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European journal of neurology · 2026

Direct Thrombectomy vs. Combined Treatment With Intravenous Thrombolysis in the Extended Time Window: A Target Trial Emulation.

СтатьяEquivalence TrialНазвание и аннотация: Перевод пока не подготовлен
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Nicolini Ettore, Ciacciarelli Antonio, Pracucci Giovanni, Saia Valentina, Simonetti Luigi, Zini Andrea, Da Ros Valerio, D'agostino Federica, Iacobucci Marta, De Michele Manuela, Andrighetti Marco, Tassi Rossana, Saletti Andra, Casetta Ilaria, Fainardi Enrico, Pauciulo Alfredo, Caggiula Marcella, Menozzi Roberto, Pezzini Alessandro, Vallone Stefano, Bigliardi Guido, Zimatore Domenico Sergio, Petruzzellis Marco, Comai Alessio, Franchini Enrica, Allegretti Luca, Tassinari Tiziana, Limbucci Nicola, Nencini Patrizia, Carità Giuseppe, Russo Monia, Filizzolo Marco, Mannino Marina, Ruggiero Maria, Longoni Marco, Boghi Andrea, Naldi Andrea, Bergui Mauro, Bosco Giovanni, Pelle Giuseppe, Alessiani Michele, Alberti Matteo, Invernizzi Paolo, Augelli Raffaele, Cappellari Manuel, Lazzarotti Guido Andrea, Giannini Nicola, Konda Daniel, Sallustio Fabrizio, Mangiafico Salvatore, Toni Danilo, IRETAS group

Аннотация

BACKGROUND: In the early time window, direct mechanical thrombectomy (MT) is not non-inferior to combined treatment with intravenous thrombolysis (IVT) for patients with large vessel occlusion (LVO) stroke, while its non-inferiority in the extended time window remains uncertain. This study assessed whether direct MT is non-inferior to IVT + MT beyond 4.5 h or at wake-up.

METHODS: We emulated a non-inferiority trial, comparing direct MT vs. IVT + MT, including patients with anterior circulation LVO between 4.5 and 24 h from symptom onset or at wake-up, without contraindications to IVT and with target perfusion mismatch. We used inverse probability weighting (IPW) adjusted for pre-specified covariates. The primary outcome was 90-day mRS 0-2, with non-inferiority defined by a lower 95% CI boundary of the Risk Difference (RD) ≥ -1.3%.

RESULTS: Among 347 patients, 212 received direct MT and 135 received IVT + MT. After IPW, patients treated with direct MT and IVT + MT had a similar likelihood of achieving a 90-day mRS of 0-2 (adjRD -2.90 [95% CI -6.64 to 0.84]) with the lower boundary of the RD 95% CI crossing the non-inferiority margin. Additionally, direct MT was associated with a shift toward a higher score on the 90-day mRS (adjusted Common OR 1.59 [95% CI 1.05-2.39]), not confirmed after IPW, and with lower odds of successful recanalization (adjOR 0.38 [95% CI 0.18-0.78]). Rates of 90-day mRS 0-1, sICH, and mortality were similar between groups.

CONCLUSIONS: In our target trial emulation, direct MT was not non-inferior to IVT + MT treatment beyond 4.5 h from symptom onset or at wake-up, with IVT before MT yielding higher successful recanalization rates.

Предметные рубрики MeSH

ИП Урсолов Владлен Сергеевич

ИНН 500118482352 · ОГРНИП 314500117700049

Реквизиты и контакты