Independence of ischemic stroke patients after alteplase systemic thrombolytic therapy

Close metadata

OBJECTIVE

Was to determine the proportion of patients with ischemic stroke (IS) who achieved functional independence by the end of the hospitalization, among those who underwent systemic thrombolytic therapy (STT) with two different alteplase preparations (Actilyse and Revelisa).

MATERIAL AND METHODS

An open, prospective observational non-interventional cohort study of the results of STT in patients with IS was carried out. The study included 195 patients, 123 men and 72 women aged 32 to 86 years, who received STT in the acute period of IS. Of these, 120 patients received Actilyse, 75 — Revelisa.

RESULTS

Patients who achieved independence in movement (0-2 points on the modified Rankin scale (MRS)) among those who received STT with Actilyse and Revelisa, the value of the χ² criterion was 0.014 (p=0.905), which showed that there was no statistical significance of the difference in the frequency of recovery of functional disorders on the MRS scale, in patients receiving STT with two different alteplase preparations.

CONCLUSION

After STT with alteplase preparations, patients with IS experienced a significant improvement, which was expressed in a statistically significant decrease in the severity of neurological deficit and a decrease in the degree of disability. When comparing the results of STT with two different alteplase preparations, no statistically significant differences were found in terms of mortality, survival, and independence during the acute period of IS.

Keywords:

ischemic stroke

systemic thrombolytic therapy

alteplase

Actilyse

Revelisa

Authors:

Belkina S.N.

Vladimirsky Moscow Regional Research Clinical Institute;
Voskresensk First Regional Hospital

Kotov S.V.

Vladimirsky Moscow Regional Research Clinical Institute

SPIN RSCI: 1798-0837
Scopus AuthorID: 7005990035
ResearcherID: E-4451-2017
ORCID: 0000-0002-8706-7317

Isakova E.V.

Vladimirsky Moscow Regional Clinical Research Institute

Kotov A.S.

Vladimirsky Moscow Regional Research Clinical Institute

Received:

20.09.2021

Accepted:

05.10.2021

List of references:

