尼可地尔、单硝酸异山梨酯或地尔硫䓬对冠状动脉旁路移植术后桡动脉移植物的影响：随机ASRAB先导试验

Effects of Nicorandil, Isosorbide Mononitrate, or Diltiazem on Radial Artery Grafts After CABG: The Randomized ASRAB-Pilot Trial.

作者信息

Zhu Yunpeng, Zhang Wei, Qin Kaijie, Liu Yun, Yao Haoyi, Wang Zhe, Ye Xiaofeng, Zhou Mi, Li Haiqing, Qiu Jiapei, Xu Hong, Sun Yanjun, Gaudino Mario, Zhao Qiang

机构信息

Department of Cardiovascular Surgery, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, China (Y.Z., K.Q., Y.L., H.Y., Z.W., X.Y., M.Z., H.L., J.Q., H.X., Y.S., Q.Z.).

School of Public Health, Fudan University, Shanghai, China (W.Z.).

出版信息

Circ Cardiovasc Interv. 2025 Apr;18(4):e014542. doi: 10.1161/CIRCINTERVENTIONS.124.014542. Epub 2025 Mar 24.

DOI:10.1161/CIRCINTERVENTIONS.124.014542

PMID:40123490

Abstract

BACKGROUND

The optimal antispastic treatment after coronary artery bypass grafting using radial artery (RA) grafts is controversial. This clinical trial aimed to generate pilot comparative data on the effects of nicorandil, isosorbide mononitrate, or diltiazem on RA grafts.

METHODS

This was a single-center, randomized, open-label, parallel-group pilot trial. Eligible patients who underwent coronary artery bypass grafting using RA grafts were randomized in a 1:1:1 ratio to receive oral nicorandil (15 mg daily), isosorbide mononitrate (50 mg daily), or diltiazem (180 mg daily) for 24 weeks post-coronary artery bypass grafting. The primary outcome was RA graft failure (modified Fitzgibbon grade B, S, or O) at 1 and 24 weeks, assessed by coronary computed tomography angiography.

RESULTS

Among 150 randomized participants, 149 (mean age, 56.8 years; 13.4% women) with 177 RA grafts were assessed at least once by coronary computed tomography angiography, including 50 participants with 64 RA grafts in the nicorandil group, 50 participants with 57 RA grafts in the isosorbide mononitrate group, and 49 participants with 56 RA grafts in the diltiazem group, respectively. At 1 week post-coronary artery bypass grafting, the RA graft failure rates were lower with nicorandil versus diltiazem (19.4% versus 25.0%; difference, -5.6% [95% CI, -20.6% to 9.3%]) and isosorbide mononitrate versus diltiazem (18.2% versus 25.0%; difference, -6.8% [95% CI, -21.8% to 8.6%]). The RA graft failure rates were slightly higher with nicorandil versus isosorbide mononitrate (19.4% versus 18.2%; difference, 1.2% [95% CI, -13.3% to 15.2%]). At 24 weeks, RA graft failure rates were lower with nicorandil versus diltiazem (16.1% versus 27.8%; difference, -11.7% [95% CI, -26.6% to 3.4%]), and isosorbide mononitrate versus diltiazem (12.5% versus 27.8%; difference, -15.3% [95% CI, -29.8% to -0.2%]), and slightly higher with nicorandil versus isosorbide mononitrate (16.1% versus 12.5%; difference, 3.6% [95% CI, -9.6% to 16.4%]).

CONCLUSIONS

In this pilot trial, treatment with nicorandil or isosorbide mononitrate was associated with a lower RA graft failure rate compared with diltiazem. Larger hypothesis-testing trials are warranted.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT04310995.

摘要

背景

使用桡动脉（RA）进行冠状动脉旁路移植术后的最佳抗痉挛治疗存在争议。本临床试验旨在生成关于尼可地尔、单硝酸异山梨酯或地尔硫䓬对RA移植物影响的初步比较数据。

方法

这是一项单中心、随机、开放标签、平行组的试点试验。接受使用RA移植物进行冠状动脉旁路移植术的符合条件的患者，以1:1:1的比例随机分组，在冠状动脉旁路移植术后接受口服尼可地尔（每日15毫克）、单硝酸异山梨酯（每日50毫克）或地尔硫䓬（每日180毫克）治疗24周。主要结局是术后1周和24周时RA移植物失败（改良菲茨吉本分级为B、S或O），通过冠状动脉计算机断层扫描血管造影进行评估。

结果

在随机分组的150名参与者中（平均年龄56.8岁；13.4%为女性），149名（共177条RA移植物）至少接受了一次冠状动脉计算机断层扫描血管造影评估，其中尼可地尔组50名参与者（64条RA移植物），单硝酸异山梨酯组50名参与者（57条RA移植物），地尔硫䓬组49名参与者（56条RA移植物）。在冠状动脉旁路移植术后1周时，尼可地尔组与地尔硫䓬组相比，RA移植物失败率较低（分别为19.4%和）。单硝酸异山梨酯组与地尔硫䓬组相比，RA移植物失败率较低（分别为%和%）。尼可地尔组与单硝酸异山梨酯组相比，RA移植物失败率略高（分别为%和%）。在24周时，尼可地尔组与地尔硫䓬组相比，RA移植物失败率较低（分别为%和%），单硝酸异山梨酯组与地尔硫䓬组相比，RA移植物失败率较低（分别为%和%），尼可地尔组与单硝酸异山梨酯组相比，RA移植物失败率略高（分别为%和%）。