In short
In a press release issued today (PR Newswire), Abbott has announced that the XIENCE PRIME and the XIENCE V®(pictured) Everolimus Eluting Coronary Stent Systems have received CE Mark in Europe for the use of dual anti-platelet therapy (DAPT) for at least three months after stent implantation in patients with coronary artery disease. The company claims this is the shortest duration of DAPT for any major drug eluting stent (DES) in Europe.
Background
Patients are prescribed DAPT, a combination of aspirin and an anti-platelet medication, following stent implantation to protect them from developing blood clots and experiencing other adverse safety events. The most recent European Society of Cardiology (ESC) guidelines for myocardial revascularisation, which were published in 2010, recommend that patients treated with a DES remain on DAPT for six to 12 months. Long-term DAPT use can lead to additional safety risks, such as increased bleeding events, which is why shorter-term duration of DAPT may be meaningful for patients. In addition, having a shorter DAPT duration after stent implantation may be beneficial in case a patient needs to interrupt or discontinue the medication prior to surgery or for other considerations.
Data presented at the EuroPCR 2012 congress this week demonstrated that in more than 10,000 real-world patients treated with XIENCE PRIME and XIENCE V, no cases of stent thrombosis were reported in patients who discontinued DAPT after three months post-stent implantation. It is likely that this data on which the regulatory decision to indicate a shortened regime was based.
Company Comments
“With this new indication, physicians in Europe can have confidence in being able to safely discontinue DAPT after a minimum of three months for patients who were treated with a XIENCE PRIME or XIENCE V stent should their patients’ circumstances require it,” said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “Clinical data from more than 10,000 patients show that XIENCE is associated with similar safety results in patients who interrupted their DAPT medication after three months compared to patients who never interrupted their medication. Reducing the amount of time patients need to remain on DAPT can have a significant impact on patient health and may lead to decreased health care costs. We are pleased that XIENCE has been recognized as the only major DES in Europe with a minimum three-month indication for DAPT a confirmation of its strong safety profile.”
Source: Abbott Vascular, PR Newswire
published: May 16, 2012 in: Abbott, Approval/Clearance, Cardio, Clinical Studies/Trials