Abbott has announced that its Xience stent has received CE mark in Europe for shorter duration of dual anti-platelet therapy (DAPT)—including for 28 days—for patients with high bleeding risk (HBR).
The approval follows recent results from two studies 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 and provide physicians more options to treat their patients.
Patients who receive stents are typically on DAPT regimens (aspirin and antiplatelet drugs known as P2Y12 inhibitors to prevent blood clots) for six to 12 months to support vessel healing and prevent clotting from blocking the stented vessel. However, HBR patients can experience side effects such as bleeding during prolonged courses of DAPT.
Abbott’s XIENCE 28 and XIENCE 901 studies show that DAPT can be safely discontinued early with no increased risk in patient adverse events, further confirming the industry-leading safety profile of the Xience stent.
“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. To see such consistency is important for physicians seeking the best possible outcome for our patients,” says Marco Valgimigli, deputy chief of CardioCentro Ticino, Lugano, Switzerland and professor of cardiology at the University of the Italian Switzerland (USI).
The XIENCE 28 and XIENCE 90 clinical trials enrolled more than 3,600 participants from Europe, the Americas and Asia. The studies monitored two different DAPT durations—one-month and three-months—in exclusively HBR patients. 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 showed a reduction in severe bleeding, proving short DAPT strategies with the Xience stent are safe in HBR 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,” says Nick West, chief medical officer and divisional vice president of global medical affairs at 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.”