Intravascular Lithotripsy for Peripheral Artery Calcification: Mid-term Outcomes From the Randomized Disrupt PAD III Trial.

BACKGROUND

Endovascular treatment of calcified peripheral artery lesions may be associated with suboptimal vessel expansion, increased complication risk, and reduced long-term patency. The primary endpoint from the Disrupt PAD III randomized controlled trial (RCT) demonstrated superior procedural success in patients treated with intravascular lithotripsy (IVL) vs percutaneous transluminal angioplasty (PTA). The present study evaluates primary patency after 1 and 2 years in this randomized population.

METHODS

The Disrupt PAD III RCT enrolled 306 patients with moderately-to-severely calcified femoropopliteal arteries treated with IVL ( = 153) or PTA ( = 153) prior to DCB treatment or stenting. The powered secondary effectiveness endpoint was primary patency at 1 year, defined as freedom from clinically driven target lesion revascularization freedom from restenosis determined by duplex ultrasound. Acute PTA failure requiring stent placement during the index procedure was prespecified as a loss of primary patency.

RESULTS

Primary patency at 1 year was significantly greater in the IVL arm (80.5% vs 68.0%, = .017). The requirement for provisional stenting was significantly lower in the IVL group (4.6% vs 18.3%, < .0001). Freedom from clinically driven target lesion revascularization (IVL: 95.7% vs PTA: 98.3%, = .94) and restenosis rates (IVL: 90.0% vs PTA: 88.8%, = .48) were similar between the 2 groups at 1 year. At 2 years, primary patency remained significantly greater in the IVL arm (70.3% vs 51.3%, = .003).

CONCLUSIONS

The Disrupt PAD III RCT secondary endpoint of superior 1-year primary patency was achieved, confirming the consistent safety and effectiveness of IVL followed by DCB treatment to facilitate a durable approach for patients with heavily calcified femoropopliteal arteries largely without stent requirement.