Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Jan 6;21(1):58-72.
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 Piccolo  1 , Paolo Calabrò  2 , Greta Carrara  3 , Attilio Varricchio  4 , Cesare Baldi  5 , Giovanni Napolitano  6 , Ciro De Simone  7 , Ciro Mauro  8 , Eugenio Stabile  9 , Gianluca Caiazzo  10 , Tullio Tesorio  11 , Marco Boccalatte  12 , Bernardino Tuccillo  13 , Plinio Cirillo  1 , Luigi Di Serafino  1 , Fiorenzo Simonetti  1 , Attilio Leone  1 , Domenico Angellotti  1 , Giuseppe Bottiglieri  14 , Enrico Russolillo  15 , Gennaro Galasso  16 , Rocco Perrotta  17 , Arturo Cesaro  2 , Tullio Niglio  4 , Michele Capasso  18 , Alessandra Spinelli  1 , Stefano Cristiano  1 , Antonella Faretra  1 , Dario Bruzzese  19 , Alaide Chieffo  20 , Giuseppe Tarantini  21 , Sergio Leonardi  22 , Simone Biscaglia  23 , Francesco Costa  24 , Salvatore Cassese  25 , Eugene McFadden  26 , Dik Heg  27 , Anna Franzone  1 , Giulio G Stefanini  28 , Davide Capodanno  29 , Giovanni Esposito  1 , For The Parthenope Investigators
Affiliations
Clinical Trial

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

Raffaele Piccolo et al. EuroIntervention. .

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.

PubMed Disclaimer

Conflict of interest statement

R. Piccolo reports personal fees from Biotronik, Amarin, Abiomed, and Medtronic, outside the submitted work. A. Chieffo reports speaker and/or consultation fees from Abiomed, Boston Scientific, Biosensors, Menarini, Medtronic, and Shockwave Medical, outside the submitted work. G. Tarantini reports lecture fees from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and Abiomed, outside the submitted work. S. Leonardi reports grants and personal fees from AstraZeneca; and has received personal fees from Daiichi Sankyo, Bayer, Pfizer/Bristol-Myers Squibb, ICON, Chiesi, and Novo Nordisk, outside the submitted work. S. Biscaglia reports grant/contract from Eukon, GE HealthCare, Insight Lifetech, Medis Medical Imaging Systems, Sahajanand Medical Technologies Ltd., and Siemens, outside the submitted work. F. Costa reports personal fees from Chiesi Farmaceutici and AstraZeneca, outside the submitted work. F. Simonetti and D. Angellotti received a research grant from the CardioPath programme at Federico II University of Naples, Italy. E. McFadden reports personal fees and consultancy fees from Abbott and Biosensors, outside the submitted work. D. Capodanno reports speaker or consulting fees from Amgen, Arena, Chiesi, Daiichi Sankyo, Novo Nordisk, Sanofi, and Terumo; and institutional fees from Medtronic, outside the submitted work. G. Esposito reports personal fees from Amgen, Boehringer Ingelheim, Edwards Lifesciences, Novartis, Amarin, and Sanofi, outside the submitted work; and research grants to the institution from Alvimedica, Boston Scientific, and Medtronic, outside the submitted work. The other authors have no conflicts of interest to declare. The Guest Editor reports consultancy fees from Novartis and Meril Life Sciences; speaker honoraria from Boston Scientific, Amgen, Daiichi Sankyo and Meril Life Sciences; reports speaker honoraria paid to his institution from BMS/Pfizer, Daiichi Sankyo, Boston Scientific, Siemens, and Amgen; and research grants paid to his institution from Boston Scientific and Abbott.

References

    1. Piccolo R, Bonaa KH, Efthimiou O, Varenne O, Baldo A, Urban P, Kaiser C, Remkes W, Räber L, de Belder, van ‘t, Stankovic G, Lemos PA, Wilsgaard T, Reifart J, Rodriguez AE, Ribeiro EE, Serruys PWJC, Abizaid A, Sabaté M, Byrne RA, de la, Wijns W, Jüni P, Windecker S, Valgimigli M Coronary Stent Trialists’ Collaboration. Drug-eluting or bare-metal stents for percutaneous coronary intervention: a systematic review and individual patient data meta-analysis of randomised clinical trials. Lancet. 2019;393:2503–10. - PubMed
    1. Wilson GJ, Nakazawa G, Schwartz RS, Huibregtse B, Poff B, Herbst TJ, Baim DS, Virmani R. Comparison of inflammatory response after implantation of sirolimus- and paclitaxel-eluting stents in porcine coronary arteries. Circulation. 2009;120:141–9, 1-2. - PubMed
    1. Piccolo R, Franzone A, Windecker S. From bare metal to barely anything: an update on coronary stenting. Heart. 2018;104:533–40. - PubMed
    1. Kufner S, Ernst M, Cassese S, Joner M, Mayer K, Colleran R, Koppara T, Xhepa E, Koch T, Wiebe J, Ibrahim T, Fusaro M, Laugwitz KL, Schunkert H, Kastrati A, Byrne RA ISAR-TEST-5 Investigators. 10-Year Outcomes From a Randomized Trial of Polymer-Free Versus Durable Polymer Drug-Eluting Coronary Stents. J Am Coll Cardiol. 2020;76:146–58. - PubMed
    1. Rozemeijer R, Stein M, Voskuil M, van den, Frambach P, Pereira B, Koudstaal S, Leenders GE, Timmers L, Rittersma SZ, Kraaijeveld AO, Agostoni P, Roes KC, Doevendans PA, Stella PR ReCre8 Study Investigators. Randomized All-Comers Evaluation of a Permanent Polymer Zotarolimus-Eluting Stent Versus a Polymer-Free Amphilimus-Eluting Stent. Circulation. 2019;139:67–77. - PubMed

Associated data