Predictors of In-Hospital Mortality in Patients with Acute Ischemic Stroke Treated with Thrombolytic Therapy

ORIGINAL CONTRIBUTION Predictors of In-Hospital Mortality in Patients With Acute Ischemic Stroke Treated With Thrombolytic Therapy Peter U. Heuschmann, MD, MPH Context Data are limited regarding the risks and benefits of thrombolytic therapy Peter L. Kolominsky-Rabas, MD for acute ischemic stroke outside of clinical trials. Joachim Roether, MD Objective To investigate predictors of in-hospital mortality in patients with ische- Bjoern Misselwitz, MPH mic stroke treated with intravenous tissue plasminogen activator (tPA) within a pooled analysis of large German stroke registers. Klaus Lowitzsch, MD Design and Setting Prospective, observational cohort study conducted at 225 com- Jan Heidrich, MD munity and academic hospitals throughout Germany cooperating within the German Peter Hermanek, MD Stroke Registers Study Group. Carsten Leffmann, MD Patients A total of 1658 patients with acute ischemic stroke who were admitted to study hospitals between 2000 and 2002 and were treated with tPA. Matthias Sitzer, MD Main Outcome Measure In-hospital mortality. Marcel Biegler, MD Results One hundred sixty-six patients (10%) who received tPA died during hospi- Hans-Joachim Buecker-Nott, MD talization, with 67.5% of these deaths occurring within 7 days. Factors predicting in- Klaus Berger, MD, MPH hospital death after tPA use were older age (for each 10-year increment in age, ad- for the German Stroke Registers justed odds ratio [OR], 1.6; 95% confidence interval [CI], 1.3-1.9) and altered level of consciousness (adjusted OR, 3.4; 95% CI, 2.4-4.7). The overall rate of symptomatic in- Study Group tracranial hemorrhage was 7.1% and increased with age. One or more serious complications was observed in 27.2% of all patients and in 83.9% of patients who died after NTRAVENOUS TREATMENT WITH TIS- tPA treatment. An inverse relation between the number of patients treated with tPA in sue plasminogen activator (tPA) is the respective hospital and the risk of in-hospital death was observed (adjusted OR, 0.97; currently the only approved treat- 95% CI, 0.96-0.99 for each additional patient treated with tPA per year). ment for patients with acute ische- Conclusion In patients with ischemic stroke who are treated with tPA, distur- Imic stroke and is recommended in the bances of consciousness and increasing age are associated with increased guidelines of several national and in- in-hospital mortality. 1 ternational stroke associations. How- JAMA. 2004;292:1831-1838 www.jama.com ever, in multicenter studies, only 1.6%2 to 2.7%3 of patients with ischemic rently approved. But even among pa- moderate, ranging from 10.4%7 to stroke treated in community hospitals tients admitted within 3 hours after 18.8%.3 In addition to a number of con- and 4.1%4 to 6.3%5 treated in aca- stroke onset, treatment rates are only traindications clearly listed in the drug demic hospitals or specialized stroke Author Affiliations: Institute of Epidemiology and So- Stroke Register Rhineland-Palatine/SQMed (Dr Low- centers received this treatment. One cial Medicine, University of Muenster (Drs Heusch- itzsch) and Institute of Quality Assurance Rhineland- major cause for the low treatment rates mann, Heidrich, and Berger), and Department of Qual- Palatine/SQMed (Dr Biegler), Mainz, Germany; Ba- is that a large proportion of patients are ity Assurance, Westphalian Board of Physicians (Dr varian Permanent Working Party for Quality Assurance, Buecker-Nott), Muenster, Germany; Unit for Stroke Munich, Germany (Dr Hermanek); and Department admitted more than 3 hours after symp- Research and Public Health Medicine, Department of of Neurology, University of Frankfurt, Frankfurt, Ger- tom onset,6 the time window for which Neurology, University of Erlangen, Erlangen, Ger- many (Dr Sitzer). many (Dr Kolominsky-Rabas); Department of Neu- A list of participating hospitals in the German Stroke application of tPA treatment is cur- rology, University of Hamburg Eppendorf (Dr Roether), Registers Study Group is listed at the end of this article. and Coordination Centre for Quality-Management Corresponding Author: Peter U. Heuschmann, MD, Projects at the Hamburg Hospital Federation (Dr Leff- MPH, Institute of Epidemiology and Social Medicine, For editorial comment see p 1883. mann), Hamburg, Germany; Institute of Quality As- University of Muenster, Domagkstrasse 3, 48149 surance Hesse, Eschborn, Germany (Mr Misselwitz); Muenster, Germany ([email protected]). ©2004 American Medical Association. All rights reserved. (Reprinted) JAMA, October 20, 2004—Vol 292, No. 15 1831 Downloaded From: https://jamanetwork.com/ on 09/29/2021 THROMBOLYTIC THERAPY AND IN-HOSPITAL MORTALITY approval, uncertainties about selec- center of the ADSR at the University of The diagnosis of ischemic stroke was tion criteria for patients who will not Muenster. Ischemic stroke patients ad- confirmed by CT or MRI scan. The ex- benefit from thrombolysis might con- mitted to any of the hospitals cooper- perience of the individual hospital