Duration of Dual Antiplatelet Therapy for Patients at High Bleeding Risk Undergoing PCI.

Marco Valgimigli, 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, James W Choi, Gianluca Campo, 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, Yan Zheng, Roxana Mehran

Journal: Journal of the American College of Cardiology 2021;78(21):2060-2072

PMID: 34794687

Abstract

BACKGROUND

The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) among patients at high bleeding risk (HBR) is unknown.

OBJECTIVES

The purpose of this analysis was to compare 1 vs 3 months of DAPT in HBR patients undergoing drug-eluting stent implantation.

METHODS

The XIENCE Short DAPT program comprised 3 prospective, multicenter, single-arm studies of HBR patients treated with a short DAPT course followed by aspirin monotherapy after PCI with a cobalt-chromium everolimus-eluting stent. In this exploratory analysis, patients who received 1-month DAPT (XIENCE 28 USA and 28 Global) were compared with those on 3-month DAPT (XIENCE 90) using propensity score stratification. Ischemic and bleeding outcomes were assessed between 1 and 12 months after index PCI.

RESULTS

A total of 3,652 patients were enrolled and 1,392 patients after 1-month DAPT and 1,972 patients after 3-month DAPT were eligible for the analyses. The primary endpoint of all-cause mortality or myocardial infarction was similar between the 2 groups (7.3% vs 7.5%; difference -0.2%; 95% CI: -2.2% to 1.7%; P = 0.41). The key secondary endpoint of BARC (Bleeding Academic Research Consortium) type 2-5 bleeding was lower with 1-month DAPT compared with 3-month DAPT (7.6% vs 10.0%; difference -2.5%; 95% CI: -4.6% to -0.3%; P = 0.012). Major BARC type 3-5 bleeding did not differ at 12 months (3.6% vs 4.7%; difference -1.1%; 95% CI: -2.6% to 0.4%; P = 0.082), but was lower with 1-month DAPT at 90 days (1.0% vs 2.1%; P = 0.015).

CONCLUSIONS

Among HBR patients undergoing PCI, 1 month of DAPT, compared with 3 months of DAPT, was associated with similar ischemic outcomes and lower bleeding risk. (XIENCE 90 Study; NCT03218787; XIENCE 28 USA Study; NCT03815175; XIENCE 28 Global Study; NCT03355742).

Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.

Address: Cardiocentro Ticino Institue, Ente Ospedaliero Cantonale, Lugano and Bern University Hospital, Bern, Switzerland.; Icahn School of Medicine at Mount Sinai, New York, New York, USA.; University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, USA.; New York University-Langone Medical Center, New York, New York, USA.; Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, Massachusetts, USA.; Zhongshan Hospital Fudan University, Shanghai, China.; St Vincent's Medical Center of Indiana, Indianapolis, Indiana, USA.; Cedars-Sinai Medical Center, Los Angeles, California, USA.; University Heart Center Freiburg, Bad Krozingen, Germany.; Shonan Kamakura General Hospital, Kamakura, Japan.; Redmond Regional Medical Center, Rome, Georgia, USA.; Segeberger Kliniken GmbH, Herzzentrum, Bad Segeberg, Germany.; Kansas Heart Hospital and University of Kansas School of Medicine, Wichita, Kansas, USA.; Ascension Via Christi Hospital, Wichita, Kansas, USA.; Baylor Scott and White Heart and Vascular Hospital, Dallas, Texas, USA.; Azienda Ospedaliero-Universitaria di Ferrara, Cona (FE), Italy.; Hospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain.; Translational and Clinical Research Institute, Newcastle University and Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.; Policlinico Umberto I di Roma, Rome, Italy.; Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.; Hospital Cochin, Paris, France.; Heart Centre Hasselt and University of Hasselt, Hasselt, Belgium.; Bern University Hospital, Bern, Switzerland.; Beijing AnZhen Hospital, Beijing, China.; Duke University Medical Center and Duke Clinical Research Institute, Durham, North Carolina, USA.; Abbott, Santa Clara, California, USA.; Icahn School of Medicine at Mount Sinai, New York, New York, USA. Electronic address: [email protected].
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