Background:
Innovations in prehospital and Emergency Department systems of care increasingly enable IV tissue plasminogen activator (tPA) delivery in the first 60 minutes after onset, a time window not tested in placebo-controlled clinical trials. We sought to characterize efficacy and safety outcomes when tPA is delivered in the “golden hour.”
Methods:
We analyzed 65,384 acute ischemic stroke patients treated with tPA within 4.5 hours of symptom onset in 1456 hospitals participating in GWTG-Stroke from Jan 2009 to Sept 2013. Multivariable logistic regression modeling was employed to evaluate the independent impact of treatment within 60 minutes of onset on outcome.
Results:
878 patients (1.3%) received lytic therapy within 60 minutes of onset, versus 6490 (9.9%) in 61-90m, 46,457 (71.1%) in 91-180m, and 11,559 (17.7%) in 181-270m. Independent patient-level factors associated with treatment in the golden hour were older age (aOR 1.15 per 5 years over age 65), higher NIHSS (aOR, 1.04 per scale point), non-EMS arrival (aOR 1.59), and arrival during on hours (aOR 1.61). Hospital level predictors were higher tPA volume (aOR 1.08 per 5 cases), non-PSC (aOR 1.27), and Western region (aOR 1.38 vs Northeast). Compared with the 61-270m window, treatment within 0-60m was associated with increased independent ambulation at d/c, aOR 1.22 (95% CI 1.03-1.45); discharge to home, aOR 1.25 (1.07-1.45); and being disability-free at d/c, aOR 1.72 (95% CI 1.21-2.46, mRS 0-1). No differences were noted in in-hospital mortality or SICH. Considering all discharge mRS transitions, golden hour treatment showed greatest impact at mRS 0-1 vs 2-6 (Figure).
Conclusions:
Ischemic stroke treatment with IV tPA in the golden hour is associated with more frequent independent ambulation at discharge, discharge to home, and, especially, being disability free at discharge. These findings support intensive efforts, including Target: Stroke and prehospital thrombolysis, to speed treatment initiation.