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3- or 1-Month DAPT in Patients at High Bleeding Risk Undergoing Everolimus-Eluting Stent Implantation |
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| Institution: | 1. Icahn School of Medicine at Mount Sinai, New York, New York, USA;2. University of Florida College of Medicine–Jacksonville, Jacksonville, Florida, USA;3. New York University Langone Medical Center, New York, New York, USA;4. Brigham and Women’s Hospital Heart & Vascular Center, Harvard Medical School, Boston, Massachusetts, USA;5. Zhongshan Hospital Fudan University, Shanghai, China;6. St. Vincent’s Medical Center of Indiana, Indianapolis, Indiana, USA;7. Cedars-Sinai Medical Center, Los Angeles, California, USA;8. University Heart Center Freiburg, Bad Krozingen, Germany;9. Shonan Kamakura General Hospital, Kamakura, Japan;10. Redmond Regional Medical Center, Rome, Georgia, USA;11. Segeberger Kliniken, Herzzentrum, Bad Segeberg, Germany;12. Kansas Heart Hospital and University of Kansas School of Medicine, Wichita, Kansas, USA;13. Ascension Via Christi Hospital, Wichita, Kansas, USA;14. Hospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain;15. Translational and Clinical Research Institute, Newcastle University and Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom;p. Policlinico Umberto I di Roma, Rome, Italy;q. Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany;r. Hospital Cochin, Paris, France;s. Heart Centre Hasselt and University of Hasselt, Hasselt, Belgium;t. Bern University Hospital, Bern, Switzerland;u. Beijing AnZhen Hospital, Beijing, China;v. Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina, USA;w. Abbott, Santa Clara, California, USA;x. Cardiocentro Ticino, Lugano and Bern University Hospital, Bern, Switzerland |
| Abstract: | ObjectivesThe 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).BackgroundCurrent-generation drug-eluting stents are preferred over bare-metal stents for HBR patients, but their optimal DAPT management remains unknown.MethodsThe 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.ResultsA 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.ConclusionsAmong 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. |
| Keywords: | bleeding everolimus-eluting stent high bleeding risk percutaneous coronary intervention short DAPT thrombosis BARC"} {"#name":"keyword" "$":{"id":"kwrd0045"} "$$":[{"#name":"text" "_":"Bleeding Academic Research Consortium DAPT"} {"#name":"keyword" "$":{"id":"kwrd0055"} "$$":[{"#name":"text" "_":"dual-antiplatelet therapy HBR"} {"#name":"keyword" "$":{"id":"kwrd0065"} "$$":[{"#name":"text" "_":"high bleeding risk PCI"} {"#name":"keyword" "$":{"id":"kwrd0075"} "$$":[{"#name":"text" "_":"percutaneous coronary intervention |
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