The SITS-UTMOST: A registry-based prospective study in Europe
investigating the impact of regulatory approval of intravenous
Actilyse in the extended time window (3-4.5 h) in acute
ischaemic stroke

J 2016

The SITS-UTMOST: A registry-based prospective study in Europe investigating the impact of regulatory approval of intravenous Actilyse in the extended time window (3-4.5 h) in acute ischaemic stroke

AHMED, Niaz, Karin HERMANSSON, Erich BLUHMKI, Thierry DANAYS, Ana Paiva NUNES et. al.

Základní údaje

Originální název

The SITS-UTMOST: A registry-based prospective study in Europe investigating the impact of regulatory approval of intravenous Actilyse in the extended time window (3-4.5 h) in acute ischaemic stroke

Autoři

AHMED, Niaz (garant), Karin HERMANSSON, Erich BLUHMKI, Thierry DANAYS, Ana Paiva NUNES, Anthony KENTON, Sekaran LAKSHMANAN, Danilo TONI, Robert MIKULÍK (203 Česká republika, domácí), Gary A. FORD, Kennedy R. LEES a Nils WAHLGREN

Vydání

EUROPEAN STROKE JOURNAL, LONDON, SAGE PUBLICATIONS LTD, 2016, 2396-9873

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30210 Clinical neurology

Stát vydavatele

Velká Británie a Severní Irsko

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Kód RIV

RIV/00216224:14110/16:00124589

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1177/2396987316661890

UT WoS

000445997000007

Klíčová slova anglicky

Actilyse; haemorrhage; ischaemia; Stroke; thrombolysis; time to treatment

Štítky

14110127, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 12. 5. 2022 14:04, Mgr. Tereza Miškechová

Anotace

V originále

Introduction: The SITS-UTMOST (Safe Implementation of Thrombolysis in Upper Time window Monitoring Study) was a registry-based prospective study of intravenous alteplase used in the extended time window (3-4.5 h) in acute ischaemic stroke to evaluate the impact of the approval of the extended time window on routine clinical practice. Patients and methods: Inclusion of at least 1000 patients treated within 3-4.5 h according to the licensed criteria and actively registered in the SITS-International Stroke Thrombolysis Registry was planned. Prospective data collection started 2 May 2012 and ended 2 November 2014. A historical cohort was identified for 2 years preceding May 2012. Clinical management and outcome were contrasted between patients treated within 3 h versus 3-4.5 h in the prospective cohort and between historical and prospective cohorts for the 3 h time window. Outcomes were functional independency (modified Rankin scale, mRS) 0-2, favourable outcome (mRS 0-1), and death at 3 months and symptomatic intracerebral haemorrhage (SICH) per SITS. Results: 4157 patients from 81 centres in 12 EU countries were entered prospectively (N = 1118 in the 3-4.5 h, N = 3039 in the 0-3 h time window) and 3454 retrospective patients in the 0-3 h time window who met the marketing approval conditions. In the prospective cohort, median arrival to treatment time was longer in the 3-4.5 h than 3 h window (79 vs. 55 min). Within the 3 h time window, treatment delays were shorter for prospective than historical patients (55 vs. 63). There was no significant difference between the 3-4.5 h versus 3 h prospective cohort with regard to percentage of reported SICH (1.6 vs. 1.7), death (11.6 vs. 11.1), functional independency (66 vs. 65) at 3 months or favourable outcome (51 vs. 50). Discussion: Main weakness is the observational design of the study. Conclusion: This study neither identified negative impact on treatment delay, nor on outcome, following extension of the approved time window to 4.5 h for use of alteplase in stroke.

Citovat

AHMED, Niaz, Karin HERMANSSON, Erich BLUHMKI, Thierry DANAYS, Ana Paiva NUNES, Anthony KENTON, Sekaran LAKSHMANAN, Danilo TONI, Robert MIKULÍK, Gary A. FORD, Kennedy R. LEES a Nils WAHLGREN. The SITS-UTMOST: A registry-based prospective study in Europe investigating the impact of regulatory approval of intravenous Actilyse in the extended time window (3-4.5 h) in acute ischaemic stroke. EUROPEAN STROKE JOURNAL. LONDON: SAGE PUBLICATIONS LTD, 2016, roč. 1, č. 3, s. 213-221. ISSN 2396-9873. Dostupné z: https://dx.doi.org/10.1177/2396987316661890.

