Thrombolysis for acute stroke in routine clinical practice

Dawn Bravata, Nancy Kim, John Concato, Harlan M. Krumholz, Lawrence M. Brass

Research output: Contribution to journalArticle

103 Citations (Scopus)

Abstract

Background: Studies have demonstrated that thrombolytic therapy for acute stroke can be given safely and effectively in study settings with experienced clinicians, but the patient outcomes associated with thrombolytic therapy in routine clinical practice require investigation. Objectives: To compare outcomes among patients given intravenous thrombolysis in routine clinical practice with the results of the National Institute of Neurological Disorders and Stroke rt-PA Study (NINDS cohort) and to examine whether protocol deviations are associated with adverse events. Methods: Retrospective cohort of community-based patients given thrombolysis for acute stroke from May 1, 1996, through December 31, 1998, in 16 Connecticut hospitals (Connecticut cohort). Results: Forty-two (67%) of 63 patients in the Connecticut cohort had at least 1 major protocol deviation, and 61 (97%) had major or minor protocol deviations. Overall, the in-hospital mortality was higher in the Connecticut cohort (16/63 [25%]) compared with the NINDS cohort (40/312 [13%]; P=.01). The serious extracranial hemorrhage rate was also higher for the Connecticut cohort (8/63 [13%] vs 5/312 [2%]; P=.001). Patients in the Connecticut cohort without major protocol deviations had outcomes similar to those in the NINDS cohort; however, patients in the Connecticut cohort with major protocol deviations had higher rates of in-hospital mortality (13/42 [31%] vs 40/312 [13%]; P=.002) and serious extracranial hemorrhage (7/42 [17%] vs 5/312 [2%]; P=.001). Conclusions: Protocol deviations occur commonly when thrombolytic therapy is given to stroke patients in routine clinical practice. Patients who receive thrombolysis with major protocol deviations have higher rates of inhospital mortality and serious extracranial hemorrhage than patients in the NINDS cohort.

Original languageEnglish (US)
Pages (from-to)1994-2001
Number of pages8
JournalArchives of Internal Medicine
Volume162
Issue number17
DOIs
StatePublished - Sep 23 2002
Externally publishedYes

Fingerprint

National Institute of Neurological Disorders and Stroke
Stroke
Thrombolytic Therapy
Hospital Mortality
Hemorrhage
Cohort Studies

ASJC Scopus subject areas

  • Internal Medicine

Cite this

Thrombolysis for acute stroke in routine clinical practice. / Bravata, Dawn; Kim, Nancy; Concato, John; Krumholz, Harlan M.; Brass, Lawrence M.

In: Archives of Internal Medicine, Vol. 162, No. 17, 23.09.2002, p. 1994-2001.

Research output: Contribution to journalArticle

Bravata, Dawn ; Kim, Nancy ; Concato, John ; Krumholz, Harlan M. ; Brass, Lawrence M. / Thrombolysis for acute stroke in routine clinical practice. In: Archives of Internal Medicine. 2002 ; Vol. 162, No. 17. pp. 1994-2001.
@article{777b2ac6f9664fe897b872a1b3519f6a,
title = "Thrombolysis for acute stroke in routine clinical practice",
abstract = "Background: Studies have demonstrated that thrombolytic therapy for acute stroke can be given safely and effectively in study settings with experienced clinicians, but the patient outcomes associated with thrombolytic therapy in routine clinical practice require investigation. Objectives: To compare outcomes among patients given intravenous thrombolysis in routine clinical practice with the results of the National Institute of Neurological Disorders and Stroke rt-PA Study (NINDS cohort) and to examine whether protocol deviations are associated with adverse events. Methods: Retrospective cohort of community-based patients given thrombolysis for acute stroke from May 1, 1996, through December 31, 1998, in 16 Connecticut hospitals (Connecticut cohort). Results: Forty-two (67{\%}) of 63 patients in the Connecticut cohort had at least 1 major protocol deviation, and 61 (97{\%}) had major or minor protocol deviations. Overall, the in-hospital mortality was higher in the Connecticut cohort (16/63 [25{\%}]) compared with the NINDS cohort (40/312 [13{\%}]; P=.01). The serious extracranial hemorrhage rate was also higher for the Connecticut cohort (8/63 [13{\%}] vs 5/312 [2{\%}]; P=.001). Patients in the Connecticut cohort without major protocol deviations had outcomes similar to those in the NINDS cohort; however, patients in the Connecticut cohort with major protocol deviations had higher rates of in-hospital mortality (13/42 [31{\%}] vs 40/312 [13{\%}]; P=.002) and serious extracranial hemorrhage (7/42 [17{\%}] vs 5/312 [2{\%}]; P=.001). Conclusions: Protocol deviations occur commonly when thrombolytic therapy is given to stroke patients in routine clinical practice. Patients who receive thrombolysis with major protocol deviations have higher rates of inhospital mortality and serious extracranial hemorrhage than patients in the NINDS cohort.",
author = "Dawn Bravata and Nancy Kim and John Concato and Krumholz, {Harlan M.} and Brass, {Lawrence M.}",
year = "2002",
month = "9",
day = "23",
doi = "10.1001/archinte.162.17.1994",
language = "English (US)",
volume = "162",
pages = "1994--2001",
journal = "JAMA Internal Medicine",
issn = "2168-6106",
publisher = "American Medical Association",
number = "17",

