Analysis of more than 79,000 acute ischemic stroke patients revealed comparable short-term efficacy and safety profiles between tenecteplase and alteplase for thrombolytic therapy.
This comparative effectiveness study from the American Heart Association's Get with the Guidelines–Stroke registry represents the largest real-world evaluation of these thrombolytics to date.
Patients treated with tenecteplase had similar rates of functional independence at discharge compared to those treated with alteplase. The rates of symptomatic intracranial hemorrhage (sICH) were also similar, as were rates of in-hospital death or discharge to hospice.
"These findings suggest that tenecteplase is a reasonable alternative to alteplase in the treatment of acute ischemic stroke," said Justin F. Rousseau, MD, MMSc and colleagues in JAMA Network Open.
The study included 79,550 adults who received IV thrombolysis within 4.5 hours of stroke onset. Among them, 9,465 (11.9%) received tenecteplase, while 70,085 (88.1%) received alteplase. Patients in both groups had a similar average age (about 69 years), and the median stroke severity score (NIHSS) was 7. Tenecteplase doses were between 0.20 and 0.30 mg/kg in 96.3% of patients after capping weight at 100 kg.
Both drugs demonstrated equivalent efficacy in functional recovery. No differences were found in the number of patients who were able to walk independently, return home after discharge, or leave the hospital without significant disability.
Tenecteplase was associated with significantly better outcomes in one specific subgroup: patients with large vessel occlusion who were eligible for endovascular thrombectomy (EVT) but did not receive it. In this group, patients given tenecteplase were more likely to be discharged home and had lower in-hospital mortality rates.
These findings are clinically significant as tenecteplase's simpler administration protocol—given as a single IV bolus versus alteplase's bolus plus 60-minute infusion—could improve workflow efficiency in time-sensitive stroke treatment, particularly in resource-limited settings.
The study included patients from over 1,800 hospitals in the U.S. Hospitals using tenecteplase were often larger academic centers with higher stroke volumes and more frequent use of thrombectomy.
Safety profiles were reassuringly similar for both agents. Symptomatic intracranial hemorrhage occurred in approximately 3.1% of patients in both groups. In-hospital mortality was 5.0% for tenecteplase and 4.6% for alteplase.
The study authors noted that their findings extend previous clinical trials showing tenecteplase's noninferiority to alteplase. Unlike controlled trials, this study examined real-world hospital settings and included a broader range of patients with varying stroke characteristics and comorbidities.
The observational design does present limitations, including potential residual confounding and missing long-term outcome data. The researchers could not assess 90-day functional outcomes, which remain the gold standard endpoint in stroke research.
While these data support tenecteplase as a viable alternative to alteplase in routine clinical practice, the authors note that future research should address whether small but clinically important differences exist between the agents across various stroke subtypes and patient populations.
Full disclosures are available in the study.