Boston Scientific Corp. has received the U.S. FDA’s nod for a high bleeding risk (HBR) indication for the Synergy drug-eluting stent system. The company said the approval makes Synergy the first such platform in the U.S. with an indication for HBR.

Last September, the Marlborough, Mass.-based company revealed primary endpoint results from the EVOLVE Short DAPT clinical trial, which looked at the safety of a shortened duration of dual antiplatelet therapy (DAPT) in patients at high risk for bleeding.

According to the American Heart Association, many heart attack and stroke patients are treated with DAPT agents to prevent blood clotting. However, HBR patients face increased risk on longer DAPT regimens.

Results from the study showed that a three-month regimen of DAPT is noninferior to a 12-month or longer regimen in individuals facing an increased risk of bleeding after being treated with the Synergy bioabsorbable polymer stent.

Patients had been implanted with at least one Synergy Bp stent and considered at high risk for bleeding after meeting at least one of the criteria. They include age of 75 or older with the risk of longer term DAPT deemed greater than the benefit, a history of stroke, renal insufficiency or failure, the need for chronic anticoagulation therapy or history of major bleeding in the prior 12 months.

Ajay Kirtane, director of Cardiac Catheterization Laboratories at Columbia University Irving Medical Center/New York-Presbyterian Hospital and principal investigator of the EVOLVE Short DAPT trial, heralded the results at the time. "These data prospectively demonstrate a low rate of adverse events for patients who are at high risk for bleeding and who then stop DAPT at three months," he said at the time. "This is critically important information because previously, the required duration of DAPT following implantation of current generation drug-eluting stent platforms was unknown. These data better inform physicians as to how best to tailor the recommended duration of DAPT to the bleeding risk of the patients they treat."

A significant patient population

“In the beginning when we started studying HBR patients, people who had not been studied in approval trials of drug-eluting stents, and yet many clinicians knew that these were people who were being treated every day,” Kirtane told BioWorld following the FDA’s latest action.

He noted that it was thought that less than 10% of the population of the people being referred to the cath lab. “That’s now evolved to the point where best estimates are somewhere [between] 20% to 30% of patients who present to the cath lab will at some point have some sort of HBR indication.”

Kirtane added that a key advantage of current-generation stent platforms is that they have been optimized for biocompatibility. They also offer thinner-strutted stents, a polymer that is bioabsorbable and goes away, and delivery systems that permit access in ways and places that were unimaginable just a few years ago.

He also noted that the 48 mm stent of Synergy is not approved for the HBR indication because they weren’t included in the study. However, he sees that option as important in terms of cost for hospitals, as clinicians could use one stent instead of two.

“This stent platform … has been optimized for biocompatibility, ease of use and familiarity, and so adding an HBR indication to that stent platform I think just broadens the scope.”

He concluded that these HBR patients are commonly receiving this treatment. “Across stent platforms, in fact, it’s important to generate this type of data. There’s a lot of interest and enthusiasm in the field on HBR, and that’s good news for patients and their physicians.”

For its part, in June, Medtronic plc, of Dublin, revealed that it had scored the CE mark for a one-month DAPT indication for HBR patients implanted with the Resolute Onyx drug-eluting stent. Medtronic heralded the approval as the first of its kind globally. It does not have the FDA’s nod for the indication, but it has submitted data to the agency.

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