Raffaele Piccolo; Paolo Calabrò; Greta Carrara; Attilio Varricchio; Cesare Baldi; Giovanni Napolitano; Ciro De Simone; Ciro Mauro; Eugenio Stabile; Gianluca Caiazzo; Tullio Tesorio; Marco Boccalatte; Bernardino Tuccillo; Plinio Cirillo; Luigi Di Serafino; Fiorenzo Simonetti; Attilio Leone; Domenico Angellotti; Giuseppe Bottiglieri; Enrico Russolillo; Gennaro Galasso; Rocco Perrotta; Arturo Cesaro; Tullio Niglio; Michele Capasso; Alessandra Spinelli; Stefano Cristiano; Antonella Faretra; Dario Bruzzese; Alaide Chieffo; Giuseppe Tarantini; Sergio Leonardi; Simone Biscaglia; Francesco Costa; Salvatore Cassese; Eugene McFadden; Dik Heg; Anna Franzone; Giulio Stefanini; Davide Capodanno; Giovanni Esposito; for PARTHENOPE investigators

doi:10.4244/EIJ-D-24-00657

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

The reference multimedia journal in interventional cardiology

Original Research

DOI: 10.4244/EIJ-D-24-00657

Polymer-free versus biodegradable-polymer drug-eluting stent in patients undergoing percutaneous coronary intervention: an assessor-blind, non-inferiority, randomised controlled trial

Raffaele Piccolo¹, MD, PhD; Paolo Calabrò², MD, PhD; Greta Carrara³, Stat; Attilio Varricchio⁴, MD; Cesare Baldi⁵, MD; Giovanni Napolitano⁶, MD; Ciro De Simone⁷, MD; Ciro Mauro⁸, MD; Eugenio Stabile⁹, MD, PhD; Gianluca Caiazzo¹⁰, MD, PhD; Tullio Tesorio¹¹, MD; Marco Boccalatte¹², MD; Bernardino Tuccillo¹³, MD; Plinio Cirillo¹, MD, PhD; Luigi Di Serafino¹, MD, PhD; Fiorenzo Simonetti¹, MD; Attilio Leone¹, MD; Domenico Angellotti¹, MD; Giuseppe Bottiglieri¹⁴, MD; Enrico Russolillo¹⁵, MD, PhD; Gennaro Galasso¹⁶, MD, PhD; Rocco Perrotta¹⁷, MD; Arturo Cesaro², MD, PhD; Tullio Niglio⁴, MD; Michele Capasso¹⁸, MD; Alessandra Spinelli¹, MSc; Stefano Cristiano¹, MSc; Antonella Faretra¹, RN; Dario Bruzzese¹⁹, MD, PhD; Alaide Chieffo²⁰, MD, PhD; Giuseppe Tarantini²¹, MD, PhD; Sergio Leonardi²², MD, PhD; Simone Biscaglia²³, MD, PhD; Francesco Costa²⁴, MD, PhD; Salvatore Cassese²⁵, MD, PhD; Eugene McFadden²⁶, MD; Dik Heg²⁷, PhD; Anna Franzone¹, MD, PhD; Giulio G. Stefanini²⁸, MD, PhD; Davide Capodanno²⁹, MD, PhD; Giovanni Esposito¹, MD, PhD; for the PARTHENOPE investigators

