Balloon Lithotripsy Added to Conventional Preparation Before Stent Implantation in Severely Calcified Coronary Lesions

Andreas T Kristensen; Evald H Christiansen; Niels R Holm; Henning Kelbæk; Thomas Engstrøm; Karsten Veien; Bent Raungaard; Ola Kleveland; Johan Bennett; Peep Laanmets; Lars Jakobsen; Ole Havndrup; Jacob T Lønborg; Ole Ahlehoff; Allan Iversen; Anil K Vatwani; Nicolaj B Støttrup; Lisette O Jensen; Martin K Christensen; Sune A Haahr-Pedersen; Mette G Charlot; Erin E Gabriel; Niels T Olsen

doi:10.1016/j.jcin.2025.09.028

Balloon Lithotripsy Added to Conventional Preparation Before Stent Implantation in Severely Calcified Coronary Lesions

Andreas T Kristensen^*, Evald H Christiansen, Niels R Holm, Henning Kelbæk, Thomas Engstrøm, Karsten Veien, Bent Raungaard, Ola Kleveland, Johan Bennett, Peep Laanmets, Lars Jakobsen, Ole Havndrup, Jacob T Lønborg, Ole Ahlehoff, Allan Iversen, Anil K Vatwani, Nicolaj B Støttrup, Lisette O Jensen, Martin K Christensen, Sune A Haahr-PedersenMette G Charlot, Erin E Gabriel, Niels T Olsen

^*Corresponding author af dette arbejde

Abstract

BACKGROUND: Percutaneous coronary intervention in severely calcified lesions is associated with an increased risk for procedural complications and impaired clinical outcomes. Intravascular lithotripsy is a balloon-based technique that uses pressure waves to fracture calcified plaques. However, no randomized evidence supports the routine use of lithotripsy in clinical practice.

OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of adding lithotripsy to conventional lesion preparation in severely calcified lesions.

METHODS: In an international and assessor-blinded trial, patients with severely calcified coronary lesions were randomized to lesion preparation with vs without lithotripsy before stent implantation. The primary composite endpoint consisted of procedural failure (failed or no stent delivery, or residual area stenosis ≥20% by optical coherence tomography) or target vessel failure (cardiac death, myocardial infarction, or clinically driven revascularization) at 1 year.

RESULTS: Ninety-nine patients were randomized to lithotripsy and 101 patients to conventional lesion preparation. The primary endpoint occurred in 35 patients (35%) in the lithotripsy group vs 52 patients (52%) in the conventional group (RR: 0.69; 95% CI: 0.48-0.97; P = 0.02). Residual area stenosis ≥20% was the most frequent component of the primary endpoint and occurred in 32 patients (32%) in the lithotripsy group vs 45 patients (45%) in the conventional group (RR: 0.73; 95% CI: 0.49-1.04). Safety endpoints did not differ between groups.

CONCLUSIONS: Adding lithotripsy to lesion preparation using conventional techniques before stent implantation in severely calcified lesions reduced the combined incidence of procedural failure or target vessel failure at 1 year. The reduced incidence was driven primarily by a reduction in residual area stenosis ≥20%. (Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions [BALI]; NCT04253171).

Originalsprog	Engelsk
Tidsskrift	JACC. Cardiovascular interventions
ISSN	1936-8798
DOI	https://doi.org/10.1016/j.jcin.2025.09.028
Status	E-pub ahead of print - 18 nov. 2025

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10.1016/j.jcin.2025.09.028

Citationsformater

Kristensen, A. T., Christiansen, E. H., Holm, N. R., Kelbæk, H., Engstrøm, T., Veien, K., Raungaard, B., Kleveland, O., Bennett, J., Laanmets, P., Jakobsen, L., Havndrup, O., Lønborg, J. T., Ahlehoff, O., Iversen, A., Vatwani, A. K., Støttrup, N. B., Jensen, L. O., Christensen, M. K., ... Olsen, N. T. (2025). Balloon Lithotripsy Added to Conventional Preparation Before Stent Implantation in Severely Calcified Coronary Lesions. JACC. Cardiovascular interventions. Advance online publication. https://doi.org/10.1016/j.jcin.2025.09.028

