The REC-CAGEFREE I randomized trial has shed light on the efficacy of drug-coated balloon (DCB) angioplasty as the initial strategy for de novo coronary artery stenoses. The study revealed that DCB, when combined with the rescue use of drug-eluting stents (DES), resulted in a significantly higher composite 24-month rate of cardiovascular death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization compared to intended stenting. This difference failed to meet the non-inferiority criterion, indicating that DCB did not measure up to stenting from the start.
The findings of the REC-CAGEFREE I trial highlight the importance of considering DES implantation as the preferred treatment strategy for de novo coronary artery stenoses. Dr. Ling Tao emphasized the superiority of DES in current practice, noting the low rate of adverse events associated with this approach. While there may be room for exploring alternative treatment options for specific lesion types, such as bifurcation lesions or those with fibrosis, the superior outcomes associated with DES cannot be ignored.
Dr. Tao mentioned the ongoing follow-up of patients in the study to assess the long-term effects of DCB and explore the potential relationship between the higher rate of revascularization in the DCB group and mortality or MI. This underscores the need for further research in this area to better understand the implications of different treatment strategies on clinical outcomes.
Although the REC-CAGEFREE I trial was powered for outcomes related to DCB, it is important to acknowledge the limitations of the study. The trial included a specific population of Chinese ethnicity, which may limit the generalizability of the findings to other populations. Additionally, the use of devices that are not FDA approved raises questions about the applicability of the results to clinical practice in other regions.
In light of the findings of the REC-CAGEFREE I trial, there is a clear need for more data to further evaluate the effectiveness of DCB angioplasty compared to stenting. Dr. Valeria Paradies emphasized the importance of conducting additional studies to build upon the existing evidence and address the gaps in our understanding of the optimal treatment approach for de novo coronary artery stenoses.
While the REC-CAGEFREE I trial has provided valuable insights into the outcomes of DCB angioplasty in the context of de novo coronary artery stenoses, there are still many unanswered questions. Further research is needed to clarify the role of DCB in the treatment of coronary artery disease and to inform clinical decision-making.
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