DISRUPT PAD III Randomized Clinical Trial

Shockwave Intravascular Lithotripsy (IVL) provides superior vessel prep and excellent long-term results in calcified vessels while preserving future treatment options.

DISRUPT PAD III RCT logo
DISRUPT PAD III Randomized Clinical Trial logo

Key Findings

  • Superior Prep

    Shockwave IVL’s unique mechanism of action (MOA) delivers significantly more luminal gain with lower dilation pressure and significantly lower dissections.

  • Preserved Options

    Shockwave IVL maintains control of the procedure by minimizing complications such as dissections, embolization and perforations. Shockwave IVL significantly reduces the need for bailout stents, preserving future treatment options.

  • Excellent Long-term Results

    Shockwave IVL has demonstrated excellent patency out to two years in a severely calcified patient population.

Study Design & Characteristics

Objective:

To assess safety and effectiveness of IVL versus percutaneous transluminal angioplasty (PTA) as a vessel preparation strategy prior to definitive treatment with drug-coated balloon (DCB) +/- stent in patients with calcified femoropopliteal lesions

Design:

  • Prospective
  • Multicenter
  • Single-blind
  • Randomized clinical trial (RCT)

Primary Endpoint:

  • Procedural success (residual stenosis ≤ 30% without flow-limiting dissection)

Powered Secondary:

  • Primary patency at one year (freedom from clinically driven target lesion revascularization (CD-TLR) + freedom from restenosis determined by duplex ultrasound (US) + freedom from provisional stenting)
306 superficial femoral artery (SFA)/popliteal lesions
83% severe calcification*; 129 mm* average calcified length

*IVL Arm

Superior Prep

Shockwave IVL’s unique MOA delivers significantly more luminal gain with lower dilatation pressure and less need for post-dilatation.

Bar and icon graph illustrating superior procedural success and atraumatic treatment outcomes between Intravascular Lithotripsy (IVL) and Percutaneous Transluminal Angioplasty (PTA).

Preserved Options

Shockwave IVL maintains control of the procedure by minimizing complications such as dissections, embolization and perforations. Shockwave IVL significantly reduces the need for bailout stents, preserving future treatment options.

Three-part infographic showing the clinical benefits of Intravascular Lithotripsy (IVL) compared to Percutaneous Transluminal Angioplasty (PTA) in terms of reduced dissections, lower complications, and reduced bailout stenting.

  • Embolic protection: Utilized in 1.3% of cases in Shockwave IVL treatment arm
  • Provisional stent: Utilized if residual stenosis ≥50% by visual estimate or unresolved ≥ type D dissection, and trans-lesional gradient > 10 mmHg

Excellent Long-term Results

Shockwave IVL has demonstrated excellent patency out to two years in a severely calcified patient population.

Graph comparing primary patency rates over 24 months between two treatment groups: IVL + DCB (Intravascular Lithotripsy + Drug-Coated Balloon, in blue) and PTA + DCB (Percutaneous Transluminal Angioplasty + Drug-Coated Balloon, in gray).

 

Number of subjects at risk:

Months After Index Procedure 0 6 12 18 24
Shockwave IVL  131  120 107 88 83
PTA  136 107 95 75 66

*Primary patency defined as freedom from provisional stenting at index procedure, freedom from clinically-driven target lesion revascularization, and freedom from restenosis determined by duplex ultrasound. 

Conclusion

  • DISRUPT PAD III compared endovascular therapy of IVL to percutaneous transluminal angioplasty (PTA) for treatment of calcified peripheral arteries.

  • Results validate Shockwave IVL as a safe and effective treatment for heavily calcified femoropopliteal lesions.

  • Shockwave IVL provides superior vessel prep and excellent long-term results in calcified vessels while preserving future treatment options.

Study Leadership

This section contains attributions including profile pictures, titles, descriptions, and Twitter handles.

  • Gunnar Tepe, MD
    Professor of Radiology, Head of Diagnostic & Interventional Radiology, RoMed Clinic, Rosenheim, Germany
  • Marianne Brodmann, MD
    Head of Division of Angiology, Medical University Graz, Graz, Austria
  • William Bachinsky, MD
    Cardiologist, Penn State Health Holy Spirit Medical Center, Mechanicsburg, PA
  • Sahil. A Parikh, MD
    Associate Professor of Medicine, Columbia University, New York, NY
  • William A. Gray, MD
    Professor of Medicine, Main Line Health, Wynnewood, PA

Tepe et al Intravascular Lithotripsy for Peripheral Artery Calcification: Mid-term Outcomes From the Randomized Disrupt PAD III Trial. JSCAI, Volume 1, Issue 4, 100341.
Tepe et al Intravascular Lithotripsy for Peripheral Artery Calcification 30-Day Outcomes From the Randomized Disrupt PAD III Trial JACC Cardiovasc Interv. 2021 Jun 28;14(12):1352-1361.

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