医学
狼牙棒
临床终点
心肌梗塞
内科学
外科
血运重建
心脏病学
临床试验
传统PCI
作者
Xiao Wang,Hong Zhang,Xiaojun Bai,Li Zhang,Chengxiang Li,Xiaobo Mao,Jue Chen,Jianfang Luo,Yan Zha,Binquan Zhou,Bei'an You,Yuelan Zhang,Likun Ma,Zhimin Du,Yan Chen,Fucheng Sun,Chunguang Qiu,Zhujun Shen,Shangyu Wen,Gary S. Mintz,Fei Ye,Shaoping Nie
摘要
Abstract Background 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. Methods 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. Results 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. Conclusions 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.
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