The Efficacy of Drug-Coated Balloons vs. Drug-Eluting Stents in Coronary Artery Disease: A Comprehensive Analysis

The recent European Society of Cardiology (ESC) meeting highlighted a significant study comparing drug-coated balloon (DCB) angioplasty to the more traditional stenting method as an initial treatment for de novo coronary artery stenoses. This investigation, known as the RECCAGEFREE I randomized trial, aimed to determine whether DCBs could match the efficacy of drug-eluting stents (DES). Unfortunately, the study did not meet its non-inferiority criterion, indicating that DCBs were less effective than DES in treating these coronary lesions. The findings revealed that using DCBs with the possibility of rescue DES resulted in almost double the rate of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularization compared to the intended stenting approach.

The disparity between the two treatments was primarily driven by the need for target lesion revascularization and a higher risk associated with treating non-small vessel disease. Dr. Ling Tao, MD, PhD, from Xijing Hospital in Xi’an, China, presented these findings at the ESC meeting, which were subsequently published in The Lancet. Dr. Tao emphasized that DES should remain the preferred treatment strategy, describing them as ‘excellent’ in current times. The study will continue to follow patients for a decade to explore the hypothesis that late events can be prevented by DCBs and to assess whether the higher revascularization rate in the DCB group will lead to increased mortality or MI.

This study was groundbreaking as it was the first randomized trial powered for outcomes related to DCB treatment. Valeria Paradies, MD, of Maasstad Hospital in Rotterdam, the Netherlands, also discussed the study at the ESC meeting, concluding that more data is needed to make definitive conclusions. The trial included 2,272 adults who had an indication for percutaneous coronary intervention after successful lesion pre-dilatation due to de novo, non-complex coronary artery disease, regardless of the target vessel diameter. Participants were randomly assigned to receive either paclitaxel-coated balloon angioplasty or a second-generation thin-strut sirolimus-eluting stent.

Neither of the devices used in the study is FDA approved, and the study population consisted mostly of Chinese males with a median age of 62. Interestingly, only 9.4% of the DCB group required bailout stenting, while none of the DES group did. There were no acute vessel closures during the procedures in the DCB group, but one occurred in the DES group. The rate of periprocedural MI was similar between the groups, suggesting that the immediate safety of both treatments is comparable. However, Paradies cautioned against assuming a ‘class effect’ for the devices, as there is variability in terms of dose concentration and drug carriers.

Crystal Phend, a contributing editor at MedPage Today, reported on the study, noting its limitations, such as the entirely Chinese ethnicity of the study population and the fact that the devices used were not FDA approved. These factors may limit the generalizability of the findings to other populations and healthcare settings. Despite these limitations, the study provides valuable insights into the comparative effectiveness of DCBs and DES in treating non-complex coronary artery disease. The results suggest that DES remains the gold standard for these patients, particularly in larger vessel disease (>3.0 mm).

Another article introduces a new marketplace, trademed.com, for buying surgical devices and equipment, highlighting the growing interest in alternative treatments for coronary artery disease (CAD). Percutaneous coronary intervention (PCI) is a common non-surgical technique for treating CAD, traditionally involving balloon angioplasty and drug-eluting stents. However, these methods come with complications and side effects, prompting interest in stent-free options like drug-coated balloons. A recent randomized trial conducted by researchers at Xijing Hospital in China compared the outcomes of DCB versus DES in patients with non-complex CAD.

The RECCAGEFREE I Trial, which enrolled patients from 43 sites across China, found that DCB did not perform as well as expected compared to DES. The primary endpoint of the trial was a combined rate of cardiac death, target vessel myocardial infarction, and target lesion revascularization. The results showed that DES had a lower rate of these combined events compared to DCB, primarily due to a higher rate of revascularization required with DCB. However, when looking at smaller vessel disease (≤3.0 mm), there was no significant difference between DCB and DES, indicating a need for more targeted studies on the effectiveness of DCB in specific patient populations.

Dr. Ling Tao, the senior author of the trial, emphasizes that DES should continue to be the standard of care for patients with non-complex CAD. This finding challenges the notion of using DCB as a ‘leave nothing behind’ strategy for treating CAD. The trial also found that for larger vessel disease (>3.0 mm), DES remains the preferable treatment. The study highlights the importance of considering vessel diameter when choosing a treatment for CAD. With over 2,000 patients enrolled and a study duration of two years, the trial provides robust evidence supporting the continued use of DES as the standard treatment for non-complex CAD.

DCBs had a higher rate of repeat procedures compared to DES, further suggesting that current standard treatment with DES is still the best option for patients with non-complex CAD. The authors recommend further research on the use of DCB in specific patient subgroups to confirm these findings. The trial’s comprehensive design and large sample size lend credibility to its conclusions, making it a significant contribution to the ongoing debate about the best treatment options for CAD.

A new study presented at the ESC Congress in London in 2024 finds that drug-coated balloons did not perform as well as expected in comparison to standard treatment with second-generation drug-eluting stents. This study was the first randomized trial to compare clinical outcomes for patients with coronary artery disease undergoing percutaneous coronary intervention. Senior author Dr. Ling Tao explains that drug-coated balloon angioplasty was not as effective because it often requires more repeat procedures. PCI is a non-surgical intervention used to treat blockages in the coronary arteries, and the conventional treatment usually involves balloon angioplasty and deployment of a stent.

However, stents can cause complications such as restenosis, leading to interest in alternative stent-free drug delivery methods like drug-coated balloons. Previous studies have shown that drug-coated balloons were just as effective as stents for small vessel coronary artery disease, but it was unclear if this was true for all sizes of coronary lesions. The RECCAGEFREE I trial aimed to determine the long-term efficacy and safety of drug-coated balloons in previously untreated coronary lesions. The trial enrolled over 2,200 patients in China between 2021 and 2022, randomly assigning them to receive either drug-coated balloon angioplasty with rescue stenting if needed, or deployment of a second-generation drug-eluting stent.

The average age of patients was 61, and 69% were men. Notably, 9% of patients in the drug-coated balloon group ended up needing a rescue stent. The primary endpoint of the study was the combined rate of cardiac death, target vessel myocardial infarction, and target lesion revascularization. The study found that the rate of these events was higher with drug-coated balloons compared to stents, mainly due to a higher rate of target lesion revascularization with drug-coated balloons. Subgroup analysis showed that the type of treatment had a different effect depending on the size of the coronary vessel, ultimately concluding that drug-coated balloons are not as effective as second-generation drug-eluting stents and should not be considered the standard treatment for patients with non-complex coronary artery disease.