Norihiro Kogame1, Patricia O Guimarães2, Rodrigo Modolo3, Fernando De Martino4, Joao Tinoco5, Expedito E Ribeiro2, Hideyuki Kawashima6, Masafumi Ono6, Hironori Hara6, Rutao Wang7, Rafael Cavalcante8, Bruno Moulin9, Breno A A Falcão10, Rogerio S Leite11, Fernanda Barbosa de Almeida Sampaio12, Gustavo R Morais13, George C Meireles14, Carlos M Campos15, Yoshinobu Onuma16, Patrick W Serruys17, Pedro A Lemos18. 1. Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands; Department of Cardiology, Toho University Medical Center Ohashi Hospital, Tokyo, Japan. 2. Heart Institute - InCor, University of São Paulo, São Paulo, Brazil. 3. Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division, University of Campinas, Campinas, Brazil. 4. Department of Internal Medicine, Discipline of Cardiology, University of Triangulo Mineiro, Uberaba, Brazil. 5. Instituto Cardiovascular de Linhares LTDA - UNICOR, Linhares, Brazil. 6. Department of Cardiology, Amsterdam University Medical Center, Amsterdam, the Netherlands. 7. Department of Cardiology, Radboud University, Nijmegen, the Netherlands. 8. Boston Scientific, Marlborough, Massachusetts. 9. Associação Evangélica Beneficiente Espírito Santense, Vila Velha, Brazil. 10. Hospital Dr. Carlos Alberto Studart Gomes de Messejana, Fortaleza, Brazil. 11. Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia, Porto Alegre, Brazil. 12. Instituto Nacional de Cardiologia, Rio de Janeiro, Brazil. 13. Hospital Nossa Senhora das Neves, João Pessoa, Brazil. 14. Hospital do Servidor Público Estadual - IAMSPE, São Paulo, Brazil. 15. Heart Institute - InCor, University of São Paulo, São Paulo, Brazil; Hospital Israelita Albert Einstein, São Paulo, Brazil. 16. Department of Cardiology, National University of Ireland Galway, Galway, Ireland. 17. Department of Cardiology, National University of Ireland Galway, Galway, Ireland; Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com. 18. Heart Institute - InCor, University of São Paulo, São Paulo, Brazil; Hospital Israelita Albert Einstein, São Paulo, Brazil. Electronic address: pedro.lemos@atscien.com.
Abstract
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).
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).
Authors: Davide Capodanno; Usman Baber; Deepak L Bhatt; Jean-Philippe Collet; George Dangas; Francesco Franchi; C Michael Gibson; Hyeon-Cheol Gwon; Adnan Kastrati; Takeshi Kimura; Pedro A Lemos; Renato D Lopes; Roxana Mehran; Michelle L O'Donoghue; Sunil V Rao; Fabiana Rollini; Patrick W Serruys; Philippe G Steg; Robert F Storey; Marco Valgimigli; Pascal Vranckx; Hirotoshi Watanabe; Stephan Windecker; Dominick J Angiolillo Journal: Nat Rev Cardiol Date: 2022-06-13 Impact factor: 32.419
Authors: Thiago Guarato Rodrigues Costa; Marcelo Katz; Pedro Alves Lemos Neto; João Carlos de Campos Guerra; Marcelo Franken; Antonio Eduardo Pereira Pesaro Journal: Einstein (Sao Paulo) Date: 2022-06-01
Authors: Amr S Gamal; Hironori Hara; Mariusz Tomaniak; Mattia Lunardi; Chao Gao; Masafumi Ono; Hideyuki Kawashima; Peter Jüni; Pascal Vranckx; Stephan Windecker; Christian Hamm; Philippe Gabriel Steg; Yoshinobu Onuma; Patrick W Serruys Journal: Eur Heart J Acute Cardiovasc Care Date: 2021-10-01