Abstract

Background
Drug-coated balloons (DCBs) are attractive for treating de novo coronary lesions, especially when involving bifurcations; however, their efficacy compared with drug-eluting stents (DES) remains uncertain.
Objectives
The aim of this study was to assess the prognosis of DCBs vs DES in patients with noncomplex bifurcation and nonbifurcation lesions.

Methods
This was a prespecified subgroup analysis of the REC-CAGEFREE I (Paclitaxel-Coated Balloon for Treatment of De-Novo Non-Complex Coronary Artery Lesions) trial, which was an investigator-initiated, noninferiority trial conducted at 43 sites in China that randomized 2,272 participants to paclitaxel-coated balloons (the DCB group) or sirolimus-eluting stents (the DES group) for the treatment of de novo lesions, regardless of vessel diameter. The primary outcome was a device-oriented composite endpoint (DoCE) at 24 months. Participants were stratified according to the presence vs absence of bifurcation, and inverse probability of treatment weighting (IPTW) was performed to adjust for between-group imbalances.

Results
A total of 2,257 of 2,272 participants (99.3%) with available angiographic results were included. At 24 months, the DoCE had occurred in 46 of 773 patients in the bifurcation group (6.0%) and 64 of 1,484 patients in the nonbifurcation group (4.3%) (HRIPTW: 1.39; 95% CI: 0.87-2.21; P = 0.164). Seven hundred nineteen of 798 of the bifurcation lesions (90.1%) had DCB or DES treatment in the main vessel. A significant interaction for the DoCE was observed between bifurcation or nonbifurcation and assigned treatment (Pinteraction = 0.031). In the nonbifurcation group, the DoCE occurred in 46 of 735 patients with DCBs (6.3%) and 18 of 749 (2.4%) with DES (HRIPTW: 2.67; 95% CI: 1.64-4.33; P < 0.001); the in bifurcation group, the DoCE occurred in 26 of 394 patients with DCBs (6.7%) and 20 of 379 (5.3%) with DES (HRIPTW: 1.03; 95% CI: 0.53-2.01; P = 0.934).

Conclusions
DCBs were associated with a numerically comparable risk for DoCE compared with DES in noncomplex bifurcations at 2 years. However, these findings should be interpreted as hypothesis generating only. (Paclitaxel-Coated Balloon for Treatment of De-Novo Non-Complex Coronary Artery Lesions; NCT04561739)