Three-Month DAPT Duration Approved in EU for Abbott Vascular's Xience DES

May 15, 2012—Abbott Vascular (Santa Clara, CA) issued a press release announcing that the company's Xience Prime and the Xience V everolimus-eluting coronary stent systems have received European CE Mark approval for use with dual-antiplatelet therapy (DAPT) for at least 3 months after stent implantation in patients with coronary artery disease.

The company made the announcement at the EuroPCR 2012 conference in Paris, where it also presented data demonstrating that in more than 10,000 real-world patients treated with Xience Prime and Xience X, no cases of stent thrombosis were reported in patients who discontinued DAPT at 3 months after stent implantation.

In its press release, Abbott Vascular stated that the most recent European Society of Cardiology guidelines for myocardial revascularization, which were published in 2010, recommend that patients treated with a drug-eluting stent remain on DAPT for 6 to 12 months. However, the company noted, long-term DAPT use can lead to additional safety risks, such as increased bleeding events. A shorter-term duration of DAPT after stent implantation may be beneficial if a patient needs to interrupt or discontinue the medication prior to surgery or for other considerations.

Abbott Vascular advised that the devices are indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions. Xience Prime is indicated to treat lesions ≤ 32 mm with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25. Xience V is indicated for lesions ≤ 28 mm with reference vessel diameters of 2.25 mm to 4.25 mm. Both devices are available in the United States, Europe, Japan, and other international markets.