TCT-374 Drug-coated balloon versus drug-eluting stent for treating coronary bifurcation lesions: insights from the REC-CAGEFREE I trial

Abstract

Background
For treating target lesions involving coronary bifurcation, drug-coated balloon (DCB) has emerged as an attractive strategy. However, its long-term efficacy and safety as compared to drug-eluting stent (DES) for such an indication remain in debate. To assess the clinical outcomes of DCB versus DES in treating de novo coronary bifurcation lesions.

Methods
REC-CAGEFREE I was an investigator-initiated, non-inferiority trial conducted at 43 sites in China, which randomized 2,272 participants 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, participants were stratified by whether the target lesion involved bifurcation or not. The primary outcome was the device-oriented composite endpoint·(DoCE; including cardiovascular death, target-vessel myocardial infarction, and·clinically·and physiologically-indicated target-lesion revascularization) at 24 months.

Results
2,257 (99.3%) participants with available angiographic results were included in the analysis, of which 773 (34.2%) had target lesions involving bifurcation. At 24 months, the DoCE occurred in 46/773 (6.0%) of patients in the bifurcation group and 64/1,484 (4.3%) of patients in the non-bifurcation group (HRIPTW:1.39, 95%CI:0.87-2.21, P=0.164). A significant interaction between bifurcation and DCB/DES for DoCE was observed (Pinteraction=0.037). In the non-bifurcation group, DoCE occurred in 46/735 (6.3%) of patients with DCB and 18/749 (2.4%) of patients with DES (HRIPTW: 2.56, 95%CI:1.45-4.54, P=0.001), respectively; whereas in the bifurcation group, DoCE occurred in 26/394 (6.7%) of patients with DCB and 20/379 (5.3%) of patients with DES (HRIPTW: 1.07, 95%CI: 0.56-2.05, P=0.836), respectively.

Conclusion
Heterogeneity in the treatment effect between DCB and DES was observed in bifurcation and non-bifurcation lesions. DCB was associated with a numerically similar risk of DoCE at 24 months compared to the DES for the treatment of bifurcation lesions. However, given the observational nature of the study, these results should be interpreted as hypothesis-generating only.