Intravenous Thrombolysis Alone versus Endovascular Thrombectomy Alone versus Intravenous Thrombolysis plus Endovascular Thrombectomy for Ischemic Stroke Beyond the 4.5-Hour Window: A Network Meta-Analysis of Randomized Clinical Trials
Marina Vilardo1, Lucas Pari Mitre2, Ahmet Günkan3, Dominique Montecino4, Filipe Ribeiro5, Bruna Leles Vieira de Souza6, Ocílio Ribeiro Gonçalves7, Raphael Camerotte8, Ana Santos9, Anthony Hong9
1Department of Medicine, Catholic University of Brasilia, 2Faculty of Medicine, Santa Casa de São Paulo School of Medical Sciences, 3Department of Radiology, Fatih Sultan Mehmet Training and Research Hospital, 4Department of Neurology, Mayo Clinic, 5Faculty of Medicine, Barão de Mauá University Center, 6Department of Neurology, Massachusetts General Hospital, 7Faculty of Medicine, Federal University of Piauí, 8Faculty of Medicine, Federal University of Rio de Janeiro, 9Faculty of Medicine, University of Costa Rica
Objective:
To compare the efficacy and safety of intravenous thrombolysis (IVT), endovascular thrombectomy (EVT), and the combined approach for acute ischemic stroke beyond 4.5 hours.
Background:
Few stroke patients qualify for IVT within the 4.5-hour window. Recent studies have revolutionized the eligibility criteria to extend the EVT window beyond 6 hours. Limited data compare these treatment approaches beyond 4.5 hours.
Design/Methods:
We systematically searched Pubmed, Embase, Cochrane, and Web-of-Science for randomized clinical trials (RCTs) analyzing IVT and/or EVT versus control in ischemic stroke beyond 4.5 hours of last-known-well. Primary outcomes were functional outcomes according to modified Rankin Scale (mRS) at 90 days, classified as excellent (0-1) or good (0-2), symptomatic intracerebral hemorrhage (sICH), and mortality at 90 days. We used frequentist and Bayesian network meta-analysis models, reporting odds ratios (ORs) with 95% confidence intervals (CIs) from the Bayesian analysis.
Results:
Thirteen RCTs (3,668 patients; mean age 67.4±9.4 years, 56.5% male) were included. Compared to control, EVT alone achieved higher rates of excellent (OR, 2.22, 95% CI, 1.40-3.79) and good functional outcomes (OR, 2.70, 95% CI, 1.60-5.11), while IVT alone and IVT plus EVT were not statistically significant. IVT alone demonstrated a higher rate of sICH (OR, 6.10, 95% CI, 2.19-21.9) than EVT alone (OR, 2.64, 95% CI 1.01-7.08), and a non-significant increase in the combined approach (OR, 1.33, 95% CI 0.32-5.24). Mortality at 90 days did not significantly differ between treatment groups.
Conclusions:
Compared to control, EVT alone for ischemic stroke beyond the 4.5-hour window achieved higher odds of excellent and good functional outcomes and lower rates of sICH. IVT alone led to increased odds of sICH, with a non-significant increase in mortality. The combined therapy may not offer substantial benefits over the isolated approaches. Future RCTs are necessary to optimize patient selection for the combined approach and consolidate protocols in the extended time window.
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