Background: The safety of intravenous tissue plasminogen activator (IV-tPA) is uncertain in acute ischemic stroke patients (AIS) with recent stroke because these patients were generally excluded from randomized stroke trials evaluating IV-tPA. We aimed to determine whether history of stroke within the previous 3 months is associated with an increased risk of intracerebral hemorrhage (ICH) or death after thrombolysis for AIS.
Methods: Using previously validated ICD-9-CM codes, we retrospectively analyzed all adult patients with AIS who received IV-tPA in nonfederal EDs or acute care hospitals in CA, FL, and NY from 2005-2013. The primary outcome was the development of ICH (ICD-9-CM code 431) during index hospitalization for AIS. The secondary outcome was inpatient death. Logistic regression was used to compare the rate of ICH and death in patients with previous ischemic stroke within 3 months of IV-tPA therapy for AIS to all other patients treated with IV-tPA for AIS.
Results: We identified 34,461 AIS patients treated with IV-tPA, including 454 with prior ischemic stroke in the past 3 months. Patients with recent stroke were on average younger and had more vascular risk factors and Elixhauser comorbidities than patients without recent stroke. The ICH rate after IV-tPA was similar in patients with AIS within the previous 3 months (6.6%, 95% CI 6.3-6.8) compared to patients without recent AIS (6.8%, 95% CI 4.5–9.1), but the rate of death was higher in those with AIS within the previous 3 months (16.5%, 95% CI 13.1-19.9 vs. 11.1%, 95% CI 10.7-11.4, p<0.001). After adjusting for demographics, vascular risk factors, and the Elixhauser comorbidity index, the risk of ICH following IV-rPA in patients with AIS in the previous 3 months was not different from those without recent AIS (OR=1.0, 95% CI 0.7-1.5, p=0.90), although the risk of death remained higher in patients with AIS in the previous 3 months (OR=1.6, 95% CI 1.2-2.1, p<0.001). Our results were unchanged in sensitivity analyses excluding patients with other approved indications for thrombolysis (e.g., MI, PE, and hemodialysis).
Conclusions: In a large, multistate cohort, prior stroke within 3 months of receiving IV-tPA for AIS was not associated with an increased risk of ICH but was associated with a higher risk of death.