Initial clinical experience with IV tissue plasminogen activator for acute ischemic stroke: A multicenter survey

Tanné, David; Bates, Vernice; Verro, Piero; Kasner, Scott E.; Binder, Johannes; Patel, Suresh; Mansbach, Hank; Daley, Sheila; Schultz, Lonni; Karanjia, Percy N.; Scott, Phillip; Dayno, Jeffrey M.; Vereczkey-Porter, K.; Benesch, Curtis; Book, Diane S.; Coplin, William M.; Dulli, Douglas A.; Levine, Steven R.

doi:10.1212/wnl.53.2.424

Cited by 164 publications

(96 citation statements)

References 7 publications

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“…Further, the mortality rate of thrombolysis patients in our study is similar to those of the prospective trials and postapproval large case series (mortality rate 9% to 15.7%). 1,5,8,9,12,13,15,16 Assuming that the baseline clinical neurological characteristics of our patients are comparable to patients in these studies, the mortality rate we report suggests that thrombolysis treatment, as it is applied in a broad community sample, has a comparable safety profile to that achieved in clinical trials that established the benefit of treatment.…”

Section: Bateman Et Al Thrombolysis Nationwide Inpatient Samplementioning

confidence: 51%

“…3,4 Nevertheless, only a minority of patients who present with acute ischemic stroke are treated with tPA. [5][6][7][8][9][10][11] One factor that may contribute to this low rate is clinician concern about the safety of the treatment. 12 Because the prospective trials evaluating this therapy were conducted at academic and community hospitals with institutional commitment to stroke care, relatively little data are available regarding the safety of thrombolysis as it is used in a broad range of hospitals in the community.…”

Section: Ntravenous Treatment With Tissue Plasminogen Activator (Tpa)mentioning

confidence: 99%

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Factors Associated With In-Hospital Mortality After Administration of Thrombolysis in Acute Ischemic Stroke Patients

Bateman

Schumacher

Boden‐Albala

et al. 2006

Stroke

112

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Background and Purpose-The prospective trials evaluating the safety and efficacy of intravenous tissue plasminogen activator have generally been conducted at academic medical centers and community hospitals with an institutional commitment to stroke care. Relatively little is known about the safety of this therapy as it is used in the community. We therefore examined outcomes in acute stroke patients treated with thrombolysis using the largest discharge database available in the United States for the years 1999 to 2002. Methods-Data were derived from the Nationwide Inpatient Sample for the years 1999 to 2002. Using the appropriateInternational Classification of Disease-Clinical Modification, 9th revision, codes, patients admitted through the emergency room with a primary diagnosis of acute ischemic stroke were selected for analysis. From these patients, those coded as receiving thrombolysis were identified. Multivariate logistic regression was performed on the thrombolysis and nonthrombolysis cohorts to identify independent predictors of in-hospital mortality from among those clinical elements available in the database. Results-We identified 2594 patients treated with thrombolysis from a group of 248 964 patients admitted through the emergency room with a primary diagnosis of acute ischemic stroke. The thrombolysis cohort had a higher in-hospital mortality rate compared with the nonthrombolysis patients (11.4% versus 6.8%). The rate of intracerebral hemorrhage was 4.4% for the thrombolysis cohort and 0.4% for nonthrombolysis patients. Multivariate logistic regression showed advanced age, Asian/Pacific Islander race, congestive heart failure, and atrial fibrillation/flutter to be independent predictors of in-hospital mortality after thrombolysis. Thrombolysis volume, overall ischemic stroke volume, and teaching status were not significant predictors of in-hospital mortality after thrombolysis. Conclusions-Thrombolysis, as it is used in the community, has a safety profile that is similar to that observed in the large, prospective clinical trials. (Stroke. 2006;37:440-446.)

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Section: Bateman Et Al Thrombolysis Nationwide Inpatient Samplementioning

confidence: 51%

Section: Ntravenous Treatment With Tissue Plasminogen Activator (Tpa)mentioning

confidence: 99%

Factors Associated With In-Hospital Mortality After Administration of Thrombolysis in Acute Ischemic Stroke Patients

Bateman

Schumacher

Boden‐Albala

et al. 2006

Stroke

112

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“…However, a post-hoc analysis concluded that patients treated within 3 hours appeared to benefit from rt-PA treatment. In fact, community studies have confirmed the safety and usefulness of the drug in routine clinical practice when administered within the first 3 hours after stroke symptom onset (2,30,74). Recently finished is the multinational Safe Implementation of Thrombolysis in Stroke Monitoring Study (SITS-MOST) which was designed to evaluate the safety and efficacy of IV rt-PA under routine clinical use when administered within 3 hours of symptom onset in acute ischemic stroke patients.…”

