Key result
Paclitaxel-coated drug-eluting balloon angioplasty with bail-out stenting did not achieve non-inferiority to sirolimus-eluting stent implantation for the primary composite endpoint at 2 years.
Why the study?
The authors report salient data from the REC-CAGEFREE1 trial to highlight details of its design, lesion selection, and clinical implications.
Does paclitaxel-coated drug-eluting balloon angioplasty and bail-out stent achieve non-inferiority to sirolimus-eluting stent implantation for reducing cardiovascular death, target vessel myocardial infarction, or target lesion revascularization in patients with non-complex coronary artery disease?
Does paclitaxel-coated drug-eluting balloon angioplasty and bail-out stent achieve non-inferiority to sirolimus-eluting stent implantation for reducing cardiovascular death, target vessel myocardial infarction, or target lesion revascularization in patients with non-complex coronary artery disease?
In non-complex coronary artery disease, paclitaxel-coated balloons failed to show non-inferiority compared to sirolimus-eluting stents, reinforcing the continued use of stents for these lesions.
Paclitaxel-coated balloon strategy failed non-inferiority versus sirolimus-eluting stents; leaves open optimal revascularization approach in non-complex CAD.
non-complex coronary artery disease in China, which demonstrated that a strategy of paclitaxel-coated drug-eluting balloon angioplasty [Swide (Shenqi Medical, Shanghai, China)] and bail-out stent did not achieve non-inferiority to sirolimus-eluting stent implantation [Firebird 2 (Microport, Shanghai, China)] on the primary composite endpoint, defined as cardiovascular death, target vessel myocardial infarction, or clinically and physiologically indicated target lesion revascularization, assessed at 2 years. In this manuscript, we report the salient data of this study, highlighting relevant details about the design, the type of lesions included, and the clinical implications of these results. The main limitation of this study is the evaluation of lesions where the drug-eluting stents have demonstrated excellent short- and long-term results.
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Leone et al. (2025) conducted an editorial in Non-complex coronary artery disease. Paclitaxel-coated drug-eluting balloon angioplasty and bail-out stent vs. Sirolimus-eluting stent implantation was evaluated on Cardiovascular death, target vessel myocardial infarction, or clinically and physiologically indicated target lesion revascularization. Paclitaxel-coated drug-eluting balloon angioplasty with bail-out stenting did not achieve non-inferiority to sirolimus-eluting stent implantation for the primary composite endpoint at 2 years.
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