Recurrent Revascularization at 10 Years After Percutaneous Treatment of Drug-Eluting Stent Restenosis

Tobias Koch; Tobias Lenz; Tobias Rheude; Salvatore Cassese; Mej Kazazi; Erion Xhepa; Thorsten Kessler; Jens Wiebe; Miroslaw Ferenc; Karl-Ludwig Laugwitz; Michael Joner; Heribert Schunkert; Adnan Kastrati; Sebastian Kufner

doi:10.1016/j.jcin.2023.10.031

Recurrent Revascularization at 10 Years After Percutaneous Treatment of Drug-Eluting Stent Restenosis

JACC Cardiovasc Interv. 2024 Jan 8;17(1):1-13. doi: 10.1016/j.jcin.2023.10.031. Epub 2023 Oct 26.

Affiliations

¹ ISAResearch Zentrum, Deutsches Herzzentrum München, an der Technische Universität München, Munich, Germany.
² ISAResearch Zentrum, Deutsches Herzzentrum München, an der Technische Universität München, Munich, Germany; Deutsches Zentrum für Herz-Kreislauf-Forschung, Partner Site Munich, Munich, Germany.
³ Department of Cardiology, Universitätsherzzentrum Freiburg Bad Krotzingen, Bad Krotzingen, Germany.
⁴ Deutsches Zentrum für Herz-Kreislauf-Forschung, Partner Site Munich, Munich, Germany; Erste Medizinische Klinik, Klinikum Rechts der Isar der Technischen Universität München, Munich, Germany.
⁵ ISAResearch Zentrum, Deutsches Herzzentrum München, an der Technische Universität München, Munich, Germany; Deutsches Zentrum für Herz-Kreislauf-Forschung, Partner Site Munich, Munich, Germany. Electronic address: sebastian.kufner@tum.de.

PMID: 37902151
DOI: 10.1016/j.jcin.2023.10.031

Abstract

Background: Treatment of patients with recurrence of in-stent restenosis (ISR) remains particularly challenging, with data and guideline recommendations for repeat percutaneous coronary intervention being scant.

Objectives: The aim of this study was to investigate the long-term incidence of recurrent revascularization events after percutaneous treatment of drug-eluting stent (DES) ISR.

Methods: In this post hoc analysis, 402 patients (500 lesions) assigned to plain balloon (PB), drug-coated balloon (DCB), or DES treatment in the randomized ISAR-DESIRE 3 (Efficacy Study of Paclitaxel-Eluting Balloon, -Stent vs. Plain Angioplasty for Drug-Eluting Stent Restenosis) trial were followed up over a median of 10.3 years. The primary endpoint was total repeat target lesion revascularization (R-TLR) including all, first and recurrent, events.

Results: At the end of follow-up, first R-TLR was required in 204 lesions, 82 in the PB group, 70 in the DCB group, and 52 in the DES group. The total number of R-TLRs was 373: 162 in the PB group, 124 in the DCB group, and 87 in the DES group. During the first year of follow-up, the risk for total R-TLR was reduced by DCB (HR: 0.36; 95% CI: 0.24-0.54) and DES (HR: 0.23; 95% CI: 0.14-0.38) treatment compared with PB treatment. After 1 year, the risk for total R-TLR was nonsignificantly reduced by DCB treatment (HR: 0.77; 95% CI: 0.51-1.16) and significantly reduced by DES treatment (HR: 0.61; 95% CI: 0.39-0.95) compared with PB treatment. Risk in the DCB and DES groups was similar during (HR: 1.54; 95% CI: 0.89-2.69) and after (HR: 1.26; 95% CI: 0.82-1.92) 1 year.

Conclusions: The total number of R-TLRs over 10 years after treatment of patients with DES ISR was high. DCBs and particularly DES were able to reduce the need for both first and recurrent revascularization compared with PB treatment.

Keywords: DCB; DES; PB; R-ISR; drug-coated balloon; drug-eluting stent; plain balloon; recurrent in-stent restenosis.

MeSH terms

Angioplasty, Balloon, Coronary
Coated Materials, Biocompatible
Coronary Angiography
Coronary Restenosis* / diagnostic imaging
Coronary Restenosis* / etiology
Coronary Restenosis* / therapy
Drug-Eluting Stents* / adverse effects
Humans
Paclitaxel
Percutaneous Coronary Intervention
Randomized Controlled Trials as Topic
Treatment Outcome

Substances

Coated Materials, Biocompatible
Paclitaxel