Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial.

IF 98.4 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL
The Lancet Pub Date : 2024-09-14 Epub Date: 2024-09-02 DOI:10.1016/S0140-6736(24)01594-0
Chao Gao, Xingqiang He, Fan Ouyang, Zhihui Zhang, Guidong Shen, Mingxing Wu, Ping Yang, Likun Ma, Feng Yang, Zheng Ji, Hua Wang, Yanqing Wu, Zhenfei Fang, Hong Jiang, Shangyu Wen, Yi Liu, Fei Li, Jingyu Zhou, Bin Zhu, Yunpeng Liu, Ruining Zhang, Tingting Zhang, Ping Wang, Jianzheng Liu, Zhiwei Jiang, Jielai Xia, Robert-Jan van Geuns, Davide Capodanno, Scot Garg, Yoshinobu Onuma, Duolao Wang, Patrick W Serruys, Ling Tao
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引用次数: 0

Abstract

Background: The long-term impact of drug-coated balloon (DCB) angioplasty for the treatment of patients with de novo coronary artery lesions remains uncertain. We aimed to assess the non-inferiority of DCB angioplasty with rescue stenting to intended drug-eluting stent (DES) deployment for patients with de novo, non-complex coronary artery lesions.

Methods: REC-CAGEFREE I was an open-label, randomised, non-inferiority trial conducted at 43 sites in China. After successful lesion pre-dilatation, patients aged 18 years or older with de novo, non-complex coronary artery disease (irrespective of target vessel diameter) and an indication for percutaneous coronary intervention were randomly assigned (1:1), via a web-based centralised system with block randomisation (block size of two, four, or six) and stratified by site, to paclitaxel-coated balloon angioplasty with the option of rescue stenting due to an unsatisfactory result (DCB group) or intended deployment of second-generation thin-strut sirolimus-eluting stents (DES group). The primary outcome was the device-oriented composite endpoint (DoCE; including cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularisation) assessed at 24 months in the intention-to-treat (ITT) population (ie, all participants randomly assigned to treatment). Non-inferiority was established if the upper limit of the one-sided 95% CI for the absolute risk difference was smaller than 2·68%. Safety was assessed in the ITT population. This study is registered with ClinicalTrials.gov, NCT04561739. It is closed to accrual and extended follow-up is ongoing.

Findings: Between Feb 5, 2021, and May 1, 2022, 2272 patients were randomly assigned to the DCB group (1133 [50%]) or the DES group (1139 [50%]). Median age at the time of randomisation was 62 years (IQR 54-69), 1574 (69·3%) of 2272 were male, 698 (30·7%) were female, and all patients were of Chinese ethnicity. 106 (9·4%) of 1133 patients in the DCB group received rescue DES after unsatisfactory DCB angioplasty. As of data cutoff (May 1, 2024), median follow-up was 734 days (IQR 731-739). At 24 months, the DoCE occurred in 72 (6·4%) of 1133 patients in the DCB group and 38 (3·4%) of 1139 in the DES group, with a risk difference of 3·04% in the cumulative event rate (upper boundary of the one-sided 95% CI 4·52; pnon-inferiority=0·65; two-sided 95% CI 1·27-4·81; p=0·0008); the criterion for non-inferiority was not met. During intervention, no acute vessel closures occurred in the DCB group and one (0·1%) of 1139 patients in the DES group had acute vessel closure. Periprocedural myocardial infarction occurred in ten (0·9%) of 1133 patients in the DCB group and nine (0·8%) in the DES group.

Interpretation: In patients with de novo, non-complex coronary artery disease, irrespective of vessel diameter, a strategy of DCB angioplasty with rescue stenting did not achieve non-inferiority compared with the intended DES implantation in terms of the DoCE at 2 years, which indicates that DES should remain the preferred treatment for this patient population.

Funding: Xijing Hospital and Shenqi Medical.

