Effectiveness and safety of endovascular therapy compared to intravenous thrombolysis in acute ischaemic stroke due to medium-vessel occlusions: a real-world multicentre study from the Italian SITS registry

Abstract Introduction Recent randomised trials have questioned the benefit of endovascular therapy (EVT) for MeVO stroke, but data from clinical practice are limited. This study aimed to assess the effectiveness and safety of EVT, with or without intravenous thrombolysis (IVT), vs IVT alone in MeVO stroke using registry-based real-world data. Patients and methods This retrospective multicentre study included patients from 82 Italian centres in the Safe Implementation of Treatments in Stroke (SITS) registry (January 2020–December 2023). Adults with acute ischaemic stroke due to MeVO (ACA A1/A2, MCA M2/M3 or more distal or PCA P1/P2), treated with IVT or EVT ± IVT, and with available 90-day mRS scores were included. Patients with tandem occlusions were excluded. Propensity score matching (1:1) was used to balance baseline variables. Primary outcome was functional independence (mRS 0–2) at 90 days. Secondary outcomes included in-hospital mortality, intracranial haemorrhage incidence and recanalisation status. Results Among 1375 total patients, 780 were included and matched (390 per group) by propensity score. Baseline characteristics were balanced. Functional independence at 90 days was achieved in 60.6% of EVT ± IVT patients vs 60.9% in the IVT-only group (odds ratio [OR] 0.99; 95% CI, 0.73–1.34; P = .939). When restricted to patients with baseline mRS < 2, functional independence rates remained comparable between groups, confirming the primary findings. In-hospital mortality was non-significantly lower in the EVT ± IVT group (5.4% vs 8.7%, P = .069). Symptomatic intracranial haemorrhage rates were comparable between groups, although overall haemorrhagic complications were higher with EVT (18.4% vs 11.2%, P < .0001). Stratified analyses by stroke severity and treatment timing showed consistent lack of benefit across all subgroups (all interaction P-values > .05). Discussion The absence of functional benefit from EVT observed in this real-world cohort is consistent with the results of the ESCAPE-MeVO and DISTAL randomized trials. Notably, the higher rate of any intracranial haemorrhage in the EVT group (18.4% vs 11.2%), driven primarily by minor haemorrhagic events, represents a clinically meaningful safety concern that must be weighed against the lack of demonstrated efficacy. A hypothesis-generating signal was observed in patients treated within 180 minutes (OR 2.16, 95% CI 1.06–4.38), warranting prospective investigation. The retrospective design and the limitations inherent to registry-based data, including incomplete procedural data and anatomical heterogeneity in MeVO classification, should be considered when interpreting these findings. Conclusions Endovascular therapy did not improve long-term functional outcomes compared to IVT alone in MeVO stroke but was associated with higher haemorrhagic risk. These findings support a cautious approach to EVT in this setting, in line with recent trial evidence.

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Journal
European Stroke Journal
Published
2026-03-01
DOI
https://doi.org/10.1093/esj/aakag020
Primary Topic
Acute Ischemic Stroke Management
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article
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article

Effectiveness and safety of endovascular therapy compared to intravenous thrombolysis in acute ischaemic stroke due to medium-vessel occlusions: a real-world multicentre study from the Italian SITS registry

Silvio Piffer, Alessandra Martignoni, Roberto Tarletti, Giovanni Bosco et al.
European Stroke Journal
Acute Ischemic Stroke Management
article

Effectiveness and safety of endovascular therapy compared to intravenous thrombolysis in acute ischaemic stroke due to medium-vessel occlusions: a real-world multicentre study from the Italian SITS registry

