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

BackgroundEndovascular 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 intravascular lithotripsy (IVL) vs percutaneous transluminal angioplasty (PTA). present study evaluates patency after 1 2 years this population.MethodsThe RCT enrolled 306 moderately-to-severely femoropopliteal arteries IVL (n = 153) or PTA prior to DCB stenting. powered secondary effectiveness was at year, defined as freedom clinically driven target lesion revascularization plus restenosis determined by duplex ultrasound. Acute failure requiring stent placement during index procedure prespecified a loss patency.ResultsPrimary year significantly greater arm (80.5% 68.0%, P .017). requirement for provisional stenting lower group (4.6% 18.3%, < .0001). Freedom (IVL: 95.7% PTA: 98.3%, .94) rates 90.0% 88.8%, .48) were similar between groups year. At years, remained (70.3% 51.3%, .003).ConclusionsThe 1-year achieved, confirming consistent safety followed facilitate durable approach heavily largely without requirement.