What is the clinical evidence from this study?

Population: Severely calcified de novo coronary artery disease (n=431). Intervention: Intravascular lithotripsy (IVL) vs. Pre-specified performance goal. Primary outcome: Freedom from major adverse cardiovascular events (cardiac death, myocardial infarction, or target vessel revascularization) at 30 days (p=<0.0001).

What question did this study set out to answer?

To assess the safety and effectiveness of intravascular lithotripsy in severely calcified de novo coronary lesions.

May 11, 2026Journal of the American College of Cardiology

Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease

Q: What are the key findings of this study?

Intravascular lithotripsy in severely calcified coronary lesions achieved 92.2% freedom from 30-day MACE and 92.4% procedural success, both significantly exceeding pre-specified performance goals.

Q: What question did this study set out to answer?

To assess the safety and effectiveness of intravascular lithotripsy in severely calcified de novo coronary lesions.

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Key result

Coronary IVL achieves ~92% 30-day freedom from MACE in severely calcified lesions.

P<0.0001
n=431

Why the study?

Coronary calcification hinders stent delivery and expansion and is associated with adverse outcomes, necessitating assessment of intravascular lithotripsy in severely calcified lesions.

Does intravascular lithotripsy safely and effectively facilitate stent implantation in patients with severely calcified de novo coronary lesions?

Key Points

To assess the safety and effectiveness of intravascular lithotripsy in severely calcified de novo coronary lesions.
Disrupt CAD III (NCT03595176) was a prospective, single-arm multicenter trial designed for regulatory approval of coronary intravascular lithotripsy, enrolling 431 patients across 47 sites in 4 countries.
The primary safety endpoint was 30-day freedom from major adverse cardiovascular events (cardiac death, myocardial infarction, or target vessel revascularization), and the primary effectiveness endpoint was procedural success, both compared against pre-specified performance goals.
Vessel compliance and the mechanism of calcium modification were evaluated through a dedicated optical coherence tomography substudy.
The primary safety endpoint of 30-day freedom from major adverse cardiovascular events was 92.2% (lower bound of 95% CI: 89.9%), significantly exceeding the performance goal of 84.4% (p < 0.0001).
The primary effectiveness endpoint of procedural success was 92.4% (lower bound of 95% CI: 90.2%), significantly exceeding the performance goal of 83.4% (p < 0.0001).
Optical coherence tomography demonstrated multiplane and longitudinal calcium fractures in 67.4% of lesions following intravascular lithotripsy, achieving an average minimum stent area of 6.5 ± 2.1 mm².

Structured PICO

Does intravascular lithotripsy safely and effectively facilitate stent implantation in patients with severely calcified de novo coronary lesions?

Population

431 patients with severely calcified de novo coronary lesions, followed for 30 days.

Intervention

Intravascular lithotripsy (IVL) prior to stent deployment

Comparator

Pre-specified performance goals (single-arm study)

Outcome

Primary safety endpoint: freedom from major adverse cardiovascular events (cardiac death, myocardial infarction, or target vessel revascularization) at 30 days. Primary effectiveness endpoint: procedural success.composite

Main Result

Absolute Event Rate: 92.2% vs 84.4%

p-value: p=<0.0001

Discussion

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Implication

Coronary intravascular lithotripsy is safe and effective for modifying severe calcium to facilitate stent deployment, exceeding pre-specified regulatory performance goals.

Cite This Study

Hill et al. (2020) studied Severely calcified de novo coronary artery disease (n=431). Intravascular lithotripsy (IVL) vs. Pre-specified performance goal was evaluated on Freedom from major adverse cardiovascular events (cardiac death, myocardial infarction, or target vessel revascularization) at 30 days (p=<0.0001). Intravascular lithotripsy in severely calcified coronary lesions achieved 92.2% freedom from 30-day MACE and 92.4% procedural success, both significantly exceeding pre-specified performance goals.

synapsesocial.com/papers/6a0247c110c286f4f661f338 https://doi.org/10.1016/j.jacc.2020.09.603

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Implication

Coronary intravascular lithotripsy is safe and effective for modifying severe calcium to facilitate stent deployment, exceeding pre-specified regulatory performance goals.

Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease

Key Points

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Artery Disease

Key Points

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Also Consider

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