Angelo Oliva; Dominick Angiolillo; Marco Valgimigli; Davide Cao; Samantha Sartori; Sripal Bangalore; Deepak Bhatt; Gianluca Campo; Bassem Chehab; James Choi; Jose de la Torre Hernandez; Yihan Feng; Junbo Ge; Mauro Gitto; James Hermiller; Mitchell Krucoff; Vijay Kunadian; Raj Makkar; Aziz Maksoud; Franz-Josef Neumann; Hector Picon; Shigeru Saito; Gennaro Sardella; Holger Thiele; Ralph Toelg; Olivier Varenne; Birgit Vogel; Pascal Vranckx; Stephan Windecker; Roxana Mehran

doi:10.4244/EIJ-D-24-00897

One- versus three-month DAPT after everolimus-eluting stent implantation in diabetic patients at high bleeding risk: results from the XIENCE Short DAPT programme

Angelo Oliva¹^,², MD; Dominick J. Angiolillo³, MD, PhD; Marco Valgimigli⁴^,⁵, MD, PhD; Davide Cao¹^,², MD; Samantha Sartori¹, PhD; Sripal Bangalore⁶, MD, MHA; Deepak L. Bhatt¹, MD, MPH, MBA; Gianluca Campo⁷, MD; Bassem M. Chehab⁸, MD; James W. Choi⁹^,¹⁰, MD; Jose M. de la Torre Hernandez¹¹, MD, PhD; Yihan Feng¹, MS; Junbo Ge¹², MD; Mauro Gitto¹^,², MD; James Hermiller¹³, MD; Mitchell W. Krucoff¹⁴, MD; Vijay Kunadian¹⁵, MD; Raj R. Makkar¹⁶, MD; Aziz Maksoud¹⁷, MD; Franz-Josef Neumann¹⁸, MD; Hector Picon¹⁹, MD; Shigeru Saito²⁰, MD; Gennaro Sardella²¹, MD; Holger Thiele²², MD; Ralph Toelg²³^,²⁴, MD; Olivier Varenne²⁵, MD, PhD; Birgit Vogel¹, MD; Pascal Vranckx²⁶, MD; Stephan Windecker²⁷, MD; Roxana Mehran¹, MD

1. Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA; 2. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy; 3. Division of Cardiology, Department of Medicine, College of Medicine-Jacksonville, University of Florida, Jacksonville, FL, USA; 4. Cardiocentro Ticino Institue, Ente Ospedaliero Cantonale, Lugano (EOC), Università della Svizzera Italiana (USI), Lugano, Switzerland; 5. Bern University Hospital, Bern, Switzerland; 6. Division of Cardiology, Department of Medicine, New York University Grossman School of Medicine, New York, NY, USA; 7. Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara, Ferrara, Italy; 8. Ascension Via Christi Hospital, Cardiovascular Research Institute of Kansas, Wichita, KS, USA; 9. Texas Health Presbyterian Hospital, Dallas, TX, USA; 10. Baylor Scott and White Research Institute, Dallas, TX, USA; 11. Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain; 12. Zhongshan Hospital Fudan University, Shanghai, China; 13. St Vincent Heart Center of Indiana, Indianapolis, IN, USA; 14. Division of Cardiology, Duke University Medical Center and Duke Clinical Research Institute, Durham, NC, USA; 15. Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, United Kingdom and Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom; 16. Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA; 17. Kansas Heart Hospital, Wichita, KS, USA and University of Kansas School of Medicine, Wichita, KS, USA; 18. Department of Cardiology and Angiology, University Heart Centre Freiburg Medical Centre - University of Freiburg, Bad Krozingen, Germany; 19. Redmond Regional Medical Center, Rome, GA, USA; 20. Shonan Kamakura General Hospital, Kamakura, Japan; 21. Policlinico Umberto I di Roma, Rome, Italy; 22. Heart Center Leipzig at University of Leipzig, Leipzig, Germany and Leipzig Heart Science, Leipzig, Germany; 23. Center for Cardiovascular and Diabetes Medicine, Asklepios Clinic Bad Oldesloe, Bad Oldesloe Germany; 24. Medical Faculty of the Christian-Albrechts-University of Kiel, Kiel, Germany; 25. Hôpital Cochin, APHP, Université de Paris Cité, Paris, France; 26. Department of Cardiology and Critical Care Medicine, Faculty of Medicine and Life Sciences, Jessa Ziekenhuis, University of Hasselt, Hasselt, Belgium; 27. Department of Cardiology, Bern University Hospital, University of Bern, Bern, Switzerland

Abstract

Background: In patients with diabetes mellitus (DM) and high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI), the optimal duration of dual antiplatelet therapy (DAPT) remains uncertain.

Aims: We sought to compare early DAPT discontinuation in DM and non-DM patients enrolled in the prospective XIENCE Short DAPT programme.

Methods: The effects of 1- versus 3-month DAPT on ischaemic and bleeding outcomes were compared using propensity score stratification. The primary endpoint was a composite of all-cause death or myocardial infarction (MI) at 1 year. The incidence of Bleeding Academic Research Consortium (BARC) Type 2 to 5 bleeding was the key secondary endpoint.

Results: Out of 3,352 included patients, 1,299 (38.8%) had DM; diabetic patients had a higher 1-year incidence of death or MI (DM vs non-DM: 10.1% vs 6.6%) and similar BARC 2-5 bleeding (DM vs non-DM: 9.5% vs 9.2%). With 1- versus 3-month DAPT, the incidence of death or MI did not statistically differ in DM patients (adjusted hazard ratio [adjHR] 0.70, 95% confidence interval [CI]: 0.47-1.05) and non-DM patients (adjHR 1.26, 95% CI: 0.87-1.81), although heterogeneity by DM status was evident (p for interaction=0.015). BARC 2-5 bleeding was numerically lower with 1-month DAPT in both groups (DM: adjHR 0.67, 95% CI: 0.45-1.01; non-DM: adjHR 0.78, 95% CI: 0.56-1.07; p for interaction=0.973).

Conclusions: Among HBR patients with DM undergoing PCI, 1-month DAPT, as compared to 3-month DAPT, was not associated with an excess of fatal or non-fatal MI and even reduced the occurrence of bleeding. These findings should be interpreted in the context of a predominantly stable patient population with low procedural complexity and may not be generalisable to higher-risk cases.

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Coronary interventions Interventions for valvular disease Interventions for heart failure Peripheral interventions Interventions for hypertension Interventions for stroke STEMI NSTEMI Stable CAD Stents and scaffolds Left main and multivessel disease Bifurcation lesions CTO TAVI Mitral valve replacement and repair Tricuspid / Pulmonary valve Acute heart failure Chronic heart failure Below the knee AAA Iliac / Femoral / Popliteal Renal artery angioplasty Renal denervation Carotid stenting LAA closure Ischaemic stroke

percutaneous coronary intervention diabetes bleeding DAPT high bleeding risk