Abbott announced Tuesday, April 6, that its Xience stent has received CE mark approval for treating patients at a high risk of bleeding with short-term dual anti-platelet therapy (DAPT) after the procedure.
The news comes after two different studies—one focused on 28-day DAPT and another on three-month DAPT—found that short-term DAPT followed by aspirin monotherapy is both safe and effective. Additional details about those studies are available here.
“The results of the studies examining the XIENCE stent in high bleeding risk patients with shorter durations of dual anti-platelet therapy were highly consistent—with no increase in cardiac events and significant reduction in severe bleeding,” Marco Valgimigli, MD, PhD, deputy chief at CardioCentro Ticino in Lugano, Switzerland, said in a prepared statement. “To see such consistency is important for physicians seeking the best possible outcome for our patients.”
“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,” added Nick West, MD, chief medical officer and divisional vice president of global medical affairs for Abbott's vascular business. “These findings build on the unrivalled volume of research confirming the Xience stent's leading performance across a range of patient and clinical situations.”
Abbott is currently seeking a similar approval from the FDA that would cover the United States.