Kristensen, AT, Christiansen, EH, Holm, NR, Kelbæk, H, Engstrøm, T, Veien, K, Raungaard, B, Kleveland, O, Bennett, J, Laanmets, P, Jakobsen, L, Havndrup, O, Lønborg, JT , Ahlehoff, O , Iversen, A, Vatwani, AK, Støttrup, NB, Jensen, LO, Christensen, MK, Haahr-Pedersen, SA, Charlot, MG, Gabriel, EE & Olsen, NT 2025, 'Balloon Lithotripsy Added to Conventional Preparation Before Stent Implantation in Severely Calcified Coronary Lesions', JACC. Cardiovascular interventions. https://doi.org/10.1016/j.jcin.2025.09.028

@article{8e4f94b68d8b44bba0126e6202f6e544,

title = "Balloon Lithotripsy Added to Conventional Preparation Before Stent Implantation in Severely Calcified Coronary Lesions",

abstract = "BACKGROUND: Percutaneous coronary intervention in severely calcified lesions is associated with an increased risk for procedural complications and impaired clinical outcomes. Intravascular lithotripsy is a balloon-based technique that uses pressure waves to fracture calcified plaques. However, no randomized evidence supports the routine use of lithotripsy in clinical practice.OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of adding lithotripsy to conventional lesion preparation in severely calcified lesions.METHODS: In an international and assessor-blinded trial, patients with severely calcified coronary lesions were randomized to lesion preparation with vs without lithotripsy before stent implantation. The primary composite endpoint consisted of procedural failure (failed or no stent delivery, or residual area stenosis ≥20% by optical coherence tomography) or target vessel failure (cardiac death, myocardial infarction, or clinically driven revascularization) at 1 year.RESULTS: Ninety-nine patients were randomized to lithotripsy and 101 patients to conventional lesion preparation. The primary endpoint occurred in 35 patients (35%) in the lithotripsy group vs 52 patients (52%) in the conventional group (RR: 0.69; 95% CI: 0.48-0.97; P = 0.02). Residual area stenosis ≥20% was the most frequent component of the primary endpoint and occurred in 32 patients (32%) in the lithotripsy group vs 45 patients (45%) in the conventional group (RR: 0.73; 95% CI: 0.49-1.04). Safety endpoints did not differ between groups.CONCLUSIONS: Adding lithotripsy to lesion preparation using conventional techniques before stent implantation in severely calcified lesions reduced the combined incidence of procedural failure or target vessel failure at 1 year. The reduced incidence was driven primarily by a reduction in residual area stenosis ≥20%. (Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions [BALI]; NCT04253171).",

author = "Kristensen, {Andreas T} and Christiansen, {Evald H} and Holm, {Niels R} and Henning Kelb{\ae}k and Thomas Engstr{\o}m and Karsten Veien and Bent Raungaard and Ola Kleveland and Johan Bennett and Peep Laanmets and Lars Jakobsen and Ole Havndrup and L{\o}nborg, {Jacob T} and Ole Ahlehoff and Allan Iversen and Vatwani, {Anil K} and St{\o}ttrup, {Nicolaj B} and Jensen, {Lisette O} and Christensen, {Martin K} and Haahr-Pedersen, {Sune A} and Charlot, {Mette G} and Gabriel, {Erin E} and Olsen, {Niels T}",

year = "2025",

month = nov,

day = "18",

doi = "10.1016/j.jcin.2025.09.028",

language = "English",

journal = "JACC. Cardiovascular interventions",

issn = "1936-8798",

publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - Balloon Lithotripsy Added to Conventional Preparation Before Stent Implantation in Severely Calcified Coronary Lesions

