Abstract TMP8: The New Alteplase Package Insert: What is the Potential Impact?

Background: Alteplase (tPA) contraindications for acute ischemic stroke (AIS) were originally derived from the 1995 NINDS trial. Recently, a history of intracranial hemorrhage (ICH) and recent stroke (within 3 months) were removed as contraindications from the drug package insert, which could increase the number of patients eligible for IV thrombolysis. We sought to define the potential impact on outcomes and health care costs in this newly eligible population. Methods: Consecutive patients (March 2014 - April 2015) who presented with AIS to our Comprehensive Stroke Center (CSC) were retrospectively analyzed. Demographics and tPA exclusions were recorded. The annual number of discharges with primary diagnosis of ischemic stroke in the U.S. was estimated from the National Inpatient Sample (2006 - 2011). A previously reported value of $25,000/patient was utilized to calculate lifetime cost savings in patients receiving tPA. Results: During the study period, 776 AIS were admitted to our CSC (median age 64; 55,74, 51% men, 62% white). Seventy-six percent of our patients (n=590) had ≥1 tPA exclusions according to the NINDS trial. Among these patients, 11 excluded had history of ICH, 15 with recent strokes, and 1 both. Following the new package insert, the proportion of patients with ≥1 tPA exclusion fell to 73% (n=563). Given the 432,000 ischemic stroke discharges annually, a 3% increase in patients eligible for tPA could translate to treatment of 12,960 more patients annually and a lifetime cost savings of $324,000,000. Furthermore, we estimate that 1,685 of these newly eligible patients will experience a favorable functional outcome based on the results of the NINDS trial (13% shift analysis for mRS 0-1). Conclusions: Our results suggest that the new tPA package insert has the potential to increase national tPA treatment rates, decrease U.S. health care costs, and improve functional outcomes in eligible AIS patients. National guidelines need to be updated to reflect these changes.