In patients at high risk of bleeding undergoing coronary stenting with a Xience stent, 1-to-3-month DAPT period resulted non-inferior to a 6-to-12-month period in terms of ischemic events, and this could be associated to a lower rate of major bleeding and lower stent thrombosis incidence.
There is no longer an indication for conventional stents in patients at bleeding risk. However, post DES implantation DAPT schemes remain controversial.
The Xience Short DAPT program included 3 prospective multicenter single-arm studies with patients at high bleeding risk undergoing PCI with a cobalt-chromium everolimus-eluting stent. After one month (Xience 28) and 3 months (Xience 90) with no events, patients could out of DAPT.
Patients from the Xience V USA were used (approved post marketing) as historical control group and for propensity score stratified analysis.
The study included 3,652 patients that after propensity score matching showed mortality or MI rate of 5.4% among 1,693 receiving 3-month DAPT vs. an amazingly identical 5.4% from those receiving 12-month DAPT (p for non-inferiority <0.00005).
For the short scheme, the outcome was 3.5% for the 1392 patients undergoing only one-month DAPT vs. 4.3% for the control group receiving 6-month DAPT (p for non-inferiority <0.00005).
There were no significant differences in types 2-5 BARC bleeding between those receiving 1- or 3-month DAPT. BARC types 3 to 5 bleeding was reduced in both experimental groups.
The rate of definite or probable stent thrombosis was 0.2% in XIENCE 90 (P < 0.0001 for the performance goal of 1.2%) and 0.3% in XIENCE 28.
In patients at high risk of bleeding receiving the Xience stent, dual antiaggregation therapy for only 1 to 3 months resulted non-inferior to 6-to-12-month DAPT in terms of ischemic end points. In addition, it might be associated to reduced rates of bleeding events and stent thrombosis.
Reference: Roxana Mehran et al. J Am Coll Cardiol Intv 2021;14:1870–1883. https://doi.org/10.1016/j.jcin.2021.07.016.