Paclitaxel-coated balloon and paclitaxel-eluting stent safe option for DES in-stent restenosis in PCI

A recent study published in the European Heart Journal suggests that compared to plain Balloon (PB), paclitaxel-coated balloon (PCB) and paclitaxel-eluting stent (PES) may be equally effective and safe options for treating drug-eluting stents in-stent restenosis (DES-ISR) in percutaneous coronary intervention (PCI).

Drug-eluting stents are widely used in the treatment of coronary artery disease. However, DES-ISR, the re-narrowing of a previously treated artery segment, remains a challenge. The ISAR-DESIRE 3 trial by Daniele Giacoppo and team aimed to define the 10-year comparative efficacy and safety of plain balloon PB, PCB, and PES for PCI of DES-ISR. The study followed 402 patients with DES-ISR who were randomly assigned to PB angioplasty, PCB angioplasty, or PES implantation.

Clinical follow-up did not significantly differ among treatments, but at 10 years, the primary composite endpoint (cardiac death, target vessel myocardial infarction, target lesion thrombosis, or target lesion revascularization) occurred in 72.0% of patients assigned to PB, 55.9% of patients assigned to PCB, and 62.4% of patients assigned to PES. 

The major secondary safety endpoint occurred in 34.1% of patients assigned to PB, 34.0% of patients assigned to PCB, and 40.0% of patients assigned to PES, with no significant differences observed among the treatments.

Target lesion revascularization occurred in 58.0% of patients assigned to PB, 43.9% of patients assigned to PCB, and 38.6% of patients assigned to PES. The pairwise comparison between PES and PCB resulted in a non-significant difference in target lesion revascularization.

The study found that both PES and PCB significantly reduced target lesion revascularization compared with PB. However, the excess of death and cardiac death associated with PES compared with PCB within 5 years after PCI and the results of the competing risk analysis are challenging to interpret and warrant further analysis.

Source:

Giacoppo, D., Alvarez-Covarrubias, H. A., Koch, T., Cassese, S., Xhepa, E., Kessler, T., Wiebe, J., Joner, M., Hochholzer, W., Laugwitz, K.-L., Schunkert, H., Kastrati, A., & Kufner, S. (2023). Coronary artery restenosis treatment with plain balloon, drug-coated balloon, or drug-eluting stent: 10-year outcomes of the ISAR-DESIRE 3 trial. In European Heart Journal. Oxford University Press (OUP). https://doi.org/10.1093/eurheartj/ehad026