Thin, Very Thin, or Ultrathin Strut Biodegradable or Durable Polymer-Coated Drug-Eluting Stents: 3-Year Outcomes of BIO-RESORT.
JACC Cardiovasc Interv
; 12(17): 1650-1660, 2019 09 09.
Article
in En
| MEDLINE
| ID: mdl-31422087
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.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Polymers
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Coronary Artery Disease
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Cardiovascular Agents
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Sirolimus
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Absorbable Implants
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Drug-Eluting Stents
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Percutaneous Coronary Intervention
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Everolimus
Type of study:
Clinical_trials
/
Etiology_studies
Limits:
Aged
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Female
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Humans
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Male
/
Middle aged
Country/Region as subject:
Europa
Language:
En
Year:
2019
Type:
Article