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.
| Autor: | Gao C; Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China., He X; Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China., Ouyang F; Department of Cardiovascular Medicine, Zhuzhou Hospital Affiliated to Xiangya School of Medicine, Central South University, Zhuzhou, China., Zhang Z; Department of Cardiovascular Medicine, Center for Circadian Metabolism and Cardiovascular Disease and Key Laboratory of Geriatric Cardiovascular and Cerebrovascular Disease, Southwest Hospital, Army Medical University, Southwest Hospital, Chongqing, China., Shen G; Department of Cardiology, Ankang Hospital of Traditional Chinese Medicine, Ankang, China., Wu M; Department of Cardiology, Xiangtan Central Hospital, Xiangtan, China., Yang P; Department of Cardiology, China-Japan Union Hospital of Jilin University, Changchun, China., Ma L; Department of Cardiology, The First Affiliated Hospital of USTC, Hefei, China., Yang F; Department of Cardiology, The First Hospital of Kunming, Kunming, China., Ji Z; Department of Cardiology, Tangshan Workers Hospital, Tangshan, China., Wang H; Department of Cardiology, West China Hospital of Sichuan University, Chengdu, China., Wu Y; Department of Cardiology, The Second Affiliated Hospital of Nanchang University, Nanchang, China., Fang Z; Department of Cardiology, The Second Xiangya Hospital of Central South University, Changsha, China., Jiang H; Department of Cardiology, Renmin Hospital of Wuhan University, Wuhan, China., Wen S; Department of Cardiology, Tianjin Fourth Central Hospital, Tianjin, China., Liu Y; Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China., Li F; Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China., Zhou J; Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China., Zhu B; Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China., Liu Y; Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China., Zhang R; Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China., Zhang T; Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China., Wang P; Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China., Liu J; Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China., Jiang Z; Beijing KeyTech Statistical Consulting, Beijing, China., Xia J; Department of Health Statistics, Fourth Military Medical University, Xi'an, China., van Geuns RJ; Department of Cardiology, Radboud UMC, Nijmegen, Netherlands., Capodanno D; Department of Cardiology, Azienda Ospedaliero-Universitaria Policlinico G Rodolico-San Marco, University of Catania, Catania, Italy., Garg S; Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK; School of Medicine, University of Central Lancashire, Preston, UK., Onuma Y; Department of Cardiology, School of Medicine, University of Galway, Galway, Ireland., Wang D; Biostatistics Unit, Liverpool School of Tropical Medicine, Liverpool, UK., Serruys PW; Department of Cardiology, School of Medicine, University of Galway, Galway, Ireland. Electronic address: patrick.w.j.c.serruys@gmail.com., Tao L; Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China. Electronic address: lingtaofmmu@qq.com. |
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| Jazyk: | angličtina |
| Zdroj: | Lancet (London, England) [Lancet] 2024 Sep 14; Vol. 404 (10457), pp. 1040-1050. Date of Electronic Publication: 2024 Sep 02. |
| DOI: | 10.1016/S0140-6736(24)01594-0 |
| Abstrakt: | 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; p 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. Competing Interests: Declaration of interests PWS reports consulting fees from Sahajanand Medical Technologies, Novartis, Merillife, Xeltis, and Philips/Volcano. DC reports honoraria from Terumo, Sanofi Aventis, and Medtronic; and participation on the advisory board of Abbott Vascular. ZJia is the founder of Beijing KeyTech Statistical Consulting and has stock in the company. R-JvG reports an unrestricted research grant to Radboud UMC from AstraZeneca. All other authors declare no competing interests. (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.) |
| Databáze: | MEDLINE |
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