Coronary bifurcations treated with thin-strut drug-eluting stents: a prespecified analysis of the randomized BIO-RESORT trial

Coron Artery Dis. 2021 Jan;32(1):51-57. doi: 10.1097/MCA.0000000000000891.

Abstract

Background: Treatment of a coronary bifurcation lesion is often required in routine clinical practice, but data on the performance of very thin-strut biodegradable polymer drug-eluting stents are scarce.

Methods: Comparison of biodegradable polymer and durable polymer drug-eluting stents in an all comers population (BIO-RESORT) is a prospective, multicenter randomized clinical trial that included 3514 all-comer patients, who were randomized to very thin-strut biodegradable polymer-coated sirolimus- or everolimus-eluting stents, versus thin-strut durable polymer-coated zotarolimus-eluting stents. The approach of bifurcation stenting was left at the operator's discretion, and provisional stenting was generally preferred. This prespecified analysis assessed 3-year clinical outcome of all patients in whom treatment involved at least one bifurcation with a side-branch diameter ≥1.5 mm.

Results: Of all BIO-RESORT trial participants, 1236 patients were treated in bifurcation lesions and analyzed. Single- and two-stent techniques were used in 85.8% and 14.2%, respectively. 'True' bifurcation lesions (main vessel and side-branch obstructed) were treated in 31.1%. Three-year follow-up was available in 1200/1236 (97.1%) patients. The main endpoint target vessel failure (composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularization) occurred in sirolimus-eluting stents in 42/412 (10.3%) and in zotarolimus-eluting stents in 49/409 (12.1%) patients (P-logrank = 0.40). In everolimus-eluting stents, target vessel failure occurred in 40/415 (9.8%) patients (vs. zotarolimus-eluting stents: P-logrank = 0.26). There was no between-stent difference in individual components of target vessel failure. Findings were consistent in patients with single-vessel treatment and patients treated with a single-stent technique.

Conclusions: Three years after stenting all-comers with bifurcation lesions, clinical outcome was similar with the sirolimus-eluting and everolimus-eluting stents versus the zotarolimus-eluting stent.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Biodegradable Plastics / therapeutic use
  • Coronary Artery Disease* / diagnosis
  • Coronary Artery Disease* / surgery
  • Coronary Vessels* / diagnostic imaging
  • Coronary Vessels* / pathology
  • Drug-Eluting Stents* / adverse effects
  • Drug-Eluting Stents* / classification
  • Equipment Failure Analysis
  • Everolimus / therapeutic use*
  • Female
  • Humans
  • Immunosuppressive Agents / therapeutic use
  • Long Term Adverse Effects* / epidemiology
  • Long Term Adverse Effects* / etiology
  • Long Term Adverse Effects* / therapy
  • Male
  • Middle Aged
  • Outcome and Process Assessment, Health Care
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation
  • Percutaneous Coronary Intervention / methods
  • Prosthesis Failure* / adverse effects
  • Prosthesis Failure* / etiology
  • Sirolimus / analogs & derivatives*
  • Sirolimus / therapeutic use

Substances

  • Biodegradable Plastics
  • Immunosuppressive Agents
  • Everolimus
  • zotarolimus
  • Sirolimus