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<p>In-stent restenosis (ISR) is the leading cause of revascularization failure, occurring in up to 10% of patients within 10&#xa0;years after drug-eluting stent (DES) implantation, and is associated with increased mortality and rehospitalization. Guideline-writing authorities recommend DES over drug-coated balloons (DCB) for ISR treatment. However, this indication is mainly based on trials that did not incorporate intravascular imaging. Recent findings suggest that optical coherence tomography (OCT) patterns in ISR may influence treatment outcomes. The ISAR-DESIRE 5 trial is a randomized study to evaluate whether OCT-defined&#xa0;ISR tissue morphology affects treatment with DES versus DCB. 376 patients with ISR will be stratified by OCT pattern (homogeneous vs. non-homogeneous) and randomized 1:1 to DES or DCB. The trial is powered to detect an interaction between OCT pattern and treatment modality on the 24-month incidence of major adverse cardiac events and represents a step toward establishing a more individualized approach to ISR management.</p><p><b>Trial registration&#xa0;(ClinicalTrials.gov):</b> NCT05544864.</p> Graphical Abstract <p>ISAR-DESIRE 5 Trial design overview. After classification of the predominant OCT restenotic pattern at the site of the MLA as either homogeneous or non-homogeneous, patients will undergo 1:1 randomization to receive either a DES or a DCB, using a stratified randomization approach. This unique design ensures balanced allocation of treatment modalities (DES or DCB) across the two OCT-defined restenotic patterns. DCB: Drug-Coated Balloon; DES: Drug-Eluting Stent; MLA: Minimum Lumen Area; OCT: Optical Coherence Tomography</p> <p></p>

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Intracoronary Stenting and Restenosis – Randomized Trial of Drug-Eluting Stent Implantation or Drug-Coated Balloon Angioplasty According to Neointima Morphology in Drug-Eluting Stent REstenosis 5: Rationale and Design of the ISAR-DESIRE 5 Trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年6月30日

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  • Fiorenzo Simonetti,
  • Felix Voll,
  • Fernando Alfonso,
  • Christian Gräßer,
  • Marion Janisch,
  • Michael Joner,
  • Thorsten Kessler,
  • Constantin Kuna,
  • David Manuel Leistner,
  • Tobias Lenz,
  • Antonia Presch,
  • Tobias Rheude,
  • Hendrik Sager,
  • Heribert Schunkert,
  • Fabian Starnecker,
  • Jens Wiebe,
  • Adnan Kastrati,
  • Salvatore Cassese,
  • Erion Xhepa

摘要

In-stent restenosis (ISR) is the leading cause of revascularization failure, occurring in up to 10% of patients within 10 years after drug-eluting stent (DES) implantation, and is associated with increased mortality and rehospitalization. Guideline-writing authorities recommend DES over drug-coated balloons (DCB) for ISR treatment. However, this indication is mainly based on trials that did not incorporate intravascular imaging. Recent findings suggest that optical coherence tomography (OCT) patterns in ISR may influence treatment outcomes. The ISAR-DESIRE 5 trial is a randomized study to evaluate whether OCT-defined ISR tissue morphology affects treatment with DES versus DCB. 376 patients with ISR will be stratified by OCT pattern (homogeneous vs. non-homogeneous) and randomized 1:1 to DES or DCB. The trial is powered to detect an interaction between OCT pattern and treatment modality on the 24-month incidence of major adverse cardiac events and represents a step toward establishing a more individualized approach to ISR management.

Trial registration (ClinicalTrials.gov): NCT05544864.

Graphical Abstract

ISAR-DESIRE 5 Trial design overview. After classification of the predominant OCT restenotic pattern at the site of the MLA as either homogeneous or non-homogeneous, patients will undergo 1:1 randomization to receive either a DES or a DCB, using a stratified randomization approach. This unique design ensures balanced allocation of treatment modalities (DES or DCB) across the two OCT-defined restenotic patterns. DCB: Drug-Coated Balloon; DES: Drug-Eluting Stent; MLA: Minimum Lumen Area; OCT: Optical Coherence Tomography