Effect of Left Ventricular Ejection Fraction on Outcomes With Drug-coated Balloons vs Drug-Eluting Stents for De Novo Coronary Artery Disease.
Bo Song, Dongdong Sun, Qiong Wang et al.
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In 30 seconds
This pre-specified subgroup analysis of the multicentre REC-CAGEFREE I randomised non-inferiority trial examined whether baseline left ventricular ejection fraction (LVEF) modified outcomes with paclitaxel-coated balloons (DCB) versus sirolimus-eluting stents (DES) for de novo coronary disease. Among 2194 patients with available LVEF, the 3-year device-oriented composite endpoint (DoCE) was higher with DCB than DES in those with LVEF <55% (13.7% vs 4.2%; weighted difference 7.19%, 95% CI 1.89% to 12.48%; P=0.008). The treatment-by-LVEF interaction was significant (P interaction =0.033); findings were exploratory.
Key findings
- Among patients with LVEF <55%, 3-year DoCE occurred in 13.7% with DCB and 4.2% with DES (weighted difference 7.19%, 95% CI 1.89% to 12.48%; P=0.008).
- With LVEF ≥55%, DoCE occurred in 7.0% with DCB and 5.2% with DES (weighted difference 1.93%, 95% CI -0.37% to 4.23%; P=0.101).
- A treatment-by-LVEF interaction was observed for DoCE (P interaction =0.033).
Why it matters
The results suggest that baseline ventricular function may be relevant when interpreting comparative outcomes of balloon-based and stent-based treatment for de novo coronary lesions. The apparent excess DoCE with DCB in the lower-LVEF subgroup highlights a potential difference between patient groups, while the exploratory subgroup design means the finding should not be treated as definitive evidence of treatment effect.
What to keep in mind
This is an exploratory subgroup analysis, and the lower-LVEF subgroup included 402 patients; the authors advise cautious interpretation.