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.

Gao, Chao, He, Xingqiang, Ouyang, Fan, Zhang, Zhihui, Shen, Guidong, Wu, Mingxing, Yang, Ping, Ma, Likun, Yang, Feng, Ji, Zheng, Wang, Hua, Wu, Yanqing, Fang, Zhenfei, Jiang, Hong, Wen, Shangyu, Liu, Yi, Li, Fei, Zhou, Jingyu, Zhu, Bin, Liu, Yunpeng, Zhang, Ruining, Zhang, Tingting, Wang, Ping, Liu, Jianzheng, Jiang, Zhiwei, Xia, Jielai, van Geuns, Robert-Jan, Capodanno, Davide, Garg, Scot, Onuma, Yoshinobu, Wang, Duolao ORCID: https://orcid.org/0000-0003-2788-2464, Serruys, Patrick W and Tao, Ling (2024) '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.'. The Lancet, Vol 404, Issue 10457, pp. 1040-1050.

	Text REC-CAGEFREE I Main Paper 2024-7-12_Final.pdf - Accepted Version Restricted to Repository staff only until 7 April 2025. Available under License Creative Commons Attribution Non-commercial No Derivatives. Download (760kB)
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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.

Item Type:	Article
Subjects:	WB Practice of Medicine > WB 102 Clinical medicine WG Cardiovascular System > WG 120 Cardiovascular diseases
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):	https://doi.org/10.1016/S0140-6736(24)01594-0
SWORD Depositor:	JISC Pubrouter
Depositing User:	JISC Pubrouter
Date Deposited:	07 Oct 2024 13:19
Last Modified:	07 Oct 2024 13:19
URI:	https://archive.lstmed.ac.uk/id/eprint/25374

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