Oral nicorandil to reduce cardiac death after coronary revascularization in hemodialysis patients: a randomized trial.
Am J Kidney Dis
; 54(2): 307-17, 2009 Aug.
Article
in En
| MEDLINE
| ID: mdl-19535190
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. STUDYDESIGN:
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Vasodilator Agents
/
Angioplasty, Balloon, Coronary
/
Renal Dialysis
/
Death, Sudden, Cardiac
/
Nicorandil
/
Heart Failure
/
Myocardial Infarction
Type of study:
Clinical_trials
/
Observational_studies
Limits:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Am J Kidney Dis
Year:
2009
Document type:
Article
Affiliation country:
Japan