Efficacy of systemic thrombolysis within 4.5 h from stroke symptom onset: a single-centre clinical and diffusion-perfusion 3T MRI study.

PURPOSE: The efficacy of thrombolytic treatment with recombinant tissue plasminogen activator (rt-PA) within 3 h from stroke onset has been extensively supported by randomised placebo-controlled multicentre trials. In our single-centre study, we investigated the efficacy of intravenous (IV) administration of rt-PA within 4.5 h of stroke onset, in terms of clinical and radiological outcome, using a 3T magnetic resonance (MR) scanner in a cohort of patients similar to that of multicentre clinical trials. MATERIALS AND METHODS: Consecutive patients treated with IV rt-PA were compared with an historical cohort of untreated patients (controls). Inclusion criteria were: (1) infarction of the middle cerebral artery territory, (2) eligibility for IV rt-PA treatment, and (3) 3T perfusion- and diffusion-weighted MR imaging and MR angiography performed within 4.5 h and repeated after 5-7 days. Stroke severity was assessed with the National Institutes of Health Stroke Scale (NIHSS). Growth of the DWI lesion, saved hypoperfused tissue, and clinical outcome was assessed and compared in treated patients and controls. RESULTS: Forty-three patients treated with rt-PA and 69 controls were eligible for the analysis. Treated patients showed higher percentages of saved hypoperfused tissue (75 vs. 40 %; p = 0.009), vessel recanalisation (65 vs. 27.5%; p = 0.003), and haemorrhagic transformation (21 vs. 7%; p = 0.004), without any clinically significant haemorrhages. Furthermore, treated patients had a significant improvement of NIHSS at 24 h (p < 0.001), at discharge (p ≤ 0.001), and at the 3-month clinical evaluation (p < 0.001), while similar rates of both treated patients and controls achieved a 3-month modified Rankin scale ≤ 2 (62 and 65%; p = 0.7). CONCLUSION: Treatment with IV rt-PA within 4.5 h of stroke onset preserves a significant amount of brain tissue from final infarction, and increases the possibility of early and late clinical improvement.