DISRUPT PAD III Observational Study

Count on it: The DISRUPT PAD III Observational Study (OS) is the largest prospective real-world evidence for the treatment of complex, heavily calcified peripheral artery disease (PAD).

DISRUPT PAD III OS logo
DISRUPT PAD III Observational Study logo

Key Findings

  • Predictable Outcomes in Challenging Situations

    DISRUPT PAD III OS saw predictably consistent results across vessel beds, challenging lesions and complex patients.

  • Real-world Outcomes Consistent with Randomized Trial

    Shockwave IVL safely and effectively modifies calcium across multiple vessel beds.

  • Optimized Procedural Insights

    The use of embolic protection was less when IVL was used as the only calcium modification tool; IVL saw better results with appropriate IVL sizing (oversizing 10%).

Study Design & Characteristics

Objective:

Assess real-world peri-procedural outcomes of Shockwave Intravascular Lithotripsy (IVL) for the treatment of calcified, stenotic peripheral arteries

Design:

  • Prospective
  • Multicenter
  • Single-blind
  • Observational study

Key Inclusion Criteria:

  • Rutherford classification 2-6
  • Moderate-severe calcification*
  • Ilio-femoral, femoral, popliteal and infrapopliteal arteries
Complex real-world patients & lesions
Results reinforce the predictability of Shockwave IVL & its ability to consistently modify calcium across vessel beds, challenging lesions & complex patients (CLTI, dialysis & female patients)

Statistics Callout

This section presents key statistical information with numbers and descriptions.

  • 1,373
    Complex real-world patients
  • 36
    %
    Chronic limb-threatening ischemia (CLTI) patients
  • 56
    %
    Diabetes mellitus
  • 27
    %
    Renal deficiency
  • 1,531
    Challenging lesions
  • 90
    %
    Moderate-severe calcium**
  • 115
    mm
    Average calcified length
  • 31
    %
    Chronic total occlusions (CTO)

Predictable Outcomes in Challenging Situations

DISRUPT PAD III OS saw predictably consistent results across vessel beds, challenging lesions and complex patients.

Majority of Stenosis Reduction Seen from IVL Treatment

Bar chart showing diameter stenosis percentages across various categories before the procedure (Pre-procedure), after Intravascular Lithotripsy (Post-IVL), and at the final measurement (Final). The chart is divided into three main sections: 'Vessel Beds,' 'Challenging Lesions,' and 'Complex Patients.'

Real-world Outcomes Consistent with Randomized Trial

Shockwave IVL safely and effectively modifies calcium across multiple vessel beds.

Strong Safety Profile

DISRUPT PAD III Randomized Clinical Trial (RCT)1 DISRUPT PAD III OS2
N 153 1,367
Vessels Superficial femoral artery (SFA)/popliteal Iliac, common femoral artery (CFA), SFA/popliteal, infrapopliteal
Dissection (Type D-F) 0% 0.7%
Perforation 0% 0.1%
Embolization 0% 0%
Slow flow/no reflow 0% 0%
Abrupt closure 0% 0%
Thrombus 0% 0%

Final angiographic complications (Core-Lab)

 

Proven Effective Calcium Modification

Bar chart showing the reduction in diameter stenosis after Shockwave IVL treatment.

Shockwave IVL Procedural Insights

  • Use of adjunctive technology was at the operator’s discretion
  • Use of embolic protection was less when Shockwave IVL was used as the only calcium modification tool
  • Shockwave IVL saw better results with appropriate Shockwave IVL sizing

When Shockwave IVL was used as the only calcium modification therapy†, there was less use of embolic protection.

A side-by-side comparison of embolic protection rates when IVL (Intravascular Lithotripsy) was used

 

Per a multivariable analysis, proper Shockwave IVL balloon sizing (≥ 1:1)‡ is an independent predictor of improved stenosis reduction but not a predictor of complications.

Illustration comparing balloon-to-artery ratio in intravascular procedures.

Conclusion

  • The DISRUPT PAD III OS 1,373 represents the largest prospective ‘real-world’ evidence for the treatment of heavily calcified peripheral artery disease.