AU - Kristensen, Andreas T

AU - Christiansen, Evald H

AU - Holm, Niels R

AU - Kelbæk, Henning

AU - Engstrøm, Thomas

AU - Veien, Karsten

AU - Raungaard, Bent

AU - Kleveland, Ola

AU - Bennett, Johan

AU - Laanmets, Peep

AU - Jakobsen, Lars

AU - Havndrup, Ole

AU - Lønborg, Jacob T

AU - Ahlehoff, Ole

AU - Iversen, Allan

AU - Vatwani, Anil K

AU - Støttrup, Nicolaj B

AU - Jensen, Lisette O

AU - Christensen, Martin K

AU - Haahr-Pedersen, Sune A

AU - Charlot, Mette G

AU - Gabriel, Erin E

AU - Olsen, Niels T

PY - 2025/11/18

Y1 - 2025/11/18

N2 - BACKGROUND: Percutaneous coronary intervention in severely calcified lesions is associated with an increased risk for procedural complications and impaired clinical outcomes. Intravascular lithotripsy is a balloon-based technique that uses pressure waves to fracture calcified plaques. However, no randomized evidence supports the routine use of lithotripsy in clinical practice.OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of adding lithotripsy to conventional lesion preparation in severely calcified lesions.METHODS: In an international and assessor-blinded trial, patients with severely calcified coronary lesions were randomized to lesion preparation with vs without lithotripsy before stent implantation. The primary composite endpoint consisted of procedural failure (failed or no stent delivery, or residual area stenosis ≥20% by optical coherence tomography) or target vessel failure (cardiac death, myocardial infarction, or clinically driven revascularization) at 1 year.RESULTS: Ninety-nine patients were randomized to lithotripsy and 101 patients to conventional lesion preparation. The primary endpoint occurred in 35 patients (35%) in the lithotripsy group vs 52 patients (52%) in the conventional group (RR: 0.69; 95% CI: 0.48-0.97; P = 0.02). Residual area stenosis ≥20% was the most frequent component of the primary endpoint and occurred in 32 patients (32%) in the lithotripsy group vs 45 patients (45%) in the conventional group (RR: 0.73; 95% CI: 0.49-1.04). Safety endpoints did not differ between groups.CONCLUSIONS: Adding lithotripsy to lesion preparation using conventional techniques before stent implantation in severely calcified lesions reduced the combined incidence of procedural failure or target vessel failure at 1 year. The reduced incidence was driven primarily by a reduction in residual area stenosis ≥20%. (Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions [BALI]; NCT04253171).

AB - BACKGROUND: Percutaneous coronary intervention in severely calcified lesions is associated with an increased risk for procedural complications and impaired clinical outcomes. Intravascular lithotripsy is a balloon-based technique that uses pressure waves to fracture calcified plaques. However, no randomized evidence supports the routine use of lithotripsy in clinical practice.OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of adding lithotripsy to conventional lesion preparation in severely calcified lesions.METHODS: In an international and assessor-blinded trial, patients with severely calcified coronary lesions were randomized to lesion preparation with vs without lithotripsy before stent implantation. The primary composite endpoint consisted of procedural failure (failed or no stent delivery, or residual area stenosis ≥20% by optical coherence tomography) or target vessel failure (cardiac death, myocardial infarction, or clinically driven revascularization) at 1 year.RESULTS: Ninety-nine patients were randomized to lithotripsy and 101 patients to conventional lesion preparation. The primary endpoint occurred in 35 patients (35%) in the lithotripsy group vs 52 patients (52%) in the conventional group (RR: 0.69; 95% CI: 0.48-0.97; P = 0.02). Residual area stenosis ≥20% was the most frequent component of the primary endpoint and occurred in 32 patients (32%) in the lithotripsy group vs 45 patients (45%) in the conventional group (RR: 0.73; 95% CI: 0.49-1.04). Safety endpoints did not differ between groups.CONCLUSIONS: Adding lithotripsy to lesion preparation using conventional techniques before stent implantation in severely calcified lesions reduced the combined incidence of procedural failure or target vessel failure at 1 year. The reduced incidence was driven primarily by a reduction in residual area stenosis ≥20%. (Balloon Lithoplasty for Preparation of Severely Calcified Coronary Lesions [BALI]; NCT04253171).

U2 - 10.1016/j.jcin.2025.09.028

DO - 10.1016/j.jcin.2025.09.028

M3 - Journal article

C2 - 41400597

SN - 1936-8798

JO - JACC. Cardiovascular interventions

JF - JACC. Cardiovascular interventions

ER -

Balloon Lithotripsy Added to Conventional Preparation Before Stent Implantation in Severely Calcified Coronary Lesions

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