Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent - 18/12/20

Doi : 10.1016/j.ahj.2020.09.019

Marco Valgimigli, MD, PhD ^a, Davide Cao, MD ^b, Rajendra R. Makkar, MD ^c, Sripal Bangalore, MD ^d, Deepak L. Bhatt, MD, MPH ^e, Dominick J. Angiolillo, MD, PhD ^f, Shigeru Saito, MD ^g, Junbo Ge, MD ^h, Franz-Josef Neumann, MD ⁱ, James Hermiller, MD ^j, Hector Picon, MD ^k, Ralph Toelg, MD ^l, Aziz Maksoud, MD ^m, Bassem M. Chehab, MD ⁿ, Lijuan Jenny Wang, PhD ^o, Jin Wang, PhD ^o, Roxana Mehran, MD ^b,^{^⁎}
^a Cardiocentro Ticino, Lugano and Bern University Hospital, Bern, Switzerland
^b Icahn School of Medicine at Mount Sinai, New York, NY
^c Cedars-Sinai Medical Center, Los Angeles, CA
^d New York University-Langone Medical Center, New York, NY
^e Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, MA
^f Division of Cardiology, University of Florida College of Medicine-Jacksonville, Jacksonville, FL
^g Shonan Kamakura General Hospital, Kamakura, Japan
^h Zhongshan Hospital Fudan University, Shanghai, China
ⁱ University Heart Center Freiburg, Bad Krozingen, Germany
^j St Vincent's Medical Center of Indiana, Indianapolis, IN
^k Redmond Regional Medical Center, Rome, GA
^l Segeberger Kliniken GmbH, Herzzentrum, Bad Segeberg, Germany
^m Kansas Heart Hospital, Wichita, KS
ⁿ Ascension Via Christi Hospital, University of Kansas, Wichita, KS
^o Abbott, Santa Clara, CA

^⁎Reprint Requests: Roxana Mehran, MD, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, NY,10029.The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount SinaiOne Gustave L. Levy Place, Box 1030New YorkNY10029

Background

Dual antiplatelet therapy (DAPT) is key for the prevention of recurrent ischemic events after percutaneous coronary intervention (PCI); however, it increases the risk of bleeding complications. While new generation drug-eluting stents have been shown superior to bare-metal stents after a short DAPT course, the optimal DAPT duration in patients at high bleeding risk (HBR) remains to be determined.

Trial design

The XIENCE Short DAPT program consists of three prospective, single-arm studies (XIENCE 90, XIENCE 28 Global and XIENCE 28 USA) investigating 3- or 1-month DAPT durations in HBR patients undergoing PCI with the XIENCE stent. The XIENCE 90 study is being conducted in the US and enrolled 2047 subjects who discontinued DAPT at 3 months if they were free from myocardial infarction (MI), repeat coronary revascularization, stroke, or stent thrombosis. The XIENCE 28 program includes the USA study, enrolling 642 patients in US and Canada, and the Global study, enrolling 963 patients in Europe and Asia. In XIENCE 28, patients were to discontinue DAPT at 1 month post-PCI if event-free. The primary hypothesis for both XIENCE 90 and XIENCE 28 is that a short DAPT regimen will be non-inferior to a conventional DAPT duration with respect to the composite of all-cause death or MI. Patients enrolled in the prospective multicenter post-market XIENCE V USA study will be used as historical control group in a stratified propensity-adjusted analysis.

Conclusions

The XIENCE Short DAPT Program will provide insights into the safety and efficacy of 2 abbreviated DAPT regimens of 3- and 1-month duration in a large cohort of HBR patients undergoing PCI with the XIENCE stent.

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Plan

Rationale for a short DAPT program

XIENCE family stent system

Study design and methods

Study design

Study objective

Study population and eligibility

Study procedures and follow-up

Study endpoints

Control group

Statistical analysis plan

Subgroup analyses

Study limitations

Conclusions

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Vol 231

P. 147-156 - janvier 2021 Retour au numéro

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Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent - 18/12/20

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