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

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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Publication Details

Journal
EuroIntervention
Published
2024-12-30
DOI
https://doi.org/10.4244/eij-d-24-00657
Citations
7
Primary Topic
Coronary Interventions and Diagnostics
Type
article
Field-Weighted Citation Impact
4.01

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article

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

Paolo Calabrò, Antonella Faretra, Domenico Angellotti, Enrico Russolillo et al.
7 citations
EuroIntervention
Coronary Interventions and Diagnostics
4.01
article

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

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

Abstract

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.

EuroInterventionVol. 21(1)
University of Bern (CH), University of Salerno (IT), University of Padua (IT), University of Ferrara (IT), University of Pavia (IT), Cork University Hospital (IE), University of Catania (IT), Ospedale Antonio Cardarelli (IT), Azienda Ospedaliera S.Giuseppe Moscati (IT), Ospedale Santa Maria (IT), Ospedale San Giovanni Bosco (IT), Policlinico Universitario di Catania (IT), Ospedali Riuniti San Giovanni di Dio e Ruggi d'Aragona (IT), Deutsches Herzzentrum München (DE), Policlinico San Matteo Fondazione (IT), Azienda Ospedaliera Carlo Poma (IT), Technical University of Munich (DE), University of Naples Federico II (IT)
Università degli Studi di Napoli Federico II, Regione Campania, Università degli Studi di Salerno, Dipartimento di Scienze Biomediche Avanzate, Università degli Studi di Napoli Federico II
Openalex Percentile: Top 5%
Coronary Interventions and Diagnostics
4.01
DOIOpen Access PDFOpenAlex
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