Tenecteplase Has Similar Profile to Alteplase for Large Vessel Occlusion Stroke

Intravenous (IV) tenecteplase has similar reperfusion, functional outcomes, and safety, compared with alteplase in patients with large vessel occlusion (LVO), according to study findings in published in JAMA Neurology.

The standard of care for acute ischemic stroke is IV thrombolysis, with or without endovascular therapy (EVT). Recent research has shown the potential for tenecteplase to be an alternative to alteplase. For the study, researchers conducted a study to assess the efficacy and safety of tenecteplase compared with alteplase in patients with an LVO.

The researchers collected data from the Intravenous Tenecteplase Compared With Alteplase for Acute Ischemic Stroke in Canada (ACT), an open-label, registry-linked randomized control trial. 

The researchers included patients aged 18 years and older with acute ischemic stroke. All participants met the criteria for IV thrombolysis and the study also included patients eligible for EVT. The participants were diagnosed with neurologic impairment and presented within 4.5 hours of symptoms onset. 

The participants were assigned either IV tenecteplase (0.25 mg/kg of body weight) or IV alteplase (0.9 mg/kg of body weight) and were monitored for up to 120 days.

This study exclusively focused on patients with LVO, which was defined by occlusions found in the intracranial internal carotid artery, the first segment of the middle cerebral artery (M1-MCA), proximal and dominant second segment (M2)-MCA, or basilar artery.

The primary outcome was the 90-day functional outcome, which was characterized by a modified Rankin scale (mRS) score of 0 to 1.

Among the 1,577 patients in the ACT trial, 520 met the inclusion criteria set for this study and were split into 2 groups (263 [50.6%] in the tenecteplase group and 257 [49.4%] in the alteplase group). Of the 520 patients diagnosed with LVO, 408 (78.5%) were treated with EVT. 

The median age of study participants was 74 years (interquartile ratio [IQR], 64 to 83 years) and 283 (54.4%) were women. At 90 to 120 days, 86 (32.7%) patients in the tenecteplase group had an mRS score of 0 to 1 compared with 76 (29.6%) in the alteplase group (adjusted risk ratio [aRR], 1.15; 95% CI, 0.98-1.35).

With regard to a 90-day mRS of 0 to 2, there were no significant differences between tenecteplase 129 (49.0%) and alteplase 131 (51.0%). The rates for mortality (19.9% vs 18.1%) and symptomatic intracerebral hemorrhage (16 [6.1%] vs 11 [4.3%]) between tenecteplase and alteplase showed no difference, respectively. 

Of the 405 patients who were treated with a thrombectomy, there were no significant differences reported for successful reperfusion rates between tenecteplase and alteplase when comparing the first (19 [9.2%] vs 21 [10.5%]) and last angiogram (174 [84.5%] vs 177 [88.9%]). 

“Given the ease of administration of tenecteplase vs alteplase and the comparable safety and efficacy between both thrombolytics shown in this study, tenecteplase could be used as a first-line thrombolytic agent for patients with LVO stroke,” the researchers concluded.

Study limitations included the inclusion of patients who were treated within 4.5 hours exclusively, a relatively small sample size, and some patients not undergoing EVT.