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Randomized Controlled Trial
. 2025 Sep 2;25(1):648.
doi: 10.1186/s12872-025-05082-z.

Comparison of the efficacy of intravascular lithotripsy and rotational atherectomy as adjunctive therapy before drug-eluting stent implantation in calcified coronary lesions (CCS- Coronary Calcification Study)

Leos Pleva  1   2 , Pavel Kukla  3 , Adela Konde  4   5
Affiliations
Randomized Controlled Trial

Comparison of the efficacy of intravascular lithotripsy and rotational atherectomy as adjunctive therapy before drug-eluting stent implantation in calcified coronary lesions (CCS- Coronary Calcification Study)

Leos Pleva et al. BMC Cardiovasc Disord. .

Abstract

Background: This prospective randomized study compares the efficacy of novel intravascular lithotripsy (IVL) to the standard preparation of calcified coronary lesions based on rotational atherectomy (RA).

Methods: A total of 50 patients with 52 calcified lesions were enrolled in the study and randomized 1:1 to be treated with IVL or RA followed by drug-eluting stent (DES) implantation. The procedural success was chosen as a primary endpoint and the 12-month late lumen loss (LLL) as measured by quantitative coronarography, the incidence of binary in-stent restenosis (ISR), 12-month major adverse cardiac events (MACE) and target lesion failure (TLF) served as secondary angiographic and clinical endpoints.

Results: Procedural success was achieved in 21 patients (84.0%) in the IVL group and in 24 patients (96%) in the RA group (p = 0.349). The secondary endpoints, including 12-month LLL (0.12 mm [IQR: - 0.06; 0.68] vs. 0.61 mm [IQR: 0.22; 0.72]; p = 0.084), the incidence of 12-month binary ISR (11.1% vs. 8.0%; p >0.999), MACE (18.5% vs. 8.0%; p = 0.422), TLR (14.8% vs. 8.0%; p = 0.670) or TLF (18.5% vs. 8.0%; p = 0.422) did not show significant differences between the IVL and RA groups.

Conclusion: Despite different approaches to the treatment of calcified coronary lesions, both therapeutic techniques achieved similar procedural, angiographic and clinical results. (ClinicalTrials.gov NCT04428177).

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Conflict of interest statement

Declarations. Consent for publication: Not Applicable. Competing interests: The authors declare no competing interests. Indexing words: intravascular lithotripsy; rotational atherectomy; coronary calcification. Ethics approval and consent.: The study protocol complied with the Declaration of Helsinki and was approved by the Ethics Committee of University Hospital Ostrava, Czech Republic. The study was registered at ClinicalTrials.gov (NCT04428177) on 09th June 2020. Written informed consent was obtained from each patient before enrolment in the study. Funding: This study is supported by the Ministry of Health, Czech Republic - conceptual development of research organizations - FNOs/2020. I would like to express my sincere gratitude to my colleagues from the Department of Invasive Cardiology, whose support was indispensable in the completion of this work. CONSORT guidelines statement: We hereby declare that our study adheres to CONSORT guidelines and include a completed CONSORT checklist as an suplementary file.

Figures

Fig. 1
Fig. 1
CONSORT 2010 Flow Diagram
Fig. 2
Fig. 2
Combined boxplot and violin plot of the LLL distribution
Fig. 3
Fig. 3
Event-free survival
See this image and copyright information in PMC

References

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