Silvio Piffer, Alessandra Martignoni, Roberto Tarletti, Giovanni Bosco, E. Medici, Maurizia Rasura, Delfina Ferrandi, Giuseppe Torgano, Maria Sessa, Stefano Meletti, L. Godi, Letizia Concari, Maurizio Melis, Simone Beretta, Claudia Balducci, Francesco Santangelo, Fabio Marchioretto, Nicola Iorio, D Toni, Margherita Bellucci, Fabio Melis, Pier Andrea Rizzo, Marco Vista, Bonaventura Ardito, M Plocco, Martina Vigano, V. Lucivero, F. Pedrazzini, Stefano Novello, Roberto Bombardi, Ivana Bosone, Francesco Pasini, Stefano Forlivesi, M. Magoni, R. Cavallo, Silvia Strumia, Laura Vandelli, Giovanni Isgrò, Elena Coco, Matteo Farè, Patrizia Julita, Massimo Del Sette, Nicola Rifino, Giovanni Boero, Maria Giovanna Pennisi, Giuseppina Calabrese, Luigi Bartolomei, Stefano Spinelli, Valerio Melas, Elisa Bianchi, Francesco Innocenti, Alessandro Trebbastoni, Danilo Antonio Montisano, Alberto Chiti, Salvatore Amarù, Giuseppe Rinaldi, Ciro Mundi, Ferrarese Carlo, Paolo Del Dotto, Cavallini Anna, Martina Mercenari, Mariantonietta Savarese, Michela Galimberti, Edoardo Pedranzini, Giorgia Orsani, Giulia Benina, Romano Giovanni Orofino, Carmela Palmieri, Mauro Gentile, Luisa Roveri, Marco Vito Rossi, Pasquinucci Antonella, Tiziana Tassinari, Sicurella Luigi, Angela Giglio, Meineri Piero, Gabriele Lucchi, Scaglione Gaspare, Enza Pinto, Gabriella Monteforte, Plutino Andrea, Reia Antonio, Guidotti Mario, Angelo Cascio Rizzo, Paolo Invernizzi, Luigi Caputi, Emanuele Spina, for the SITS-MeVO Study Group, Fabrizio Sallustio, Maria Luisa Dell'Acqua, Matteo Paolucci, Tassi Rossana, Napoletano Rosa, Andrea Salmaggi, Riccardo Altavilla, Andrea Zini, Guido Bigliardi, Cardinali Patrizio, Baldi Antonio, Martusciello Gioacchino, Marco Longoni, Antonio Gasparro, Mauro Galletti, Cristina Paci, Massimo Filippi, Alessandra Sanna, Agostoni Elio
article en

Abstract

Abstract Introduction Recent randomised trials have questioned the benefit of endovascular therapy (EVT) for MeVO stroke, but data from clinical practice are limited. This study aimed to assess the effectiveness and safety of EVT, with or without intravenous thrombolysis (IVT), vs IVT alone in MeVO stroke using registry-based real-world data. Patients and methods This retrospective multicentre study included patients from 82 Italian centres in the Safe Implementation of Treatments in Stroke (SITS) registry (January 2020–December 2023). Adults with acute ischaemic stroke due to MeVO (ACA A1/A2, MCA M2/M3 or more distal or PCA P1/P2), treated with IVT or EVT ± IVT, and with available 90-day mRS scores were included. Patients with tandem occlusions were excluded. Propensity score matching (1:1) was used to balance baseline variables. Primary outcome was functional independence (mRS 0–2) at 90 days. Secondary outcomes included in-hospital mortality, intracranial haemorrhage incidence and recanalisation status. Results Among 1375 total patients, 780 were included and matched (390 per group) by propensity score. Baseline characteristics were balanced. Functional independence at 90 days was achieved in 60.6% of EVT ± IVT patients vs 60.9% in the IVT-only group (odds ratio [OR] 0.99; 95% CI, 0.73–1.34; P = .939). When restricted to patients with baseline mRS < 2, functional independence rates remained comparable between groups, confirming the primary findings. In-hospital mortality was non-significantly lower in the EVT ± IVT group (5.4% vs 8.7%, P = .069). Symptomatic intracranial haemorrhage rates were comparable between groups, although overall haemorrhagic complications were higher with EVT (18.4% vs 11.2%, P < .0001). Stratified analyses by stroke severity and treatment timing showed consistent lack of benefit across all subgroups (all interaction P-values > .05). Discussion The absence of functional benefit from EVT observed in this real-world cohort is consistent with the results of the ESCAPE-MeVO and DISTAL randomized trials. Notably, the higher rate of any intracranial haemorrhage in the EVT group (18.4% vs 11.2%), driven primarily by minor haemorrhagic events, represents a clinically meaningful safety concern that must be weighed against the lack of demonstrated efficacy. A hypothesis-generating signal was observed in patients treated within 180 minutes (OR 2.16, 95% CI 1.06–4.38), warranting prospective investigation. The retrospective design and the limitations inherent to registry-based data, including incomplete procedural data and anatomical heterogeneity in MeVO classification, should be considered when interpreting these findings. Conclusions Endovascular therapy did not improve long-term functional outcomes compared to IVT alone in MeVO stroke but was associated with higher haemorrhagic risk. These findings support a cautious approach to EVT in this setting, in line with recent trial evidence.

