Changes in European Label and Guideline Adherence After Updated Recommendations for Stroke Thrombolysis: Results From the Safe Implementation of Treatments in Stroke Registry

Circ Cardiovasc Qual Outcomes. 2015 Oct;8(6 Suppl 3):S155-62. doi: 10.1161/CIRCOUTCOMES.115.002097.


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.

Keywords: contraindications; guideline adherence; practice guidelines; stroke; tissue plasminogen activator.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Administration, Intravenous
  • Aged, 80 and over
  • Brain Ischemia / drug therapy*
  • Clinical Trials as Topic
  • Contraindications
  • Europe
  • Guideline Adherence*
  • Hospitals, High-Volume
  • Humans
  • Practice Guidelines as Topic
  • Registries
  • Stroke / drug therapy*
  • Thrombolytic Therapy*
  • Time-to-Treatment
  • Tissue Plasminogen Activator / therapeutic use*


  • Tissue Plasminogen Activator