A recent randomized trial, REC-CAGEFREE I, has shed light on the inefficacy of drug-coated balloon (DCB) angioplasty as an initial strategy for de novo coronary artery stenoses. The study revealed that DCB with 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 target lesion revascularization compared to intended stenting. The findings were presented by Ling Tao, MD, PhD, at the European Society of Cardiology (ESC) meeting and simultaneously published in The Lancet.
The trial included 2,272 adults in China with an indication for percutaneous coronary intervention. They were randomly assigned to either DCB angioplasty with optional rescue stenting or intended deployment of a second-generation thin-strut sirolimus-eluting stent. The study population consisted entirely of Chinese ethnicity, with a majority of male participants. The results showed that the use of DCB led to a higher rate of target lesion revascularization, particularly in non-small vessel disease cases requiring a large device diameter.
As per the lead researcher, DES implantation should continue to be the preferred treatment strategy due to its superior outcomes. The study emphasized the need for further research to identify lesion types that could potentially be treated without stenting. Additionally, the long-term effects of DCB, including late events and mortality rates, require further investigation. Valeria Paradies, MD, highlighted the importance of collecting more data to better understand the efficacy and safety of DCB in coronary interventions.
It is crucial to note that neither the DCB nor the DES used in the trial are FDA approved, and their safety and efficacy profiles may vary in different populations. The study also did not evaluate the devices in terms of long-term outcomes or in European populations. These limitations underscore the need for caution when interpreting the results and implementing them in clinical practice.
The REC-CAGEFREE I trial revealed that DCB angioplasty with rescue stenting did not meet the non-inferiority criterion compared to intended stenting in de novo coronary artery stenoses. The higher rate of adverse cardiovascular events associated with DCB raises concerns about its efficacy and safety in coronary interventions. Future research efforts should focus on addressing these limitations and identifying strategies to optimize the outcomes of coronary interventions.
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