Abbott has today announced that its Xience family of stents has received US Food and Drug Administration (FDA) approval for one-month (as short as 28 days) dual antiplatelet therapy (DAPT) labelling for high bleeding risk (HBR) patients in the USA. This follows the receipt of CE mark in Europe for shorter duration DAPT in April 2021.
In addition to the HBR indication, Abbott has also received FDA approval and European CE mark approval for its next-generation Xience Skypoint stent. Xience Skypoint is easier to place and allows physicians to treat larger blood vessels through improved stent expansion that can open clogged vessels more effectively, Abbott said in a press release.
“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 high bleeding risk. A short DAPT duration minimises risks for high bleeding risk patients and allows them to return to daily life sooner and with more assurance,” says Roxana Mehran, 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, New York, USA, and the global principal investigator for Abbott’s Short DAPT programme (XIENCE 28 and XIENCE 90).
Patients who receive stents are typically on DAPT regimens (aspirin and P2Y12 inhibitors) for six to 12 months to prevent blood clots from blocking the stented vessel. However, HBR patients can experience side effects such as bleeding during prolonged courses of DAPT.