Abbott yesterday announced that the XIENCE PRIME™ and the XIENCE V®
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. This is the
shortest duration of DAPT for any major drug eluting stent (DES) in Europe.
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 revascularization, 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.
"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."
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.
About XIENCE PRIME and XIENCE V
Abbott's market-leading XIENCE family of drug eluting stents (XIENCE PRIME and XIENCE V) is available in the United States, Europe, Japan and other international markets.
XIENCE PRIME is indicated for improving coronary artery luminal diameter in
patients with symptomatic heart disease due to de novo native coronary artery
lesions (lesions ≤32 mm) with reference vessel diameters of ≥2.25 mm to ≤4.25.
XIENCE V is indicated for improving coronary luminal diameter in patients
with symptomatic heart disease due to de novo native coronary artery lesions
(lesions ≤28 mm) with reference vessel diameters of 2.25 mm to 4.25 mm.
Everolimus, developed by Novartis Pharma AG, is a proliferation signal
inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its
drug eluting vascular devices. Everolimus has been shown to inhibit in-stent
neointimal growth in the coronary vessels following stent implantation, due to
its anti-proliferative properties.
About Abbott Vascular
Abbott Vascular is the world's leader in drug eluting stents. Abbott Vascular has an industry-leading pipeline and a comprehensive portfolio of market-leading products for cardiac and vascular care, including products for coronary artery disease, vessel closure, endovascular disease and structural heart disease.