Translation: For the Chinese translation of the abstract see Supplementary Materials section.

在治疗新发冠状动脉病变患者时,药物涂层球囊血管成形术联合支架植入术与预定支架植入术(REC-CAGEFREE I):一项开放标签、随机、非劣效试验。
背景:药物涂层球囊(DCB)血管成形术治疗新发冠状动脉病变患者的长期效果仍不确定。我们的目的是评估在新发、非复杂冠状动脉病变患者中,DCB血管成形术加支架置入术与药物洗脱支架(DES)置入术的非劣效性:REC-CAGEFREE I 是一项开放标签、随机、非劣效试验,在中国 43 个地点进行。在成功进行病变预扩张后,年龄在 18 岁或以上、患有新发、非复杂性冠状动脉疾病(不考虑靶血管直径)且有经皮冠状动脉介入治疗指征的患者被随机分配(1:1),通过基于网络的集中系统进行分块随机分配(分块大小为 2、4 或 6),并按部位进行分层,将患者分配到紫杉醇涂层球囊血管成形术组(DCB 组),如果效果不理想,可选择进行支架置入术(DCB 组)或打算部署第二代薄支架西罗莫司洗脱支架组(DES 组)。主要结果是在意向治疗(ITT)人群(即所有随机分配接受治疗的参与者)中,在24个月时评估以设备为导向的复合终点(DoCE,包括心血管死亡、靶血管心肌梗死以及临床和生理学指示的靶病变血运重建)。如果绝对风险差异的单侧 95% CI 上限小于 2-68%,则确定为非劣效性。安全性在 ITT 群体中进行评估。该研究已在 ClinicalTrials.gov 登记,编号为 NCT04561739。该研究已经结束,目前正在进行延长随访:2021年2月5日至2022年5月1日期间,2272名患者被随机分配到DCB组(1133人[50%])或DES组(1139人[50%])。随机分配时的中位年龄为 62 岁(IQR 54-69),2272 例患者中有 1574 例(69-3%)为男性,698 例(30-7%)为女性,所有患者均为华裔。DCB组1133名患者中有106名(9-4%)在DCB血管成形术不满意后接受了DES治疗。截至数据截止日(2024年5月1日),中位随访时间为734天(IQR为731-739)。24个月时,DCB组1133例患者中有72例(6-4%)发生DoCE,DES组1139例患者中有38例(3-4%)发生DoCE,累积事件发生率的风险差异为3-04%(单侧95% CI上限为4-52;非劣效性=0-65;双侧95% CI上限为1-27-4-81;p=0-0008);未达到非劣效性标准。在干预期间,DCB 组未发生急性血管闭塞,而 DES 组的 1139 名患者中有 1 名(0-1%)发生急性血管闭塞。DCB组1133例患者中有10例(0-9%)发生了围手术期心肌梗死,DES组有9例(0-8%):在新发、非复杂性冠状动脉疾病患者中,无论血管直径大小,DCB血管成形术加支架植入术的策略与DES植入术相比,在2年后的DoCE方面没有达到非劣效性,这表明DES仍应是这一患者群体的首选治疗方法:资助:西京医院和神启医疗:摘要中译文见补充材料部分。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
The Lancet
The Lancet 医学-医学:内科
CiteScore
148.10
自引率
0.70%
发文量
2220
审稿时长
3 months
期刊介绍: The Lancet is a world-leading source of clinical, public health, and global health knowledge. It was founded in 1823 by Thomas Wakley and has been an independent, international weekly general medical journal since then. The journal has an Impact Factor of 168.9, ranking first among 167 general and internal medicine journals globally. It also has a Scopus CiteScore of 133·2, ranking it second among 830 general medicine journals. The Lancet's mission is to make science widely available to serve and transform society, positively impacting people's lives. Throughout its history, The Lancet has been dedicated to addressing urgent topics, initiating debate, providing context for scientific research, and influencing decision makers worldwide.
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