US study bolsters recent evidence supporting tenecteplase in ischaemic stroke care

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Tenecteplase, a newer-generation intravenous thrombolysis (IVT) drug, has outperformed the traditional treatment (alteplase) for ischaemic strokes in several key areas, demonstrating better health outcomes and lower costs, according to a recent study published in the journal Stroke.

The study was led by a team of neurologists at Dell Medical School at the University of Texas at Austin (Austin, USA) and, starting in September 2019, was carried out over a 15-month period across 10 Ascension Seton hospitals in central Texas.

“The Dell Med Neurology Stroke Program was one of the first in the USA to make this change,” said Steven Warach (Dell Medical School, Austin, USA), lead author of the study. “Based on even the earliest results from this study, other experts across the country were convinced and made the switch from alteplase to tenecteplase at their own stroke centres—including at Ascension hospitals nationwide.”

Both tenecteplase and alteplase are federally approved for use in dissolving clots in blocked heart arteries. However, tenecteplase—the newer of the two drugs—is also being used by clinicians, off-label, to treat ischaemic strokes, because clinical trials in this space have indicated that it may be at least as effective as alteplase. Tenecteplase is delivered via a single five- to 10-second intravenous injection, meaning that, crucially, it is the easier of the two to administer as well.

In the aforementioned study, researchers compared its performance with alteplase, which is widely considered the standard drug for IVT stroke treatments and is injected over a period of 60 minutes.

“When it comes to treating patients with a stroke, every second matters,” said Warach. “The shorter preparation and injection time with tenecteplase not only eliminates a lot of dosing errors related to alteplase, but it is also more efficient. We were able to deliver the clot-busting medicine more quickly after patients arrived in the emergency department and, for patients who needed to be transferred to another hospital for more advanced care after receiving the clot-buster, we were able to initiate the transfer sooner in those treated with tenecteplase.”

For patients who come into the emergency department after a stroke, Warach and his colleagues’ study found that the door-to-needle time—the time between a patient’s arrival and the moment they receive treatment—was, on average, six minutes quicker with tenecteplase. And, for patients who also required surgical removal of a stroke-causing blood clot via a mechanical thrombectomy procedure, tenecteplase sped up the process of transferring the patient to a thrombectomy-capable stroke centre by 25 minutes.

The researchers saw further improvements in clinical outcomes for those patients who received tenecteplase, including a 5% increase in patients who were able to walk independently at the time of hospital discharge to home, and a 4% decrease in occurrences of adverse events like brain haemorrhages, discharge to hospice care or death. Warach and colleagues also noted potential economic benefits that were seen in their study, as tenecteplase treatments cost the hospitals about US$2,500 less than alteplase per patient.

“If this price differential continues, the magnitude of savings could equate to [a number] in excess of US$150 million every year in the USA,” said David Paydarfar (Dell Medical School, Austin, USA), co-author of the study. “This is a great example of value-based care—better care, for less money.”

The researchers conclude their Stroke study by adding that evaluation in larger, multicentre cohorts is recommended to determine if these observations generalise.

These findings follow The Lancet’s publication of positive data from the AcT study earlier this year. In what was claimed to be the largest stroke trial ever conducted in Canada, researchers showed that tenecteplase is an effective treatment for acute ischaemic stroke, with 0.25mg/kg of the drug working “as well as, if not better than” 0.9mg/kg of alteplase across 1,600 patients.

The Dell Med Neurology Stroke Program is now working with colleagues in the state-funded Lone Star Stroke Research Consortium—a clinical research network focused on innovations in the prevention, diagnosis, treatment and rehabilitation of stroke patients in Texas—to disseminate its study findings across the state, in an attempt to help more stroke centres make the switch to tenecteplase. Warach is also working with Lone Star Stroke colleagues to build a state-wide database to “further confirm their results and answer lingering questions”, according to a University of Texas at Austin press release.

“For example, we have such a large Latinx population in Texas,” he stated, “I would like to know if we are seeing the same advantages from tenecteplase in that community as we are in the larger population. The more data we have, the more questions we can answer.”


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