Oral nicorandil to reduce cardiac death after coronary revascularization in hemodialysis patients: a randomized trial.

Abstract

BACKGROUND:

Survival after invasive coronary revascularization is worse in patients with chronic kidney disease than in patients without chronic kidney disease. We examined whether oral administration of nicorandil, a hybrid nitrate and adenosine triphosphate-sensitive potassium channel opener, could improve outcome after coronary revascularization in hemodialysis patients.

STUDY DESIGN:

Open-labeled prospective randomized trial.

SETTING & PARTICIPANTS:

Maintenance hemodialysis patients who underwent percutaneous coronary artery intervention and had complete coronary revascularization (absence of both restenosis and de novo coronary lesion) at coronary arteriography 6 months later. Enrollment occurred between January 1, 2002, and December 31, 2004.

INTERVENTIONS:

Treatment with or without oral administration of nicorandil, 15 mg/d.

OUTCOMES & MEASUREMENTS:

The primary end point was cardiac death (sudden cardiac death or death from acute myocardial infarction or congestive heart failure). The secondary end point was all-cause death. End-point adjudication was performed masked to the intervention.

RESULTS:

129 patients (91 men, 38 women) with a mean age of 66 +/- 9 (SD) years. During a 2.7 +/- 1.5-year follow-up, 26 died of cardiac events (acute myocardial infarction, 6; congestive heart failure, 5; sudden cardiac death, 15), and 12 died of noncardiac causes. Cardiac death-free survival rates were greater in the nicorandil group than in the control group (P = 0.009; at 3 years, 86.6% in the nicorandil group and 70.7% in the control group). All-cause death-free survival rates were also greater in the nicorandil group than in the control group (P = 0.01; at 3 years, 79.2% in the nicorandil group versus 60.5% in the control group). Additional percutaneous coronary artery intervention was performed in 6 participants in the nicorandil group and 2 participants in the control group. No serious side effects of nicorandil were reported during the course of the study.

LIMITATIONS:

Small sample size and open-label design.

CONCLUSIONS:

Oral administration of nicorandil may reduce cardiac death and improve the survival of hemodialysis patients after coronary revascularization.

• Authors: Masato Nishimura, Toshiko Tokoro, Masasya Nishida, Tetsuya Hashimoto, Hiroyuki Kobayashi, Ryo Imai, Satoru Yamazaki, Koji Okino, Noriyuki Iwamoto, Hakuo Takahashi, Toshihiko Ono
• Journal: American journal of kidney diseases : the official journal of the National Kidney Foundation (Am J Kidney Dis) Vol. 54 Issue 2 Pg. 307-17 (Aug 2009) ISSN: 1523-6838 [Electronic] United States
• PMID: 19535190 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Vasodilator Agents
• Nicorandil

Topics

• Administration, Oral
• Aged
• Angioplasty, Balloon, Coronary (adverse effects)
• Death, Sudden, Cardiac (prevention & control)
• Female
• Heart Failure (mortality, prevention & control)
• Humans
• Male
• Middle Aged
• Myocardial Infarction (mortality, prevention & control)
• Nicorandil (administration & dosage)
• Postoperative Complications (prevention & control)
• Prospective Studies
• Renal Dialysis
• Vasodilator Agents (administration & dosage)