Three contemporary thin-strut drug-eluting stents implanted in severely calcified coronary lesions of participants in a randomized all-comers trial

Rosaly A Buiten, Eline H Ploumen, Paolo Zocca, Carine J M Doggen, K Gert van Houwelingen, Peter W Danse, Carl E Schotborgh, Martin G Stoel, Martijn Scholte, Gerard C M Linssen, Frits H A F de Man, Clemens von Birgelen, Rosaly A Buiten, Eline H Ploumen, Paolo Zocca, Carine J M Doggen, K Gert van Houwelingen, Peter W Danse, Carl E Schotborgh, Martin G Stoel, Martijn Scholte, Gerard C M Linssen, Frits H A F de Man, Clemens von Birgelen

Abstract

Objective: The objective was to assess the 2-year clinical performance of three drug-eluting stents in all-comer patients with severely calcified coronary lesions.

Background: Severe lesion calcification increases cardiovascular event risk after coronary stenting, but there is a lack of data on the clinical outcome of all-comers with severely calcified lesions who were treated with more recently introduced drug-eluting stents.

Methods: The BIO-RESORT trial (clinicaltrials.gov: NCT01674803) randomly assigned 3,514 all-comer patients to biodegradable polymer Synergy everolimus-eluting stents (EES) or Orsiro sirolimus-eluting stents (SES), versus durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). In a post hoc analysis, we assessed 783 patients (22.3%) with at least one severely calcified target lesion.

Results: At 2-year follow-up (available in 99% of patients), the main composite endpoint target vessel failure occurred in 19/252 (7.6%) of the EES and in 33/265 (12.6%) of the ZES-treated patients (p = .07). Target vessel failure occurred in 24/266 (9.1%) of the SES-treated patients (vs. ZES: p = .21). There was a difference in target vessel revascularization, which was required in EES in 6/252 (2.4%) patients and in ZES in 20/265 (7.7%) patients (p = .01); the target vessel revascularization rate in SES was 9/266 (3.4%, vs. ZES: p = .04). Multivariate analysis showed that implantation of EES, but not SES, was independently associated with lower target vessel revascularization rates than in ZES.

Conclusions: In BIO-RESORT participants with severely calcified target lesions, treatment with EES was associated with a lower 2-year target vessel revascularization rate than treatment with ZES.

Keywords: calcified stenosis; clinical trial; coronary stents; percutaneous coronary intervention.

Conflict of interest statement

CvB reports that the research department of Thoraxcentrum Twente has received institutional research grants provided by Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. All other authors declared that they have no conflict of interest. The present substudy received no additional financial support. The investigator‐initiated BIO‐RESORT trial was equally funded by Biotronik, Boston Scientific, and Medtronic.

© 2020 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals, Inc.

Figures

FIGURE 1
FIGURE 1
Study flow diagram. *Total number of patients treated with drug‐eluting stents during enrolment period, irrespective of study eligibility. EES, everolimus‐eluting stents; SES, sirolimus‐eluting stents; ZES, zotarolimus‐eluting stents
FIGURE 2
FIGURE 2
Kaplan–Meier cumulative event curves for target vessel failure and its individual components at 2‐year follow‐up. Target vessel failure (a), a composite of cardiac death (b), target vessel‐related myocardial infarction (c), or clinically indicated target vessel revascularization (d). HR, hazard ratio; MI, myocardial infarction; ZES, zotarolimus‐eluting stents

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Source: PubMed

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