Abstract

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