October 15, 2020
Shorter DAPT Regimen With Abbott's Xience V DES Is Noninferior to Standard DAPT for Ischemic Events
October 15, 2020—Results from the XIENCE 90/28 clinical trials presented by Roxana Mehran, MD, at TCT Connect have shown that a shorter course of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) was noninferior to standard DAPT up to 12 months.
The XIENCE 28 (USA; GLOBAL) and XIENCE 90 trials were prospective, single-arm, multicenter, open-label nonrandomized trials conducted to evaluate the safety of 1-month (28) or 3-month (90) DAPT in high bleeding-risk (HBR) patients undergoing PCI with the Xience everolimus-eluting stent (Abbott).
Dr. Mehran commented in the TCT Connect press release, “Among high bleeding-risk patients undergoing PCI with the Xience stent, a short DAPT regimen of 1 or 3 months compared with standard DAPT up to 12 months resulted in noninferior ischemic outcomes and similar rates of clinically relevant (BARC 2-5) bleeding, with a significant reduction in major (BARC 3-5) bleeding. Additionally, there was a very low incidence of stent thrombosis.”
TCT Connect is the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14–18, 2020.
According to TCT Connect's announcement, the primary endpoint evaluated safety (all-cause death or myocardial infarction) of a short DAPT regimen (1 or 3 months) compared to DAPT up to 12 months. The secondary endpoints were the incidence of clinically relevant bleeding (BARC 2-5) and stent thrombosis (definite/probable) against a performance goal (only for XIENCE 90). The XIENCE V USA postapproval study served as the historical control group through a propensity score stratified analysis.
After successful PCI, enrolled patients in XIENCE 28 were prescribed 1 month of DAPT while patients in XIENCE 90 were prescribed 3 months of DAPT. Those patients who were free from ischemic events and adhered to the antiplatelet regimen during the first 1 month or 3 months received “1-month” or “3-month” clear assessments and were eligible to be placed on antiplatelet monotherapy (aspirin) from 1 or 3 months to 12 months.
As summarized by TCT Connect, XIENCE 90 demonstrated similar rates of all death or MI between 3 and 12 months in the test group versus the control (5.4% vs 5.4%; one-sided 97.5% UCL, 2.23%; Pnoninferiority = .0063). XIENCE 28 also demonstrated noninferiority of death or MI in the test group between 1 and 6 months (3.5% vs 4.3%; one-sided 97.5% UCL, 0.97%; Pnoninferiority = .0005).
For the secondary endpoint, the incidence of bleeding (BARC 2-5) in XIENCE 90 was 5.1% versus 7.0% (Psuperiority = .0687); in XIENCE 28, it was 4.9% versus 5.9% (Psuperiority =0.19). Major bleeding (BARC 3-5) was significantly reduced in both trials: XIENCE 90, 2.2% versus 6.3% (Psuperiority < .0001); XIENCE 28, 2.2% versus 4.5% (Psuperiority = .0156).