Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Disrupt PAD III Observational
Ehrin J Armstrong1, George Adams2, Peter A Soukas3
1Department of Cardiology, School of Medicine, University of Colorado, Denver, CO, USA.
Summary
Intravascular lithotripsy (IVL) effectively treats calcified peripheral artery disease (PAD) in real-world settings. This large study confirmed IVL’s safety and efficacy, even in complex cases, demonstrating consistent stenosis reduction.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Vascular Surgery
Background:
- Calcified peripheral artery disease (PAD) poses significant treatment challenges.
- Intravascular lithotripsy (IVL) has shown promise in smaller studies for PAD.
- Real-world data on IVL for complex calcified PAD is limited.
Purpose of the Study:
- To evaluate the real-world acute performance of intravascular lithotripsy (IVL).
- To assess IVL's safety and effectiveness in treating calcified peripheral artery disease (PAD).
- To identify predictors of procedural outcomes in a large, diverse patient cohort.
Main Methods:
- Prospective, multicenter, single-arm observational study (Disrupt PAD III OS).
- Inclusion of patients with claudication or critical limb-threatening ischemia (CLTI) and moderate-to-severe calcification.
- Multivariable analysis to determine independent predictors of procedural outcomes.
Main Results:
- 1373 patients and 1677 lesions were analyzed across 30 global sites.
- Excellent acute outcomes with 23.8% residual stenosis and low complication rates (0.9%).
- Predictors of success included lesion length, female sex, younger age, appropriate IVL balloon sizing, and CTOs.
Conclusions:
- The Disrupt PAD III OS is the largest assessment of IVL in calcified PAD.
- IVL demonstrates excellent safety and effectiveness in real-world practice, translating trial results to broader populations.
- Proper IVL balloon sizing is crucial for optimal acute stenosis reduction in complex PAD.
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