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

Masato Nishimura, Toshiko Tokoro, Masasya Nishida, Tetsuya Hashimoto, Hiroyuki Kobayashi, Ryo Imai, Satoru Yamazaki, Koji Okino, Noriyuki Iwamoto, Hakuo Takahashi, Toshihiko Ono
American Journal of Kidney Diseases 2009, 54 (2): 307-17

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.

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