Changes in European Label and Guideline Adherence After Updated Recommendations for Stroke Thrombolysis: Results From the Safe Implementation of Treatments in Stroke Registry.
Details
Serval ID
serval:BIB_41F6B3423DA9
Type
Article: article from journal or magazin.
Publication sub-type
Review (review): journal as complete as possible of one specific subject, written based on exhaustive analyses from published work.
Collection
Publications
Institution
Title
Changes in European Label and Guideline Adherence After Updated Recommendations for Stroke Thrombolysis: Results From the Safe Implementation of Treatments in Stroke Registry.
Journal
Circulation. Cardiovascular Quality and Outcomes
ISSN
1941-7705 (Electronic)
ISSN-L
1941-7713
Publication state
Published
Issued date
2015
Peer-reviewed
Oui
Volume
8
Number
6 Suppl 3
Pages
S155-S162
Language
english
Abstract
BACKGROUND: Intravenous thrombolysis (IVT) for acute ischemic stroke is subject to label and guideline contraindications. Updated European guidelines in 2008/2009 recommended IVT in selected patients aged >80 years and stroke onset-to-treatment time 3 to 4.5 hours, which the label still prohibited. Our aim was to compare contraindication nonadherence before and after the guideline update.
METHODS AND RESULTS: Data on IVT-treated patients with stroke at 232 European hospitals participating in the Safe Implementation of Treatments in Stroke registry during both periods 2006 to 2007 (n=6354) and 2010 to 2011 (n=12 046). After the 2008/2009 guideline update, the proportion of patients nonadherent to label increased from 23.6% to 51.1% (P<0.001). Specifically, nonadherence to onset-to-treatment time >3 hours increased from 8.2% to 27.9% and IVT in patients aged >80 years from 8.9% to 17.2% (both P<0.001). Nonadherence also increased to the contraindications severe stroke (National Institutes of Health Stroke Scale score >25), onset-to-treatment time >4.5 hours, blood pressure >185/110 mm Hg, and ongoing oral anticoagulation (all P≤0.001). Higher hospital IVT patient volumes were associated with higher nonadherence rates.
CONCLUSIONS: After the European guideline update, new recommendations were promptly adopted and nonadherence to the unchanged label increased. Label contraindications should be updated.
METHODS AND RESULTS: Data on IVT-treated patients with stroke at 232 European hospitals participating in the Safe Implementation of Treatments in Stroke registry during both periods 2006 to 2007 (n=6354) and 2010 to 2011 (n=12 046). After the 2008/2009 guideline update, the proportion of patients nonadherent to label increased from 23.6% to 51.1% (P<0.001). Specifically, nonadherence to onset-to-treatment time >3 hours increased from 8.2% to 27.9% and IVT in patients aged >80 years from 8.9% to 17.2% (both P<0.001). Nonadherence also increased to the contraindications severe stroke (National Institutes of Health Stroke Scale score >25), onset-to-treatment time >4.5 hours, blood pressure >185/110 mm Hg, and ongoing oral anticoagulation (all P≤0.001). Higher hospital IVT patient volumes were associated with higher nonadherence rates.
CONCLUSIONS: After the European guideline update, new recommendations were promptly adopted and nonadherence to the unchanged label increased. Label contraindications should be updated.
Keywords
Acute Disease, Administration, Intravenous, Aged, 80 and over, Brain Ischemia/drug therapy, Clinical Trials as Topic, Europe, Guideline Adherence, Hospitals, High-Volume, Humans, Practice Guidelines as Topic, Registries, Stroke/drug therapy, Thrombolytic Therapy, Time-to-Treatment, Tissue Plasminogen Activator/contraindications, Tissue Plasminogen Activator/therapeutic use
Pubmed
Web of science
Open Access
Yes
Create date
05/04/2016 17:23
Last modification date
20/08/2019 13:43