Bioresorbable polymer-coated thin strut sirolimus-eluting stent vs durable polymer-coated everolimus-eluting stent in daily clinical practice: Propensity matched one-year results from interventional cardiology network registry

Catheter Cardiovasc Interv. 2019 Jun 1;93(7):E362-E368. doi: 10.1002/ccd.27919. Epub 2018 Oct 8.

Abstract

Objectives: We sought to determine the 1-year clinical follow-up in patients treated with the thin strut (71 μm) bioabsorbable polymer-coated sirolimus-eluting stent (BP-SES) vs durable coating everolimus eluting stent (DP-EES) in daily clinical routine.

Background: Presence of durable polymers may be associated with late/very late stent thrombosis occurrence and the need for prolonged dual antiplatelet therapy. Bioabsorbable polymers may facilitate stent healing, thus enhancing clinical safety.

Methods: Interventional Cardiology Network Registry is a prospective, multicenter, observational registry of 21,400 consecutive patients treated with PCI since 2010. We analyzed 4,670 patients treated with either a BP-SES (ALEX, Balton, Poland) or DP-EES (XIENCE, Abbott, USA) with available 1-year clinical follow-up using propensity-score matching. Outcomes included target vessel revascularization (TVR) as efficacy outcome and all cause death, myocardial infarction (MI), and definite/probable stent thrombosis as safety outcomes.

Results: After propensity score matching, 1,649 patients treated with BP-SES and 1,649 patients treated with DP-EES were selected. Procedural and clinical characteristics were similar between both groups. There was no significant difference between tested groups in in-hospital mortality. One-year follow-up demonstrated comparable efficacy outcome, TVR (BP-SES 5.9% vs DP-EES 4.6% P = 0.45), as well as comparable safety outcomes, all cause death, MI and definite/probable stent thrombosis.

Conclusions: In this multicenter registry, the BP-SES thin strut biodegradable polymer-coated sirolimus-eluting stent demonstrated comparable clinical outcomes at 1-year after implantation to the DP-EES. These data support the relative safety and efficacy of DP-SES in a broad range of patients undergoing percutaneous coronary intervention.

Keywords: Bioresorbable polymer; Drug-Eluting Stents; Percutaneous Coronary Intervention.

Publication types

  • Comparative Study
  • Multicenter Study
  • Observational Study

MeSH terms

  • Absorbable Implants*
  • Aged
  • Angioplasty, Balloon, Coronary / adverse effects
  • Angioplasty, Balloon, Coronary / instrumentation*
  • Angioplasty, Balloon, Coronary / mortality
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Drug-Eluting Stents*
  • Everolimus / administration & dosage
  • Female
  • Humans
  • Male
  • Middle Aged
  • Poland
  • Polymers*
  • Propensity Score
  • Prosthesis Design
  • Registries
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Sirolimus / administration & dosage*
  • Sirolimus / adverse effects
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Polymers
  • Everolimus
  • Sirolimus