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Xience Stents Receive CE Mark for 3-Month DAPT Duration
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The Xience Prime and Xience V everolimus-eluting stents have received CE mark approval for the use of dual antiplatelet therapy for at least 3 months after implantation, making it the shortest duration for any major drug-eluting stent in Europe, according to a press release.
The expanded indication was supported by data from a study presented at EuroPCR in May that included more than 10,000 real-world patients from a post-hoc analysis of observational studies. In the study, patients were treated with the Xience Prime and Xience V everolimus-eluting stents (Abbott), and among those who discontinued DAPT 3 months after implantation, there were no reported cases of stent thrombosis.
These findings follow 2 years after the European Society of Cardiology published guidelines for myocardial revascularization recommending that patients who have received a DES remain on DAPT for 6 to 12 months, despite the additional safety risks associated with long-term DAPT, including increased bleeding events, the release stated.
Tullio Palmerini
Although the results presented at EuroPCR are remarkable, they should be considered hypothesis-generating and be confirmed by further randomized controlled trials. If it turns out that just 3 months of DAPT are enough with this kind of stent, it would be a real breakthrough and could lead to a significant shift in how we handle these kinds of patients.
– Tullio Palmerini, MD
Department of Cardiology, Policlinico S. Orsola University of Bologna, Italy
Disclosure: Dr. Palmerini presented the post-hoc analysis at EuroPCR and receives speakers’ fees from Abbott Vascular.