The REC-CAGEFREE I randomized trial revealed disappointing results regarding the use of drug-coated balloon (DCB) angioplasty as the initial strategy for de novo coronary artery stenoses. In comparison to stenting, DCB with rescue use of drug-eluting stents (DES) nearly doubled the composite 24-month rate of cardiovascular death, target vessel myocardial infarction (MI), and clinically and physiologically indicated target lesion revascularization. This failure to meet the non-inferiority criterion signals a significant setback in the field of cardiology.
Ling Tao, MD, PhD, of Xijing hospital in Xi’an, China, emphasized the superiority of DES implantation as the preferred treatment strategy based on the findings of the trial. Describing DES as excellent in current days, Tao highlighted the low 3.4% rate of adverse events over 2 years, making it challenging to improve upon. The increased risk in patients with non-small vessel disease further underscores the importance of utilizing DES over DCB in clinical practice.
While acknowledging the limitations of DCB angioplasty, Tao suggested exploring lesion types that might be suitable for treatment without the need for stenting. Bifurcation lesions and those with fibrosis were identified as potential candidates for DCB therapy. Additionally, the development of DCB that deliver a more sustained drug dose could enhance the effectiveness of this approach. Continued follow-up of patients over 10 years will provide valuable insights into the long-term outcomes associated with DCB treatment.
Despite being the first randomized trial powered for outcomes in the context of DCB, the REC-CAGEFREE I trial raised important questions and highlighted the need for additional data. Valeria Paradies, MD, of Maasstad Hospital in Rotterdam, the Netherlands, emphasized the necessity for more comprehensive research in this area. The trial included a specific population of Chinese ethnicity, which may limit the generalizability of the results to a broader patient population.
One of the critical points raised during the analysis of the trial was the lack of FDA approval for either the paclitaxel-coated balloon or the sirolimus-eluting stent used in the study. The absence of randomized trials or registries in Europe further complicates the interpretation of the results. It is crucial to conduct further studies with approved devices to validate the efficacy and safety of these interventions.
The REC-CAGEFREE I trial shed light on the shortcomings of DCB angioplasty compared to stenting in the treatment of de novo coronary artery stenoses. The preference for DES implantation and the identification of potential areas for improvement underscore the importance of evidence-based practice in interventional cardiology. Moving forward, continued research and the use of approved devices will be essential in enhancing patient outcomes and advancing the field of percutaneous coronary intervention.
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