Center for Coronary Artery Disease, Division of Cardiology, Beijing Anzhen Hospital, Beijing, China.
Cardiometabolic Medicine Center, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Fuwai Hospital, Beijing, China.
Catheter Cardiovasc Interv. 2024 Oct;104(4):664-675. doi: 10.1002/ccd.31211. Epub 2024 Sep 3.
Rotational atherectomy (RA) remains an integral tool for the treatment of severe coronary calcified lesions despite emergence of newer techniques. We aimed to evaluate the contemporary clinical practices and outcomes of RA in China.
The Rota China Registry (NCT03806621) was an investigator-initiated, prospective, multicenter registry based on China Rota Elite Group. Consecutive patients treated with RA were recruited. A pre-designed, standardized protocol was recommended for the RA procedure. The primary safety endpoint was major adverse cardiovascular events (MACE: composite of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) at 30 days. The primary efficacy endpoint was procedural success.
Between July 2018 and December 2020, 980 patients were enrolled at 19 sites in China. Mean patient age was 68.4 years, and 61.4% were men. Radial access was used in 79.1% patients, and 32.7% procedures were guided by intravascular imaging. A total of 22.6% procedures used more than 1 burr, and the maximal burr size was ≥1.75 mm in 24.4% cases, with burr upsizing in 19.3% cases, achieving a final burr-to-artery ratio of 0.52. Procedural success was achieved in 91.1% of patients, and the rate of 30-day and 1-year MACE was 4.9% and 8.2%, respectively. Multivariable analysis identified the total lesion length (HR 1.014, 95% CI: 1.002-1.027; p = 0.021) as predictor of 30-day MACE, and renal insufficiency (HR 1.916, 95% CI: 1.073-3.420; p = 0.028) as predictor of 1-year MACE.
In this contemporary prospective registry in China, the use of RA was effective in achieving high procedural success rate with good short- and long-term outcomes in patients with severely calcified lesions.
尽管出现了新技术，但旋转血管成形术（RA）仍然是治疗严重冠状动脉钙化病变的重要工具。我们旨在评估 RA 在我国的当代临床实践和结果。
中国旋转精英组发起了一项名为 Rota China Registry（NCT03806621）的前瞻性、多中心注册研究，连续招募接受 RA 治疗的患者。建议采用预先设计的标准化方案进行 RA 手术。主要安全性终点为 30 天内的主要不良心血管事件（MACE：心脏死亡、心肌梗死或缺血驱动的靶病变血运重建的复合终点）。主要疗效终点为手术成功率。
2018 年 7 月至 2020 年 12 月，中国 19 个中心共纳入 980 例患者。平均患者年龄为 68.4 岁，61.4%为男性。79.1%的患者采用桡动脉入路，32.7%的患者采用血管内成像指导。共有 22.6%的手术使用了超过 1 个磨头，24.4%的病例最大磨头直径≥1.75mm，19.3%的病例进行了磨头升级，最终磨头与动脉的比例为 0.52。91.1%的患者手术成功，30 天和 1 年的 MACE 发生率分别为 4.9%和 8.2%。多变量分析发现总病变长度（HR 1.014，95%CI：1.002-1.027；p=0.021）是 30 天 MACE 的预测因素，肾功能不全（HR 1.916，95%CI：1.073-3.420；p=0.028）是 1 年 MACE 的预测因素。
在这项中国当代前瞻性注册研究中，RA 的应用在严重钙化病变患者中实现了高手术成功率，并取得了良好的短期和长期结果。
