Five-year follow-up of polymer-free sirolimus- and probucol-eluting stents versus new generation zotarolimus-eluting stents in patients presenting with st-elevation myocardial infarction

Catheter Cardiovasc Interv. 2017 Feb 15;89(3):367-374. doi: 10.1002/ccd.26597. Epub 2016 Jul 5.

Abstract

Background: Patients with ST-segment elevation myocardial infarction (STEMI) undergoing drug-eluting stent (DES) implantation are at increased risk of late adverse events, partly explained by an exaggerated inflammatory reaction to durable-polymer stent coatings.

Objectives: We sought to investigate whether implantation of polymer-free DES would reduce this risk.

Methods: In the ISAR-TEST 5 (the Intracoronary Stenting and Angiographic Results: Test Efficacy of Sirolimus- and Probucol- and Zotarolimus-Eluting Stents) trial, patients were randomly allocated to receive a polymer-free sirolimus- and probucol-eluting stent or a new generation durable-polymer zotarolimus-eluting stent. We analyzed late clinical outcomes in the subgroup of patients presenting with STEMI. The primary endpoint was the combined incidence of cardiac death, target vessel-related myocardial infarction or target lesion revascularization at 5 years.

Results: 311 patients with STEMI were randomized to receive sirolimus- and probucol-eluting stents (n = 215) or zotarolimus-eluting stents (n = 96). At 5 years, there was no difference in the incidence of the primary endpoint in patients treated with sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents (18.3% versus 20.1% respectively, hazard ratio = 0.87, 95% CI, 0.50-1.51; P = 0.62). Rates of the individual components of the primary endpoint were also comparable in both groups. The incidence of definite/probable stent thrombosis was 1.4% versus 1.0% respectively (hazard ratio = 1.35, 95% CI, 0.14-12.94, P = 0.80).

Conclusions: Long-term outcomes of patients with STEMI treated with polymer-free sirolimus- and probucol-eluting stents versus durable-polymer zotarolimus-eluting stents were similar. Stent thrombosis rates were low and comparable in both treatment groups, with no events beyond 12 months.

Clinical trial registration: Registered at ClinicalTrials.gov (Identifier NCT 00598533) © 2016 Wiley Periodicals, Inc.

Trial registration: ClinicalTrials.gov NCT00598533.

Keywords: STEMI; drug-eluting stent; long-term follow-up; probucol; randomized controlled trial; sirolimus; zotarolimus.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Coronary Thrombosis / etiology
  • Disease-Free Survival
  • Drug-Eluting Stents*
  • Female
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Percutaneous Coronary Intervention / mortality
  • Polymers / chemistry*
  • Probucol / administration & dosage*
  • Probucol / adverse effects
  • Proportional Hazards Models
  • Prosthesis Design
  • Recurrence
  • Risk Factors
  • ST Elevation Myocardial Infarction / diagnostic imaging
  • ST Elevation Myocardial Infarction / mortality
  • ST Elevation Myocardial Infarction / therapy*
  • Sirolimus / administration & dosage
  • Sirolimus / adverse effects
  • Sirolimus / analogs & derivatives*
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Polymers
  • zotarolimus
  • Probucol
  • Sirolimus

Associated data

  • ClinicalTrials.gov/NCT00598533