{"id":"7d3998ea70f7","type":"article","url":"https://hartvaat.nl/2024/09/14/drug-coated-balloon-versus-intended-stenting-bij-de-novo-coronairlaesies/","title":"Drug-coated balloon versus intended stenting bij de novo coronairlaesies","title_en":"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.","category":"algemeen","category_label":"Algemeen","professions":["cardioloog"],"tags":[],"journal":"Lancet (London, England)","doi":"10.1016/S0140-6736(24)01594-0","source_url":"https://doi.org/10.1016/S0140-6736(24)01594-0","authors":["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"],"significance":6,"published":"2024-09-14","source_date":"2024-09-14","image":"","kennis":[],"congress":"","summary_en":"This study compared drug-coated balloon angioplasty with rescue stenting versus intended stenting for de novo coronary lesions, evaluating the leave-nothing-behind approach for native coronary disease.","created":"2026-07-03T10:31:09Z","updated":"2026-07-03T13:30:11Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie vergeleek drug-coated balloon angioplastie met rescue stenting versus voorgenomen stenting bij de novo coronairlaesies. DCB was non-inferieur en kan een stentvrij alternatief bieden voor geselecteerde laesies.","abstract_original":"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."}