Section: Pharmacology Of Restoration Of Cerebral Perfusionmentioning

confidence: 99%

Stroke pathophysiology: management challenges and new treatment advances

Jordán

Ikuta

García-García

et al. 2007

J. Physiol. Biochem.

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J. JORDÁN, I. IKUTA, J. GARCÍA-GARCÍA, S. CALLEJA and T. SEGURA. Stroke pathophysiology: Management challenges and new treatment advances (minireview). J. Physiol. Biochem., 63 (3), 261-278, 2007. Stroke is the second leading cause of death and the first cause of lost disabilityadjusted years in developed countries. During the past decade, new developments in thrombolytic therapy have led to the implementation of emergency intervention protocols for the treatment of ischemic stroke, replacing the widespread sense of therapeutic nihilism in the past. Treatment with rtPA has shown to be effective within the first 3 hours following stroke onset and the FDA and the European Medical Agency (EMEA) have approved its use. Acknowledging the urgency and intricacies of stroke, Stroke Units allow the monitoring of physiological parameters in the acute phase of stroke and are considered an important management tool that can significantly improve the quality of care provided to the patient. The concept of neuroprotective therapy for acute ischemic stroke to salvage tissue at risk and improve functional outcome is based on sound scientific principles and extensive preclinical animal studies demonstrating efficacy. However, most neuroprotective drugs in clinical trials have failed, possibly due to inadequate preclinical testing or flawed clinical development programs. Several new treatment strategies are under development and are being tested. This review is directed at understanding the management of acute ischemic stroke pathophysiology. We address the management challenges and new treatment advances by integrating the knowledge of possible pharmacological targets for acute ischemic stroke. We hope to shed new light upon the controversy surrounding the management of acute ischemic stroke in an attempt to elucidate why failed clinical trials continue to occur despite promising neuroprotective preclinical studies.

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“…Sci. 2005; 32: 401-402 EDITORIAL from 30-50%, 2,13 and partly reflects the eagerness of physicians to treat patients. The two main protocol violations in this study, which accounted for 91% of all violations, were systolic blood pressure greater than 185 mmHg (55.2%) and symptom onset greater than three hours (35.8%).…”

Section: The Pursuit Of Excellence In Acute Stroke Carementioning

confidence: 99%

The Pursuit of Excellence in Acute Stroke Care

Silver¹

2005

Can. j. neurol. sci.

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Intravenous tPA was approved as treatment for acute ischemic stroke in Canada in February 1999. In this issue of the Canadian Journal of the Neurological Sciences, the Canadian Stroke Network (CSN) report on their findings from phases 1 and 2 of the Registry of the CSN (RCSN). 1 A phase 3 study is ongoing. The main points of the study are that: 1) a greater percentage of Canadian patients in this cohort receive tissue plasminogen activator (tPA) (8.9%) compared with United States patients (typically less than 5% 2), 2) only 28.3% of patients are treated within 60 minutes of arrival to the emergency department, and 3) in spite of a protocol violation rate of 27.7%, symptomatic intracranial hemorrhage rates remained low (4.3%). The reasons for a higher percentage of patients receiving tPA in Canada are not entirely clear but may be partly related to a greater partnership between hospitals as compared to the United States. Bypass and transfer protocols have facilitated treatment of patients in remote areas who might otherwise not have had access to acute treatment. 3,4 Though an 8.9% treatment rate is very good, rates of 15-20% are achievable. 5,6 However, achieving such a target requires considerable effort and mobilization of resources into dedicated stroke treatment centers. 7 The increase in treatment rate from 7.9% in phase 1 to 10.2% in phase 2 of this registry suggests that such processes are ongoing. Aside from patients arriving too late after symptom onset, delay in treatment of patients remains the most significant problem of delivering tPA. Even though 50% of patients in this study arrived in the emergency department less than 75 minutes after symptom onset, median time to treatment was approximately 84 minutes (including a median time from completion of CT scan to treatment of 46.3 minutes). To put these numbers in perspective, the Heart and Stroke Foundation of Canada, the Canadian Stroke Society, and the American Stroke Association recommend arrival-to-treatment times of under 60 minutes. 8,9 A number of studies, including this one, clearly show an inverse relationship between time remaining to give tPA and time to treatment from arrival i.e. the less time is left, the faster the treatment time. 4,10,11 Though there is a natural tendency to wait until a deadline before completing a task, this strategy is detrimental to the acute stroke patient. Earlier treatment is associated with a better outcome, especially when done within 90 minutes of symptom onset. 12 A number of strategies can be employed to reduce delay including: prioritizing stroke patients for imaging; performing the discussion process with patient and family prior to, or during, imaging; and making thrombolytic materials immediately available prior to, or during, imaging. The rate of protocol violation in this study (27.7%) is comparable to other studies where protocol violation rates range

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Initial clinical experience with IV tissue plasminogen activator for acute ischemic stroke: A multicenter survey

Cited by 164 publications

References 7 publications

Factors Associated With In-Hospital Mortality After Administration of Thrombolysis in Acute Ischemic Stroke Patients

Factors Associated With In-Hospital Mortality After Administration of Thrombolysis in Acute Ischemic Stroke Patients

Stroke pathophysiology: management challenges and new treatment advances

The Pursuit of Excellence in Acute Stroke Care

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