TY - JOUR
T1 - 3-Year Clinical Outcomes After Implantation of Permanent-Polymer Versus Polymer-Free Stent
T2 - ReCre8 Landmark Analysis
AU - van Hemert, Nicole D.
AU - Voskuil, Michiel
AU - Rozemeijer, Rik
AU - Stein, Mèra
AU - Frambach, Peter
AU - Pereira, Bruno
AU - Rittersma, Saskia Z.
AU - Kraaijeveld, Adriaan O.
AU - Leenders, Geert E.H.
AU - Timmers, Leo
AU - van der Harst, Pim
AU - Agostoni, Pierfrancesco
AU - Stella, Pieter R.
N1 - Funding Information:
The authors thank all involved research and clinical personnel who contributed to the successful execution of this trial. The authors would like to give special thanks to Yvonne Breuer, manager; Manon Kuikhoven, clinical research coordinator; Marlies van Doleweerd, clinical research coordinator; and Karen Vlaardingerbroek, clinical research coordinator, Department of Research and Development, University Medical Center Utrecht.
Publisher Copyright:
© 2021 American College of Cardiology Foundation
PY - 2021/11/22
Y1 - 2021/11/22
N2 - Objectives: The aim of this analysis was to assess long-term clinical outcomes of the polymer-free Amphilimus-eluting stent (PF-AES) compared with a latest generation permanent-polymer drug-eluting stent (DES) in an all-comers population. Background: PF-AES possess multiple properties improving targeted drug elution without the presence of polymers. Evaluation of long-term clinical performance of PF-AES versus latest generation permanent-polymer DES has not yet been performed in a large randomized trial introducing shortened dual-antiplatelet therapy. Methods: In this physician-initiated, multicenter, randomized, all-comers trial, patients undergoing percutaneous coronary intervention with implantation of DES were enrolled. Patients were stratified for diabetes and troponin status and randomized to implantation of a permanent-polymer zotarolimus-eluting stent (PP-ZES) or a PF-AES. Dual-antiplatelet therapy duration was 12 months in troponin-positive patients and 1 month in troponin-negative patients. A noninferiority analysis was conducted to compare the 2 arms regarding target lesion failure (TLF) between 1 and 3 years. Results: A total of 1,491 patients were randomized and treated. In this landmark analysis, between 1- and 3-year follow-up, TLF occurred in 35 patients (4.9%) in the PP-ZES arm and 37 PF-AES patients (5.1%). Clinical noninferiority of the PF-AES was confirmed, with a risk difference of 0.2% (upper limit 1-sided 95% CI: 2.2%; Pnoninferiority = 0.0031). Conclusions: ReCre8 (Randomized “All-Comer” Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent) is the first randomized, multicenter trial with a head-to-head comparison of PP-ZES compared with PF-AES to investigate clinical outcomes of these new-generation DES in an all-comers population with long-term follow-up. On the basis of the present results, PF-AES are clinically noninferior to PP-ZES regarding TLF between 1 and 3 years. (Randomized “All-Comer” Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent; NCT02328898)
AB - Objectives: The aim of this analysis was to assess long-term clinical outcomes of the polymer-free Amphilimus-eluting stent (PF-AES) compared with a latest generation permanent-polymer drug-eluting stent (DES) in an all-comers population. Background: PF-AES possess multiple properties improving targeted drug elution without the presence of polymers. Evaluation of long-term clinical performance of PF-AES versus latest generation permanent-polymer DES has not yet been performed in a large randomized trial introducing shortened dual-antiplatelet therapy. Methods: In this physician-initiated, multicenter, randomized, all-comers trial, patients undergoing percutaneous coronary intervention with implantation of DES were enrolled. Patients were stratified for diabetes and troponin status and randomized to implantation of a permanent-polymer zotarolimus-eluting stent (PP-ZES) or a PF-AES. Dual-antiplatelet therapy duration was 12 months in troponin-positive patients and 1 month in troponin-negative patients. A noninferiority analysis was conducted to compare the 2 arms regarding target lesion failure (TLF) between 1 and 3 years. Results: A total of 1,491 patients were randomized and treated. In this landmark analysis, between 1- and 3-year follow-up, TLF occurred in 35 patients (4.9%) in the PP-ZES arm and 37 PF-AES patients (5.1%). Clinical noninferiority of the PF-AES was confirmed, with a risk difference of 0.2% (upper limit 1-sided 95% CI: 2.2%; Pnoninferiority = 0.0031). Conclusions: ReCre8 (Randomized “All-Comer” Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent) is the first randomized, multicenter trial with a head-to-head comparison of PP-ZES compared with PF-AES to investigate clinical outcomes of these new-generation DES in an all-comers population with long-term follow-up. On the basis of the present results, PF-AES are clinically noninferior to PP-ZES regarding TLF between 1 and 3 years. (Randomized “All-Comer” Evaluation of a Permanent Polymer Resolute Integrity Stent Versus a Polymer Free Cre8 Stent; NCT02328898)
KW - coronary artery disease
KW - drug-eluting stent(s)
KW - percutaneous coronary intervention
KW - polymer-free
UR - http://www.scopus.com/inward/record.url?scp=85118572432&partnerID=8YFLogxK
U2 - 10.1016/j.jcin.2021.08.078
DO - 10.1016/j.jcin.2021.08.078
M3 - Article
AN - SCOPUS:85118572432
SN - 1936-8798
VL - 14
SP - 2477
EP - 2486
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 22
ER -