Study shows drug-coated balloon angioplasty less effective than second-generation drug-eluting stents

New drug-coated balloons (DCB) have not surpassed standard treatment with second-generation drug-eluting stents (DES), as expected. This is evident from a surprising finding from the first randomized trial to examine clinical outcomes in previously untreated patients with non-complex disease undergoing percutaneous coronary intervention (PCI). The research was presented this year during a Hot Line Session ESC Congress 2024 in London, UK (August 30–September 2).

“Drug-coated balloon angioplasty failed to achieve non-inferiority compared to standard treatment with second-generation drug-eluting stents with thin struts, mainly due to the need for more repeat procedures (revascularization),” said senior author Dr. Ling Tao from Xijing Hospital. Xi’an, China.

Every year, millions of people around the world undergo PCI, a non-surgical procedure to treat blockages in the coronary arteries (which supply blood to the heart).

Conventional treatment for coronary artery disease (CAD) usually involves a procedure known as balloon angioplasty, in which a deflated balloon, attached to a catheter, is inserted into a narrowed artery. Once in place, the balloon is inflated, opening the narrowed blood vessel and restoring blood flow to the heart, followed by the deployment of a DES to provide an immediate foundation and to reduce the long-term risk of restenosis (a re-constriction). of the treated artery and recurrence of symptoms that may require additional repair).

“Although PCI with DES is highly effective, 2% of patients experience in-stent restenosis annually after the procedure,” explains Dr. Tao out. “Because of the metallic skeleton left behind, a DES can deform and permanently trap the coronary vessel from adaptive remodeling, impairing vessel pulsatility, disrupting cell signaling and mechanotransduction, and promoting chronic inflammation. Such stent-related side effects have the sparked interest in research. Alternative stent-free methods for local drug delivery, such as the use of drug-coated balloons.”

Previous studies have shown that the strategy of DCB angioplasty, with the option of stent placement if the outcome is unsatisfactory, is as effective as DES for previously untreated CAD of small vessels (diameter ≤ 3.0 mm). However, the long-term efficacy and safety of this strategy in previously untreated coronary lesions, regardless of coronary artery diameter, remains uncertain.

To find out more, the RECCAGEFREE I randomized, non-inferiority trial enrolled patients requiring PCI who had previously had untreated, non-complex CAD (regardless of target vessel diameter) from 43 sites across China.

Between February 2021 and May 2022, a total of 2,272 patients (18 years and older) who achieved successful pre-dilation of the target vessel were randomly assigned in a 1:1 ratio to receive treatment with paclitaxel-coated balloon angioplasty with the option of stent salvage due to an unsatisfactory result (DCB; 1,133 patients), or the deployment of a second-generation, thin-strut, sirolimus-eluting stent (DES; 1,139 patients). The average age of the patients was 61 years, 69% were male, 27% had diabetes and 6% were insulin dependent.

Overall, approximately 9% (106/1,133) of patients required rescue DES after unsatisfactory DCB angioplasty.

The primary endpoint of the two-year combined rate of cardiac death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularization (device-oriented composite endpoint [DoCE]) was 6.4% (72 patients) for DCB and 3.4% (38 patients) for DES, with an absolute risk difference of 3.04% (which was above the prespecified threshold of 2.68% for non-inferiority ). This was mainly due to higher rates of clinically and physiologically indicated target lesion revascularization with DCBs (3.1% vs. 1.2%, difference: 1.90%).

However, subgroup analysis revealed that there was notable heterogeneity in the treatment effect across vessel diameters, which requires further confirmation in appropriately designed studies. Although DES was the most favorable option in the subpopulation of non-small vessel disease (device diameter > 3.0 mm), the results in the subpopulation of small vessel disease (≤3.0 mm), with more than 1,000 patients, were in line with previous studies showing that DCB and DES had similar DoCE rates over the two-year follow-up (p-value for the interaction between treatment (DCB or DES) and the small vessel disease subgroup was 0.02)

“Our results demonstrate that the attempted ‘leave nothing behind’ strategy of using paclitaxel-coated balloons in de novo non-complex coronary artery disease has been refuted, and that DES implantation should remain the standard of care for these patients” , said Dr. .