ESC Meeting Highlights Results of REC-CAGEFREE I Trial

In a recent presentation at the European Society of Cardiology (ESC) meeting, Ling Tao, MD, PhD, of Xijing Hospital in Xi’an, China, revealed significant findings from the REC-CAGEFREE I trial. The study assessed the effectiveness of drug-coated balloon (DCB) angioplasty as an initial treatment for de novo coronary artery stenoses and found it inadequate compared to drug-eluting stent (DES) implantation.

DCB Angioplasty Shows Doubled Adverse Event Rate

The trial demonstrated that DCB angioplasty, when combined with the potential need for rescue DES, resulted in a composite 24-month adverse event rate of 6.4%. This rate was nearly double that observed in the DES group, which had a 3.4% rate. The higher adverse event rate primarily stemmed from the increased need for target lesion revascularization, particularly in non-small vessel disease cases requiring a device diameter of at least 3.0 mm.

DES Recommended as Preferred Treatment Strategy

Given the trial’s results, Tao advocates for DES implantation as the current preferred treatment strategy due to its superior performance. Despite these findings, she acknowledges that there may be specific lesion types, such as bifurcation lesions or those with fibrosis, that could benefit from DCB-based therapies. Further research is needed to identify these potential candidates and refine treatment strategies.

Need for Broader Validation of Findings

Valeria Paradies, MD, of Maasstad Hospital in Rotterdam, the Netherlands, emphasized the importance of the REC-CAGEFREE I trial as the first randomized trial powered for outcomes in the context of DCB. However, Paradies stressed the necessity for additional data to validate these findings across diverse patient populations.

Study Details and Implications

The trial involved 2,272 adults across 43 sites in China, highlighting the complexities in choosing optimal treatments for patients with de novo, non-complex coronary artery disease. The study’s randomized design provided valuable insights into the risks and benefits of DCB angioplasty versus intended stenting, underscoring the need for flexible treatment algorithms tailored to individual patient needs.

The REC-CAGEFREE I trial has sparked important discussions about the efficacy of DCB angioplasty and reinforces the need for ongoing research to improve patient outcomes in coronary artery disease management.