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Original Investigation
May 21, 2019

Outcomes in Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels: A Prespecified Analysis of the Randomized BIO-RESORT Trial

Author Affiliations
  • 1Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands
  • 2Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands
  • 3Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands
  • 4Department of Cardiology, Haga Hospital, The Hague, the Netherlands
  • 5Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands
  • 6Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, the Netherlands
JAMA Cardiol. Published online May 21, 2019. doi:10.1001/jamacardio.2019.1776
Key Points

Question  Are very thin- or ultrathin-strut drug-eluting stents associated with reduced adverse cardiovascular events in all-comer patients with lesions in small coronary vessels?

Findings  In this small-vessel substudy including 1506 participants of the 3-arm randomized BIO-RESORT trial, patients experienced fewer repeated target lesion revascularizations within 3 years after treatment with ultrathin-strut sirolimus-eluting stents (2.1%) vs previous-generation thin-strut zotarolimus-eluting stents (5.3%).

Meaning  In small-vessel lesions, the implantation of the ultrathin-strut sirolimus-eluting stent that is examined in the BIO-RESORT trial may reduce the need for repeated revascularization.

Abstract

Importance  Stenting small-vessel lesions has an increased adverse cardiovascular event risk. Very thin-strut or ultrathin-strut drug-eluting stents might reduce this risk, but data are scarce.

Objective  To assess the outcome of all-comer patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents.

Design  This is a prespecified substudy of the Comparison of Biodegradable Polymer and Durable Polymer Drug-eluting Stents in an All Comers Population (BIO-RESORT) trial, an investigator-initiated, randomized, patient-blinded comparative clinical drug-eluting stent trial. Patients treated with ultrathin-strut sirolimus-eluting stents, very thin-strut everolimus-eluting stents, or previous-generation thin-strut zotarolimus-eluting stents were enrolled from December 2012 to August 2015. This multicenter trial was conducted in 4 Dutch centers for cardiac intervention. Of all 3514 all-comer BIO-RESORT participants, 1506 patients with treatment in at least 1 small-vessel lesion (reference vessel <2.5 mm) were included. Data were analyzed between September 2018 and February 2019.

Main Outcomes and Measures  Target lesion failure at 3-year follow-up, a composite of cardiac death, target vessel–related myocardial infarction, or target lesion revascularization, analyzed by Kaplan-Meier methods.

Results  In 1452 of 1506 participants (96.4%) (1057 men [70.2%]; 449 women [29.8%]; mean [SD] age, 64.3 [10.4] years), follow-up was available. Target lesion failure occurred in 36 of 525 patients (7.0%) treated with sirolimus-eluting stents, 46 of 496 (9.5%) with everolimus-eluting stents, and 48 of 485 (10.0%) with zotarolimus-eluting stents (sirolimus-eluting vs zotarolimus-eluting hazard ratio [HR], 0.68; 95% CI, 0.44-1.05; P = .08; everolimus-eluting vs zotarolimus-eluting HR, 0.93; 95% CI, 0.62-1.39; P = .72). There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02). In the everolimus-eluting stents, the revascularization rate was 4.0% (vs zotarolimus-eluting, HR, 0.74; 95% CI, 0.41-1.34; P = .31). There was no significant between-stent difference in cardiac death, target vessel myocardial infarction, or stent thrombosis.

Conclusions and Relevance  Patients stented in small coronary vessels experienced fewer repeated revascularizations if treated with ultrathin-strut sirolimus-eluting stents vs previous generation thin strut zotarolimus-eluting stents. Further research is required to evaluate the potential effect of particularly thin stent struts.

Trial Registration  ClinicalTrials.gov identifier: NCT01674803.

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