Prospective Observational Cohort Study Of Tenecteplase Versus Alteplase In Routine Clinical Practice

Abstract

ABSTRACTBackground and PurposeA 10-hospital regional network transitioned to tenecteplase as the standard of care stroke thrombolytic in September 2019 because of its workflow advantages and reported non-inferior clinical outcomes relative to alteplase in meta-analyses of randomized trials. We assessed whether tenecteplase use in routine clinical practice reduces thrombolytic workflow times with non-inferior clinical outcomes.MethodsWe designed a prospective registry-based observational, sequential cohort comparison tenecteplase (n=234) to alteplase (n=354) treated stroke patients. We hypothesized: (1) an increase in the proportion of patients meeting target times for target door to needle (DTN) and transfer door-in-door-out (DIDO), and (2) non-inferior favorable (discharge to home with independent ambulation) and unfavorable (symptomatic intracranial hemorrhage, in-hospital mortality or discharge to hospice) in the tenecteplase group. Total hospital cost associated with each treatment was also compared.ResultsTarget DTN within 45 minutes was superior for tenecteplase, 41% versus 29%; aOR 1.76 (95% CI 1.24, 2.52), P = 0.002. Target DIDO within 90 minutes was superior for tenecteplase 37% (15/43) versus 14% (9/65); OR 3.69 (95% CI 1.47, 9.7), P =0.006, overall, and 67% (12/18) versus 14% (2/14) for those transferred for thrombectomy after thrombolytic treatment (P =0.009). Favorable outcome for tenecteplase fell within the 6.5% non-inferiority margin; aOR 1.28 (95% CI 0.92, 1.77). Unfavorable outcome was less for tenecteplase 7.7% versus 11.9%, aOR 0.79 (95% CI 0.46, 1.32), but did not fall within the pre-specified 1% non-inferior boundary. Net benefit (%favorable – %unfavorable) was greater for the tenecteplase sample: 36% v 27%. P =0.022. Median cost per hospital encounter was less for tenecteplase cases ($13,382 vs $15,841; P <0.001).ConclusionsSwitching to tenecteplase in routine clinical practice in a 10-hospital network was associated with shorter DTN and DIDO times, non-inferior favorable clinical outcomes at discharge, and reduced hospital costs. Evaluation in larger, multicenter cohorts is recommended to determine if these observations generalize.