European Stroke JournalVol. 11(3)
University of Foggia (IT), Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT), IMT School for Advanced Studies Lucca (IT), Vita-Salute San Raffaele University (IT), University of Sassari (IT), University of Cagliari (IT), Mario Negri Institute for Pharmacological Research (IT), University of Pavia (IT), Agostino Gemelli University Polyclinic (IT), Eagle Ridge Hospital (CA), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), Accademia di Belle Arti di Carrara (IT), Ospedale Antonio Cardarelli (IT), Azienda Unita' Sanitaria Locale Di Modena (IT), ASL Roma (IT), Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (IT), Ospedale Civile Edoardo Agnelli (IT), Ospedale di Rivoli (IT), Ospedale Vincenzo Cervello (IT), Ospedale Sacro Cuore Don Calabria (IT), Ospedale San Carlo (IT), Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT), Ospedale A. Perrino (IT), Ospedale Sant Antonio (IT), Azienda Ospedaliero Universitaria di Sassari (IT), Ospedale Papa Giovanni XXIII (IT), Ospedale di Santo Spirito (IT), Fatebenefratelli Hospital (IT), Provincia Autonoma di Trento (IT), Alessandro Manzoni Hospital (IT), Ospedale “M. Bufalini” di Cesena (IT), Azienda Ospedaliero Universitaria Maggiore della Carita (IT), Ospedale San Giovanni Bosco (IT), Presidio Ospedaliero (IT), Istituto delle Scienze Neurologiche di Bologna (IT), Ospedale G.B. Morgagni - L.Pierantoni (IT), Azienda Ospedaliera Sant'Andrea (IT), Imamura Hospital (JP), Azienda Socio Sanitaria Territoriale Lariana (IT), Azienda Sanitaria Locale Alessandria (IT), Torino e-district (IT), A. O. Ordine Mauriziano di Torino (IT), Ospedale Infermi di Rimini (IT), IRCCS Ospedale San Raffaele (IT), Ospedale di Mirano (IT), Ospedale Cannizzaro (IT), Novamedia (Italy) (IT), Ospedale Santa Maria Goretti (IT), Ospedale Maria Vittoria (IT), FHU Neurovasc (FR), Azienda Ospedaliera Ospedale Maggiore (IT), Ospedale Policlinico San Martino (IT), Fondazione Poliambulanza Istituto Ospedaliero (IT), Ospedale SS. Annunziata (IT), Ospedale degli Infermi (IT), Ospedale Versilia (IT), Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo (IT), Azienda Sanitaria Locale Roma 3 (IT), Ospedale generale di zona San Camillo Treviso (IT), Ospedale Santa Corona (IT), Polyclinic General Hospital (GR), Azienda Ospedaliera G. Brotzu (IT), University of Macerata (IT), University of Turin (IT), University of Bari Aldo Moro (IT), University of Milano-Bicocca (IT), Sapienza University of Rome (IT)
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