Stent platform now indicated for patients with high bleeding risk
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Boston Scientific announced that its bioabsorbable polymer stent platform has received a new indication from the FDA to treat patients at high bleeding risk.
This stent platform (Synergy), which is the only system approved for this indication in the U.S., was designed to allow a shorter duration of dual antiplatelet therapy for patients at high bleeding risk, according to an email from the company.
“[This approval] indicates a recognition that higher bleeding risk patients are a frequent population of patients we treat and that clinical studies demonstrating the efficacy and safety of drug-eluting stents in this population are necessary,” Ajay J. Kirtane, MD, SM, associate professor of medicine at Columbia University Irving Medical Center, chief academic officer of the Center for Interventional Vascular Therapy and director of cardiac catheterization laboratories at NewYork-Presbyterian/Columbia University Irving Medical Center, told Healio.
Approval for the new indication was based on data from the EVOLVE Short DAPT study, which was presented at the Transcatheter Cardiovascular Therapeutics Scientific Symposium in 2019, according to the email. The study showed that DAPT for 3 months was noninferior to a 12-month or longer regimen for patients with increased risk for bleeding after treatment with the bioabsorbable polymer stent.
“I hope that the generation of the data from EVOLVE Short DAPT as well as other studies in high bleeding risk patients, which led to FDA approval, allows clinicians and patients the flexibility to be able to optimize the use of PCI (and obligate antiplatelet therapy) as suitable for a patient’s needs,” Kirtane, who was the principal investigator for the EVOLVE Short DAPT trial, said in an interview. “That is really the aim here. In the past, many clinicians and patients had limited data upon which to make clinical decisions, especially in high bleeding risk patients. These data and the approval hopefully change that.”
The stent has thin struts and abluminal polymer coating for rapid healing within the vessel, according to the product page on the company’s website. Polymer exposure is minimized as the drug completely elutes after 3 months.
“This specific stent platform is categorized by an open-cell thin-strutted stent with a bioresorbable polymer that elutes everolimus,” Kirtane told Healio. “With data now generated in higher bleeding risk patients, there is demonstrated efficacy and safety across a range of patient and lesion subsets.”
The DES system was previously approved by the FDA in 2015 for the treatment of CAD, as Healio previously reported.
For more information:
Ajay J. Kirtane, MD, SM, can be reached at ak189@cumc.columbia.edu; Twitter: @ajaykirtane.
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