Does the Addition of Non-Approved Inclusion and Exclusion Criteria for rtPA Impact Treatment Rates? Findings in Australia, the UK, and the USA

Louise E Craig; Sandy Middleton; Helen Hamilton; Fern Cudlip; Victoria Swatzell; Andrei V Alexandrov; Elizabeth Lightbody; Dame Caroline Watkins; Sheeba Philip; Dominique A Cadilhac; Elizabeth McInnes; Simeon Dale; Anne W Alexandrov

doi:10.1159/000493020

Does the Addition of Non-Approved Inclusion and Exclusion Criteria for rtPA Impact Treatment Rates? Findings in Australia, the UK, and the USA

Interv Neurol. 2020 Feb;8(1):1-12. doi: 10.1159/000493020. Epub 2018 Sep 25.

Authors

Affiliations

¹ Nursing Research Institute, St Vincent's Health AUS (Sydney) and Australian Catholic University, Sydney, New South Wales, Australia.
² Centre for Research in Evidence-Based Practice (CREBP), Bond University, Robina, Queensland, Australia.
³ Stroke Team, Good Samaritan Comprehensive Stroke Center, San Jose, California, USA.
⁴ Mobile Stroke Unit, University of Tennessee Health Science Center at Memphis, Memphis, Tennessee, USA.
⁵ Department of Neurology, University of Tennessee Health Science Center at Memphis, Memphis, Tennessee, USA.
⁶ College of Health and Wellbeing, University of Central Lancashire, Preston, United Kingdom.
⁷ Faculty of Health and Wellbeing, University of Central Lancashire, Preston, United Kingdom.
⁸ East Lancashire Hospitals NHS Trust, Blackburn, United Kingdom.
⁹ Stroke and Ageing Research, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia.
¹⁰ Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Victoria, Australia.
¹¹ College of Medicine, Department of Neurology & College of Nursing, University of Tennessee Health Science Center at Memphis, Memphis, Tennessee, USA.

Abstract

Background: Strict criteria for recombinant tissue plasminogen activator (rtPA) eligibility are stipulated on licences for use in ischaemic stroke; however, practitioners may also add non-standard rtPA criteria. We examined eligibility criteria variation in 3 English-speaking countries including use of non-standard criteria, in relation to rtPA treatment rates.

Methods: Surveys were mailed to 566 eligible hospitals in Australia (AUS), the UK, and the USA. Criteria were pre-classified as standard (approved indication and contraindications) or non-standard (approved warning or researcher "decoy"). Percentage for criterion selection was calculated/compared; linear regression was used to assess the association between use of non-standard criteria and rtPA treatment rates, and to identify factors associated with addition of non-standard criteria.

Results: Response rates were 74% AUS, 65% UK, and 68% USA; mean rtPA treatment rates were 8.7% AUS, 12.7% UK, and 8.7% USA. Median percentage of non-standard inclusions was 33% (all 3 countries) and included National Institutes of Health Stroke Scale (NIHSS) scores > 4, computed tomography (CT) angiography documented occlusion, and favourable CT perfusion. Median percentage of non-standard exclusions was 25% AUS, 28% UK, and 60% USA, and included depressed consciousness, NIHSS > 25, and use of antihypertensive infusions. No AUS or UK sites selected 100% of standard exclusions.

Conclusions: Non-standard criteria for rtPA eligibility were evident in all three countries and could, in part, explain comparably low use of rtPA. Differences in the use of standard criteria may signify practitioner intolerance for those derived from original efficacy studies that are no longer relevant.

Keywords: Eligibility criteria; Recombinant tissue plasminogen activator; Survey; Thrombolysis.