Oral Nicorandil to Reduce Cardiac Death After Coronary Revascularization in Hemodialysis Patients: A Randomized Trial

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.

Index Words: End-stage renal disease, microcirculation, ischemia, potassium channel, preconditioning, sudden death