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-Pedersen

Mette G Charlot, Erin E Gabriel, Niels T Olsen

^*Corresponding author for this work

Cardiology

Research output: Contribution to journal › Article › Research › peer-review

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).

Original language	English
Pages (from-to)	331-341
Number of pages	11
Journal	JACC: Cardiovascular Interventions
Volume	19
Issue number	3
Early online date	18 Nov 2025
DOIs	https://doi.org/10.1016/j.jcin.2025.09.028
Publication status	Published - 9 Feb 2026

Keywords

Humans
Male
Female
Vascular Calcification/therapy
Aged
Treatment Outcome
Coronary Artery Disease/therapy
Severity of Illness Index
Stents
Middle Aged
Time Factors
Lithotripsy/adverse effects
Angioplasty, Balloon, Coronary/adverse effects
Risk Factors
Coronary Stenosis/therapy
Coronary Angiography
Tomography, Optical Coherence
Percutaneous Coronary Intervention/instrumentation
Europe
Prospective Studies
Percutaneous coronary intervention
Rotational atherectomy
Ischemic heart disease
Lithotripsy
Vascular calcification
KEY WORDS calcium modification

Access to Document

10.1016/j.jcin.2025.09.028

Cite this

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. (2026). Balloon Lithotripsy Added to Conventional Preparation Before Stent Implantation in Severely Calcified Coronary Lesions. JACC: Cardiovascular Interventions, 19(3), 331-341. https://doi.org/10.1016/j.jcin.2025.09.028

@article{823cf741e0814bcfb097bea3a4ed01ee,

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).",

keywords = "Humans, Male, Female, Vascular Calcification/therapy, Aged, Treatment Outcome, Coronary Artery Disease/therapy, Severity of Illness Index, Stents, Middle Aged, Time Factors, Lithotripsy/adverse effects, Angioplasty, Balloon, Coronary/adverse effects, Risk Factors, Coronary Stenosis/therapy, Coronary Angiography, Tomography, Optical Coherence, Percutaneous Coronary Intervention/instrumentation, Europe, Prospective Studies, Percutaneous coronary intervention, Rotational atherectomy, Ischemic heart disease, Lithotripsy, Vascular calcification, KEY WORDS calcium modification",

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 = "2026",

month = feb,

day = "9",

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

language = "English",

volume = "19",

pages = "331--341",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier",

number = "3",

}

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 2026, 'Balloon Lithotripsy Added to Conventional Preparation Before Stent Implantation in Severely Calcified Coronary Lesions', JACC: Cardiovascular Interventions, vol. 19, no. 3, pp. 331-341. https://doi.org/10.1016/j.jcin.2025.09.028

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 - 2026/2/9

Y1 - 2026/2/9

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).

KW - Humans

KW - Male

KW - Female

KW - Vascular Calcification/therapy

KW - Aged

KW - Treatment Outcome

KW - Coronary Artery Disease/therapy

KW - Severity of Illness Index

KW - Stents

KW - Middle Aged

KW - Time Factors

KW - Lithotripsy/adverse effects

KW - Angioplasty, Balloon, Coronary/adverse effects

KW - Risk Factors

KW - Coronary Stenosis/therapy

KW - Coronary Angiography

KW - Tomography, Optical Coherence

KW - Percutaneous Coronary Intervention/instrumentation

KW - Europe

KW - Prospective Studies

KW - Percutaneous coronary intervention

KW - Rotational atherectomy

KW - Ischemic heart disease

KW - Lithotripsy

KW - Vascular calcification

KW - KEY WORDS calcium modification

U2 - 10.1016/j.jcin.2025.09.028

DO - 10.1016/j.jcin.2025.09.028

M3 - Article

C2 - 41400597

SN - 1936-8798

VL - 19

SP - 331

EP - 341

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 3

ER -

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

Abstract

Keywords

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