Department of Cardiovascular Surgery, Ruijin Hospital Shanghai Jiao Tong University School of Medicine, No.197 Ruijin Er Road, Shanghai, China.
Department of Biostatistics, School of Public Health, Fudan University, Shanghai, China.
Adv Ther. 2023 Aug;40(8):3588-3597. doi: 10.1007/s12325-023-02548-4. Epub 2023 Jun 17.
The current evidence for chronic oral antispastic medication use after coronary artery bypass grafting using radial artery grafts (RA-CABG) is controversial. Calcium channel blockers, such as diltiazem, are the most commonly used antispastic medications after RA-CABG; other options include nitrates and nicorandil, but to date no sufficiently powered randomized controlled trials have been conducted to compare their efficacy.
This is a single-center, open-label, parallel three-arm, pilot randomized controlled trial. Patients without contraindications to any study medications and who successfully underwent RA-CABG surgery will be consecutively screened. Eligible patients will be randomized in a ratio of 1:1:1 (a total of 150 patients, 50 per arm) to receive nicorandil 5 mg orally thrice daily, diltiazem 180 mg orally once daily, or isosorbide mononitrate 50 mg orally once daily for 24 weeks. The primary outcomes are RA graft failure at week 1 and week 24. The secondary outcomes include major adverse cardiovascular event (MACE, a composite of all-cause death, myocardial infarction, stroke, and unplanned revascularization) and angina recurrence. The safety outcomes include hypotension occurrence, withdrawal of renin angiotensin aldosterone system inhibitors, serious adverse events, and other concerned adverse events within 24 weeks.
This pilot trial will compare the preliminary effects of nicorandil, diltiazem, and isosorbide mononitrate on angiographic and clinical outcomes in patients who have undergone RA-CABG. Recruitment began in June 2020, and the estimated primary completion date is early 2023. Results of this study will provide much needed information for design of large confirmatory trials on the effectiveness of oral antispastic medications after RA-CABG.
目前关于桡动脉桥（RA-CABG）后慢性口服抗痉挛药物使用的证据存在争议。钙通道阻滞剂，如地尔硫䓬，是 RA-CABG 后最常用的抗痉挛药物；其他选择包括硝酸盐和尼可地尔，但迄今为止，尚无足够效力的随机对照试验来比较它们的疗效。
这是一项单中心、开放标签、平行三臂、先导性随机对照试验。将连续筛选无任何研究药物禁忌且成功接受 RA-CABG 手术的患者。符合条件的患者将以 1:1:1 的比例（共 150 例，每组 50 例）随机分配接受尼可地尔 5mg 口服，每日 3 次；地尔硫䓬 180mg 口服，每日 1 次；或单硝酸异山梨酯 50mg 口服，每日 1 次，持续 24 周。主要结局是第 1 周和第 24 周时 RA 移植物失败。次要结局包括主要不良心血管事件（MACE，包括全因死亡、心肌梗死、卒中和计划外血运重建）和心绞痛复发。安全性结局包括低血压发生、肾素-血管紧张素-醛固酮系统抑制剂停药、严重不良事件和 24 周内其他相关不良事件。
这项初步试验将比较尼可地尔、地尔硫䓬和单硝酸异山梨酯对接受 RA-CABG 的患者血管造影和临床结局的初步效果。招募于 2020 年 6 月开始，预计主要完成日期为 2023 年初。这项研究的结果将为 RA-CABG 后口服抗痉挛药物有效性的大型确证性试验的设计提供急需的信息。
