Trial will assess safety of 3-month DAPT after stent implantation

Abbott Vascular has announced the initiation of a randomized controlled trial to evaluate the use of dual antiplatelet therapy for a 3-month duration following implantation with the company’s Xience drug-eluting stents.

The trial will include 4,000 blinded patients randomly assigned to 3 or 12 months of DAPT after DES implantation. The primary endpoint of the study is the incidence of major adverse cerebral and CV events, according to a press release.

“The appropriate duration of DAPT following treatment with a drug-eluting stent is one of the most important and highly debated topics among cardiologists,” primary investigator Mitch Krucoff, MD, professor of medicine and cardiology at Duke University Medical Center, stated in the release. “Prolonged use of DAPT can be associated with issues such as bleeding complications, patient noncompliance and increased cost, and it is not clear that it is associated with a marked safety benefit.”

The intent of the study is to support a change to the US labeling for Xience stents, which currently calls for at least 12 months of DAPT therapy after DES implantation, according to the release.

Roxanna Mehran

“Patients often struggle with taking blood thinners for a year or more following implantation of their stent,” primary investigator Roxanna Mehran, MD, director of interventional cardiovascular research and clinical trials at Mount Sinai School of Medicine and Associate Medical Editor of Cardiology Today’s Intervention, stated in the release. “This randomized trial will provide the highest level of clinical evidence to inform physicians about the appropriate duration of dual anti-platelet therapy for patients in the US treated with the Xience family of drug-eluting stents.”