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Are the results of intravenous thrombolysis trials reproduced in clinical practice? Comparison of observed and expected outcomes with the stroke-thrombolytic predictive instrument (STPI)
- Source :
- Revue Neurologique. 173:381-387
- Publication Year :
- 2017
- Publisher :
- Elsevier BV, 2017.
-
Abstract
- Aim In patients with cerebral ischemia, intravenous (i.v.) recombinant tissue plasminogen activator (rt-PA) increases survival without handicap or dependency despite an increased risk of bleeding. This study evaluated whether the results of randomized controlled trials are reproduced in clinical practice. Method Data from a registry of consecutive patients treated by rt-PA at Lille University Hospital were retrospectively analyzed for outcomes, using modified Rankin Scale (mRS) scores, at 3 months. The observed outcomes were then compared with the probability of good (mRS 0–1) and of catastrophic (mRS 5–6) outcomes, as predicted by the stroke-thrombolytic predictive instrument (STPI). Results Of the 1000 consecutive patients (469 male, median age 74 years, median baseline National Institutes of Health Stroke Scale 11, median onset-to-needle time 143 min), 438 (43.8%) had a good outcome, 565 (56.5%) had an mRS score 0–2 or similar to their pre-stroke mRS, 155 (15.5%) died within 3 months and 74 (7.4%) developed symptomatic intracerebral hemorrhage according to ECASS-II (Second European–Australasian Acute Stroke Study) criteria. Of the 613 patients (61.3%) eligible for evaluation by the s-TPI, the observed rate of good outcomes was 41.3% (95% CI: 37.5–45.3%), while expected rates with and without rt-PA were 48.8% (95% CI: 44.8–52.7%) and 32.5% (95% CI: 28.8–36.2%), respectively; the observed rate of catastrophic outcomes was 17.0% (95% CI: 14.0–19.9%), while the expected rate was 19.2% (95% CI: 16.1–22.4%) with or without rt-PA. Conclusion In clinical practice, the rate of good outcomes is slightly lower than expected, according to the s-TPI, except for the most severe cases, whereas the rate of catastrophic outcomes is roughly similar. However, the rate of good outcomes is higher than predicted without treatment. This finding suggests that rt-PA is effective for improving outcomes in clinical practice.
- Subjects :
- Adult
Male
medicine.medical_specialty
medicine.medical_treatment
030204 cardiovascular system & hematology
Severity of Illness Index
Brain Ischemia
law.invention
03 medical and health sciences
0302 clinical medicine
Fibrinolytic Agents
Randomized controlled trial
Modified Rankin Scale
law
Internal medicine
medicine
Humans
Thrombolytic Therapy
Practice Patterns, Physicians'
Stroke
Aged
Cerebral Hemorrhage
Randomized Controlled Trials as Topic
Retrospective Studies
Intracerebral hemorrhage
Stroke scale
business.industry
Cerebral Infarction
Thrombolysis
Middle Aged
Prognosis
medicine.disease
University hospital
Surgery
Clinical Practice
Treatment Outcome
Neurology
Administration, Intravenous
Female
Neurology (clinical)
Intracranial Thrombosis
business
030217 neurology & neurosurgery
Subjects
Details
- ISSN :
- 00353787
- Volume :
- 173
- Database :
- OpenAIRE
- Journal :
- Revue Neurologique
- Accession number :
- edsair.doi.dedup.....b3363fe9931ace367100971b249b9a4d