}

TY - JOUR

T1 - Thrombolysis for acute stroke in routine clinical practice

AU - Bravata, Dawn

AU - Kim, Nancy

AU - Concato, John

AU - Krumholz, Harlan M.

AU - Brass, Lawrence M.

PY - 2002/9/23

Y1 - 2002/9/23

N2 - Background: Studies have demonstrated that thrombolytic therapy for acute stroke can be given safely and effectively in study settings with experienced clinicians, but the patient outcomes associated with thrombolytic therapy in routine clinical practice require investigation. Objectives: To compare outcomes among patients given intravenous thrombolysis in routine clinical practice with the results of the National Institute of Neurological Disorders and Stroke rt-PA Study (NINDS cohort) and to examine whether protocol deviations are associated with adverse events. Methods: Retrospective cohort of community-based patients given thrombolysis for acute stroke from May 1, 1996, through December 31, 1998, in 16 Connecticut hospitals (Connecticut cohort). Results: Forty-two (67%) of 63 patients in the Connecticut cohort had at least 1 major protocol deviation, and 61 (97%) had major or minor protocol deviations. Overall, the in-hospital mortality was higher in the Connecticut cohort (16/63 [25%]) compared with the NINDS cohort (40/312 [13%]; P=.01). The serious extracranial hemorrhage rate was also higher for the Connecticut cohort (8/63 [13%] vs 5/312 [2%]; P=.001). Patients in the Connecticut cohort without major protocol deviations had outcomes similar to those in the NINDS cohort; however, patients in the Connecticut cohort with major protocol deviations had higher rates of in-hospital mortality (13/42 [31%] vs 40/312 [13%]; P=.002) and serious extracranial hemorrhage (7/42 [17%] vs 5/312 [2%]; P=.001). Conclusions: Protocol deviations occur commonly when thrombolytic therapy is given to stroke patients in routine clinical practice. Patients who receive thrombolysis with major protocol deviations have higher rates of inhospital mortality and serious extracranial hemorrhage than patients in the NINDS cohort.

AB - Background: Studies have demonstrated that thrombolytic therapy for acute stroke can be given safely and effectively in study settings with experienced clinicians, but the patient outcomes associated with thrombolytic therapy in routine clinical practice require investigation. Objectives: To compare outcomes among patients given intravenous thrombolysis in routine clinical practice with the results of the National Institute of Neurological Disorders and Stroke rt-PA Study (NINDS cohort) and to examine whether protocol deviations are associated with adverse events. Methods: Retrospective cohort of community-based patients given thrombolysis for acute stroke from May 1, 1996, through December 31, 1998, in 16 Connecticut hospitals (Connecticut cohort). Results: Forty-two (67%) of 63 patients in the Connecticut cohort had at least 1 major protocol deviation, and 61 (97%) had major or minor protocol deviations. Overall, the in-hospital mortality was higher in the Connecticut cohort (16/63 [25%]) compared with the NINDS cohort (40/312 [13%]; P=.01). The serious extracranial hemorrhage rate was also higher for the Connecticut cohort (8/63 [13%] vs 5/312 [2%]; P=.001). Patients in the Connecticut cohort without major protocol deviations had outcomes similar to those in the NINDS cohort; however, patients in the Connecticut cohort with major protocol deviations had higher rates of in-hospital mortality (13/42 [31%] vs 40/312 [13%]; P=.002) and serious extracranial hemorrhage (7/42 [17%] vs 5/312 [2%]; P=.001). Conclusions: Protocol deviations occur commonly when thrombolytic therapy is given to stroke patients in routine clinical practice. Patients who receive thrombolysis with major protocol deviations have higher rates of inhospital mortality and serious extracranial hemorrhage than patients in the NINDS cohort.

UR - http://www.scopus.com/inward/record.url?scp=0037163461&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0037163461&partnerID=8YFLogxK

U2 - 10.1001/archinte.162.17.1994

DO - 10.1001/archinte.162.17.1994

M3 - Article

VL - 162

SP - 1994

EP - 2001

JO - JAMA Internal Medicine

JF - JAMA Internal Medicine

SN - 2168-6106

IS - 17

ER -