The biggest drawback to drug-eluting stents has been the requirement for prolonged dual antiplatelet (DAPT) therapy following stent implantation to prevent stent thrombosis and other potential complications. The precise length of DAPT has been the subject of considerable discussion and research.
Now the Xience Prime and Xience V everolimus-eluting stents have received the CE Mark in Europe for a DAPT length of only three months, according to an Abbott press release. The manufacturer of the stents, Abbott, said this was the “shortest duration for any major drug eluting stent (DES) in Europe.”
Abbott said that data presented this week at the EuroPCR congress found no cases of stent thrombosis in more than 10,000 patients who received a Xience stent and who discontinued DAPT after three months.
An Abbott spokesperson told CardioBrief that the company is “currently exploring our filing strategies with the FDA for a three-month DAPT indication.”
Here is the press release from Abbott:
- Three-Month Dual Anti-Platelet Therapy (DAPT) is Shortest Duration For Any Major Drug Eluting Stent in Europe
- New Indication Supported by Data From More Than 10,000 Patients
Paris — Abbott (NYSE: ABT) today 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. Additional information about XIENCE PRIME, including important safety information, is available at www.xiencestent.com or http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/XIENCE_PRIME_Everolimus_Eluting_Coronary_Stent_System.pdf.
XIENCE V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due tode novo native coronary artery lesions (lesions ≤28 mm) with reference vessel diameters of 2.25 mm to 4.25 mm. Additional information about XIENCE V, including important safety information, is available at www.xiencestent.com or http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/XIENCE_V_Everolimus_Eluting_Coronary_Stent_System.pdf.
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.
Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs approximately 91,000 people and markets its products in more than 130 countries.