The REC-CAGEFREE I randomized trial has shed light on the inadequacy of drug-coated balloon (DCB) angioplasty as the initial strategy for de novo coronary artery stenoses. According to the findings presented at the European Society of Cardiology (ESC) meeting by Ling Tao, MD, PhD, of Xijing Hospital in Xi’an, China, DCB with rescue use of drug-eluting stents (DES) resulted in a nearly doubled composite 24-month rate of cardiovascular death, target vessel myocardial infarction (MI), and clinically and physiologically indicated target lesion revascularization compared to randomization to intended stenting.
The significant difference in outcomes, with a 6.4% rate of adverse events in the DCB group compared to 3.4% in the intended stenting group, failed to meet the non-inferiority criterion. This discrepancy was primarily driven by the need for target lesion revascularization and the substantially higher risk observed in non-small vessel disease cases requiring a device diameter of at least 3.0 mm. These results have led Tao to advocate for DES implantation as the preferred treatment strategy currently due to its superior performance.
Tao emphasized the exceptional efficacy of DES in the present day, highlighting the difficulty in achieving similar outcomes with DCB-based strategies. However, she also suggested that there is still room for exploration in identifying lesion types that may be suitable for treatment without the need for stent placement. Bifurcation lesions or those with fibrosis were proposed as potential candidates for DCB-based therapies, emphasizing the importance of continued research in this area.
Valeria Paradies, MD, of Maasstad Hospital in Rotterdam, the Netherlands, acknowledged the significance of the REC-CAGEFREE I trial as the first randomized trial powered for outcomes in the context of DCB. Despite the valuable insights gained from this study, Paradies stressed the necessity for more data to fully understand the implications of these findings. The trial, which included a diverse population of Chinese ethnicity, underscored the importance of continued research to validate the results in broader patient populations.
The study’s inclusion of 2,272 adults across 43 sites in China highlighted the challenges encountered in selecting appropriate treatment strategies for patients with de novo, non-complex coronary artery disease. The randomized assignment to either DCB angioplasty or intended stenting provided valuable insights into the risks and benefits associated with each approach. Bailout stenting was utilized in a small percentage of cases in the DCB group, emphasizing the need for flexibility in treatment algorithms based on individual patient characteristics.
The REC-CAGEFREE I trial has raised important questions about the efficacy of DCB angioplasty as the initial strategy in coronary artery stenoses. While DES implantation remains the preferred treatment option based on the trial results, further research is warranted to explore alternative treatment approaches and optimize patient outcomes. The findings of this trial contribute significantly to the existing knowledge about coronary artery disease management and underscore the importance of ongoing research in this field.
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