Drug-Coated Balloons Versus Drug-Eluting Stents for Patients With Long De Novo Coronary Artery Lesions: Insights From the REC-CAGEFREE I Trial.

BACKGROUND

For long coronary lesions, drug-coated balloons (DCBs) might be an attractive alternative compared with drug-eluting stents (DES); however, supporting evidence remains scarce.

AIMS: To compare the efficacy of DCBs versus DES for treating long de novo coronary lesions.

METHODS

REC-CAGEFREE I was a non-inferiority trial conducted at 43 sites in China, which randomized 2272 patients to paclitaxel-coated balloon angioplasty with the option of rescue stenting or sirolimus-eluting stents for treating de novo lesions, regardless of vessel diameter. In this pre-specified subgroup analysis, patients were stratified by quantitative coronary angiography-assessed lesion length into short (< 20 mm) and long (≥ 20 mm) groups. The primary endpoint was a device-oriented composite endpoint (DoCE, including cardiovascular death, target vessel myocardial infarction, or clinically and physiologically-indicated target lesion revascularization) at 3 years.

RESULTS

2,223 (97.8%) participants with available angiograms were included, of which 302 (13.6%) had long lesions and 1921 (86.4%) had short lesions. At 3 years, DoCE occurred in 24/302 (8.0%) and 121/1921 (6.3%) patients in long and short groups, respectively. In the long lesions group, DoCE occurred in 14/121 (11.6%) and 10/181 (5.6%) in the DCBs and DES groups, respectively (HRIPTW: 2.46, 95% CI: 1.07-5.67, p = 0.034). In the short lesions group, DoCE occurred in 75/983 (7.7%) and 46/938 (4.9%) in the DCBs and DES groups, respectively (HRIPTW: 1.52, 95% CI: 1.03-2.22, p = 0.033). No significant interaction was observed between lesion length and DES/DCBs (Pinteraction = 0.460).

CONCLUSION

DCBs were associated with a higher risk of DoCE compared to DES for treating de novo lesions, regardless of lesion length.