Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates

J Am Coll Cardiol. 2015 Mar 3;65(8):805-815. doi: 10.1016/j.jacc.2014.11.053.

Abstract

Background: The use of drug-eluting stents (DES) in patients at high risk of bleeding or thrombosis has not been prospectively studied; limited data are available in patients who have a low restenosis risk.

Objectives: This study sought to compare a hydrophilic polymer-based, second-generation zotarolimus-eluting stent (ZES) with a unique drug fast-release profile versus bare-metal stents (BMS) under similar durations of dual-antiplatelet therapy (DAPT).

Methods: We randomly assigned 1,606 patients with stable or unstable symptoms, and who on the basis of thrombotic bleeding or restenosis risk criteria, qualified as uncertain candidates for DES, to receive ZES or BMS. DAPT duration was on the basis of patient characteristics, rather than stent characteristics, and allowed for a personalized 1-month dual antiplatelet regimen. The primary endpoint was the risk of 1-year major adverse cardiovascular events (MACE), which included death, myocardial infarction (MI), or target vessel revascularization (TVR).

Results: Median DAPT duration was 32 days (interquartile range [IQR]: 30 to 180 days) and did not differ between the groups. In the ZES group, 140 patients (17.5%) reached the primary endpoint, compared with 178 patients (22.1%) in the BMS group (hazard ratio: 0.76; 95% confidence interval: 0.61 to 0.95; p = 0.011) as a result of lower MI (2.9% vs. 8.1%; p < 0.001) and TVR rates (5.9% vs.10.7%; p = 0.001) in the ZES group. Definite or probable stent thrombosis was also significantly reduced in ZES recipients (2.0% vs. 4.1%; p = 0.019).

Conclusions: Compared with BMS, DES implantation using a stent with a biocompatible polymer and fast drug-eluting characteristics, combined with an abbreviated, tailored DAPT regimen, resulted in a lower risk of 1-year MACE in uncertain candidates for DES implantation. (Zotarolimus-eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS] Study; NCT01385319).

Keywords: drug-eluting stent(s); dual-antiplatelet therapy; high bleeding risk; high thrombotic risk; zotarolimus-eluting stent(s).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aspirin / administration & dosage
  • Aspirin / adverse effects
  • Biocompatible Materials / therapeutic use
  • Clopidogrel
  • Coronary Angiography / methods
  • Coronary Artery Disease / diagnosis
  • Coronary Artery Disease / surgery*
  • Coronary Restenosis* / diagnosis
  • Coronary Restenosis* / etiology
  • Coronary Restenosis* / prevention & control
  • Drug-Eluting Stents / adverse effects*
  • Female
  • Hemorrhage* / etiology
  • Hemorrhage* / prevention & control
  • Humans
  • Immunosuppressive Agents / therapeutic use
  • Male
  • Percutaneous Coronary Intervention* / adverse effects
  • Percutaneous Coronary Intervention* / methods
  • Platelet Aggregation Inhibitors / administration & dosage
  • Platelet Aggregation Inhibitors / adverse effects
  • Postoperative Complications* / diagnosis
  • Postoperative Complications* / prevention & control
  • Risk Assessment
  • Risk Factors
  • Sirolimus / analogs & derivatives*
  • Sirolimus / therapeutic use
  • Ticlopidine / administration & dosage
  • Ticlopidine / adverse effects
  • Ticlopidine / analogs & derivatives*
  • Treatment Outcome

Substances

  • Biocompatible Materials
  • Immunosuppressive Agents
  • Platelet Aggregation Inhibitors
  • Clopidogrel
  • zotarolimus
  • Ticlopidine
  • Aspirin
  • Sirolimus

Associated data

  • ClinicalTrials.gov/NCT01385319