1. Department of Advanced Biomedical Sciences, University of Naples “Federico II”, Naples, Italy; 2. Department of Translational Medical Sciences, University of Campania “Luigi Vanvitelli”, Caserta, Italy and Division of Cardiology, A.O.R.N. “Sant’Anna e San Sebastiano”, Caserta, Italy; 3. Advice Pharma Group, Milan, Italy; 4. P.O.S. Anna e SS. Madonna della Neve di Boscotrecase, Ospedali Riuniti Area Vesuviana, Naples, Italy; 5. Division of Interventional Cardiology, Cardiovascular and Thoracic Department, San Giovanni di Dio e Ruggi, Salerno, Italy; 6. Division of Cardiology, “San Giuliano” Hospital of Giugliano in Campania, ASL Napoli2 Nord, Giugliano in Campania, Italy; 7. Division of Cardiology, Clinica Villa Dei Fiori, Acerra, Italy; 8. Division of Cardiology, Antonio Cardarelli Hospital, Naples, Italy; 9. Division of Cardiology, Azienda Ospedaliera Regionale “San Carlo”, Potenza, Italy; 10. Division of Cardiology, San Giuseppe Moscati Hospital, Aversa, Italy; 11. Department of Invasive Cardiology, Clinica Montevergine, Mercogliano, Italy; 12. Division of Cardiology, Ospedale Santa Maria delle Grazie, Pozzuoli, Italy; 13. Department of Cardiology, Ospedale del Mare, Naples, Italy; 14. Division of Cardiology, Presidio Ospedaliero di Eboli, Eboli, Italy; 15. Division of Cardiology, Ospedale San Giovanni Bosco, Naples, Italy; 16. Department of Medicine, Surgery and Dentistry, University of Salerno, Baronissi, Salerno, Italy; 17. Division of Interventional Cardiology, A.O.R.N. Sant’Anna e San Sebastiano, Caserta, Italy; 18. Division of Cardiology, Ospedale di Nola, Nola, Italy; 19. Department of Public Health, University of Naples “Federico II”, Naples, Italy; 20. IRCCS San Raffaele Scientific Institute, Milan, Italy and Vita-Salute San Raffaele University, Milan, Italy; 21. Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy; 22. Department of Molecular Medicine, University of Pavia, Pavia, Italy and Division of Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy; 23. Department of Cardiology, University of Ferrara, Ferrara, Italy; 24. Department of Biomedical and Dental Sciences and Morphological and Functional Imaging, University of Messina, Messina, Italy and A.O.U. Policlinico “G. Martino”, Messina, Italy; 25. Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; 26. Interventional Cardiology, Cork University Hospital, Cork, Ireland; 27. CTU Bern, University of Bern, Bern, Switzerland; 28. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy and Cardio Center, IRCCS Humanitas Research Hospital, Rozzano, Italy; 29. Division of Cardiology, Azienda Ospedaliero Universitaria Policlinico “G. Rodolico-San Marco”, University of Catania, Catania, Italy

Abstract

Background: Few data are available on polymer-free drug-eluting stents in patients undergoing percutaneous coronary intervention (PCI).

Aims: We aimed to determine the efficacy and safety of a polymer-free amphilimus-eluting stent (AES), using a reservoir-based technology for drug delivery, compared with a biodegradable-polymer everolimus-eluting stent (EES).

Methods: This was a randomised, investigator-initiated, assessor-blind, non-inferiority trial conducted at 14 hospitals in Italy (ClinicalTrials.gov: NCT04135989). All-comer patients undergoing PCI were randomly assigned to either polymer-free AES or biodegradable-polymer EES. The primary endpoint was a device-oriented composite endpoint, including cardiovascular death, target vessel myocardial infarction, or target lesion revascularisation at 1-year follow-up.

Results: Between January 2020 and June 2022, a total of 2,107 patients with 3,042 coronary lesions were randomised to polymer-free AES (1,051 patients) or biodegradable-polymer EES (1,056 patients). At 1-year follow-up, the primary endpoint occurred in 86 (8.2%) patients randomised to polymer-free AES and 76 (7.2%) patients randomised to biodegradable-polymer EES (risk difference 1%, upper limit of the 1-sided 95% confidence interval [CI] of 2.9%; p for non-inferiority=0.041). There were no significant differences in the incidence of the components of the primary endpoint between groups. However, definite or probable stent thrombosis occurred more frequently in patients randomised to polymer-free stents (1.0% vs 0.3%; hazard ratio 3.72, 95% CI: 1.04-13.33; p=0.044) due to an increased risk of early stent thrombosis within 30 day

Conclusions: In all-comer patients undergoing PCI, polymer-free AES were non-inferior to biodegradable-polymer EES at 1-year follow-up in terms of a device-oriented composite endpoint despite being associated with an increased risk of early stent thrombosis.

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