Rescue Stenting and Intravenous Thrombolysis In Patients With Large Vessel Ischemic Stroke

Official title

Stroke, Thrombolysis and Rescue Stenting

Overview

Intravenous thrombolysis (IVT) and mechanical thrombectomy (MT) are the standard of care for treating selected patients with acute large-vessel occlusion stroke (LVOS). Successful revascularization is strongly correlated with favorable outcomes. Nevertheless, recanalization failure with stent retrieval and contact aspiration has been observed in up to 29% of patients. If primary thrombectomy fails to achieve recanalization, rescue stenting (RS) has proven to be a feasible rescue therapy. Currently, approved evidence-based alternatives for LVOS patients who have failed MT are lacking, but permanent stenting is suggested as a rescue treatment in expert consensus statements. Dual antiplatelet therapy (DAPT), typically consisting of clopidogrel and aspirin, is recommended after stent implantation to reduce the risk of stent thrombosis; however, these medications are not suitable in the acute setting, and optimal platelet inhibition strategies remain unclear. Glycoprotein (GP) IIb/IIIa receptor inhibitors have intravenous administration, a rapid onset of action, and their effects subside within a few hours after discontinuation. For these reasons, an increasing number of studies have investigated their use in conjunction with primary stenting for acute stroke. Currently, there is no evidence supporting the superiority of any particular antithrombotic strategy, so decisions are guided by clinical judgment. An additional challenge for clinicians arises when IVT is combined with stenting. Stroke guidelines recommend starting antiplatelets 24 hours after IVT and the risk associated with antithrombotic therapy within the first 24 hours after IVT remains uncertain. This is multicenter, prospective, observational study of patients with LVOS undergoing mechanical thrombectomy and rescue stenting. The aim of this study is to evaluate real-world antithrombotic strategies in emergency stenting, particularly in patients treated with IVT, and to assess the safety of emergent stenting following intravenous thrombolysis.

Primary outcome measures

• Rate of symptomatic cerebral hemorrhage [Time frame: 24 hours]

Secondary outcome measures (1)

• modified Rankin Scale (mRS) [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

• Patients with large vessel occlusion strokes undergoing thrombectomy and rescue stenting within 24 hours of stroke onset
• Patients ≥ 18 years of age

Exclusion criteria

• Patients < 18 years
• Refusal to give informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Italy · 7 centers

• ASST Papa Giovanni XXIII — Bergamo
• Ospedale Bufalini — Cesena
• Azienda Sanitaria Lecce - Ospedale "Vito Fazzi" — Lecce
• ASST Santi Paolo e Carlo — Milan
• ASST Grande Ospedale Metropolitano Niguarda — Milan
• Fondazione IRCCS San Gerardo dei Tintori — Monza
• ASL 2 Savonese - Ospedale Santa Corona — Pietra Ligure

Publications

• Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guid PMID 31662037
• Berge E, Whiteley W, Audebert H, De Marchis GM, Fonseca AC, Padiglioni C, de la Ossa NP, Strbian D, Tsivgoulis G, Turc G. European Stroke Organisation (ESO) guidelines on intravenous thrombolysis for acute ischaemic stroke. Eur Stroke J. 2021 Mar;6(1):I-LXII. doi: 10.1177/2396987321989865. Epub 2021 Feb 19. PMID 33817340
• Heck DV, Brown MD. Carotid stenting and intracranial thrombectomy for treatment of acute stroke due to tandem occlusions with aggressive antiplatelet therapy may be associated with a high incidence of intracranial hemorrhage. J Neurointerv Surg. 2015 Mar;7(3):170-5. doi: 10.1136/neurintsurg-2014-011224. Epub 2014 Nov 11. PMID 25387730
• Baek BH, Yoon W, Lee YY, Kim SK, Kim JT, Park MS. Intravenous Tirofiban Infusion After Angioplasty and Stenting in Intracranial Atherosclerotic Stenosis-Related Stroke. Stroke. 2021 May;52(5):1601-1608. doi: 10.1161/STROKEAHA.120.033551. Epub 2021 Apr 1. PMID 33793319
• Lee JI, Gliem M, Gerdes G, Turowski B, Kaschner M, Kraus B, Hartung HP, Jander S. Safety of bridging antiplatelet therapy with the gpIIb-IIIa inhibitor tirofiban after emergency stenting in stroke. PLoS One. 2017 Dec 27;12(12):e0190218. doi: 10.1371/journal.pone.0190218. eCollection 2017. PMID 29281734
• Osteraas ND, Crowley RW, Panos N, Dafer RM. Eptifibatide use following emergent carotid stenting in acute anterior circulation ischemic stroke with tandem occlusion. J Stroke Cerebrovasc Dis. 2020 Sep;29(9):105021. doi: 10.1016/j.jstrokecerebrovasdis.2020.105021. Epub 2020 Jun 17. PMID 32807436
• Delvoye F, Maier B, Escalard S, Labreuche J, Thion LA, Aknouche S, Hebert S, Redjem H, Smajda S, Ciccio G, Allard J, Sabben C, Obadia M, Maertens de Noordhout A, Olivot JM, Blanc R, Piotin M, Desilles JP, Mazighi M. Antiplatelet Therapy During Emergent Extracranial Internal Carotid Artery Stenting: Comparison of Three Intravenous Antiplatelet Perioperative Strategies. J Stroke Cerebrovasc Dis. 202 PMID 33310073
• Naylor R, Rantner B, Ancetti S, de Borst GJ, De Carlo M, Halliday A, Kakkos SK, Markus HS, McCabe DJH, Sillesen H, van den Berg JC, Vega de Ceniga M, Venermo MA, Vermassen FEG, Esvs Guidelines Committee, Antoniou GA, Bastos Goncalves F, Bjorck M, Chakfe N, Coscas R, Dias NV, Dick F, Hinchliffe RJ, Kolh P, Koncar IB, Lindholt JS, Mees BME, Resch TA, Trimarchi S, Tulamo R, Twine CP, Wanhainen A, Doc PMID 35598721

Identifiers

NCT: NCT06727006 · STARS12042023

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