Intravascular lithotripsy for the treatment of calcified coronary lesions in individuals of advanced age: a post-hoc analysis of the multicentre, prospective BENELUX-IVL studyResearch in context
Summary: Background: Patients of advanced age are frequently underrepresented or excluded from major clinical trials, leading to limited evidence in this population and a reliance on data extrapolated from younger populations. The present study aims to compare and evaluate the safety and efficacy o...
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| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-07-01
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| Series: | EClinicalMedicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589537025002743 |
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| Summary: | Summary: Background: Patients of advanced age are frequently underrepresented or excluded from major clinical trials, leading to limited evidence in this population and a reliance on data extrapolated from younger populations. The present study aims to compare and evaluate the safety and efficacy of intravascular lithotripsy (IVL) for the treatment of calcified coronary lesions in individuals of advanced age and in younger populations. Methods: In this post-hoc analysis, from the ongoing prospective, multicenter BENELUX-IVL registry involving nine hospitals across four countries in the European Union, patients undergoing percutaneous coronary intervention (PCI) with intravascular lithotripsy (IVL) were retrospectively stratified into two groups: advanced age (≥80 years) and younger (<80 years). The primary technical endpoint was technical success, defined as successful IVL catheter crossing of the target lesion with residual stenosis <30%. The primary safety endpoint was in-hospital major adverse cardiac events (MACE). This study is registered with ClinicalTrials.gov, number NCT06577038. Findings: Between January 2019 and April 2025, 583 patients underwent PCI with IVL; of these, 147 (25.2%) patients were aged ≥80 years (advanced age cohort), and the remaining 436 (74.8%) were aged <80 years (younger cohort). Compared to younger patients, the advanced age cohort had higher SYNTAX score (23 [IQR 15–32] vs. 18 [IQR 11–28], p = 0.01) and more comorbidities. Intraprocedural complications (severe dissection, abrupt vessel closure, and perforation) were low in both groups, with no significant differences between them. Technical success was comparable between the advanced age and younger populations (87.8% vs. 90.6%, RR: 0.97 (0.91–1.04), p = 0.32). In-hospital MACE rates were similar between the advanced age and younger cohorts (1.4% vs. 2.1%, RR: 0.64 (0.19–2.18), p = 0.59), and these results remained consistent at 1-year follow-up (6.1% vs. 8.0%, RR: 0.76 (0.38–1.55) p = 0.51). Interpretation: In patients of advanced age, IVL for calcified coronary lesions demonstrates a favorable safety and efficacy profile, with high technical success and low rates of device-related adverse events. Nonetheless, larger studies with extended follow-up are warranted to confirm these findings and establish long-term outcomes. Funding: This work was funded through a research grant from Shockwave Medical. |
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| ISSN: | 2589-5370 |