Introduction: The recently updated FDA label for intravenous recombinant tissue plasminogen activator (IV-tPA) for stroke removed a history of intracranial hemorrhage (ICH) as a contraindication. The safety of IV-tPA in patients with prior ICH is not well-established, as only a few cases are described in the literature. We sought to determine (1) the proportion of patients treated with IV-tPA for stroke who have prior history of ICH and (2) whether this circumstance influences in-hospital mortality.
Methods: Using administrative claims data on admissions to California hospitals between 2005-2011, we performed a cross-sectional study of adult patients admitted with acute ischemic stroke who received IV-tPA. ICD-9-CM codes were used to identify these patients and to ascertain prior diagnoses of (1) ICH, including intracerebral hemorrhage (IPH), subarachnoid hemorrhage (SAH), subdural hematoma (SDH), or epidural hematoma (EDH); and (2) existing comorbidities. We used multivariable logistic regression to model the odds of in-hospital mortality as a function of prior ICH, after adjusting for potential confounders.
Results: Among 372,167 patients admitted with acute ischemic stroke during the study period, 10,882 (2.9%) received IV-tPA (mean age 70.6 [SD 14.6], female 5,614 [54.8%]). Among these, 268 (2.5%) patients had a diagnosis of prior ICH on admission, including IPH 194 (1.8%), SAH 81 (0.7%), SDH 9 (0.1%) and EDH 2 (0.0%). In-hospital mortality was 12.2% overall, 11.7% for patients without prior ICH, and 31.0% for patients with prior ICH (p<0.001). In adjusted analyses, prior ICH remained independently associated with in-hospital mortality (OR 3.48, 95% CI 2.63-4.56, p<0.001), as did most ICH subtypes, including IPH (OR 2.97, CI 2.12-4.09, P<0.001), SAH (OR 3.15, CI 1.89-5.12, P<0.001), and SDH (OR 4.27, CI 0.87-16.95, P=0.047).
Conclusions: In California between 2005-2011, 2.5% of acute ischemic stroke patients who received thrombolysis had a prior diagnosis of ICH. In this population, a history of ICH was associated with mortality; this association held true for ICH subtypes IPH, SAH and SDH. Further observational and experimental studies are needed to confirm the observed associations.