@article{1852761,
   author = {Ahmed, Niaz and Hermansson, Karin and Bluhmki, Erich and Danays, Thierry and Nunes, Ana Paiva and Kenton, Anthony and Lakshmanan, Sekaran and Toni, Danilo and Mikulík, Robert and Ford, Gary A. and Lees, Kennedy R. and Wahlgren, Nils},
   article_location = {LONDON},
   article_number = {3},
   doi = {http://dx.doi.org/10.1177/2396987316661890},
   keywords = {Actilyse; haemorrhage; ischaemia; Stroke; thrombolysis; time to treatment},
   language = {eng},
   issn = {2396-9873},
   journal = {EUROPEAN STROKE JOURNAL},
   title = {The SITS-UTMOST: A registry-based prospective study in Europe investigating the impact of regulatory approval of intravenous Actilyse in the extended time window (3-4.5 h) in acute ischaemic stroke},
   url = {https://journals.sagepub.com/doi/10.1177/2396987316661890},
   volume = {1},
   year = {2016}
}

TY  - JOUR
ID  - 1852761
AU  - Ahmed, Niaz - Hermansson, Karin - Bluhmki, Erich - Danays, Thierry - Nunes, Ana Paiva - Kenton, Anthony - Lakshmanan, Sekaran - Toni, Danilo - Mikulík, Robert - Ford, Gary A. - Lees, Kennedy R. - Wahlgren, Nils
PY  - 2016
TI  - The SITS-UTMOST: A registry-based prospective study in Europe investigating the impact of regulatory approval of intravenous Actilyse in the extended time window (3-4.5 h) in acute ischaemic stroke
JF  - EUROPEAN STROKE JOURNAL
VL  - 1
IS  - 3
SP  - 213-221
EP  - 213-221
PB  - SAGE PUBLICATIONS LTD
SN  - 23969873
KW  - Actilyse
KW  - haemorrhage
KW  - ischaemia
KW  - Stroke
KW  - thrombolysis
KW  - time to treatment
UR  - https://journals.sagepub.com/doi/10.1177/2396987316661890
N2  - Introduction: The SITS-UTMOST (Safe Implementation of Thrombolysis in Upper Time window Monitoring Study) was a registry-based prospective study of intravenous alteplase used in the extended time window (3-4.5 h) in acute ischaemic stroke to evaluate the impact of the approval of the extended time window on routine clinical practice. Patients and methods: Inclusion of at least 1000 patients treated within 3-4.5 h according to the licensed criteria and actively registered in the SITS-International Stroke Thrombolysis Registry was planned. Prospective data collection started 2 May 2012 and ended 2 November 2014. A historical cohort was identified for 2 years preceding May 2012. Clinical management and outcome were contrasted between patients treated within 3 h versus 3-4.5 h in the prospective cohort and between historical and prospective cohorts for the 3 h time window. Outcomes were functional independency (modified Rankin scale, mRS) 0-2, favourable outcome (mRS 0-1), and death at 3 months and symptomatic intracerebral haemorrhage (SICH) per SITS. Results: 4157 patients from 81 centres in 12 EU countries were entered prospectively (N = 1118 in the 3-4.5 h, N = 3039 in the 0-3 h time window) and 3454 retrospective patients in the 0-3 h time window who met the marketing approval conditions. In the prospective cohort, median arrival to treatment time was longer in the 3-4.5 h than 3 h window (79 vs. 55 min). Within the 3 h time window, treatment delays were shorter for prospective than historical patients (55 vs. 63). There was no significant difference between the 3-4.5 h versus 3 h prospective cohort with regard to percentage of reported SICH (1.6 vs. 1.7), death (11.6 vs. 11.1), functional independency (66 vs. 65) at 3 months or favourable outcome (51 vs. 50). Discussion: Main weakness is the observational design of the study. Conclusion: This study neither identified negative impact on treatment delay, nor on outcome, following extension of the approved time window to 4.5 h for use of alteplase in stroke.
ER  -

AHMED, Niaz, Karin HERMANSSON, Erich BLUHMKI, Thierry DANAYS, Ana Paiva NUNES, Anthony KENTON, Sekaran LAKSHMANAN, Danilo TONI, Robert MIKULÍK, Gary A. FORD, Kennedy R. LEES a Nils WAHLGREN. The SITS-UTMOST: A registry-based prospective study in Europe investigating the impact of regulatory approval of intravenous Actilyse in the extended time window (3-4.5 h) in acute ischaemic stroke. \textit{EUROPEAN STROKE JOURNAL}. LONDON: SAGE PUBLICATIONS LTD, 2016, roč.~1, č.~3, s.~213-221. ISSN~2396-9873. Dostupné z: https://dx.doi.org/10.1177/2396987316661890.

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