • brain
  • thrombectomy
  • technique
  • complication
  • technology
  • catheter
  • balloon
  • thrombolysis
  • stroke
  • stent
  • stenosis
  • malformation
  • embolic
  • coil
  • atherosclerosis
  • angioplasty
  • angiography
  • aneurysm
  • thrombolysis
  • thrombectomy
  • arteriovenous malformation
  • stroke
  • angiography
  • atherosclerosis
  • artery
  • drug
  • thrombolysis
  • tumor
  • subarachnoid
  • thrombectomy

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Footnotes

  • Disclosures Genentech provides drug supply to the Massachusetts General Hospital at no charge for an NINDS funded clinical trial in the SPOTRIAS network.

  • Competing interests RGN: Consultant/Scientific Advisory Board for Concentric Medical, ev3 Neurovascular, CoAxia and Rapid Medical. AJY: Research grant from Penumbra Inc. LHS: Consultant/Scientific Advisory Board for CoAxia and Stroke Systems Consultant to the Massachusetts Department of Public Health. JAH: Equity interest: IntraTech. SM, LMB, RH: none.

  • Ethics approval Ethics approval was provided by Massachusetts General Hospital IRB.

  • Provenance and peer review Not commissioned; externally peer reviewed.