1-Month DAPT Approved in Europe for Abbott’s Xience Stent in Patients at High Bleeding Risk

April 6, 2021—Abbott announced its Xience stent has received CE Mark approval in Europe for shorter duration of dual antiplatelet therapy (DAPT) for patients at high bleeding risk (HBR). Abbott is also seeking an indication for HBR for the Xience stent in the United States.

According to the company, the approval follows recent results from two studies that demonstrated both 1- or 3-month DAPT followed by aspirin monotherapy is safe in HBR patients and is intended to improve patient outcomes and provide physicians with more options to treat their patients. Xience now has evidence and data for both 1- and 3-month DAPT followed by two different types of blood-thinning medications in HBR patients, noted the company.

The company advised that Abbott’s XIENCE 28 and XIENCE 90 studies show that DAPT can be safely discontinued early—as short as 28 days—with no increased risk in patient adverse events, further confirming the Xience device’s safety profile. The data are available on the company’s website. Roxana Mehran, MD, presented the findings at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020.

“The results of the studies examining the Xience stent in HBR patients with shorter durations of DAPT were highly consistent—with no increase in cardiac events and significant reduction in severe bleeding,” commented Marco Valgimigli, MD, in Abbott’s announcement. “To see such consistency is important for physicians seeking the best possible outcome for our patients.” Dr. Valgimigli is Deputy Chief of CardioCentro Ticino and Professor of Cardiology at the University of the Italian Switzerland in Lugano, Switzerland.

The XIENCE 28 and XIENCE 90 clinical trials enrolled > 3,600 patients in Europe, the Americas, and Asia. The studies monitored 1- and 3-month DAPT durations in exclusively HBR patients.

Abbott stated that the results are consistent and conclusive. Patients who receive the Xience stent with shorter DAPT durations do not have an increase in cardiac events and show a reduction in severe bleeding, thus proving that short DAPT strategies with the Xience stent are safe in HBR patients.