Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents: 3-Year Outcomes of BIO-RESORT.

Abstract

OBJECTIVES:

The aim of this study was to assess the 3-year safety and efficacy of treating all-comer patients with 3 contemporary drug-eluting stents (DES).

BACKGROUND:

The BIO-RESORT (Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population) (TWENTE III) randomized trial (NCT01674803) found similar 1-year safety and efficacy for the 2 biodegradable-polymer DES (i.e., ultrathin-strut cobalt-chromium Orsiro sirolimus-eluting stent [SES] and very-thin-strut platinum-chromium Synergy everolimus-eluting stent) compared with the durable-polymer thin-strut cobalt-chromium Resolute Integrity zotarolimus-eluting stent (ZES). Two-year follow-up suggested that the SES might reduce repeat revascularizations beyond 1 year compared with the ZES.

METHODS:

A total of 3,514 all-comer patients were treated at 4 centers for coronary intervention. The main clinical endpoint, target vessel failure, was a composite of safety (cardiac death or target vessel-related myocardial infarction) and efficacy (target vessel revascularization). Secondary endpoints included the individual components of target vessel failure and stent thrombosis.

RESULTS:

Three-year follow-up data were available for 3,393 of 3,514 patients (96.6%). Target vessel failure occurred in 8.5% with SES and 10.0% with ZES (plog rank = 0.22) and in 8.8% with everolimus-eluting stents (vs. ZES, plog rank = 0.32). Rates of cardiac death, target vessel myocardial infarction, and target vessel revascularization were similar between stent groups. Landmark analyses found no statistically significant between-stent difference in repeat revascularization between 1 and 3 years. Definite or probable stent thrombosis rates were low (SES, 1.1%; everolimus-eluting stent, 1.1%; ZES, 0.9%) and similar with all 3 DES.

CONCLUSIONS:

Despite substantial differences in stent backbone and polymer coating, all 3 DES showed favorable 3-year safety and efficacy in all comers, without significant between-stent differences. Further follow-up is required to definitely answer the question of whether one stent might improve clinical outcomes at a later stage.

• Authors: Rosaly A Buiten, Eline H Ploumen, Paolo Zocca, Carine J M Doggen, Peter W Danse, Carl E Schotborgh, Martijn Scholte, K Gert van Houwelingen, Martin G Stoel, Marc Hartmann, R Melvyn Tjon Joe Gin, Samer Somi, Gerard C M Linssen, Marlies M Kok, Clemens von Birgelen
• Journal: JACC. Cardiovascular interventions (JACC Cardiovasc Interv) Vol. 12 Issue 17 Pg. 1650-1660 (09 09 2019) ISSN: 1876-7605 [Electronic] United States
• PMID: 31422087 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Chemical References

• Cardiovascular Agents
• Polymers
• Everolimus
• zotarolimus
• Sirolimus

Topics

• Absorbable Implants
• Aged
• Cardiovascular Agents (administration & dosage, adverse effects)
• Coronary Artery Disease (diagnostic imaging, mortality, therapy)
• Coronary Thrombosis (etiology)
• Drug-Eluting Stents
• Everolimus (administration & dosage, adverse effects)
• Female
• Humans
• Male
• Middle Aged
• Netherlands
• Percutaneous Coronary Intervention (adverse effects, instrumentation, mortality)
• Polymers (chemistry)
• Prosthesis Design
• Risk Factors
• Sirolimus (administration & dosage, adverse effects, analogs & derivatives)
• Time Factors
• Treatment Outcome