Shockwave Medical Peripheral Lithoplasty System Study for PAD - Disrupt PAD III

Jul 06, 2021
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Author/Summarized by Author:
Anthony A. Bavry, MD,MPH,FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Shockwave Medical
Date Published:
06/21/2021
Date Updated:
07/06/2021
Original Posted Date:
07/06/2021
References

Contribution To Literature:

The Disrupt PAD III trial showed that intravascular lithotripsy was beneficial for vessel preparation prior to drug-coated balloon or stenting.

Description:

The goal of the trial was to evaluate intravascular lithotripsy compared with percutaneous transluminal angioplasty among patients with symptomatic femoropopliteal artery disease.

Study Design

  • Randomized
  • Parallel

Patients with symptomatic femoropopliteal artery disease were randomized to intravascular lithotripsy (n = 153) versus percutaneous transluminal angioplasty (n = 153) prior to drug-coated balloon or stenting.

  • Total number of enrollees: 306
  • Duration of follow-up: 30 days
  • Mean patient age: 72 years
  • Percentage female: 26%
  • Percentage with diabetes: 42%

Inclusion criteria:

  • Symptomatic (leg claudication or rest pain) femoropopliteal artery disease
  • Moderate to severe calcification
  • Lesion length up to 180 mm
  • Reference vessel diameter 4-7 mm

Principal Findings:

The primary outcome, procedural success (residual stenosis ≤30% without flow-limiting dissection) prior to drug-coated balloon or stenting, occurred in 65.8% of the intravascular lithotripsy group compared with 50.4% of the percutaneous transluminal angioplasty group (p = 0.01).

Secondary outcomes:

  • Percentage of lesions with residual stenosis ≤30%: 66.4% of the intravascular lithotripsy group vs. 51.9% of the percutaneous transluminal angioplasty group (p = 0.02)
  • Flow-limiting dissections: 1.4% of the intravascular lithotripsy group vs. 6.8% of the percutaneous transluminal angioplasty group (p = 0.03)
  • Stent placement: 4.6% of the intravascular lithotripsy group vs. 18.3% of the percutaneous transluminal angioplasty group (p < 0.001)
  • Clinically driven target lesion revascularization at 30 days: 0.7% of the intravascular lithotripsy group vs. 0.7% of the percutaneous transluminal angioplasty group (p = 1.0)

Interpretation:

Among patients with symptomatic femoropopliteal artery disease, lesion preparation with intravascular lithotripsy was beneficial. Intravascular lithotripsy compared with percutaneous transluminal angioplasty was associated with a higher frequency of procedural success, defined as residual stenosis ≤30% without flow-limiting dissection. Intravascular lithotripsy was also associated with a lower frequency of stent implantation. Clinically driven target lesion revascularization was the same between treatment groups.

References:

Tepe G, Brodmann M, Werner M, et al., on behalf of the Disrupt PAD III Investigators. Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial. JACC Cardiovasc Interv 2021;14:1352-61.

Editorial Comment: White CJ, Beckman JA. Making Lemonade Out of the Lemons of Lesion Preparation. JACC Cardiovasc Interv 2021;14:1362-3.

Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Prevention, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and Arrhythmias, Interventions and Vascular Medicine

Keywords: Angioplasty, Angioplasty, Balloon, Constriction, Pathologic, Coronary Stenosis, Diabetes Mellitus, Dissection, Femoral Artery, Geriatrics, Intermittent Claudication, Lithotripsy, Myocardial Revascularization, Peripheral Arterial Disease, Secondary Prevention, Stents, Vascular Calcification, Vascular Diseases


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