The Canadian journal of cardiology · 2026
Effect of Left Ventricular Ejection Fraction on Outcomes With Drug-coated Balloons vs Drug-Eluting Stents for De Novo Coronary Artery Disease.
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Song Bo, Sun Dongdong, Wang Qiong, Jiang Hong, Yin Zhiyong, Wen Shangyu, Jin Yuanzhe, Chen Hui, Yuan Ming, Zhong Lin, Hu Sigan, Lian Zhexun, Zeng Hesong, Pan Hongwei, Qin Xing, Xia Yunlong, Mou Fangjun, Yang Wangwei, Yan Wenjun, Zhang Fuyang, Garg Scot, Onuma Yoshinobu, Wang Duolao, Serruys Patrick W, Gao Chao, Tao Ling
Аннотация
BACKGROUND: The influence of left ventricular ejection fraction (LVEF) on clinical outcomes in patients treated with drug-coated balloons (DCBs) versus drug-eluting stents (DES) for de novo coronary lesions remains uncertain.
METHODS: REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China, randomizing 2272 patients to paclitaxel-coated balloons with optional rescue stenting or to sirolimus-eluting stents. In this pre-specified subgroup analysis, 2194 patients with available baseline LVEF were stratified into LVEF <55% and LVEF ≥55%. The primary endpoint was the device-oriented composite endpoint (DoCE; including cardiovascular death, target-vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization) at 3 years.
RESULTS: Among 2194 patients, 402 (18.3%) had an LVEF <55%, and 1792 (81.7%) had an LVEF ≥55%. At 3 years, the risk of DoCE was numerically higher in patients with an LVEF <55% versus LVEF ≥55% (9.0% vs. 6.1%; P=0.237). A significant treatment-by-LVEF interaction was observed for DoCE (Pinteraction=0.033). In patients with an LVEF <55%, DoCE occurred in 28/206 (13.7%) and 8/196 (4.2%) patients in the DCB and DES groups (DifferenceIPTW: 7.19%, 95% CI: 1.89% to 12.48%, P=0.008), respectively; in patients with an LVEF ≥55%, DoCE occurred in 62/886 (7.0%) and 47/906 (5.2%) patients in the DCB and DES groups (DifferenceIPTW: 1.93%, 95% CI: -0.37% to 4.23%, P=0.101), respectively.
CONCLUSIONS: Baseline LVEF may modify clinical outcomes after DCB versus DES for de novo coronary artery disease, with excess risk of DoCE with DCB mainly observed in patients with LVEF <55%. These exploratory findings should be interpreted cautiously.
CLINICAL TRIAL REGISTRATION: www.
CLINICALTRIALS: gov; number, NCT04561739.
METHODS: REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China, randomizing 2272 patients to paclitaxel-coated balloons with optional rescue stenting or to sirolimus-eluting stents. In this pre-specified subgroup analysis, 2194 patients with available baseline LVEF were stratified into LVEF <55% and LVEF ≥55%. The primary endpoint was the device-oriented composite endpoint (DoCE; including cardiovascular death, target-vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization) at 3 years.
RESULTS: Among 2194 patients, 402 (18.3%) had an LVEF <55%, and 1792 (81.7%) had an LVEF ≥55%. At 3 years, the risk of DoCE was numerically higher in patients with an LVEF <55% versus LVEF ≥55% (9.0% vs. 6.1%; P=0.237). A significant treatment-by-LVEF interaction was observed for DoCE (Pinteraction=0.033). In patients with an LVEF <55%, DoCE occurred in 28/206 (13.7%) and 8/196 (4.2%) patients in the DCB and DES groups (DifferenceIPTW: 7.19%, 95% CI: 1.89% to 12.48%, P=0.008), respectively; in patients with an LVEF ≥55%, DoCE occurred in 62/886 (7.0%) and 47/906 (5.2%) patients in the DCB and DES groups (DifferenceIPTW: 1.93%, 95% CI: -0.37% to 4.23%, P=0.101), respectively.
CONCLUSIONS: Baseline LVEF may modify clinical outcomes after DCB versus DES for de novo coronary artery disease, with excess risk of DoCE with DCB mainly observed in patients with LVEF <55%. These exploratory findings should be interpreted cautiously.
CLINICAL TRIAL REGISTRATION: www.
CLINICALTRIALS: gov; number, NCT04561739.