The recent REC-CAGEFREE I randomized trial conducted to compare the effectiveness of drug-coated balloon (DCB) angioplasty and stenting in treating de novo coronary artery stenoses revealed some startling results. Contrary to expectations, DCB angioplasty with rescue use of drug-eluting stents (DES) proved to be inferior to stenting as an initial strategy, leading to a higher composite 24-month rate of cardiovascular events. These findings, presented by Dr. Ling Tao at the European Society of Cardiology (ESC) meeting and simultaneously published in The Lancet, raise significant concerns about the efficacy of DCB angioplasty in comparison to traditional stenting.
Key Findings of the Study
The REC-CAGEFREE I trial involved 2,272 adults in China with indications for percutaneous coronary intervention. Participants were randomly assigned to receive either DCB angioplasty with optional rescue stenting or intended deployment of a second-generation sirolimus-eluting stent. The results showed a nearly doubled rate of cardiovascular death, target vessel myocardial infarction, and target lesion revascularization with the DCB group compared to intended stenting (6.4% vs 3.4%, P=0.0008). This difference was primarily driven by the need for target lesion revascularization, particularly in non-small vessel disease cases requiring a device diameter of at least 3.0 mm.
Implications of the Study
The implications of these findings are significant, as they challenge the current treatment paradigm that favors DES implantation as the preferred strategy for coronary artery disease. Dr. Tao emphasized the superiority of DES in the present scenario, acknowledging the low event rates observed with stenting over a 2-year follow-up period. However, she also highlighted the need to explore lesion types that might be amenable to treatment without stenting, suggesting potential areas of research in bifurcation lesions and fibrotic plaques.
Despite the negative findings regarding DCB angioplasty in the REC-CAGEFREE I trial, there is still room for further investigation and optimization of this treatment approach. Dr. Tao mentioned the ongoing follow-up of patients for 10 years to evaluate the long-term outcomes and potential benefits of DCB in preventing late events. Additionally, the study discussant, Dr. Valeria Paradies, stressed the importance of accumulating more data to better understand the role of DCB in contemporary interventional cardiology practice.
It is essential to acknowledge the limitations of the REC-CAGEFREE I trial, including the specific patient population in China and the lack of FDA-approved devices used in the study. The trial was also not powered to detect differences in mortality or myocardial infarction rates between the DCB and DES groups, indicating the need for further research in this area. Moving forward, it is crucial to conduct comprehensive studies that address these limitations and provide more robust evidence on the efficacy and safety of DCB angioplasty.
The REC-CAGEFREE I trial highlights the challenges and drawbacks associated with using DCB angioplasty as the initial treatment strategy for de novo coronary artery stenoses. While DES implantation remains the preferred approach based on current evidence, ongoing research and clinical trials are necessary to explore the potential benefits of DCB in specific lesion types and patient populations. By critically analyzing the findings of this trial, the medical community can gain valuable insights into optimizing treatment strategies for coronary artery disease and improving patient outcomes in the future.
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