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

The role of stroke nurses in thrombolysis administration in Australia and the United Kingdom: A cross‐sectional survey of current practice

“…The cross‐sectional survey, using a self‐administered questionnaire, was conducted between 2013–2016. Other results from this survey previously have been reported elsewhere (Craig et al., 2019).…”

“…Barriers to receiving rt‐PA treatment for acute ischaemic stroke are well documented and include delays in stroke symptom recognition in the community resulting in prolonged time to hospital presentation (Hargis et al., 2015), delays in obtaining and interpreting radiology imaging (Kwan et al., 2004), relatively common use of non‐standard eligibility criteria (Craig et al., 2019), availability of appropriately experienced staff to assess eligibility for rt‐PA, delays in obtaining consent, availability of stroke specialists to make the final decision to thrombolyse (Ehlers et al., 2007; Paul et al., 2016); and poor documentation of assessment of rt‐PA eligibility (Middleton et al., 2019). Traditionally, medical practitioners have been responsible for thrombolysis treatment (Catangui, 2013); however, working as part of a multi‐disciplinary team, nurses have an integral role in all phases of stroke patient care, including activating and facilitating the thrombolysis treatment pathway (Fitzpatrick & Birns, 2004; Middleton et al., 2015; Summers et al., 2009).…”

Dementia is Associated With Poorer Quality of Care and Outcomes After Stroke: An Observational Study

“…Although intravenous thrombolysis in patients with dementia is not specifically recommended against in guidelines (4), they are often excluded from clinical trials from which this evidence is drawn (2). There are concerns regarding increased risk of cerebral hemorrhage and mortality (17), and evidence that pre-existing low functional levels in patients with dementia is a reason for exclusion (18,19). Alternatively, dementia may impair communication, making it difficult for clinicians to determine the time of stroke onset, complete a reliable examination, or obtain consent for treatment if family are unable to act as advocates (2).…”

Cerebral Autoregulation in Ischemic Stroke: From Pathophysiology to Clinical Concepts

“…Although there has been an increase in patients treated with these therapies, especially in developed countries [ 4 ], this is not the reality for many centers and not all patients are eligible for treatment due to a limited time window [ 2 ] and/or access to advanced imaging modalities and their interpretation to define a viable tissue window. Thrombolysis with recombinant tissue plasminogen activator (rtPA) is available, on average, for only 7 to 12% of patients [ 5 ] and this is reduced further for thrombectomy [ 6 ]. This remains the case in developed countries, and this number is likely to be much lower in less developed countries [ 7 ].…”