Drug-coated balloon versus drug-eluting stent for treating de novo proximal left anterior descending artery lesions: Insights from the REC-CAGEFREE I trial

Background: The safety and efficacy of drug-coated balloon (DCB) angioplasty for the treatment of proximal left anterior descending (LAD) lesions remain unclear. We aim to assess the prognosis of DCB versus drug-eluting stent (DES) in treating de novo proximal LAD lesions. 

Methods: In this prespecified, exploratory subgroup analysis of the investigator-initiated, multicenter, randomized, non-inferiority REC-CAGEFREE I trial, 2272 patients were stratified into two groups based on whether target lesion was located in proximal LAD. The primary endpoint was device-oriented composite endpoint (DoCE, a composite of cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization) at 2 years. 

Results: Of 2272 patients randomized, 688 (30.3%) had target lesion in proximal LAD. In patients with proximal LAD lesions, compared to DES treatment, DCB treatment had a higher risk of 2-year DoCE (8.8% versus 3.4%, HR_IPTW:2.68, 95%CI:1.34–5.35, P = 0.008). Similar results were observed in patients with non-proximal LAD lesions (DCB versus DES: 5.4% versus 3.3%, HR_IPTW:1.72, 95%CI:1.04–2.85, P = 0.038). No significant interaction was observed between the lesion location and the treatment strategy (DES/DCB) (P_interaction = 0.257). In patients with DCB treatment, proximal LAD had a higher risk of DoCE compared to non-proximal LAD (8.8% vs. 5.4%, HR_IPTW:1.68, 95%CI:1.01–2.81, P = 0.049). 

Conclusions: For patients with de novo, non-complex coronary artery disease, DCB was associated with a higher 2-year risk of DoCE than DES across all lesion locations, with a numerically larger effect in proximal LAD. Due to the exploratory nature of the analysis, the results should be interpreted cautiously and considered hypothesis-generating.