American journal of kidney diseases : the official journal of the National Kidney Foundation · 2009
Oral nicorandil to reduce cardiac death after coronary revascularization in hemodialysis patients: a randomized trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Nishimura Masato, Tokoro Toshiko, Nishida Masasya, Hashimoto Tetsuya, Kobayashi Hiroyuki, Imai Ryo, Yamazaki Satoru, Okino Koji, Iwamoto Noriyuki, Takahashi Hakuo, Ono Toshihiko
Аннотация
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.
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.