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Published on: February 26, 2013
3- or 1-Month DAPT in Patients at High Bleeding Risk Undergoing Everolimus-Eluting Stent Implantation
Roxana Mehran1, Davide Cao1, Dominick J Angiolillo2
1Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Insights
Short dual-antiplatelet therapy (DAPT) of 1 or 3 months was found to be noninferior for ischemic outcomes in high bleeding risk patients undergoing PCI. This abbreviated DAPT approach may also reduce major bleeding events.
Area of Science:
- Cardiology
- Interventional Cardiology
- Pharmacology
Background:
- Optimal dual-antiplatelet therapy (DAPT) duration for high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) with current drug-eluting stents is not well-defined.
- Drug-eluting stents are preferred for HBR patients, necessitating research into safe and effective DAPT strategies.
Purpose of the Study:
- To evaluate two abbreviated DAPT regimens in HBR patients who have undergone PCI.
- To compare the safety and efficacy of 1-month and 3-month DAPT versus longer durations.
Main Methods:
- The XIENCE Short DAPT program comprised three prospective, single-arm studies in HBR patients receiving cobalt-chromium everolimus-eluting stents.
- Patients received 1-month (XIENCE 28) or 3-month (XIENCE 90) DAPT, discontinuing P2Y12 inhibitors thereafter.
- Propensity score-stratified analysis was used with historical controls (XIENCE V USA).
Main Results:
- A total of 3,652 patients were enrolled.
- 1-month and 3-month DAPT were noninferior to 6-month and 12-month DAPT for ischemic outcomes (all-cause mortality or myocardial infarction).
- While not significantly reducing BARC types 2-5 bleeding, both abbreviated DAPT durations reduced BARC types 3-5 bleeding; stent thrombosis rates were low (0.2%-0.3%).
Conclusions:
- Abbreviated DAPT durations of 1 or 3 months are noninferior to longer durations for ischemic outcomes in HBR patients treated with cobalt-chromium everolimus-eluting stents.
- These shorter DAPT regimens may be associated with reduced major bleeding and maintain a low incidence of stent thrombosis.
Objectives:
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).
Background:
Current-generation drug-eluting stents are preferred over bare-metal stents for HBR patients, but their optimal DAPT management remains unknown.
Methods:
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.
Results:
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.
Conclusions:
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.
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