LB-1
Intravascular Lithotripsy for Peripheral Artery Calcification: One-Year Outcomes From the Randomized Disrupt PAD III Trial
Presenter
William Anthony Gray, M.D., FSCAI, Main Line Health, Wynnewood, PA
William Anthony Gray, M.D., FSCAI, Main Line Health, Wynnewood, PA and Gunnar Tepe, M.D., RoMed Klinikum, Rosenheim, Germany
Keywords: Drug-coated Balloon (DCB), Intravascular Lithotripsy (IVL), Peripheral Artery Disease (PAD) and Superficial Femoral Artery (SFA)
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 receiving vessel preparation with intravascular lithotripsy (IVL) vs percutaneous transluminal angioplasty (PTA) prior to drug-coated balloon (DCB) treatment in moderately-to-severely calcified femoropopliteal arteries, but comparative longer-term primary patency (PP) results have not been reported. The present study evaluates 1-year PP outcomes in this randomized population.
Methods
The powered secondary effectiveness endpoint was PP at 1-year, defined as freedom from clinically-driven target lesion revascularization (CD-TLR) by an independent Clinical Events Committee and freedom from restenosis determined by duplex ultrasound (DUS) as assessed by an independent core laboratory. Acute PTA failure requiring a stent during the index procedure was pre-specified
per protocol as a loss of PP.
Results
For IVL (n=153) or PTA (n=153) arms, PP follow-up is available in 80.4% and 83.7% of patients, respectively (p=0.55). Primary patency at 1-year was significantly greater in the IVL arm (80.5% vs. 68.0%, p=0.017). The
per protocol requirement for provisional stenting was significantly lower in the IVL group (4.6% vs 18.3%, p<0.0001). Freedom from CD-TLR (IVL: 95.7% vs PTA: 98.3%, p=0.94) and restenosis (IVL: 90.0% vs PTA: 88.8%, p=0.48) were similar between the two groups at 1-year.
Conclusions
The Disrupt PAD III RCT powered secondary endpoint of superior 1-year PP was achieved, confirming the consistent safety and effectiveness of IVL treatment to facilitate a durable approach for patients with heavily calcified femoropopliteal arteries largely without stent requirement.