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Abstract
Objective To assess the utility of IV thrombolysis (IVT) treatment in patients with acute ischemic stroke (AIS) with unclear symptom onset time or outside the 4.5-hour time window selected by advanced neuroimaging.
Methods We performed random-effects meta-analyses on the unadjusted and adjusted for potential confounders associations of IVT (alteplase 0.9 mg/kg) with the following outcomes: 3-month favorable functional outcome (FFO; modified Rankin Scale [mRS] scores 0–1), 3-month functional independence (FI; mRS scores 0–2), 3-month mortality, 3-month functional improvement (assessed with ordinal analysis on the mRS scores), symptomatic intracranial hemorrhage (sICH), and complete recanalization (CR).
Results We identified 4 eligible randomized clinical trials (859 total patients). In unadjusted analyses, IVT was associated with a higher likelihood of 3-month FFO (odds ratio [OR] 1.48, 95% confidence interval [CI] 1.12–1.96), FI (OR 1.42, 95% CI 1.07–1.90), sICH (OR 5.28, 95% CI 1.35–20.68), and CR (OR 3.29, 95% CI 1.90–5.69), with no significant difference in the odds of all-cause mortality risk at 3 months (OR 1.75, 95% CI 0.93–3.29). In the adjusted analyses, IVT was also associated with higher odds of 3-month FFO (adjusted OR [ORadj] 1.62, 95% CI 1.20–2.20), functional improvement (ORadj 1.42, 95% CI 1.11–1.81), and sICH (ORadj 6.22, 95% CI 1.37–28.26). There was no association between IVT and FI (ORadj 1.61, 95% CI 0.94–2.75) or all-cause mortality (ORadj 1.75, 95% CI 0.93–3.29) at 3 months. No evidence of heterogeneity was evident in any of the analyses (I2 = 0).
Conclusion IVT in patients with AIS with unknown symptom onset time or elapsed time from symptom onset >4.5 hours selected with advanced neuroimaging results in a higher likelihood of CR and functional improvement at 3 months despite the increased risk of sICH.
Glossary
- AIS=
- acute ischemic stroke;
- CI=
- confidence interval;
- DWI=
- diffusion-weighted imaging;
- ECASS=
- European Cooperative Acute Stroke Study;
- EPITHET=
- Echoplanar Imaging Thrombolytic Evaluation Trial;
- EXTEND=
- Extending the Time for Thrombolysis in Emergency Neurological Deficits;
- FLAIR=
- fluid-attenuated inversion recovery;
- FFO=
- favorable functional outcome;
- FI=
- functional independence;
- IVT=
- IV thrombolysis;
- mRS=
- modified Rankin Scale;
- OR=
- odds ratio;
- RCT=
- randomized clinical trial;
- sICH=
- symptomatic intracranial hemorrhage
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
- Received June 3, 2019.
- Accepted in final form September 30, 2019.
- © 2019 American Academy of Neurology
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