News Release Details
Shockwave IVL Is Superior to Angioplasty in Severely Calcified Peripheral Artery Disease
Disrupt PAD III is a prospective, multicenter, randomized study designed to demonstrate the safety and effectiveness of IVL as a vessel preparation procedure in moderate to severely calcified superficial femoral and popliteal lesions, followed by a drug-coated balloon (DCB) or stent. The study enrolled 306 patients randomized between IVL and PTA at 45 sites in
“Until the Shockwave PAD III trial, there have been few data available to provide treatment guidance for this challenging population, as patients with severe calcification have historically been excluded from endovascular treatment trials,” said
IVL demonstrated superiority over PTA in the primary endpoint analysis, defined as procedural success with a residual stenosis less than or equal to 30 percent without flow-limiting dissection (greater or equal to Grade D), prior to DCB or stenting, with a rate of 65.8 percent versus 50.4 percent (p=0.0065) as determined by an independent angiographic core lab. Additionally, PAD III showed that IVL achieved more atraumatic treatment based on the following findings:
- Reduction in frequency and severity of major arterial dissections (Grade C and Grade D, both p=0.03)
- Reduction in the need for bail-out stenting (75% relative risk reduction) and stent implantation rate (4.6% vs 18.3%, p=0.0002)
- Lower balloon maximum inflation pressure (6.3 atm vs 11.3 atm, p<0.0001)
- Reduction in categorical percent diameter stenosis after treatment with IVL versus PTA (p=0.02)
“I would like to compliment the physicians, clinical coordinators and institutions who worked diligently to generate this new Level I evidence in a difficult-to-treat patient population,” said
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Source: Shockwave Medical, Inc.