in tribute to the low rates of stroke pa- ating within the ADSR network be- tPA use was defined as number of patients treated with tPA in routine care.8 tween January, 1 2000, and December tients treated with tPA per hospital.7 Clarification of clinical factors associ- 31, 2002, were included. Given the fact that not all hospitals par- ated with early death in patients treated The following definitions were used: ticipated during the entire 3-year study with tPA can help identify subgroups Age was categorized into younger than period, the mean number of patients of patients with increased risks and 55 years, 55 to 64 years, 65 to 74 years, treated with tPA per hospital per year thereby allow clinicians to give spe- and 75 years or older; no further age cat- was defined as the total number of pa- cial attention to patients who are at high egorization was done because the num- tients receiving tPA divided by num- risk of death after tPA treatment. ber of patients aged 85 years or older ber of calendar years under observa- The aim of our study was to iden- treated with tPA was too small. Diabe- tion for which the respective hospital tify predictors of in-hospital mortality tes mellitus was defined as elevated fast- provided data and administered tPA. in patients with ischemic stroke treated ing blood glucose level, patient self- The effect of the number of thrombo- with tPA outside of clinical trials. report of diabetes, or use of antidiabetic lytic therapies per hospital per year on drugs. Hypertension was defined as sys- early outcome was assessed as a con- METHODS tolic blood pressure of 160 mm Hg or tinuous and as a discrete variable. As a Data were assessed within the German higher, diastolic blood pressure of 95 discrete variable, the mean number of Stroke Registers Study Group (Arbe- mm Hg or higher, or patient self-report tPA administrations per hospital per itsgemeinschaft Deutscher Schlaganfall of treated hypertension. Previous stroke year was classified into categories of 5 Register [ADSR]). The ADSR is a net- was a neurological deficit more than 24 per year, up to more than 20. The lower work of regional hospital-based stroke hours prior to current event. Atrial fi- cutoff of 5 or fewer tPA administra- registers that monitors quality of stroke brillation was documented by electro- tions per hospital per year was used in care in Germany.9 The registers include cardiogram. Neurological deficits of previous studies to classify hospital ex- academic and community hospitals as stroke included motor deficits (weak- perience in tPA use.7,15 No major well as departments of neurology, inter- ness or paresis), speech disturbances changes were observed between 6 to 10 nal medicine, and geriatric medicine. In (aphasia, dysarthria), and disturbances and 11 to 15 tPA administrations and the present analyses, data from the stroke of level of consciousness (semicon- between 16 to 20 and more than 20 tPA registers in Bavaria, Hamburg,10 Hesse,11 scious, eg, not fully rousable; coma- administrations. Thus, mean number of Rhineland-Palatinate, and Westphalia12 tose, eg, either response to pain only or patients receiving thrombolytic therapy were included. In total, 225 hospitals par- no response at all). per hospital was categorized into 1 to ticipated between 2000 and 2002 in the Symptomatic intracranial hemor- 5, 6 to 15, and more than 15 thrombo- ADSR network, representing about 10% rhage (ICH) was defined as clinically lytic therapies per hospital per year. of all 2240 German acute care hospi- relevant bleeding (eg, deterioration of tals.13 symptoms) and verification of ICH by Statistical Analyses All registers applied a common set computed tomography (CT) or mag- The t test was used to test differences in of variables for all stroke patients.9 In- netic resonance imaging (MRI) scan. In- continuous variables and the ␹2 test was formation gathered for each patient increased intracranial pressure was de- used for differences in proportions. Lo- cluded sociodemographic characteris- fined by evidence of symptomatic gistic regression analysis was per- tics, comorbidities, neurological deficits, increased intracranial pressure; eg, by formed to calculate odds ratios (ORs) complications, diagnostic procedures, edema, mass effect, or brain shift syn- and corresponding 95% confidence in- admission procedures, and treatment drome in CT or MRI scan, with clini- tervals (CIs) for the probability of death strategies during the in-hospital pe- cal findings. Recurrent stroke was a new during hospitalization in patients re- riod. Data collection in the treating hos- neurological deficit more than 24 hours ceiving thrombolytic therapy. In mul- pitals was standardized and each hos- after the current event. Pulmonary em- tivariate analyses, the influence of age, pital sent the documented forms to the bolism was defined by clinical and/or sex, comorbidities, and neurological coordinating center of the regional diagnostic findings. Epileptic seizure deficits on risk of early death was inves- stroke register.

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