Upon analyzing the REC-CAGEFREE I randomized trial, it was found that drug-coated balloon (DCB) angioplasty as the initial strategy for de novo coronary artery stenoses did not perform as well as stenting. The study showed that DCB with rescue use of drug-eluting stents (DES) almost doubled the 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. This 6.4% versus 3.4% difference failed to meet the non-inferiority criterion, with the variance being driven by target lesion revascularization and the heightened risk in non-small vessel disease, emphasizing the necessity of a device diameter of at least 3.0 mm.
Based on the findings presented at the European Society of Cardiology (ESC) meeting, Ling Tao, MD, PhD, of Xijing hospital in Xi’an, China, suggested that DES implantation should continue to be the preferred treatment strategy for de novo coronary artery stenoses. The effectiveness of DES was evident from the low percentage of adverse events during the 2-year follow-up period. Tao highlighted the challenge of improving upon the success rate achieved by DES and indicated that further research is needed to identify lesion types that may be appropriate for treatment without the use of stents, such as bifurcation lesions or those with fibrosis. Additionally, Tao mentioned the possibility of utilizing DCB that can provide a more sustained drug dose.
Despite the initial results favoring stenting over DCB angioplasty, Tao emphasized the importance of continuing to monitor patients for a longer period of up to 10 years to examine whether late events can be prevented by DCB. The study also aims to explore whether the higher rate of revascularization in the DCB group would translate into increased rates of mortality or MI. It was noted that this trial was the first of its kind to be powered for outcomes related to DCB in the context of coronary artery disease.
Valeria Paradies, MD, of Maasstad Hospital in Rotterdam, the Netherlands, discussed the need for additional data despite the outcomes of the REC-CAGEFREE I trial. The study included 2,272 Chinese adults with an indication for percutaneous coronary intervention, with participants randomly assigned to either DCB angioplasty or stenting. The use of a paclitaxel-coated balloon for angioplasty and a second-generation thin-strut sirolimus-eluting stent for stenting was investigated, with bailout stenting being utilized in a small percentage of cases. However, caution was advised as neither device used in the trial is FDA approved, and more research is required to determine the efficacy and safety of these devices in a broader population.
While the REC-CAGEFREE I trial provided valuable insights into the effectiveness of DCB angioplasty versus stenting for de novo coronary artery stenoses, further research is necessary to fully understand the implications of these treatment strategies. The preference for DES implantation as the primary treatment option in such cases underscores the need for continuous advancement in interventional cardiology to improve patient outcomes and reduce the risks associated with complex coronary artery disease.
Leave a Reply