中国旋转动脉粥样硬化切除术的实践和结果:Rota 中国登记。

IF 2.1 3区 医学 Q3 CARDIAC & CARDIOVASCULAR SYSTEMS Catheterization and Cardiovascular Interventions Pub Date : 2024-09-03 DOI:10.1002/ccd.31211
Xiao Wang MD, Hong Zhang MD, Xiaojun Bai MD, Li Zhang MD, Chengxiang Li MD, Xiaobo Mao MD, Jue Chen MD, Jianfang Luo MD, Yan Zhao MD, Binquan Zhou MD, Bei'an You MD, Yuelan Zhang MD, Likun Ma MD, Zhimin Du MD, Yan Chen MD, Fucheng Sun MD, Chunguang Qiu MD, Zhujun Shen MD, Shangyu Wen MD, Gary S. Mintz MD, Fei Ye MD, Shaoping Nie MD, PhD, China Rota Elite Group
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引用次数: 0

摘要

背景:尽管出现了更新的技术,但旋转动脉粥样硬化切除术(RA)仍是治疗严重冠状动脉钙化病变不可或缺的工具。我们旨在评估中国RA的当代临床实践和疗效:罗塔中国登记(NCT03806621)是一项由研究者发起的前瞻性多中心登记,以中国罗塔精英小组为基础。研究人员招募了连续接受治疗的 RA 患者。建议采用预先设计的标准化方案进行 RA 手术。主要安全性终点是 30 天内的主要心血管不良事件(MACE:心源性死亡、心肌梗死或缺血导致的靶病变血管再通的复合指标)。主要疗效终点是手术成功率:2018 年 7 月至 2020 年 12 月期间,中国的 19 个研究机构共招募了 980 名患者。患者平均年龄为 68.4 岁,61.4% 为男性。79.1%的患者使用桡动脉入路,32.7%的手术由血管内成像引导。22.6%的手术使用了1个以上的毛刺,24.4%的手术使用的最大毛刺尺寸≥1.75毫米,19.3%的手术使用了更大的毛刺,最终毛刺与动脉的比率为0.52。91.1%的患者手术成功,30天和1年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:结论:在这一中国当代前瞻性登记中,对于严重钙化病变患者,使用RA能有效提高手术成功率,并获得良好的短期和长期疗效。
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Practices and outcomes of rotational atherectomy in China: The Rota China registry

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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来源期刊
CiteScore
5.40
自引率
8.70%
发文量
419
审稿时长
2 months
期刊介绍: Catheterization and Cardiovascular Interventions is an international journal covering the broad field of cardiovascular diseases. Subject material includes basic and clinical information that is derived from or related to invasive and interventional coronary or peripheral vascular techniques. The journal focuses on material that will be of immediate practical value to physicians providing patient care in the clinical laboratory setting. To accomplish this, the journal publishes Preliminary Reports and Work In Progress articles that complement the traditional Original Studies, Case Reports, and Comprehensive Reviews. Perspective and insight concerning controversial subjects and evolving technologies are provided regularly through Editorial Commentaries furnished by members of the Editorial Board and other experts. Articles are subject to double-blind peer review and complete editorial evaluation prior to any decision regarding acceptability.
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