M A Soldatov1, N A Marskaya1, K A Barsegova1, O V Androfagina2, D N Borisov3, D Yu Karpov4, M V Kishinevsky5, M V Kucheryavaya6, S V Tabakman7, Yu A Telyatnik8, A S Fadeeva9, D S Khan10, A N Chirkov11, N A Shamalov1. 1. Institute of Cerebrovascular Pathology and Stroke, Federal Center for Brain and Neurotechnology of the Federal Medical and Biological Agency, Moscow, Russia. 2. Seredavin Samara Regional Clinical Hospital, Samara, Russia. 3. Kirov Regional Clinical Hospital, Kirov, Russia. 4. City Hospital No. 5, Barnaul, Russia. 5. Berzon Krasnoyarsk Interdistrict Clinical Hospital No. 20, Krasnoyarsk, Russia. 6. Sergiev Posad District Hospital, Sergiev Posad, Russia. 7. Pirogov City Hospital No. 1, Sevastopol, Russia. 8. Research Institute - Ochapovsky Regional Clinical Hospital No. 1, Krasnodar, Russia. 9. Vladivostok Clinical Hospital No. 1, Vladivostok, Russia. 10. Primorskaya Regional Clinical Hospital No. 1, Vladivostok, Russia. 11. Orenburg Regional Clinical Hospital, Orenburg, Russia.
Abstract
OBJECTIVE: To assess the safety and efficacy of Revelisa in patients with ischemic stroke in real-world clinical practice. MATERIAL AND METHODS: The interim analysis of an open-label, prospective, multicenter, non-interventional study IVT-AIS-R included 223 patients (50.2% women and 49.8% men, mean age 66.6 (13.5) years) with ischemic stroke who were admitted to the study sites since July 2019 and who, in the absence of contraindications, underwent thrombolytic therapy (TLT) with Revelisa within the first 4.5 hours from the onset of stroke. Data were collected as a continuous sample. According to the reperfusion therapy protocol for ischemic stroke, all patients included in the study underwent clinical examination, investigations and laboratory tests before TLT and within the first days after it. Symptomatic hemorrhagic transformation was determined in accordance with the ECASS 3 criteria. RESULTS: Most of the patients (96%) had hypertension, 74% of patients had chronic heart failure, 57.4% had coronary artery disease, of which 8.5% were patients with a previous myocardial infarction. Various cardiac arrhythmias were observed in 33.2% of cases, 21.5% of patients had type 2 diabetes, 18.4% had a history of previous acute cerebrovascular accidents. Hemorrhagic transformation (HT) of a cerebral lesion developed in 7.1% of cases, with the frequency of symptomatic HT being 3.1% (7 patients). The hospital mortality rate was 13.9%. The median NIHSS score was 4 points (p<0.0001) on day 7 versus baseline. The proportion of patients with good functional recovery (the modified Rankin scale score 0-2) at discharge was 48.2%. CONCLUSION: The data obtained with the use of Revelisa in patients with ischemic stroke in real-world clinical practice allow drawing conclusions about a comparable safety and efficacy profile to that in previously published registry studies of alteplase.
OBJECTIVE: To assess the safety and efficacy of Revelisa in patients with ischemic stroke in real-world clinical practice. MATERIAL AND METHODS: The interim analysis of an open-label, prospective, multicenter, non-interventional study IVT-AIS-R included 223 patients (50.2% women and 49.8% men, mean age 66.6 (13.5) years) with ischemic stroke who were admitted to the study sites since July 2019 and who, in the absence of contraindications, underwent thrombolytic therapy (TLT) with Revelisa within the first 4.5 hours from the onset of stroke. Data were collected as a continuous sample. According to the reperfusion therapy protocol for ischemic stroke, all patients included in the study underwent clinical examination, investigations and laboratory tests before TLT and within the first days after it. Symptomatic hemorrhagic transformation was determined in accordance with the ECASS 3 criteria. RESULTS: Most of the patients (96%) had hypertension, 74% of patients had chronic heart failure, 57.4% had coronary artery disease, of which 8.5% were patients with a previous myocardial infarction. Various cardiac arrhythmias were observed in 33.2% of cases, 21.5% of patients had type 2 diabetes, 18.4% had a history of previous acute cerebrovascular accidents. Hemorrhagic transformation (HT) of a cerebral lesion developed in 7.1% of cases, with the frequency of symptomatic HT being 3.1% (7 patients). The hospital mortality rate was 13.9%. The median NIHSS score was 4 points (p<0.0001) on day 7 versus baseline. The proportion of patients with good functional recovery (the modified Rankin scale score 0-2) at discharge was 48.2%. CONCLUSION: The data obtained with the use of Revelisa in patients with ischemic stroke in real-world clinical practice allow drawing conclusions about a comparable safety and efficacy profile to that in previously published registry studies of alteplase.