TCT-518 Impact of Left Ventricular Ejection Fraction on Outcomes with Drug-Coated Balloon versus Drug-Eluting Stent for de novo Coronary Artery Disease: Insights from the REC-CAGEFREE I Trial

Abstract

Background
The impact of left ventricular ejection fraction (LVEF) on clinical outcomes in patients treated with drug-coated balloon (DCB) versus drug-eluting stent (DES) for de novo coronary lesions remains unclear.

Methods
REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China, which randomized 2272 patients to paclitaxel-coated balloon with the option of rescue stenting (DCB group) or sirolimus-eluting stents (DES group) for treating de novo lesions, regardless of vessel diameter. In this pre-specified subgroup analysis, patients were stratified by baseline LVEF (<55% and ≥55%). The primary endpoint was the device-oriented composite endpoint (DoCE, defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization) at 2 years.

Results
Among 2194 (96.4%) patients with available baseline LVEF, 1792 (81.7%) had LVEF≥55% and 402 (18.3%) had LVEF<55%. At 2 years, patients with LVEF<55% was associated with a numerically higher risk of DoCE (26/402 [6.5%] versus 81/1792 [4.5%], DifferenceIPTW: 1.62%, 95%CI: -0.93 to 4.16, P =0.214) and a significantly higher risk of cardiovascular death compared to LVEF≥55% (16/402 [4.0%] versus 23/1792 [1.3%], DifferenceIPTW: 2.40%, 95%CI: 0.48 to 4.31, P =0.014). A significant treatment-by-LVEF interaction was observed for DoCE (Pinteraction =0.028). In patients with LVEF<55%, DoCE occurred in 22/206 (10.7%) and 4/196 (2.1%) in the DCB and DES groups (DifferenceIPTW: 7.31%, 95%CI: 2.93 to 11.69, P =0.001), respectively; in patients with LVEF≥55%, DoCE occurred in48/886 (5.4%) and 33/906 (3.7%) in the DCB and DES groups (DifferenceIPTW: 2.06%, 95%CI: 0.06 to 4.07, P =0.044), respectively.

Conclusion
In de novo coronary artery disease, DCB was associated with a higher risk of DoCE compared to DES, especially in patients with LVEF<55%.