Results of intravenous thrombolysis within 4.5 to 6 hours and updated results within 3 to 4.5 hours of onset of acute ischemic stroke recorded in the Safe Implementation of Treatment in Stroke International Stroke Thrombolysis Register (SITS-ISTR) : an observational study / Niaz Ahmed, MD; Lars Kellert, MD; Kennedy R. Lees, MD; Robert Mikulik, MD; Turgut Tatlisumak, MD; Danilo Toni, MD; for the SITS Investigators

IMPORTANCE: Pooled analysis of randomized controlled trials of intravenous thrombolysis shows no statistically significant benefit beyond 4.5 hours, with the possible advantage perhaps offset by risk. - OBJECTIVE: To compare the outcomes of patients who were treated within 4.5 to 6 hours or within 3 to 4.5 hours of the onset of an ischemic stroke with the outcomes of patients who were treated within 3 hours in the SITS-ISTR. - DESIGN: An observational study based on SITS-ISTR data during the period from 2002 to 2011. - SETTING: Acute and emergency care. - PARTICIPANTS: Of 29 618 patients with acute ischemic stroke, 283 (1.0%) were treated within 4.5 to 6 hours of onset, 4056 (13.7%) were within 3 to 4.5 hours of onset, and 25 279 (85.4%) were treated within 3 hours of onset, in compliance with other European Union approval criteria. - EXPOSURE: Intravenous thrombolysis with alteplase. - MAIN OUTCOMES AND MEASURES: Functional independence (modified Rankin Scale score of 0-2) and mortality at 3 months and symptomatic intracerebral hemorrhage (SICH). P values are based on comparisons between patients treated within 4.5 to 6 hours or within 3 to 4.5 hours of onset against patients treated within 3 hours of onset. - RESULTS: Results are presented as within 4.5 to 6 hour vs within 3 to 4.5 hours vs within 3 hours. Median time from stroke onset to treatment was 295 vs 210 minutes vs 138 minutes (P < .01), median age was 65 vs 67 vs 68 years (P < .01), and median baseline National Institutes of Health Stroke Scale score was 9 vs 9 vs 12 (P < .01). Rate of functional independence was 61.3% (P = .40) vs 62.7% (P < .01) vs 58.4%; mortality rate was 11.8% (P = .99) vs 11.1% (P = .21) vs 11.8%; and rate of SICH was 2.6% (P = .17) vs 1.8% (P = .27) vs 1.5%. Multivariate analysis detected no significant difference in SICH (P > .05), mortality (P > .05), or independence (P > .05). Time from stroke onset to treatment as a continuous variable was significantly associated with higher rates of SICH and poor 3-month outcome after adjustment for age and National Institutes of Health Stroke Scale score. - CONCLUSIONS AND RELEVANCE: The treatment remains safe and effective for patients treated within 3 to 4.5 hours compared with patients treated within 3 hours. Our selected group of patients treated within 4.5 to 6 hours of stroke onset did not have worse outcomes than patients treated within 3 hours. An inevitable limitation of our observational study is the possible nonequivalence of the cohorts, particularly the 4.5- to 6-hour cohort relative to the other 2 cohorts..

Medienart:	E-Artikel

Erscheinungsjahr:	May 20, 2013 2013
Erschienen:	May 20, 2013

Enthalten in:	Zur Gesamtaufnahme - volume:70
Enthalten in:	JAMA neurology - 70(2013), 7 vom: Juli, Seite 837-844

Sprache:	Englisch

Beteiligte Personen:	Ahmed, Niaz [VerfasserIn] Kellert, Lars, 1976- [VerfasserIn] Lees, Kennedy R. [VerfasserIn] Mikulik, Robert [VerfasserIn] Tatlisumak, Turgut [VerfasserIn] Toni, Danilo [VerfasserIn]

Links:	Volltext [lizenzpflichtig] Volltext [lizenzpflichtig]

Themen:	Acute Disease Aged Brain Ischemia Clinical Protocols Female Fibrinolytic Agents Humans Injections, Intravenous Male Middle Aged Registries Stroke Thrombolytic Therapy Time Factors Tissue Plasminogen Activator Treatment Outcome

Anmerkungen:	Gesehen am 06.05.2021

Umfang:	8

doi:	10.1001/jamaneurol.2013.406

funding:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	1757421319