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

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Endovascular Interventions

Background:

• Endovascular treatment of calcified peripheral artery lesions poses challenges, including suboptimal expansion and reduced long-term patency.
• The Disrupt PAD III randomized controlled trial (RCT) previously showed superior procedural success with intravascular lithotripsy (IVL) over percutaneous transluminal angioplasty (PTA).

Purpose of the Study:

• To evaluate the primary patency rates at 1 and 2 years following endovascular treatment of calcified femoropopliteal arteries using IVL versus PTA.
• To assess the long-term effectiveness and safety of IVL in managing complex peripheral artery disease.

Main Methods:

• The Disrupt PAD III RCT enrolled 306 patients with moderately-to-severely calcified femoropopliteal arteries.
• Patients were randomized to receive either IVL (n=153) or PTA (n=153) before drug-coated balloon (DCB) treatment or stenting.
• Primary patency was defined as freedom from clinically driven target lesion revascularization and restenosis, assessed by duplex ultrasound.

Main Results:

• Primary patency at 1 year was significantly higher in the IVL group (80.5%) compared to the PTA group (68.0%; P=.017).
• The need for provisional stenting was significantly lower with IVL (4.6%) versus PTA (18.3%; P<.0001).
• At 2 years, primary patency remained significantly greater for IVL (70.3%) compared to PTA (51.3%; P=.003).

Conclusions:

• The study met its secondary endpoint, demonstrating superior 1-year primary patency with IVL.
• IVL followed by DCB treatment offers a safe and effective durable approach for heavily calcified femoropopliteal arteries, often avoiding the need for stenting.