The use of drug-coated balloon (DCB) angioplasty as the primary treatment strategy for de novo coronary artery stenoses was found to be less effective compared to stenting, according to the REC-CAGEFREE I randomized trial. The trial indicated that DCB with rescue use of drug-eluting stents (DES) resulted in a significantly higher composite rate of adverse cardiovascular events over 24 months, including cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularization. The data presented at the European Society of Cardiology (ESC) meeting raised concerns about the efficacy of DCB as an initial treatment option for coronary artery disease.
The REC-CAGEFREE I trial, led by Ling Tao, MD, PhD, of Xijing hospital in Xi’an, China, revealed that the use of DCB with rescue stenting led to a 24-month composite event rate that was nearly double that of intended stenting. This difference was primarily driven by the need for target lesion revascularization and was more pronounced in non-small vessel disease cases where larger device diameters were required. The findings, published in The Lancet, emphasized the superiority of DES implantation as the preferred treatment strategy for de novo coronary artery stenoses.
Despite the disappointing results of the REC-CAGEFREE I trial, Ling Tao highlighted the need to explore lesion types that may benefit from DCB treatment without the use of stents, such as bifurcation lesions or fibrotic plaques. She also suggested the development of DCB technologies that provide more sustained drug delivery to improve outcomes. The ongoing follow-up of patients for 10 years will assess the impact of late events on mortality and MI rates in the DCB group, offering valuable insights into the long-term efficacy of this approach.
The REC-CAGEFREE I trial, involving 2,272 Chinese adults with non-complex coronary artery disease, was noted for its robust design as the first randomized trial focused on DCB outcomes. However, study discussant Valeria Paradies, MD, emphasized the need for additional data to support the conclusions drawn from the trial. The lack of FDA approval for either the DCB or DES devices used in the study raises concerns about the generalizability of the findings to broader populations. Paradies also highlighted the importance of conducting randomized trials and registries in Europe to validate the results observed in Chinese patients.
The REC-CAGEFREE I trial underscored the limitations of DCB as an initial treatment option for de novo coronary artery stenoses compared to stenting. While DES implantation remains the preferred strategy based on current evidence, ongoing research is needed to identify patient subgroups that may benefit from DCB therapy. The long-term follow-up of patients will provide valuable insights into the impact of DCB treatment on mortality and MI rates, guiding future clinical practice in the management of coronary artery disease. Further studies are warranted to confirm the efficacy and safety of DCB technology in diverse patient populations and to address the limitations of the REC-CAGEFREE I trial.
Leave a Reply