|Paper title||History of Intracranial Hemorrhage is Associated with In-Hospital Mortality in Ischemic Stroke Patients Treated with Intravenous Thrombolytics|
|Form of presentation||Poster|
The recently updated FDA label removed history of ICH from its list of contraindications, possibly due to lack of data on risks and benefits. In a survey of United States stroke clinicians, just over 10% reported willingness to treat patients with history of ICH with IV-tPA. Our objective was to evaluate whether history of ICH increases in-hospital mortality in AIS patients treated with IV-tPA.
We performed a retrospective analysis of prospectively collected administrative claims data on discharges from California hospitals between 2005-2011 from the Healthcare Cost and Utilization Project State Inpatient Database. Subjects were adult patients admitted for the first time with acute ischemic stroke and received IV-tPA. We used ICD-9-CM codes to identify stroke patients and those with the exposure of interest, history of ICH. The primary outcome was in-hospital mortality of any cause. The secondary outcome was disposition at discharge. We used multivariable logistic regression to model the risk of in-hospital death in ischemic stroke patients who received IV-tPA as a function of prior ICH status, after adjusting for potential confounders, including demographic and medical risk factors.
A total of 11,259 patients who received IV-tPA during first-time AIS admissions were included in the study (mean age 71 [SD 14], female 5,660 [50.3%]). Among these, 246 (2.2%) had prior diagnoses of ICH, including spontaneous intraparenchymal hemorrhage (n=158), subarachnoid hemorrhage (n=72), subdural hemorrhage (n=7), and multicompartmental hemorrhage (n=9). In-hospital mortality of any cause was 12.9% (n=1,455) overall, 12.6% (n=1,387) for patients without history of ICH, and 27.6% (n=68) for patients with history of ICH. In adjusted analyses, history of ICH remained independently associated with in-hospital mortality (OR 3.04, 95% CI 2.27-4.02; p: 2E-14), as did the ICH subtypes intraparenchymal hemorrhage (OR 2.27, CI 1.58-3.21; p: 5E-6) and subarachnoid hemorrhage (OR 4.34, CI 2.64-6.97; p: 3E-9).
In a large population of AIS patients treated with IV-tPA, a prior history of ICH was independently associated with increased in-hospital mortality. Further studies, including randomized clinical trials, are needed to definitively establish the safety of IV-tPA treatment in AIS patients. Caution should be exercised when considering treatment with intravenous thrombolytics in patients with an AIS who have history of ICH.