Does the Addition of Non-Approved Inclusion and Exclusion Criteria for rtPA Impact Treatment Rates? Findings in Australia, the UK, and the USA (original) (raw)
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Review, Historical Context, and Clarifications of the NINDS rt-PA Stroke Trials Exclusion Criteria
Stroke, 2013
Background and Purpose— Since Food and Drug Administration approval of intravenous tissue-type plasminogen activator (tPA) for treatment of acute ischemic stroke in 1996, it has become clear that several criteria used for exclusion from therapy were not based on actual data or operationally defined for use in clinical practice. All eligibility criteria from the National Institute of Neurological Disorders and Stroke (NINDS) recombinant tPA Stroke Study were adopted within the alteplase package insert as contraindications/warnings. Many clinicians have expressed the need for clarification and better definition of these treatment criteria. Methods— A group of investigators who also practice as stroke physicians convened a collaborative endeavor to work toward developing more clinically meaningful and consensus-driven exclusion criteria for intravenous tPA. The first of these exclusion criteria chosen was rapidly improving stroke symptoms (RISS). We reviewed and clarified the historica...
Stroke; a journal of cerebral circulation, 2012
The publication of the European Cooperative Acute Stroke Study (ECASS III) expanded the treatment time to thrombolysis for acute ischemic stroke from 3 to 4.5 hours from symptom onset. The impact of the expanded time window on treatment rates has not been comprehensively evaluated in a population-based study. All patients with an ischemic stroke presenting to an emergency department during calendar year 2005 in the 17 hospitals that compromise the large 1.3 million Greater Cincinnati/Northern Kentucky population were included in the analysis. Criteria for exclusion from thrombolytic therapy are analyzed retrospectively for both the standard and expanded timeframes with varying door-to-needle times. During the study period, 1838 ischemic strokes presenting to an emergency department were identified. A small proportion of them arrived in the expanded time window (3.4%) compared with the standard time window (22%). Only 0.5% of those who arrived in this timeframe met eligibility criter...
Journal of Stroke and Cerebrovascular Diseases, 2010
Background-In 1995 two studies by the NINDS showed that intravenous t-PA was superior to placebo in stroke patients when given less than 3 hours from stroke onset. The recently published ECASS III study introduced new patient selection criteria and treatment between 3 and 4.5 hours. Using these criteria, t-PA was shown effective at the later time window. Both analyses used the 3 month mRS as main primary outcome. We sought to study the effect of applying the ECASS III selection criteria to the original NINDS cohort. Methods-We analyzed the subgroup of patients from NINDS sample who matched the ECASSS III study criteria and examined 3-month outcomes adjusted and unadjusted for confounding factors. Results-The NINDS t-PA study included 624 patients. Two hundred in the t-PA treated and 199 in the placebo group were selected after applying ECASS III criteria. Of these selected patients, 52% in the t-PA group versus 31% had an mRS of 0 or 1 at 3 months (p<0.001). The unadjusted OR for t-PA treatment versus placebo on day 90 mRS 0-1 versus 2-6 was 2.45 (95% CI: 1.63-3.69) When adjusted for baseline NIHSS, smoking status, time to treatment and history of hypertension the OR was 2.14 (95% CI: 1.34-3.41) (p<0.001). Conclusion-Using the ECASS III patient selection in patient treated in less than 3 hours, 52% of t-PA treated patient had a favorable outcome at 3 months.
Barriers to Receiving Tissue Plasminogen Activator in Patients with Ischemic Stroke
Background: Cerebrovascular diseases are the second common cause of mortality worldwide. The onset of reperfusion in the first 3-4.5 hours is a predictive factor of treatment. Objective: The present study investigated barriers to receiving tissue plasminogen activator in patients with ischemic stroke. Methods: This cross-sectional study examined 191 patients with first-ever stroke referring to the emergency department of the Persian Gulf Martyrs Hospital of Bushehr City, Iran, in 2016. One checklist was completed which included demographic data, history of diseases, knowledge of stroke symptoms, and intervals regarding the onset of symptoms to informing emergency, informing emergency on arrival at the emergency department of the hospital, and making the diagnosis for the patients. The obtained data were analyzed in SPSS v. 19. Results: Mean±SD age of the patients was 65.92±12.48 years. The majority of patients under investigation (55.5%) were female, 63.4% were married, 56% were illiterate and 72.3% resided in other districts of Bushehr province. Mean duration between onset of symptoms and arrival at emergency department, onset of symptoms and call the emergency service, time of arrival at emergency department to perform brain Computer Tomography (CT) scan and also to be counseled by a neurologist were 699.66, 195.51, 45.11 and 423.62 minutes, respectively. Finally 14.6 percent of patients were qualified to be treated with tPA. Conclusion: The main barrier to timely therapy is a delay in golden time. Therefore, public education to promote public awareness could be of great benefit in reducing the referral delay time.
