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
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...
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| Main Authors: | , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
May 20, 2013
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| In: |
JAMA neurology
Year: 2013, Volume: 70, Issue: 7, Pages: 837-844 |
| ISSN: | 2168-6157 |
| DOI: | https://doi.org/10.1001/jamaneurol.2013.406 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/https://doi.org/10.1001/jamaneurol.2013.406 Verlag, lizenzpflichtig, Volltext: https://jamanetwork.com/journals/jamaneurology/fullarticle/1688415 
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| Author Notes: | Niaz Ahmed, MD; Lars Kellert, MD; Kennedy R. Lees, MD; Robert Mikulik, MD; Turgut Tatlisumak, MD; Danilo Toni, MD; for the SITS Investigators |
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| 245 | 1 | 0 | |a 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) |b an observational study |c Niaz Ahmed, MD; Lars Kellert, MD; Kennedy R. Lees, MD; Robert Mikulik, MD; Turgut Tatlisumak, MD; Danilo Toni, MD; for the SITS Investigators |
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| 520 | |a 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. | ||
| 650 | 4 | |a Acute Disease | |
| 650 | 4 | |a Aged | |
| 650 | 4 | |a Brain Ischemia | |
| 650 | 4 | |a Clinical Protocols | |
| 650 | 4 | |a Female | |
| 650 | 4 | |a Fibrinolytic Agents | |
| 650 | 4 | |a Humans | |
| 650 | 4 | |a Injections, Intravenous | |
| 650 | 4 | |a Male | |
| 650 | 4 | |a Middle Aged | |
| 650 | 4 | |a Registries | |
| 650 | 4 | |a Stroke | |
| 650 | 4 | |a Thrombolytic Therapy | |
| 650 | 4 | |a Time Factors | |
| 650 | 4 | |a Tissue Plasminogen Activator | |
| 650 | 4 | |a Treatment Outcome | |
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| 700 | 1 | |a Lees, Kennedy R. |e VerfasserIn |4 aut | |
| 700 | 1 | |a Mikulik, Robert |e VerfasserIn |4 aut | |
| 700 | 1 | |a Tatlisumak, Turgut |e VerfasserIn |4 aut | |
| 700 | 1 | |a Toni, Danilo |e VerfasserIn |4 aut | |
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