Demographic Yearbook of Russia. 2019: Stat. sb./D 31 Rosstat. M. 2019:252. (In Russ).
GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019;18(5):439-458. https://doi.org/10.1016/S1474-4422(19)30034-1
Rand K, Dahl FA, Viana J, et al. Fewer ischemic strokes, despite an ageing population: stroke models from observed incidence in Norway 2010-2015. BMC Health Serv Res. 2019;19(1):705. https://doi.org/10.1186/s12913-019-4538-7.
Sims JR, Rordorf G, Smith EE, et al. Arterial occlusion revealed by CT angiography predicts NIH stroke score and acute outcomes after IV tPA treatment. Am J Neuroradiol. 2005;26(2):246-251.
Mair G, Boyd EV, Chappell FM, et al. IST-3 Collaborative Group. Sensitivity and specificity of the hyperdense artery sign for arterial obstruction in acute ischemic stroke. Stroke. 2015;46(1):102-107. https://doi.org/10.1161/STROKEAHA.114.007036
Laypanova LR. Reperfusion therapy for ischemic stroke. Pharmateca. 2020;3:50-54. (In Russ). https://doi.org/10.18565/pharmateca.2020.3.50-54
National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333(24):1581-1587. https://doi.org/10.1056/NEJM199512143332401
Amiri H, Bluhmki E, Bendszus M, et al. European Cooperative Acute Stroke Study-4: Extending the time for thrombolysis in emergency neurological deficits ECASS-4: ExTEND. Int J Stroke. 2016;11(2):260-267. https://doi.org/10.1177/1747493015620805
Alper BS, Foster G, Thabane L, et al. Thrombolysis with alteplase 3-4.5 hours after acute ischaemic stroke: trial reanalysis adjusted for baseline imbalances. BMJ Evid Based Med. 2020;25(5):168-171. https://doi.org/10.1136/bmjebm-2020-111386.
Shamalov NA, Stakhovskaya LV, Tikhonova MA, et al. Development of reperfusion therapy for ischemic stroke in the Russian Federation: achievements and prospects. Pharmateca. 2017;9(342):66-70. (In Russ.).
Hacke W, Donnan G, Fieschi C, et al. ATLANTIS Trials Investigators; ECASS Trials Investigators; NINDS rt-PA Study Group Investigators. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials. Lancet. 2004;363(9411):768-774. https://doi.org/10.1016/S0140-6736(04)15692-4
Lees KR, Bluhmki E, von Kummer R, et al. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet. 2010;375(9727):1695-1703. https://doi.org/10.1016/S0140-6736(10)60491-6
Adams HP Jr, Bendixen BH, Kappelle LJ, et al. Classification of subtype of acute ischemic stroke. Definitions for use in a multicenter clinical trial. TOAST. Trial of Org 10172 in Acute Stroke Treatment. Stroke. 1993;24(1):35-41.
Gusarova VD, Pantyushenko MS, Simonov VM, et al. Physicochemical and biological properties of biosimilar and reference preparations of tissue plasminogen activator. BIOPreparations. Prevention, diagnosis, treatment. 2019;19(1):39-49. (In Russ.). https://doi.org/10.30895/2221-996X-2019-19-1-39-49
Kokorin VA, Markova OA, Gordeev IG, et al. Comparative study of the efficacy and safety of the domestic recombinant tissue plasminogen activator Revelisa in patients with myocardial infarction. Therapy. 2019;5:2(28):42-57. (In Russ.). https://doi.org/10.18565/therapy.2019.2.42-57
Soldatov MA, Marskaya NA, Barsegova KA, et al. Intravenous thrombolytic therapy of ischemic stroke with Revelisa in real clinical practice: interim results of the IVT-AIS-R study. Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova. Spetsvypuski. 2021;121(3-2):33-37. https://doi.org/10.17116/jnevro202112103133
Emberson J, Lees KR, Lyden P, et al. Stroke Thrombolysis Trialists’ Collaborative Group. Effect of treatment delay, age, and stroke severity on the effects of intravenous thrombolysis with alteplase for acute ischaemic stroke: a meta-analysis of individual patient data from randomised trials. Lancet. 2014;384(9958):1929-1935. https://doi.org/10.1016/S0140-6736(14)60584-5
Pfaff JA, Bendszus M, Donnan G, et al. The impact of the DWI-FLAIR-mismatch in the ECASS-4 trial - A post hoc analysis. Eur Stroke J. 2020 Dec;5(4):370-373. https://doi.org/10.1177/2396987320920114
Thomalla G, Simonsen CZ, Boutitie F, et al. WAKE-UP Investigators. MRI-Guided Thrombolysis for Stroke with Unknown Time of Onset. N Engl J Med. 2018;379(7):611-622. https://doi.org/10.1056/NEJMoa1804355
Campbell BCV, Ma H, Ringleb PA, et al. EXTEND, ECASS-4, and EPITHET Investigators. Extending thrombolysis to 4·5-9 h and wake-up stroke using perfusion imaging: a systematic review and meta-analysis of individual patient data. Lancet. 2019 Jul 13;394(10193):139-147. https://doi.org/10.1016/S0140-6736(19)31053-0.
Schwamm LH, Wu O, Song SS, et al. MR WITNESS Investigators. Intravenous thrombolysis in unwitnessed stroke onset: MR WITNESS trial results. Ann Neurol. 2018;83(5):980-993. https://doi.org/10.1002/ana.25235
Knight RA, Dereski MO, Helpern JA, et al. Magnetic resonance imaging assessment of evolving focal cerebral ischemia. Comparison with histopathology in rats. Stroke. 1994;25(6):1252-1261. https://doi.org/10.1161/01.str.25.6.1252

Close metadata