Abbott’s Xience Stent Approved for 1-Month DAPT, Xience Skypoint Approved in United States and Europe

June 30, 2021—Abbott announced that its Xience family of stents received FDA approval for 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) labeling for high-bleeding-risk (HBR) patients in the United States. In April, the company announced that the Xience stent received European CE Mark approval for DAPT as short as 28 days.

Abbott has also received FDA and European CE Mark approval for its next-generation Xience Skypoint stent, which is designed to be easier to place and to treat larger blood vessels through improved stent expansion that can open clogged vessels more effectively. Skypoint is also approved for use in HBR patients with 1-month (as short as 28 days) DAPT labeling in the United States and Europe.

“The new FDA approval for DAPT for the Xience family of stents provides interventional cardiologists confidence they are delivering the best care to patients with HBR,” commented Roxana Mehran, MD, in Abbott’s press release. “A short DAPT duration minimizes risks for HBR patients and allows them to return to daily life sooner and with more assurance.”

Dr. Mehran, who serves as Global Principal Investigator for Abbott’s short DAPT program (the XIENCE 28 and XIENCE 90 studies), is Professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute at Icahn School of Medicine at Mount Sinai in New York, New York.

At the Transcatheter Cardiovascular Therapeutics Connect conference in October 2020, Dr. Mehran presented results from the XIENCE 28 and XIENCE 90 clinical trials, which showed that a shorter course of DAPT after percutaneous coronary intervention was noninferior to standard DAPT up to 12 months.

Abbott advised that the data from XIENCE 28 and XIENCE 90 showing that DAPT can be safely discontinued early as short as 28 days with no increased risk in patient adverse events are available on the company website here.