Abstract WP129: The Potential Impact of Maintaining a 3-Hour IV tPA Window
Background: In 2008, the ECASS-3 trial demonstrated that IV-tPA could be safely administered for acute stroke patients presenting between 3 and 4.5 hours from symptom onset. Recently, the FDA rejected expansion of the 3 hour time window. We sought to determine the safety of the ECASS protocol at our center and assess how many fewer patients would be treated by restricting treatment to 3 hours.
Methods: We reviewed charts from patients who received IV tPA at our comprehensive stroke center and excluded patients who were drip and ship. Patients were divided into two groups (receiving tPA within 3 hours of onset, receiving tPA between 3 and 4.5 hours from onset). Demographics, admission NIHSS and protocol deviations (NINDS and ECASS-3) were collected. Safety was assessed using any hemorrhagic transformation (MRI or CT), symptomatic ICH and systemic hemorrhage.
Results: Two hundred and twelve patients were identified in our tPA registry between 2009 and 2011, of whom 36 received tPA between 3 and 4.5 hours. No statistical differences were seen between age (p=0.633), gender (p=0.677), race (p=0.207) or admission NIHSS (0.737). Protocol deviations from the ECASS 3 criteria were found in 20 patients (56%). The most common deviations were age > 80 (8/36, 22%) and aggressive blood pressure management (5/20, 25%). Safety outcomes were not different between the two groups (Table).
Conclusions: Our data are consistent with previously reported international data that IV thrombolysis can safely be used up to 4.5 hours from symptom onset. By expanding the three hour time window, we were able to treat an additional 17% over three years at our stroke center without an increase in adverse outcomes. Physicians should not withhold thrombolytic therapy based solely on a three hour time window as this unnecessarily restricts the population of patients who could potentially benefit from treatment.
- © 2012 by American Heart Association, Inc.