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.


METHODS
Open-labeled prospective randomized trial.


METHODS
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.


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


METHODS
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.


CONCLUSIONS
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.
Nishimura
Masato
M
Cardiovascular Division, Toujinkai Hospital, Kyoto, Japan. mnishimura@tea.ocn.ne.jp
Tokoro
Toshiko
T
Nishida
Masasya
M
Hashimoto
Tetsuya
T
Kobayashi
Hiroyuki
H
Imai
Ryo
R
Yamazaki
Satoru
S
Okino
Koji
K
Iwamoto
Noriyuki
N
Takahashi
Hakuo
H
Ono
Toshihiko
T
D000284:Administration, Oral; D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects*; D016757:Death, Sudden, Cardiac / Q000517:prevention & control*; D005260:Female; D006333:Heart Failure / Q000401:mortality* / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality* / Q000517:prevention & control*; D020108:Nicorandil / Q000008:administration & dosage*; D011183:Postoperative Complications / Q000517:prevention & control; D011446:Prospective Studies; D006435:Renal Dialysis; D014665:Vasodilator Agents / Q000008:administration & dosage*
D014665:Vasodilator Agents; D020108:Nicorandil