New anticoagulant drug faster and equally effective in the treatment of strokes

A newly approved blood-thinning drug for stroke works just as well as a decades-old drug still used by most U.S. hospitals, and it can be administered even faster, a new study notes.

Tenecteplase (TNKase) is the first new blood-thinning drug to be approved in nearly 30 years, and the U.S. Food and Drug Administration (FDA) gave it the go-ahead earlier this month.

And now, research shows that tenecteplase works just as well as alteplase, a standard blood-thinning drug, which is used to treat strokes, according to findings published recently in the journal JAMA Network Open.

"In the treatment of acute ischemic stroke, there is a saying that 'time is brain.' The longer patients go without effective treatment, the more brain cells die, and the worse their outcome," lead researcher Dr. Justin Rousseau, an assistant professor of neurology at UT Southwestern Medical Center in Dallas, said in a news release.

"Our study shows that tenecteplase is a safe and effective alternative to traditional alteplase treatment, and in some cases, it could cause patients to recover faster," Rousseau said.

Each year, nearly 800,000 people in the U.S. have a stroke, and this occurs most often because a blood clot has blocked blood flow to the brain (an ischemic stroke), the researchers noted in background notes.

Alteplase was approved in 1996 to help treat strokes by dissolving these clots quickly, but the drug has significant disadvantages, the researchers said.

Alteplase is given with a rapid initial dose, followed by a slow-drip infusion over the next hour, the researchers said. This is a complicated process that can cause interruptions or delays in treatment.

By comparison, tenecteplase is given with a single injection lasting a few seconds, the researchers said. The new drug was approved for use in stroke in early March, but it has already been on the market for the treatment of heart attacks caused by clots and is sometimes used as an off-label stroke treatment.

In the new study, researchers compared nearly 9,500 patients who received tenectplase for stroke with more than 70,000 who received alteplase between July 2020 and June 2022.

Both groups had nearly identical results in terms of functional independence, absence of disability, discharge from home rather than a rehabilitation center, and ability to walk unassisted.

The drugs also had comparable safety measures, the researchers said.

However, using tenecteplase, which is easier to administer, may allow for greater flexibility in stroke treatment, the researchers said. For example, patients might have clot removal surgery more quickly.

In fact, among patients who had surgery to remove the clot, tenecteplase appeared to perform better, improving the odds of people being discharged home and reducing rates of hospital deaths or hospice discharge.

"This large, national-level comparative effectiveness study using data from routine clinical practice demonstrated similar short-term safety and effectiveness results with tenecteplase compared to alteplase in patients with acute ischemic stroke," the researchers concluded in their study.

"This study supports tenecteplase as a reasonable alternative to alteplase, with practical advantages for the preparation and administration of tenecteplase."