Dr. Yunus Çalapkulu

Name of the Study: Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I)

Published in Congress: ESC Congress 2024

Link: Full Text
https://www.sciencedirect.com/science/article/abs/pii/S0140673624015940

Background:
Second-generation drug-eluting stents (DES) are the standard treatment for coronary artery disease. However, stent implantation continues to face significant challenges because the metallic scaffold placed in the vessel can distort and restrict the vessel, impede vessel pulsatility and adaptive remodeling, and promote chronic inflammation. Drug-coated balloons (DCBs) are a treatment option for in-stent restenosis, and studies have demonstrated their efficacy and safety in treating native small vessel disease. The long-term efficacy of DCB angioplasty in the treatment of patients with de novo coronary artery lesions remains unclear.

Objective:
The REC-CAGEFREE I study aimed to evaluate the non-inferiority of DCB angioplasty over DES placement in patients with non-complex coronary artery lesions.

Methods:
In this open-label, randomized, non-inferiority study, patients with non-complex coronary artery disease (regardless of target vessel diameter) and indication for percutaneous coronary intervention after successful lesion pre-dilation were randomly assigned to the paclitaxel-coated DCB group with the option of rescue stenting due to an unsatisfactory outcome or the second-generation thin-beam sirolimus-eluting DES group.

The primary outcome of the study was a composite endpoint of cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization (DoCE). Noninferiority was defined if the upper limit of the one-sided 95% CI for the absolute risk difference was less than 2.68%.

Results:
In the REC-CAGEFREE I study, 2272 patients were enrolled in the DCB group (1133 [50%)] or the DES group (1139 [50%)]. The median age at randomization was 62 years, 69.3% of the 2272 patients were male and 30.7% were female, and all patients were of Chinese ethnicity. The median follow-up of this study was 734 days. The composite endpoint of DoCE at 24 months occurred in 72 of 1133 patients (6.4%) in the DCB group and in 38 of 1139 patients (3.4%) in the DES group, resulting in a 3.04% risk difference in cumulative event rate (upper limit of one-sided 95% CI 4.52; p=0.65; two-sided 95% CI 1.27–4.81; p=0.0008). The non-inferiority criterion was not met with these statistical data.

Conclusion:
In conclusion, the DCB angioplasty strategy with rescue stenting was not achieve non-inferiority compared to DES implantation.

Interpretations:
Results from the REC-CAGEFREE I study showed that despite the presumed benefit of avoiding stent placement to prevent metal scaffold deposits in the vessel lumen, the use of paclitaxel-coated balloons for the treatment of patients with de novo noncomplex coronary artery disease of any vessel diameter was found to be non-inferior to an intended DES strategy. DES implantation should remain the preferred treatment strategy for these patients, especially those without small vessel disease.