  • The data reinforces the predictability of Shockwave IVL and its ability to consistently modify calcium across vessel beds, challenging lesions, and complex patients (CLI, dialysis & female patients).

  • Use of adjunctive technology was at the operator’s discretion – use of embolic protection was less when Shockwave IVL was used as the only the only calcium modification tool; IVL saw better results with appropriate IVL sizing.

  • Real-world outcomes of DISRUPT PAD III OS are consistent with the previously reported PAD III RCT showing that Shockwave IVL safely and effectively modifies calcium across multiple vessel beds.

Study Leadership

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

  • Ehrin J. Armstrong, MD
    Interventional Cardiologist, Advanced Heart & Vein Center, Thornton, CO
  • George Adams, MD
    Director of Clinical Cardioascular & Peripheral Vascular Research, UNC REX, Garner, NC
  • Peter A. Soukas, MD
    Director of Vascular Medicine, Brown University, Providence, RI
  • Sarang S. Mangalmurti, MD
    Interventional Cardiologist, Main Line Health, Bryn Mawr, PA
  • Nicolas W. Shammas, MD
    Medical Director of Cardiology Services, Trinity Bettendorf Hospital, Bettendorf, IA
  • Anderson Mehrle, MD
    Interventional Cardiologist, BlueStem Cardiology, Bartlesville, OK
  • Barry Bertolet, MD
    Director of Cardiac Catheterization Laboratory NMMC, Cardiology Associates of North Mississippi, Tupelo, MS
  • William A. Gray, MD
    Professor of Medicine, Main Line Health, Wynnewood, PA
  • Gunnar Tepe, MD
    Professor of Radiology, Head of Diagnostic & Interventional Radiology, RoMed Clinic, Rosenheim, Germany
  • Edward Y. Woo, MD
    Director of Vascular Program, Chief of Vascular Surgery, MedStar Regional, Washington D.C.
  • James F. McKinsey, MD
    Professor of Vascular Surgery & Interventional Radiology, Mount Sinai Health System, New York, NY
  • Andrew Holden, MD
    Professor, Director of Interventional Radiology, Auckland Hospital, Grafton, Auckland, New Zealand
  • Sahil A. Parikh, MD
    Associate Professor of Medicine, Columbia University, New York, NY
  • William Bachinsky, MD
    Cardiologist, Penn State Health Holy Spirit Medical Center, Mechanicsburg, PA
Explore peripheral studies
Explore peripheral studies
  • DISRUPT BTK II
    Global prospective, multi-center, single-arm study assessing the safety and effectiveness of Shockwave peripheral IVL in treating long, calcified BTK lesions.
    Peripheral IVL
  • DISRUPT PAD III Randomized Clinical Trial
    The largest-ever randomized clinical study of Shockwave peripheral IVL treatment in severely calcified peripheral lesions, out to 24 months.
    Peripheral IVL
  • DISRUPT PAD II
    Core lab adjudicated, long-term, multi-center study exclusively enrolling heavily calcified lesions building upon DISRUPT PAD I.
    Peripheral IVL

From Our Education Library

Explore more

*Presence of fluoroscopic evidence of calcification by PARC definition: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50 mm in length; or extending for minimum of 20 mm if lesion is <50 mm in length.
**PARC definition.
†Ca modifying therapy: atherectomy and/or scoring/cutting balloon.
‡PAD OS data analysis is consistent with prior PAD II data analysis and continues to support 1.1:1 sizing in the product instructions for use (IFU).

1: Tepe et al, J Am Coll Cardiol Intv 2021.
2: Armstrong EJ, Adams G, Soukas PA, Mangalmurti SS, Shammas NW, Mehrle A, Bertolet B, Gray WA, Tepe G, Woo EY, McKinsey JF, Holden A, Parikh SA. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Disrupt PAD III Observational Study. J Endovasc Ther. 2024 Oct 18:15266028241283716. doi: 10.1177/15266028241283716. Epub ahead of print. PMID: 39422234.