Xience Cleared in Europe for 1-Month DAPT in High-Bleeding-Risk Patients
CE Mark approval for what the company called the shortest DAPT indication in the world follows the XIENCE 28/XIENCE 90 trials.
European regulators say the Xience stent (Abbott) can be used with as little as 1 month of dual antiplatelet therapy (DAPT) in certain patients at high risk of bleeding, the company announced Tuesday.
The new CE Mark comes in the wake of positive results from the nonrandomized XIENCE 28 and XIENCE 90 trials, released at last year’s virtual TCT 2020 meeting. The studies tested DAPT durations of 1 month and 3 months, respectively, among approximately 3,600 high-bleeding-risk patients: XIENCE 90 enrolled 2,047 patients at 101 US sites and XIENCE 28 enrolled 963 patients at 52 global sites and 642 patients at 58 US sites.
In both studies, patients had rates of death or MI similar to those seen in matched controls during the trial-specific follow-up period and bleeding rates that were lower among the reduced-DAPT patients.
According to Abbott, Xience is the “most widely used stent worldwide and is the only stent to have evidence and data for both 1-month and 3-months DAPT followed by two different types of blood-thinning medication in high-bleeding-risk patients.”