Abbott’s stent receives CE mark in Europe for one-month DAPT

7 April 2021 (Last Updated April 7th, 2021 16:28)

Abbott’s XIENCE stent has received CE Mark in Europe for shorter, 28-day duration of dual anti-platelet therapy (DAPT) for high bleeding risk (HBR) patients. 

Abbott’s stent receives CE mark in Europe for one-month DAPT
Abbott’s XIENCE stent has received CE Mark in Europe. Credit: DennisM2 on Flickr.

Abbott’s XIENCE stent has received CE Mark in Europe for a shorter, 28-day duration of dual anti-platelet therapy (DAPT) for high bleeding risk (HBR) patients.

The latest development comes following results from two recent studies that showed aspirin monotherapy after both one-month or three-month DAPT is safe in HBR patients. It is hoped that the approval will improve patient outcomes and offer additional options for doctors treating patients.

Broadly used across the globe, XIENCE is the only stent to demonstrate evidence and data for both one-month and three-month DAPT before two types of blood-thinning medication in HBR patients.

Abbott vascular business global medical affairs vice-president Nick West said: “In patients with high bleeding risk, the XIENCE stent has proven that it can ensure patient safety without compromising efficacy when duration of blood-thinning medications is shortened.

“These findings build on the unrivalled volume of research confirming the XIENCE stent’s leading performance across a range of patient and clinical situations.”

Patients receiving stents are usually on DAPT regimens, such as aspirin or antiplatelet drugs known as P2Y12 inhibitors, for six to 12 months to aid in vessel healing and preventing the stented vessel from becoming obstructed by blood clots. However, during extended courses of DAPT, HBR patients can experience bleeding as a side effect.

According to Abbott’s XIENCE 28 and XIENCE 90 studies, discontinuation of DAPT as early as 28 days has no higher risk of patient adverse events, thereby validating the XIENCE stent’s safety profile.

These studies enrolled more than 3,600 subjects in Europe, Asia and the US.

University of Lugano cardiology professor Marco Valgimigli said: “The results of the studies examining the XIENCE stent in high bleeding risk patients with shorter durations of DAPT were highly consistent – with no increase in cardiac events and significant reduction in severe bleeding.

“To see such consistency is important for physicians seeking the best possible outcome for our patients.”

Recently, the US Food and Drug Administration granted emergency use authorization to Abbott’s BinaxNOW COVID-19 Ag Self Test for over the counter, non-prescription, asymptomatic use.