Tenecteplase more likely to lead to ‘excellent’ stroke recovery, study finds

Taking action to dissolve clots can be part of ischemic stroke treatment. Alteplase has to be administered within hours of when stroke symptoms start.

The authors of the current review noted that “alteplase is the only approved systemic reperfusion treatment of acute ischemic stroke.” However, they also noted that some groups, like the European Stroke Organisation, have recommended using tenecteplase as an alternative for ischemic stroke treatment.

Researchers sought to compare the use of tenecteplase and alteplase within four and a half hours of stroke symptom onset. They also examined tenecteplase’s efficacy and safety.

This review and meta-analysis included 11 randomized controlled trials. The authors identified these trials through a systematic literature search.

From all the trials, researchers were able to examine data from 3,788 participants who received tenecteplase, and 3,757 participants who received alteplase. These participants had similar baseline characteristics, stroke symptoms, and time of treatment intervention.

The main outcome researchers looked for was excellent function outcome at 3 months after a stroke occurred.

Excellent function was described as a score of 0 to 1 on the modified Rankin Scale, which corresponds to either no symptoms post-stroke or some symptoms but no significant disability.

Researchers also looked at several secondary outcomes, like good functional outcome, which indicates a stroke recovery level range of no symptoms to slight disability.

Based on their analyses, participants who received tenecteplase were more likely to experience an excellent functional outcome compared to participants who received alteplase. Tenecteplase-treated participants also had a lower risk for disability 3 months post-stroke compared to alteplase-treated participants.

Researchers observed similar rates of good functional outcome, safety, all-cause mortality, and symptomatic intracranial hemorrhage between the treatment groups.

In a subgroup analysis, the researchers distinguished between two types of tenecteplase: original and biocopy.

Based on the findings from two studies, the review authors did not find a significant difference in excellent functional outcome rates in participants who received biocopy tenecteplase and participants who received alteplase.

However, the authors noted that these two studies likely “do not have enough statistical power to demonstrate superiority.”

They further conducted a trial sequential analysis to see if they could firmly conclude teneteplase’s effectiveness. This analysis suggested that tenecteplase is effective.

José Morales, MD, a vascular neurologist and neurointerventional surgeon at Providence Saint John’s Health Center in Santa Monica, CA, who was not involved in this review, explained to Medical News Today that:

“When tenecteplase (TNK) was first released and trialed for clinical use in acute stroke, there were a lot of mixed signals. Some initial reports indicated TNK achieved better recanalization rates, had less bleeding complications, and possibly could provide a longer therapeutic window ([over] 4.5 hours). None of these have been borne out in randomized trials, but there was a clear signal of TNK’s non-inferiority both in terms of safety and efficacy compared to tPA [alteplase]. Meta analyses such as these are helpful to consolidate data and achieve the sample size necessary to draw meaningful statistical comparisons where individual trials might have fallen short.”

This research suggests that tenecteplase may lead to slightly better outcomes for people who experience ischemic stroke. Thus, the study authors advocate for transitioning to tenecteplase in clinical practice.

Morales noted that: “The capacity to administer clot-busting medications is the first step for any hospital hoping to serve patients at need. The ease of use of TNK continues to be backed by valid clinical data and has implications for systems of care.”

“For instance,” he added, “since tPA administration required an infusion, this impacted timely transfer between stroke centers for escalation of care. TNK offers the advantage of not only being easier to use, but also now has growing validated clinical data supporting its safety and efficacy.”

Christopher Yi, MD, a board-certified vascular surgeon at Memorial Orange Coast Medical Center in Fountain Valley, CA, also not involved in the study, further emphasized the clinical benefits of using tenecteplase:

“The clinical implications include a shift in standard practice towards using TNK as the preferred thrombolytic agent for AIS [acute ischemic stroke] within the early 4.5-hour window. Given its ease of administration, TNK could streamline the thrombolysis process, reduce treatment times, and facilitate faster transfers between hospitals. Additionally, adopting TNK widely may improve patient outcomes and reduce healthcare costs due to its effectiveness.”

“However,” Yi cautioned, “challenges such as regulatory barriers, availability, and medicolegal considerations must be addressed to implement this transition effectively. The findings advocate for TNK’s broader implementation, potentially leading to modifications in treatment protocols and guidelines across various healthcare systems.”

The limitations of this review are also worth acknowledging. First, its authors pointed out, that at the time they conducted the meta-analysis, three of the trials had not had detailed study results published.

Second, the meta-analysis was a study-level analysis, which does not allow for certain actions like subgroup analyses and confounding adjustments.

There were also different types of tenecteplase under review, so more research may be required to examine the difference between original tenecteplase and biocopy tenecteplase.

Researchers were also limited by trials available for analysis, which came from a limited number of countries. Finally, all included trials had their own limitations that could have affected any of the results of the analyzed trials.

The researchers were able to identify certain concerns of the trials that could have affected the results, such as certain participants not receiving randomized treatment and one trial where they could not guarantee masking. The trial sequential analyses also made certain assumptions.

Despite these limitations, if future research continues to confirm tenecteplase’s superiority, it may become more widely used in clinical practice.

Alteplase has been a first-line treatment for ischemic stroke for decades and has approval from the Food and Drug Administration (FDA) for this purpose.

Currently, tenecteplase, while approved as a treatment for heart attacks, does not have FDA approval for this purpose, so future action may involve seeking this approval.