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Comparison of long-term outcome in patients with in-stent restenosis treated with intravascular lithotripsy or with modified balloon angioplasty

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Abstract

Background

Modified balloon angioplasty (MB) using a cutting-/scoring balloon or intravascular lithotripsy (IVL) is used in patients with in-stent restenosis (ISR). However, IVL is an off-label use in this setting. The aim of this subgroup analysis of an all-comers registry was to compare IVL to MB angioplasty in patients with ISR.

Methods

The subgroup (n = 117) included all patients with an ISR treated by MB or IVL between 2019 and 2021. Primary endpoint was strategy success (< 20% residual stenosis). The secondary endpoint was cardiac death, acute myocardial infarction (AMI) and target lesion failure/revascularization (TVR). Quantitative coronary angiography was performed in all patients.

Results

A total of n = 36 patients were treated by IVL and n = 81 patients by MB. No significant differences in baseline characteristics were observed between the groups. The primary endpoint was reached in 99 patients (84.6%). Patients in the IVL group had less residual stenosis (2.8% vs. 21.0%; p = 0.012). Multivariate regression analysis revealed that IVL had a significant positive effect on reaching the primary end point (Estimate 2.857; standard error (SE) 1.166; p = 0.014).

During the follow-up period (450 days) there were no significant differences in rates of cardiac death (IVL n = 2 (1.7%) vs. MB n = 3 (2.6%); p = 0.643), AMI (IVL n = 2 (1.7%) vs. MB n = 4 (3.4%); p = 0.999) and TVR (IVL n = 5 (4.3%) vs. MB n = 14 (12%); p = 0.851).

Conclusion

IVL results in a significantly lower rate of residual stenosis than MB in patients with ISR. During the long-term follow-up, no differences in rates of cardiac death, AMI or TVR were observed.

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Data availability

The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.

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Acknowledgements

We thank Sebastian Runge, of the Runge Statistik GmbH for statistical analysis and advice.

Funding

Unrestricted grant, Shockwave Medical Inc (Santa Clara, CA, USA).

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Contributions

Each author has contributed significantly to the manuscript including: substantial contributions to the conception and design, acquisition of data, or analysis and interpretation of data, drafting the article or revising it critically for important intellectual content, and final approval of the version to be published.

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Correspondence to Jürgen Leick.

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Conflict of interest

JL: Speaker honorarium AstraZeneca, Boston Scientific, Shockwave Medical, Abiomed. NW: speaker honorarium, travel grants, and adviser Abiomed, Boston Scientific, Shockwave Medical. TR: lecture fees SIS Medical AG and AstraZeneca, not related to the current work. Other authors have no relevant disclosures.

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Leick, J., Rheude, T., Denne, M. et al. Comparison of long-term outcome in patients with in-stent restenosis treated with intravascular lithotripsy or with modified balloon angioplasty. Clin Res Cardiol (2023). https://doi.org/10.1007/s00392-023-02357-3

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