September 1, 2021Open Access
View Full Paper3- or 1-Month DAPT in Patients at High Bleeding Risk Undergoing Everolimus-Eluting Stent Implantation
Key Result
In high bleeding risk patients undergoing PCI, 1-month and 3-month DAPT were noninferior to 6- and 12-month DAPT for all-cause mortality or MI (P=0.0005 and P=0.0063 for noninferiority).
Study Design
Type
Cohort (n=3,652)
Multicenter
Yes
Structured PICO
Does 1- or 3-month DAPT prevent ischemic events non-inferiorly to 6- or 12-month DAPT in high bleeding risk patients undergoing PCI with everolimus-eluting stents?
P
Population
3,652 patients at high bleeding risk (HBR) who underwent successful percutaneous coronary intervention (PCI) with a cobalt-chromium everolimus-eluting stent.
I
Intervention
Abbreviated dual-antiplatelet therapy (DAPT) for 1 month or 3 months, followed by discontinuation of the P2Y12 inhibitor.
C
Comparator
Historical control from the XIENCE V USA study receiving 6-month DAPT (for the 1-month comparison) or 12-month DAPT (for the 3-month comparison), analyzed via propensity score stratification.
O
Outcome
Composite of all-cause mortality or myocardial infarction.composite
In high bleeding risk patients undergoing PCI with everolimus-eluting stents, 1- or 3-month DAPT is noninferior to 6- or 12-month DAPT for ischemic outcomes and reduces major bleeding.
Main Result
Absolute Event Rate: 3.5% vs 4.3%
p-value: p=0.0005 for noninferiority
Abstract
The aim of this study was to evaluate 2 abbreviated dual-antiplatelet therapy (DAPT) regimens in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). Current-generation drug-eluting stents are preferred over bare-metal stents for HBR patients, but their optimal DAPT management remains unknown. The XIENCE Short DAPT program included 3 prospective, multicenter, single-arm studies enrolling HBR patients who underwent successful PCI with a cobalt-chromium everolimus-eluting stent. After 1 month (XIENCE 28 USA and XIENCE 28 Global) or 3 months (XIENCE 90) of DAPT, event-free patients discontinued the P2Y12 inhibitor. The postmarketing approval XIENCE V USA study was used as historical control in a propensity score–stratified analysis. A total of 3,652 patients were enrolled. The propensity-adjusted rate of the primary endpoint of all-cause mortality or myocardial infarction was 5.4% among 1,693 patients on 3-month DAPT versus 5.4% in the 12-month DAPT historical control (Pnoninferiority = 0.0063) and 3.5% among 1,392 patients on 1-month DAPT versus 4.3% in the 6-month DAPT historical control (Pnoninferiority = 0.0005). Bleeding Academic Research Consortium (BARC) types 2 to 5 bleeding was not significantly lower with 3- or 1-month DAPT, while 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. Among HBR patients undergoing PCI with cobalt-chromium everolimus-eluting stents, DAPT for 1 or 3 months was noninferior to 6 or 12 months of DAPT for ischemic outcomes and may be associated with less major bleeding and a low incidence of stent thrombosis.
Cite This Study
Mehran et al. (Wed,) conducted a cohort in High bleeding risk undergoing percutaneous coronary intervention (n=3,652). 1-month or 3-month dual-antiplatelet therapy (DAPT) vs. 6-month or 12-month DAPT (historical control) was evaluated on all-cause mortality or myocardial infarction (p=0.0005 for noninferiority). In high bleeding risk patients undergoing PCI, 1-month and 3-month DAPT were noninferior to 6- and 12-month DAPT for all-cause mortality or MI (P=0.0005 and P=0.0063 for noninferiority).