Rosaly A Buiten1, Eline H Ploumen1, Paolo Zocca1, Carine J M Doggen2, Peter W Danse3, Carl E Schotborgh4, Martijn Scholte5, K Gert van Houwelingen6, Martin G Stoel6, Marc Hartmann6, R Melvyn Tjon Joe Gin3, Samer Somi4, Gerard C M Linssen7, Marlies M Kok1, Clemens von Birgelen8. 1. Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands. 2. Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands. 3. Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands. 4. Department of Cardiology, Haga Hospital, The Hague, the Netherlands. 5. Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands. 6. Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands. 7. Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, the Netherlands. 8. Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands. Electronic address: c.vonbirgelen@mst.nl.
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.
RCT Entities:
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: Mahesh V Madhavan; James P Howard; Azim Naqvi; Ori Ben-Yehuda; Bjorn Redfors; Megha Prasad; Bahira Shahim; Martin B Leon; Sripal Bangalore; Gregg W Stone; Yousif Ahmad Journal: Eur Heart J Date: 2021-07-15 Impact factor: 29.983
Authors: Eline H Ploumen; Rosaly A Buiten; Marlies M Kok; Carine J M Doggen; K Gert van Houwelingen; Martin G Stoel; Frits H A F de Man; Marc Hartmann; Paolo Zocca; Gerard C M Linssen; Cees Doelman; Gert D Kant; Clemens von Birgelen Journal: Catheter Cardiovasc Interv Date: 2019-10-17 Impact factor: 2.692