FDA Permits 28-Day DAPT in Xience-Treated Patients at High Bleeding Risk

The US Food and Drug Administration now says that just 1 month of dual antiplatelet therapy (DAPT) can be used in patients at high bleeding risk (HBR) treated with the Xience family of drug-eluting stents, according to an announcement today from Abbott.

The new labelling approval comes on the heels of positive results from the XIENCE 28 nonrandomized study showing that 1 month of DAPT was not associated with an increased risk of ischemic events but was linked to a lower risk of BARC 3-5 bleeding.

In the study, which included approximately 1,600 patients considered at high risk for bleeding, the risk of death or MI between 1 and 6 months was 3.5% in those treated with 1 month of DAPT after Xience. In comparison, the rate was 4.3% among patients from XIENCE V, an all-comers study published in 2012 that served as the historical control arm.  

Earlier this year, European regulators also approved 1-month DAPT for HBR patients treated with Xience DES. In 2020, European authorities and the FDA approved 1 month of DAPT for HBR patients treated with the Resolute Onyx DES (Medtronic).