Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III...

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Endovascular Interventions

Background:

• Endovascular treatment of heavily calcified femoropopliteal lesions poses challenges, including suboptimal vessel expansion and increased complication risks.
• Comparative evidence from randomized trials for vessel preparation devices in severe calcification is limited.

Purpose of the Study:

• To compare short-term outcomes of intravascular lithotripsy (IVL) versus percutaneous transluminal angioplasty (PTA) for vessel preparation prior to drug-coated balloon (DCB) use in patients with femoropopliteal artery calcification.
• To evaluate procedural success rates and complications in the Disrupt PAD III randomized trial.

Main Methods:

• The Disrupt PAD III trial randomized 306 patients with moderate to severe femoropopliteal calcification to receive vessel preparation with either IVL or PTA before DCB or stenting.
• The primary endpoint was core lab-adjudicated procedural success, defined as residual stenosis ≤30% without flow-limiting dissection.

Main Results:

• Procedural success was significantly higher with IVL (65.8%) compared to PTA (50.4%) (p=0.01).
• IVL also achieved a higher rate of residual stenosis ≤30% (66.4% vs. 51.9%; p=0.02) and fewer flow-limiting dissections (1.4% vs. 6.8%; p=0.03).
• Post-dilatation and stent placement were less frequent after IVL, and 30-day major adverse events and target lesion revascularization rates were comparable between groups.

Conclusions:

• Intravascular lithotripsy is an effective vessel preparation strategy for treating calcified femoropopliteal arteries in peripheral artery disease.
• IVL facilitates definitive endovascular treatment, offering improved procedural success compared to PTA in this challenging patient population.