Author + information
- Received January 25, 2019
- Revision received March 27, 2019
- Accepted April 9, 2019
- Published online September 2, 2019.
- Rosaly A. Buiten, MDa,b,∗,
- Eline H. Ploumen, MDa,b,∗,
- Paolo Zocca, MDa,b,
- Carine J.M. Doggen, PhDb,
- Peter W. Danse, MD, PhDc,
- Carl E. Schotborgh, MDd,
- Martijn Scholte, MDe,
- K. Gert van Houwelingen, MDa,
- Martin G. Stoel, MD, PhDa,
- Marc Hartmann, MD, PhDa,
- R. Melvyn Tjon Joe Gin, MDc,
- Samer Somi, MD, PhDd,
- Gerard C.M. Linssen, MD, PhDf,
- Marlies M. Kok, MD, PhDa,b and
- Clemens von Birgelen, MD, PhDa,b,∗ ()
- aDepartment of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands
- bDepartment of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands
- cDepartment of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands
- dDepartment of Cardiology, Haga Hospital, The Hague, the Netherlands
- eDepartment of Cardiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands
- fDepartment of Cardiology, Hospital Group Twente, Almelo and Hengelo, the Netherlands
- ↵∗Address for correspondence:
Dr. Clemens von Birgelen, Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Koningsplein 1, 7512 KZ Enschede, the Netherlands.
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.
↵∗ Drs. Buiten and Ploumen contributed equally to this paper.
The BIO-RESORT trial was funded equally by Biotronik, Boston Scientific, and Medtronic. Dr. von Birgelen has reported that the research department of Thoraxcentrum Twente has received research grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 25, 2019.
- Revision received March 27, 2019.
- Accepted April 9, 2019.
- 2019 American College of Cardiology Foundation
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