Literature DB >> 32231690

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 Craig1,2, Sandy Middleton1, Helen Hamilton1, Fern Cudlip3, Victoria Swatzell4, Andrei V Alexandrov5, Elizabeth Lightbody6, Dame Caroline Watkins7, Sheeba Philip8, Dominique A Cadilhac9,10, Elizabeth McInnes1, Simeon Dale1, Anne W Alexandrov4,11.   

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.
Copyright © 2018 by S. Karger AG, Basel.

Entities:  

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

Year:  2018        PMID: 32231690      PMCID: PMC7098288          DOI: 10.1159/000493020

Source DB:  PubMed          Journal:  Interv Neurol        ISSN: 1664-5545


  47 in total

Review 1.  Increasing response rates to postal questionnaires: systematic review.

Authors:  Phil Edwards; Ian Roberts; Mike Clarke; Carolyn DiGuiseppi; Sarah Pratap; Reinhard Wentz; Irene Kwan
Journal:  BMJ       Date:  2002-05-18

2.  Off-label thrombolysis is not associated with poor outcome in patients with stroke.

Authors:  Atte Meretoja; Jukka Putaala; Turgut Tatlisumak; Sari Atula; Ville Artto; Sami Curtze; Olli Häppölä; Perttu J Lindsberg; Satu Mustanoja; Katja Piironen; Janne Pitkäniemi; Kirsi Rantanen; Tiina Sairanen; Oili Salonen; Heli Silvennoinen; Lauri Soinne; Daniel Strbian; Marjaana Tiainen; Markku Kaste
Journal:  Stroke       Date:  2010-06-10       Impact factor: 7.914

3.  Off-label thrombolysis versus full adherence to the current European Alteplase license: impact on early clinical outcomes after acute ischemic stroke.

Authors:  Manuel Cappellari; Giuseppe Moretto; Nicola Micheletti; Francesco Donato; Giampaolo Tomelleri; Giosuè Gulli; Monica Carletti; Giovanna Maddalena Squintani; Tiziano Zanoni; Sarah Ottaviani; Silvia Romito; Giorgio Tommasi; Anna Maria Musso; Luciano Deotto; Giuseppe Gambina; Domenico Sergio Zimatore; Paolo Bovi
Journal:  J Thromb Thrombolysis       Date:  2014-05       Impact factor: 2.300

4.  Endovascular thrombectomy with or without systemic thrombolysis?

Authors:  Georgios Tsivgoulis; Aristeidis H Katsanos; Dimitris Mavridis; Anne W Alexandrov; Georgios Magoufis; Adam Arthur; Valeria Caso; Peter D Schellinger; Andrei V Alexandrov
Journal:  Ther Adv Neurol Disord       Date:  2016-12-01       Impact factor: 6.570

5.  Telemedicine expedites access to optimal acute stroke care.

Authors:  Kathleen L Bagot; Dominique A Cadilhac; Peter J Hand; Michelle Vu; Christopher F Bladin
Journal:  Lancet       Date:  2016-08-20       Impact factor: 79.321

6.  The use and misuse of thrombolytic therapy within the Veterans Health Administration.

Authors:  Salomeh Keyhani; Greg Arling; Linda S Williams; Joseph S Ross; Diana L Ordin; Jennifer Myers; Gary Tyndall; Bruce Vogel; Dawn M Bravata
Journal:  Med Care       Date:  2012-01       Impact factor: 2.983

7.  Off-label thrombolysis for acute ischemic stroke: rate, clinical outcome and safety are influenced by the definition of 'minor stroke'.

Authors:  L Breuer; C Blinzler; H B Huttner; I C Kiphuth; S Schwab; M Köhrmann
Journal:  Cerebrovasc Dis       Date:  2011-08-15       Impact factor: 2.762

8.  Thrombolysis outcomes in acute ischemic stroke patients with prior stroke and diabetes mellitus.

Authors:  N K Mishra; N Ahmed; A Davalos; H K Iversen; T Melo; L Soinne; N Wahlgren; K R Lees
Journal:  Neurology       Date:  2011-11-16       Impact factor: 9.910

9.  Systemic thrombolysis in acute ischemic stroke patients with unruptured intracranial aneurysms.

Authors:  Nitin Goyal; Georgios Tsivgoulis; Ramin Zand; Vijay K Sharma; Kristian Barlinn; Shailesh Male; Aristeidis H Katsanos; Ulf Bodechtel; Sulaiman Iftikhar; Adam Arthur; Lucas Elijovich; Anne W Alexandrov; Andrei V Alexandrov
Journal:  Neurology       Date:  2015-09-25       Impact factor: 9.910

10.  Safety of Intravenous Thrombolysis in Chronic Intracranial Hemorrhage: A Five-Year Multicenter Study.

Authors:  Ramin Zand; Georgios Tsivgoulis; Alireza Sadighi; Mantinderpreet Singh; Michael McCormack; Shima Shahjouei; Nitin Goyal; Nariman Noorbakhsh-Sabet; Anne W Alexandrov; Andrei V Alexandrov
Journal:  J Stroke Cerebrovasc Dis       Date:  2018-03       Impact factor: 2.136

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  1 in total

Review 1.  Cerebral Autoregulation in Ischemic Stroke: From Pathophysiology to Clinical Concepts.

Authors:  Ricardo C Nogueira; Lucy Beishon; Edson Bor-Seng-Shu; Ronney B Panerai; Thompson G Robinson
Journal:  Brain Sci       Date:  2021-04-16
  1 in total

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