Compared with plain balloons, drug-coated balloons (DCB) and, particularly, drug-eluting stents (DES) are able to reduce the need of both first and recurrent revascularizations after percutaneous treatment of drug-eluting in-stent restenosis (DES-ISR), based on a post-hoc analysis of the ISAR-DESIRE 3 trial presented Oct. 26 during TCT 2023 and simultaneously published in JACC: Cardiovascular Interventions.

Researchers analyzed data from 402 patients (500 lesion) randomized to plain balloon, DCB or DES in the ISAR-DESIRE 3 trial. Median follow-up was 10.3 years. The primary endpoint was total repeat target lesion revascularization (R-TLR) including all, first and recurrent events.

Results found that first R-TLR was required in 204 lesions, broken down by 82 in the plain balloon group, 70 in the DCB group and 52 in the DES group, after roughly 10-years follow-up. The total number of R-TLR was 373, with 162 in the plain balloon group, 124 in the DCB group and 87 in the DES group. Researchers noted that the risk of total R-TLR was reduced by DCB (HR=0.36) and by DES (HR=0.23) as compared with plain balloon during the first year of follow-up. After one year, the risk of total R-TLR was not significantly reduced by DCB (HR=0.77), but significantly reduced by DES (HR=0.61), as compared with plain balloon.

"In this unique long-term follow-up analysis out to 10 years, the absolute number of recurrent events was considerable and accountable for almost every second revascularization event," said Tobias Koch, MD, who presented the findings. "Prospective trials in the specific setting of recurrent ISR are required to further evaluate the clinical impact and optimal treatment strategies."

In a related editorial, Ron Waksman, MD, FACC, and Kalyan R. Chitturi, DO, note that the study unravels "myths and truths" about late DES-ISR. "This study dispels the myths that [plain balloon] is effective for DES-ISR, and that implantation of another DES is harmful and should be avoided," they write. "The study confirms that DES-ISR is challenging to treat and supports the need for more data from the ongoing pivotal trials of DCBs for DES-ISR to definitively address whether DCBs can outperform current-generation DES and their role in the treatment of DES-ISR."

Meanwhile, in a separate study out of China, Bo Yu, MD, PhD, FACC, et al., assessed use of DCBs as a strategy for treating patients with acute coronary syndrome (ACS) and de novo lesions – a population in which stent-related complications remain a challenging issue following PCI.

The DCB-ACS trial findings found DCB was noninferior to DES for treating de novo lesions of ACS patients in terms of the primary endpoint looking at functional assessment of target lesion at nine months. In other findings, angiographic follow-up at nine months showed the DCB group had higher in-segment diameter stenosis than the DES group, however, there was no difference in late lumen loss between the two groups. Additionally, the DCB and the DES group had comparable risk of target lesion and patient-oriented composite endpoint at 12 months. However, the incidence of target lesion failure and patient-oriented composite endpoint were numerically higher with DES treatment.

"In the future, a larger randomized controlled trial will be required to compare DCB with DES for de novo lesions in ACS patients in terms of clinical adverse outcomes," the researchers said.