Impact of candesartan on cardiovascular events after drug-eluting stent implantation in patients with coronary artery disease: The 4C trial

J Cardiol. 2016 Apr;67(4):371-7. doi: 10.1016/j.jjcc.2015.06.009. Epub 2015 Aug 4.

Abstract

Objective: The purpose of this study was to examine the cardiovascular protective effects of candesartan in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DESs).

Background: Candesartan has been reported to reduce cardiovascular events when therapy was started 6 months after PCI with bare-metal stents in patients who survived restenosis. Candesartan started immediately after PCI with DESs was also effective in preventing cardiovascular events.

Methods: The 4C trial was a multicenter, prospective, randomized, open-label study. A total of 1145 patients at 39 centers in Japan were randomly assigned to receive candesartan plus standard medical treatment or standard medical treatment alone. The primary endpoints were all-cause death, and a composite of non-fatal myocardial infarction (MI), unstable angina pectoris (uAP), congestive heart failure (CHF), and non-fatal cerebrovascular events. The follow-up period was up to 3 years after the index PCI (ClinicalTrials.gov NCT00139386).

Results: The incidence of total death, one of the primary endpoints, was comparable between the two treatment groups (3.8% each, p=0.9702). Another primary endpoint, non-fatal major cardiovascular events, tended to occur more often in the control group than in the candesartan group (9.2% vs. 12.5%, p=0.0985). In contrast, candesartan significantly reduced one of the pre-specified secondary endpoints: cardiovascular events that included non-fatal MI, uAP, and CHF (4.4% vs. 6.7%, p=0.0136). Furthermore, candesartan significantly reduced another secondary endpoint that included cardiovascular events and cardiovascular death (5.0% vs. 7.7%, p=0.0493).

Conclusions: The 4C trial showed that candesartan administered immediately after PCI with DESs did not improve the prognosis after the index procedure, but did reduce some cardiac-related events for 3 years.

Keywords: Angiotensin II receptor blocker; Drug-eluting stent; Percutaneous coronary intervention; Randomized controlled trial.

Publication types

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

MeSH terms

  • Aged
  • Angina, Unstable / etiology
  • Angina, Unstable / prevention & control
  • Antihypertensive Agents / therapeutic use*
  • Benzimidazoles / therapeutic use*
  • Biphenyl Compounds
  • Cardiovascular Diseases / etiology
  • Cardiovascular Diseases / prevention & control*
  • Coronary Artery Disease / surgery
  • Drug-Eluting Stents / adverse effects*
  • Female
  • Follow-Up Studies
  • Heart Failure / etiology
  • Heart Failure / prevention & control
  • Humans
  • Japan
  • Male
  • Middle Aged
  • Myocardial Infarction / etiology
  • Myocardial Infarction / prevention & control
  • Percutaneous Coronary Intervention / adverse effects*
  • Percutaneous Coronary Intervention / instrumentation
  • Percutaneous Coronary Intervention / methods
  • Postoperative Period
  • Prospective Studies
  • Tetrazoles / therapeutic use*
  • Treatment Outcome

Substances

  • Antihypertensive Agents
  • Benzimidazoles
  • Biphenyl Compounds
  • Tetrazoles
  • candesartan

Associated data

  • ClinicalTrials.gov/NCT00139386