Circulation. Cardiovascular interventions · 2026
Nicorandil to Prevent Contrast-Associated Kidney Injury in High-Risk PCI.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Liao Minqi, Zhou Weiliang, Wang Wenbin, Yang Yanhua, Yao Yongzhao, Zhou Guoxiang, Wu Zhihao, Zhang Xiaoming, Wei Bailiang, Liang Guangzhu, Li Zheng, Wei Zhanyang, Lu Jiongbin, Wu Zekui, Wang Yanna, Lin Ailing, Chen Yan, Zhang Bin, Guo Suxia
Аннотация
BACKGROUND: Patients with renal dysfunction remain at high risk for contrast-associated acute kidney injury despite standard peri-procedural volume administration. This study aims to investigate whether peri-procedural oral nicorandil provides additional protection in this population, and to evaluate its potential dose-response relationship.
METHODS: We conducted a prospective, multicenter, randomized controlled trial enrolling patients with renal dysfunction undergoing percutaneous coronary intervention. Participants were randomized into 3 groups, including a high-dose nicorandil group (30 mg/d, 10 mg 3× daily), a conventional-dose nicorandil group (15 mg/d, 5 mg 3× daily), and a saline hydration-only control group. The primary end point was the incidence of contrast-associated acute kidney injury. Secondary end points included changes in serum creatinine, blood urea nitrogen, CysC (cystatin C), and CRP (C-reactive protein).
RESULTS: A total of 585 patients were recruited and randomized. The incidence of contrast-associated acute kidney injury was significantly lower in both nicorandil groups, with 19.8% (39/197) in the control group, compared with 10.9% (21/193) in the conventional-dose group and 8.7% (17/195) in the high-dose group (P<0.001). This represented a relative risk reduction of 50% and 61% for the conventional- and high-dose groups, respectively.
CONCLUSIONS: Adjunctive nicorandil, particularly at a dose of 10 mg 3× daily, significantly reduced the incidence of contrast-associated acute kidney injury in patients with renal dysfunction undergoing percutaneous coronary intervention. Oral nicorandil represents a readily available, effective, and dose-dependent prophylactic strategy to enhance renoprotection. Future studies are warranted to evaluate the long-term clinical benefits of this intervention.
REGISTRATION: URL: https://www.chictr.org.cn; Unique identifier: CTR2200064264.
METHODS: We conducted a prospective, multicenter, randomized controlled trial enrolling patients with renal dysfunction undergoing percutaneous coronary intervention. Participants were randomized into 3 groups, including a high-dose nicorandil group (30 mg/d, 10 mg 3× daily), a conventional-dose nicorandil group (15 mg/d, 5 mg 3× daily), and a saline hydration-only control group. The primary end point was the incidence of contrast-associated acute kidney injury. Secondary end points included changes in serum creatinine, blood urea nitrogen, CysC (cystatin C), and CRP (C-reactive protein).
RESULTS: A total of 585 patients were recruited and randomized. The incidence of contrast-associated acute kidney injury was significantly lower in both nicorandil groups, with 19.8% (39/197) in the control group, compared with 10.9% (21/193) in the conventional-dose group and 8.7% (17/195) in the high-dose group (P<0.001). This represented a relative risk reduction of 50% and 61% for the conventional- and high-dose groups, respectively.
CONCLUSIONS: Adjunctive nicorandil, particularly at a dose of 10 mg 3× daily, significantly reduced the incidence of contrast-associated acute kidney injury in patients with renal dysfunction undergoing percutaneous coronary intervention. Oral nicorandil represents a readily available, effective, and dose-dependent prophylactic strategy to enhance renoprotection. Future studies are warranted to evaluate the long-term clinical benefits of this intervention.
REGISTRATION: URL: https://www.chictr.org.cn; Unique identifier: CTR2200064264.