Background: A 10-hospital regional network transitioned to tenecteplase as the standard of care stroke thrombolytic in September 2019 because of potential workflow advantages and reported noninferior clinical outcomes relative to alteplase in meta-analyses of randomized trials. We assessed whether tenecteplase use in routine clinical practice reduced thrombolytic workflow times with noninferior clinical outcomes. Methods: We designed a prospective registry-based observational, sequential cohort comparison of tenecteplase- (n=234) to alteplase-treated (n=354) stroke patients. We hypothesized: (1) an increase in the proportion of patients meeting target times for target door-to-needle time and transfer door-in-door-out time, and (2) noninferior 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. Results: Target door-to-needle time within 45 minutes for all patients was superior for tenecteplase, 41% versus 29%; adjusted odds ratio, 1.85 (95% CI, 1.27–2.71); P =0.001; 58% versus 41% by Get With The Guidelines criteria. Target door-in-door-out time within 90 minutes was superior for tenecteplase 37% (15/43) versus 14% (9/65); adjusted odds ratio, 3.62 (95% CI, 1.30–10.74); P =0.02. Favorable outcome for tenecteplase fell within the 6.5% noninferiority margin; adjusted odds ratio, 1.26 (95% CI, 0.89–1.80). Unfavorable outcome was less for tenecteplase, 7.3% versus 11.9%, adjusted odds ratio, 0.77 (95% CI, 0.42–1.37) but did not fall within the prespecified 1% noninferior boundary. Net benefit (%favorable–%unfavorable) was greater for the tenecteplase sample: 37% versus 27%. P =0.02. Median cost per hospital encounter was less for tenecteplase cases ($13 382 versus $15 841; P <0.001). Conclusions: Switching to tenecteplase in routine clinical practice in a 10-hospital network was associated with shorter door-to-needle time and door-in-door-out times, noninferior favorable clinical outcomes at discharge, and reduced hospital costs. Evaluation in larger, multicenter cohorts is recommended to determine if these observations generalize.
Background: Our 10-hospital network (2 CSCs, 2PSCs, 6 non-SCs) switched our standard stroke thrombolytic from alteplase (ALT) to tenecteplase (TNK; 0.25 mg/kg) in September 2019. Methods: We designed a two-year prospective cohort analysis of key processes and clinical outcomes for TNK-treated patients with planned quarterly assessments of feasibility and safety. The TNK cohort is compared to the retrospective historical cohort of all unique patients at these hospitals treated with ALT during the prior 2-year period (n=354). Analysis were taken from a local REDcap registry that recorded data fields required for Stroke Center certification and submission to Get-With-The Guidelines (GWTG). Interim results through three quarters ending June 30, 2020. Results: 151 patients were treated with TNK. The samples TNK v ALT were well matched on age (median, IQR) 66.0 (55.0, 76.0) v 67.0 (55.0, 78.8) and NIHSS at admission (median, IQR), 8 (4, 13) v 8 (4, 15). Symptomatic ICH (ECASS 3 definition) occurred in 2.0% of TNK and 2.3% of ALT treated patients; all but one symptomatic ICH occurred in patients treated with both thrombolytic and endovascular therapies. All cause in-hospital mortality was 3.3% and 6.8%, respectively. No differences were observed in early outcomes of discharge to home (52%, 53%) or independent ambulation (46%, 45%). Day 90 Rankin Score (last observation carried forward for missing values) was available only for TNK: mRS 0-1 in 46.4% (95%CI 38.6%-54.3%), 0-2 in 55.6% (95%CI 47.7%-63.3%). A significantly greater proportion of patients were treated with the lytic within 45 minutes of hospital arrival after the switch to TNK using Get-With-The-Guidelines DTN time criteria (Table), most notably at the primary stroke centers. Conclusions: To date, the transition to TNK was associated with reductions in DTN times and in Drip-and-Ship transfer times (see related abstract). No differences were seen on early indices of safety or efficacy.
Recommendation: There is no universal algorithm for addressing the infected ankle or subtalar arthrodesis. A potential algorithm created by consensus is: Level of Evidence: Consensus. Delegate Vote: Agree: 100%, Disagree: 0%, Abstain: 0% (Unanimous, Strongest Consensus).
Background and Purpose: A 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 noninferior clinical outcomes. Methods We 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. Results: Target 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 minus %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). Conclusions: Switching 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.
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