Author + information
- Received April 17, 2020
- Revision received May 19, 2020
- Accepted June 9, 2020
- Published online October 5, 2020.
- Norihiro Kogame, MDa,b,
- Patricia O. Guimarães, MD, PhDc,
- Rodrigo Modolo, MDa,d,
- Fernando De Martino, MD, PhDe,
- Joao Tinoco, MDf,
- Expedito E. Ribeiro, MD, PhDc,
- Hideyuki Kawashima, MDa,
- Masafumi Ono, MDa,
- Hironori Hara, MDa,
- Rutao Wang, MDg,
- Rafael Cavalcante, MD, PhDh,
- Bruno Moulin, MDi,
- Breno A.A. Falcão, MDj,
- Rogerio S. Leite, MD, PhDk,
- Fernanda Barbosa de Almeida Sampaio, MDl,
- Gustavo R. Morais, MDm,
- George C. Meireles, MDn,
- Carlos M. Campos, MD, PhDc,o,
- Yoshinobu Onuma, MD, PhDp,
- Patrick W. Serruys, MD, PhDp,q,∗∗ ( and )
- Pedro A. Lemos, MD, PhDc,o,∗ ()
- aDepartment of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands
- bDepartment of Cardiology, Toho University Medical Center Ohashi Hospital, Tokyo, Japan
- cHeart Institute – InCor, University of São Paulo, São Paulo, Brazil
- dDepartment of Internal Medicine, Cardiology Division, University of Campinas, Campinas, Brazil
- eDepartment of Internal Medicine, Discipline of Cardiology, University of Triangulo Mineiro, Uberaba, Brazil
- fInstituto Cardiovascular de Linhares LTDA – UNICOR, Linhares, Brazil
- gDepartment of Cardiology, Radboud University, Nijmegen, the Netherlands
- hBoston Scientific, Marlborough, Massachusetts
- iAssociação Evangélica Beneficiente Espírito Santense, Vila Velha, Brazil
- jHospital Dr. Carlos Alberto Studart Gomes de Messejana, Fortaleza, Brazil
- kInstituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia, Porto Alegre, Brazil
- lInstituto Nacional de Cardiologia, Rio de Janeiro, Brazil
- mHospital Nossa Senhora das Neves, João Pessoa, Brazil
- nHospital do Servidor Público Estadual – IAMSPE, São Paulo, Brazil
- oHospital Israelita Albert Einstein, São Paulo, Brazil
- pDepartment of Cardiology, National University of Ireland Galway, Galway, Ireland
- qImperial College London, London, United Kingdom
Objectives The aim of this study was to evaluate the hypothesis that prasugrel monotherapy following successful everolimus-eluting stent implantation is feasible and safe in patients with stable coronary artery disease (CAD).
Background Recent studies have suggested that short dual-antiplatelet therapy strategies may provide an adequate balance between ischemic and bleeding risks. However, the complete omission of aspirin immediately after percutaneous coronary intervention (PCI) has not been tested so far.
Methods The study was a multicenter, single-arm, open-label trial with a stopping rule based on the occurrence of definite stent thrombosis (if >3, trial enrollment would be terminated). Patients undergoing successful everolimus-eluting stent implantation for stable CAD with SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) scores <23 were included. All participants were on standard dual-antiplatelet therapy at the time of index PCI. Aspirin was discontinued on the day of the index procedure but given prior to the procedure; prasugrel was administered in the catheterization laboratory immediately after the successful procedure, and aspirin-free prasugrel became the therapy regimen from that moment. Patients were treated solely with prasugrel for 3 months. The primary ischemic endpoint was the composite of cardiac death, spontaneous target vessel myocardial infarction, or definite stent thrombosis, and the primary bleeding endpoint was Bleeding Academic Research Consortium types 3 and 5 bleeding up to 3 months.
Results From February 22, 2018, to May 7, 2019, 201 patients were enrolled. All patients underwent PCI for stable CAD. Overall, 98.5% of patients were adherent to prasugrel at 3-month follow-up. The primary ischemic and bleeding endpoints occurred in 1 patient (0.5%). No stent thrombosis events occurred.
Conclusions Aspirin-free prasugrel monotherapy following successful everolimus-eluting stent implantation demonstrated feasibility and safety without any stent thrombosis in selected low-risk patients with stable CAD. These findings may help underpin larger randomized controlled studies to evaluate the aspirin-free strategy compared with traditional dual-antiplatelet therapy following PCI. (Acetyl Salicylic Elimination Trial: The ASET Pilot Study [ASET]; NCT03469856)
This trial is an investigator-initiated trial. The academic research organization InCor in São Paulo was responsible for site management and monitoring. This trial was supported by grants from Boston Scientific and Daiichi-Sankyo. Dr. Cavalcante is an employee of Boston Scientific. Dr. Serruys has received personal fees from Sino Medical Sciences Technology, Philips/Volcano, and Xeltis outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received April 17, 2020.
- Revision received May 19, 2020.
- Accepted June 9, 2020.
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