Oct 15th 2020

XIENCE 90/28—coverage of TCT Connect 2020

Evaluating the Safety of 3-month and 1-month DAPT in HBR Patients

The XIENCE 90/28 trial was a prospective, multi-center, open-label, non-randomized trial evaluating the safety of a short DAPT regimen (1 or 3 months) versus DAPT for up to 12 months in patients receiving Xience stents. Patients enrolled in XIENCE 28 were prescribed one month of DAPT while patients in XIENCE 90 were prescribed three months of DAPT. Both XIENCE 90 and XIENCE 28 demonstrated non-inferiority in terms of ischemic outcomes as compared to 12 months of DAPT.  The XIENCE 90 and XIENCE 28 patient subsets had similar rates of clinically relevant bleeding (BARC 2-5), however, there was a significant reduction in major (BARC 3-5) bleeding amongst patients receiving 1–3 months of DAPT as compared to 12 months of DAPT (5.4% vs. 5.4%). It is important to note that STEMI patients, patients with EF<30% and patients with planned surgery within 1–3 months of PCI were excluded. There were also angiographic exclusion criteria including overlapping stents, thrombotic lesions, left main PCI, lesions within bypass grafts, CTO’s and ISR. High bleeding risk patients are a challenging subset of patients for interventional cardiologists to manage and this study provides some evidence that DAPT duration of 1–3 months followed by aspirin monotherapy may be sufficient in some of these patients.