Abstract WP72: Safety of Label- and Protocol Violations in Acute Stroke tPA Administration
Background: IV-tPA remains the only FDA approved therapy for acute ischemic stroke, however less than 10% of patients receive treatment. This is partially due to the large number of contraindications on the drug label and continued use of NINDS trial criteria for patient selection.
Methods: We retrospectively analyzed consecutive patients who received IV-tPA at our stroke center for label or NINDS protocol violations, as well as safety according to the NINDS t-PA Stroke Study definition of sICH. Other outcome variables included systemic hemorrhage, mRS at discharge and disposition.
Results: A total of 308 patients were identified in our tPA registry between 2009 and 2011. Ninety six patients were excluded because they received tPA at an outside facility prior to transfer, leaving 212 patients for analysis. Median patient age was 68 (IQR 55, 82), median pretreatment NIHSS score was 8 (IQR 5, 14). Protocol violations occurred in 103 patients (49%). The most common violations were tPA delivery beyond 3 hours (26%), aggressive blood pressure management with nicardipine (15%), elevated PT/PTT (6.6%), minor or resolving deficits (4.2%), unclear time of onset (3.9%) and stroke within 3 months (3%). Three patients had a history of ICH. There were no significant differences in any of the safety outcomes between patients with or without protocol violations (Table). Furthermore, after controlling for age, admission NIHSS and glucose, there was no significant increase in the rate of any hemorrhagic transformation (OR 1.046, p= 0.905) or sICH (OR 0.569, p= 0.613) in patients with protocol violations.
Conclusions: Despite nearly half of patients receiving tPA off label or in violation of the NINDS protocol, overall rates of hemorrhage remained low and did not differ from those who did not have violations. Our data support the need to mitigate restrictions for IV-tPA in patients presenting with acute ischemic stroke.
- © 2012 by American Heart Association, Inc.