Protective effect of nicorandil on myocardial injury following percutaneous coronary intervention in older patients with stable coronary artery disease: Secondary analysis of a randomized, controlled trial (RINC)

PLoS One. 2018 Apr 16;13(4):e0194623. doi: 10.1371/journal.pone.0194623. eCollection 2018.

Abstract

Background: Our previous study examined an effect of remote ischemic preconditioning (RIPC) or intravenous nicorandil on reduction of periprocedural myocardial injury (pMI) following percutaneous coronary intervention (PCI) in patients with stable coronary artery disease (CAD). We further investigated the effect of RIPC or nicorandil on pMI in older patients.

Methods: Patients with stable CAD who planned to undergo PCI were assigned to a 1:1:1 ratio to control, intravenous nicorandil, or upper-limb RIPC groups. This substudy analyzed patients aged >65 years (n = 282) from the principal cohort. The primary outcome was the incidence of pMI following PCI. We defined pMI as an elevated level of high-sensitive cardiac troponin T or creatine kinase myocardial band 12 or 24 hours after PCI.

Results: We found that pMI following PCI was significantly reduced in the nicorandil group compared with the control group (37.2% vs. 53.7%, multiplicity-adjusted p = 0.046), but not in the RIPC group compared with the control group (43.0% vs. 53.7%, multiplicity-adjusted p = 0.245). The adjusted odds ratios (95% confidence interval) for pMI in the RIPC and nicorandil groups versus the control group were 0.63 (0.34 to 1.16) and 0.51 (0.27 to 0.96), respectively.

Conclusion: Intravenous nicorandil significantly reduces pMI following PCI in a subgroup of older patients with stable CAD. Phase 3 trials are required to validate our results.

Trial registration: UMIN Clinical Trials Registry UMIN000005607.

Publication types

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

MeSH terms

  • Aged
  • Coronary Artery Disease / drug therapy*
  • Coronary Artery Disease / mortality
  • Coronary Artery Disease / pathology
  • Coronary Vessels / physiology
  • Creatine Kinase, MB Form / metabolism
  • Female
  • Heart Injuries / etiology*
  • Heart Injuries / prevention & control
  • Humans
  • Ischemic Preconditioning, Myocardial
  • Kaplan-Meier Estimate
  • Logistic Models
  • Nicorandil / therapeutic use*
  • Odds Ratio
  • Percutaneous Coronary Intervention / adverse effects*
  • Pregnancy
  • Proportional Hazards Models
  • Protective Agents / therapeutic use*
  • Treatment Outcome

Substances

  • Protective Agents
  • Nicorandil
  • Creatine Kinase, MB Form

Grants and funding

This study was funded by the Okayama Medical Foundation, http://omf.umin.ac.jp. TM received honorarium from Chugai Pharmaceutical Co. HI received a research grant and honorarium from Chugai Pharmaceutical Co. The funder provided support in the form of salaries for authors [TM and HI], but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.