Disrupt PAD III trial reveals consistent safety and efficacy of intravascular lithotripsy

One-year results from the Disrupt PAD III trial comparing intravascular lithotripsy (IVL) with a drug-coated balloon (DCB) to percutaneous transluminal angioplasty (PTA) with a DCB were presented today as a research last-minute clinic at the Society for Cardiovascular Angiography & Interventions (SCAI) Scientific Sessions 2022. Results revealed consistent safety and efficacy of VILI with durable patency.

Affecting approximately 6.5 million Americans over the age of 40, peripheral artery disease (PAD) is the narrowing of the peripheral arteries that carry blood from the heart to other parts of the body. PAD is caused by a buildup of fatty plaque in the arteries, and treatment options may include lifestyle changes, medical treatment, or surgery depending on the severity of the condition. However, patients with severe calcifications are often excluded from clinical trials.

The Disrupt PAD III study provides the largest randomized controlled evidence to guide the endovascular treatment of severely calcified superficial femoral artery lesions. In examining 45 global sites, 306 SFA-pop lesions and more than 80% of lesions were defined as severely calcified by the PARC definition with a mean calcified length greater than 125 mm. The objective of the study was to evaluate the long-term primary patency (PP) in patients treated with IVL and DCB compared to patients treated with ATP with DCB. PP was defined as the absence of revascularization of the clinically determined target lesion (CD-TLR) by an independent clinical events committee and the absence of restenosis determined by duplex ultrasound (DUS) as assessed by a central laboratory independent. Acute PTA failure requiring stenting during index procedure was pre-specified by protocol as a loss of PP.

For the IVL or PTA arms, PP monitoring is available in 80.4% and 83.7% of patients, respectively. Primary patency at one year was significantly higher in the IVL arm (80.5% versus 68.0%). The per protocol the requirement for temporary stenting was significantly lower in the VILI group (4.6% versus 18.3%). The absence of CD-TLR (VILI: 95.7% vs PTA: 98.3%) and restenosis (VILI: 90.0% vs PTA: 88.8%) was similar between the two groups at 1 year. With VILI, serious complications and the need for additional interventions are reduced compared to ATP.

This trial offers important new information because patients with severe PAD are often excluded from trials, resulting in a very limited amount of randomized data to guide treatment. The trial demonstrated the usefulness of VILI, making these difficult procedures safe and predictable. This offers patients future treatment avenues without the potential long-term risk of adverse clinical events such as stent fracture and restenosis. »

William A. Gray, MD, FSCAI, Lankenau Heart Institute/Main Line Health, Wynnewood, PA and lead study author

The researchers note that continued evaluation of VILI for the treatment of calcified PAD in a “real-world” setting is ongoing as part of the Disrupt PAD III observational study.


Society of Angiography and Cardiovascular Procedures

Sara H. Byrd