Circulation: Cardiovascular Quality and Outcomes, 2013
A n estimated 795 000 Americans experience a stroke each year, with ≈610 000 of these being first events and 185 000 recurrent episodes. 1 Stroke is the fourth leading cause of mortality and accounted for 1 in every 18 deaths in the United States in 2007. 1 With improvements in prevention and acute treatment, between 1997 and 2007, the annual per capita stroke death rate decreased by 34.3%, and the annual number of actual strokes decreased by 18.8%. 1 The use of intravenous recombinant tissue plasminogen activator (tPA), which was approved in 1996 for the treatment of acute ischemic stroke (AIS), 2 has played an essential role in reducing morbidity and disability after stroke. Although tPA improves clinical outcomes and has a Class I recommendation in national guidelines, many patients with AIS arrive at the hospital within 3 hours of stroke onset without documented contraindications who still do not receive tPA. 1 Substantial efforts by professional societies, state and federal government agencies, and national patient support organizations have led to increased tPA use in eligible patients. 3 Participation over the past decade by almost 2000 hospitals in quality improvement registries like the American Heart Association's Get With the Guideline-Stroke (GWTG-Stroke) has resulted in increased access to acute stroke care and administration of tPA. 4 Although previous studies do suggest overall increases in tPA-treated patients, little is known about the changes over the past decade regarding which patients are or are not receiving intravenous tPA in the United States. We sought to analyze temporal trends in tPA treatment among AIS patients and identify changes in demographic and clinical characteristics over the 9-year period since GWTG-Stroke implementation in 2003. Background-Substantial efforts over the past decade have increased rates of intravenous tissue plasminogen activator (tPA) use in the United States. We sought to determine changes in patient characteristics and rates of tPA use over time among hospitalized acute ischemic stroke (AIS) patients. Methods and Results-We analyzed all AIS patients (n=1 093 895) and those arriving ≤2 hours and treated with tPA ≤3 hours after onset (n=50 798) from 2003 to 2011 in the American Heart Association's Get with the Guideline-Stroke (GWTG-Stroke). Categorical data were analyzed by Pearson χ 2 and continuous data by Wilcoxon test. Intravenous tPA use ≤3 hours after onset increased from 4.0% to 7.0% in all AIS admissions and 42.6% to 77.0% in AIS patients arriving ≤2 hours and fully eligible for tPA (P<0.001). In univariate analysis, tPA use increased over time, especially in those aged >85 years, nonwhite, and with milder strokes (National Institutes of Health Stroke Scale 0-4). Door-to-image time (median 24 versus 20 minutes) and door-to-tPA time (median 81 versus 72 minutes) also improved, with ≈65% of tPA-treated patients getting brain imaging ≤25 minutes after arrival. Multivariable analysis showed that with each additional calendar year, the odds that an eligible patient would receive tPA increased by 1.37-fold, adjusting for other covariates. Conclusions-The frequency of IV tPA use among all AIS patients, regardless of contraindications, nearly doubled from 2003 to 2011. Treatment with tPA has expanded to include more patients with mild deficits, nonwhite race/ethnicity, and oldest old age.
Stroke; a journal of cerebral circulation, 2015
Sex differences in recombinant tissue-type plasminogen activator (r-tPA) administration are present in some populations. It is unknown whether this is because of eligibility differences or the modifiable exclusion criterion of severe hypertension. Our aim was to investigate sex differences in r-tPA eligibility, in individual exclusion criteria, and in the modifiable exclusion criterion, hypertension. We included all ischemic stroke patients ≥18 years among residents of the Greater Cincinnati/Northern Kentucky region who presented to 16-area emergency departments in 2005. Eligibility for r-tPA and individual exclusion criteria were determined using 2013 American Heart Association (AHA) and European Cooperative Acute Stroke Study (ECASS) III guidelines. Of 1837 ischemic strokes, 58% were women, 24% were black. Mean age in years was 72.2 for women and 66.1 for men. Eligibility for r-tPA was similar by sex (6.8% men and 6.1% women; P=0.55), even after adjusting for age (7.0% and 5.9%; P...
Journal of Iranian Medical Council
Background: One of the main parts of the early treatment of Acute Ischemic Stroke (AIS) is the attitude and knowledge of Emergency Medicine (EM) specialists. This study aimed to investigate the knowledge and attitude of emergency physicians working in Iran about the prescription of tissue Plasminogen Activator (tPA) in AIS. Methods: This was a cross-sectional questionnaire-based study including EM physicians working in different cities of Iran in 2020. A previously used English questionnaire was translated into Persian. After face validity and reliability assessment, the final questionnaire was designed as a Google form and sent to 400 EM professionals. Results: 128 physicians filled in the forms. 64.8% of participants had sufficient attitude and 68% had sufficient knowledge about tPA treatment in AIS. The knowledge regarding tPA treatment was higher in the age>40 years, male gender and physicians with up-to-date information (P<0.05), but no significant association was found f...
Why are stroke patients excluded from TPA therapy? An analysis of patient eligibility
2009
Article abstract—Background: Thrombolytic therapy for acute stroke (,3 hours) will not have a major impact on death and dependency unless it is accessible to more patients. Objective: To determine why patients with ischemic stroke did not receive IV TPA and assess the availability of this therapy to patients with ischemic stroke. Methods: Consecutive patients with acute ischemic stroke were prospectively