3- or 1-Month DAPT in Patients at High Bleeding Risk Undergoing Everolimus-Eluting Stent Implantation

Roxana Mehran; Davide Cao; Dominick J Angiolillo; Sripal Bangalore; Deepak L Bhatt; Junbo Ge; James Hermiller; Raj R Makkar; Franz-Josef Neumann; Shigeru Saito; Hector Picon; Ralph Toelg; Aziz Maksoud; Bassem M Chehab; Jose M De la Torre Hernandez; Vijay Kunadian; Gennaro Sardella; Holger Thiele; Olivier Varenne; Pascal Vranckx; Stephan Windecker; Yujie Zhou; Mitchell W Krucoff; Karine Ruster; Jin Wang; Marco Valgimigli; XIENCE 90 and XIENCE 28 Investigators

doi:10.1016/j.jcin.2021.07.016

3- or 1-Month DAPT in Patients at High Bleeding Risk Undergoing Everolimus-Eluting Stent Implantation

JACC Cardiovasc Interv. 2021 Sep 13;14(17):1870-1883. doi: 10.1016/j.jcin.2021.07.016.

Authors

Roxana Mehran¹, Davide Cao², Dominick J Angiolillo³, Sripal Bangalore⁴, Deepak L Bhatt⁵, Junbo Ge⁶, James Hermiller⁷, Raj R Makkar⁸, Franz-Josef Neumann⁹, Shigeru Saito¹⁰, Hector Picon¹¹, Ralph Toelg¹², Aziz Maksoud¹³, Bassem M Chehab¹⁴, Jose M De la Torre Hernandez¹⁵, Vijay Kunadian¹⁶, Gennaro Sardella¹⁷, Holger Thiele¹⁸, Olivier Varenne¹⁹, Pascal Vranckx²⁰, Stephan Windecker²¹, Yujie Zhou²², Mitchell W Krucoff²³, Karine Ruster²⁴, Jin Wang²⁴, Marco Valgimigli²⁵; XIENCE 90 and XIENCE 28 Investigators

Affiliations

¹ Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: roxana.mehran@mountsinai.org.
² Icahn School of Medicine at Mount Sinai, New York, New York, USA.
³ University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, USA.
⁴ New York University Langone Medical Center, New York, New York, USA.
⁵ Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, Massachusetts, USA.
⁶ Zhongshan Hospital Fudan University, Shanghai, China.
⁷ St. Vincent's Medical Center of Indiana, Indianapolis, Indiana, USA.
⁸ Cedars-Sinai Medical Center, Los Angeles, California, USA.
⁹ University Heart Center Freiburg, Bad Krozingen, Germany.
¹⁰ Shonan Kamakura General Hospital, Kamakura, Japan.
¹¹ Redmond Regional Medical Center, Rome, Georgia, USA.
¹² Segeberger Kliniken, Herzzentrum, Bad Segeberg, Germany.
¹³ Kansas Heart Hospital and University of Kansas School of Medicine, Wichita, Kansas, USA.
¹⁴ Ascension Via Christi Hospital, Wichita, Kansas, USA.
¹⁵ Hospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain.
¹⁶ Translational and Clinical Research Institute, Newcastle University and Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.
¹⁷ Policlinico Umberto I di Roma, Rome, Italy.
¹⁸ Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.
¹⁹ Hospital Cochin, Paris, France.
²⁰ Heart Centre Hasselt and University of Hasselt, Hasselt, Belgium.
²¹ Bern University Hospital, Bern, Switzerland.
²² Beijing AnZhen Hospital, Beijing, China.
²³ Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina, USA.
²⁴ Abbott, Santa Clara, California, USA.
²⁵ Cardiocentro Ticino, Lugano and Bern University Hospital, Bern, Switzerland.

PMID: 34503737
DOI: 10.1016/j.jcin.2021.07.016

Abstract

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 (P_{noninferiority} = 0.0063) and 3.5% among 1,392 patients on 1-month DAPT versus 4.3% in the 6-month DAPT historical control (P_{noninferiority} = 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.

Keywords: bleeding; everolimus-eluting stent; high bleeding risk; percutaneous coronary intervention; short DAPT; thrombosis.

Publication types

Multicenter Study
Research Support, Non-U.S. Gov't

MeSH terms

Drug Therapy, Combination
Drug-Eluting Stents*
Everolimus / adverse effects
Hemorrhage / chemically induced
Humans
Percutaneous Coronary Intervention* / adverse effects
Platelet Aggregation Inhibitors / adverse effects
Prospective Studies
Treatment Outcome

Substances

Platelet Aggregation Inhibitors
Everolimus