The REC-CAGEFREE I trial, presented at the European Society of Cardiology Congress 2024, investigated the efficacy and safety of paclitaxel-coated balloon (DCB) angioplasty compared to drug-eluting stent (DES) implantation in patients with de novo coronary artery lesions. The study, conducted in China, randomized 2,272 patients to either DCB or DES treatment, revealing that DCB failed to demonstrate noninferiority to DES for major cardiovascular outcomes at 2 years.
The trial enrolled patients undergoing percutaneous coronary intervention (PCI) for acute or chronic coronary syndrome with de novo, noncomplex target lesions. Patients were randomized after successful pre-dilation to either the DCB group (Swide DCB, Shenqi Medical, Shanghai, China) or the DES group (Firebird 2 DES, MicroPort, Shanghai, China). The primary outcome was a device-oriented composite endpoint of cardiovascular death, target vessel MI, and clinically indicated target lesion revascularization at 24 months.
Key Findings
The primary outcome occurred in 6.4% of patients in the DCB group compared to 3.4% in the DES group (p for noninferiority = 0.65; p for superiority = 0.0008). This indicates that DCB angioplasty was not noninferior to DES and, in fact, showed signs of inferiority. Notably, in patients with small vessel disease (device diameter <3.0 mm), DCB and DES had comparable outcomes. However, for larger vessels, DCB was inferior to DES (p for interaction = 0.02).
Secondary outcomes also favored DES, with a patient-oriented composite endpoint (target vessel failure) occurring in 11.9% of the DCB group versus 7.9% of the DES group (p = 0.0017). Any revascularization was also more frequent in the DCB group (7.0% vs. 4.6%, p = 0.016). All-cause mortality was numerically higher in the DCB group, but this difference was not statistically significant (3.3% vs. 2.0%, p = 0.064).
Implications and Context
These results suggest that, for de novo lesions, the Swide paclitaxel-coated balloon does not offer the same benefits as traditional DES, particularly concerning the need for repeat revascularization. The exception appears to be patients with small vessel disease, a finding consistent with the BASKET-SMALL 2 trial, where a different DCB (SeQuent Please) showed noninferiority to DES in small vessels at 1 year.
It is important to note that the Swide balloon used in this trial has a paclitaxel dose of 3 μg/mm² and is currently available only in China. The Agent balloon, recently approved in the US, uses a lower dose of paclitaxel (2 μg/mm²). Further research is needed to determine if varying paclitaxel doses impact clinical outcomes and to identify specific patient subgroups that may benefit most from DCB angioplasty.
