Abbott (NYSE:ABT) announced today that its Xience stent received CE mark approval for a shorter duration of dual anti-platelet therapy (DAPT).
The European approval for the stent allows for the DAPT to go as short as 28 days, the shortest indication available in the world for patients with high bleeding risk (HBR), according to a news release.
Abbott Park, Ill.-based Abbott said approval follows study results that demonstrated both one-month or three-month DAPT followed by aspirin monotherapy is safe in HBR patients and is intended to improve patient outcomes while providing more treatment options to physicians and patients.
The Xience 28 and Xience 90 clinical trials evaluated more than 3,600 participants from Europe, the Americas and Asia across the two different DAPT durations in exclusively HBR patients. The results proved consistent and demonstrated that those who receive the Xience stent with shorter DAPT durations do not have an increase in cardiac events and showed a reduction in severe bleeding.
Xience is the only stent to have evidence and data for both one-month and three-months DAPT, followed by two different types of blood-thinning medication in HBR patients, Abbott said. The company is seeking an indication for HBR for the Xience stent in the U.S., too.
“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,” Abbott vascular business CMO & divisional VP of global medical affairs Dr. Nick West said in the release. “These findings build on the unrivaled volume of research confirming the XIENCE stent’s leading performance across a range of patient and clinical situations.”
