Is Bare-Metal Stent Implantation Still Justifiable in High Bleeding Risk Patients Undergoing Percutaneous Coronary Intervention?: A Pre-Specified Analysis From the ZEUS Trial

JACC Cardiovasc Interv. 2016 Mar 14;9(5):426-36. doi: 10.1016/j.jcin.2015.11.015.

Abstract

Objectives: This study sought to investigate the ischemic and bleeding outcomes of patients fulfilling high bleeding risk (HBR) criteria who were randomized to zotarolimus-eluting Endeavor Sprint stent (E-ZES) or bare-metal stent (BMS) implantation followed by an abbreviated dual antiplatelet therapy (DAPT) duration for stable or unstable coronary artery disease.

Background: DES instead of BMS use remains controversial in HBR patients, in whom long-term DAPT poses safety concerns.

Methods: The ZEUS (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates) is a multinational, randomized single-blinded trial that randomized among others, in a stratified manner, 828 patients fulfilling pre-defined clinical or biochemical HBR criteria-including advanced age, indication to oral anticoagulants or other pro-hemorrhagic medications, history of bleeding and known anemia-to receive E-ZES or BMS followed by a protocol-mandated 30-day DAPT regimen. The primary endpoint of the study was the 12-month major adverse cardiovascular event rate, consisting of death, myocardial infarction, or target vessel revascularization.

Results: Compared with patients without, those with 1 or more HBR criteria had worse outcomes, owing to higher ischemic and bleeding risks. Among HBR patients, major adverse cardiovascular events occurred in 22.6% of the E-ZES and 29% of the BMS patients (hazard ratio: 0.75; 95% confidence interval: 0.57 to 0.98; p = 0.033), driven by lower myocardial infarction (3.5% vs. 10.4%; p < 0.001) and target vessel revascularization (5.9% vs. 11.4%; p = 0.005) rates in the E-ZES arm. The composite of definite or probable stent thrombosis was significantly reduced in E-ZES recipients, whereas bleeding events did not differ between stent groups.

Conclusions: Among HBR patients with stable or unstable coronary artery disease, E-ZES implantation provides superior efficacy and safety as compared with conventional BMS. (Zotarolimus-Eluting Endeavor Sprint Stent in Uncertain DES Candidates [ZEUS]; NCT01385319).

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

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cardiovascular Agents / administration & dosage
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / therapy*
  • Drug Therapy, Combination
  • Drug-Eluting Stents
  • Female
  • Hemorrhage / chemically induced*
  • Hemorrhage / mortality
  • Humans
  • Male
  • Metals*
  • Myocardial Infarction / etiology
  • Patient Selection
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Percutaneous Coronary Intervention / mortality
  • Platelet Aggregation Inhibitors / adverse effects*
  • Prosthesis Design
  • Risk Assessment
  • Risk Factors
  • Single-Blind Method
  • Sirolimus / administration & dosage
  • Sirolimus / analogs & derivatives
  • Stents*
  • Time Factors
  • Treatment Outcome

Substances

  • Cardiovascular Agents
  • Metals
  • Platelet Aggregation Inhibitors
  • zotarolimus
  • Sirolimus

Associated data

  • ClinicalTrials.gov/NCT01385319