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

Abstract

Objectives: The study sought to compare short-term outcomes in patients with femoropopliteal artery calcification receiving vessel preparation with intravascular lithotripsy (IVL) or percutaneous transluminal angioplasty (PTA) prior to drug-coated balloon (DCB) for symptomatic peripheral artery disease.

Background: Endovascular treatment of calcified peripheral artery lesions is associated with suboptimal vessel expansion and increased complication risk. Although initial results from single-arm studies with IVL have been reported, comparative evidence from randomized trials is lacking for most devices in the presence of heavy calcification.

Methods: The Disrupt PAD III (Shockwave Medical Peripheral Lithoplasty System Study for PAD) randomized trial enrolled patients with moderate or severe calcification in a femoropopliteal artery who underwent vessel preparation with IVL or PTA prior to DCB or stenting. The primary endpoint was core lab-adjudicated procedural success (residual stenosis ≤30% without flow-limiting dissection) prior to DCB or stenting.

Results: In patients receiving IVL (n = 153) or PTA (n = 153), procedural success was greater in the IVL group (65.8% vs. 50.4%; p = 0.01) and the percentage of lesions with residual stenosis ≤30% (66.4% vs. 51.9%; p = 0.02) was greater in the IVL group, while flow-limiting dissections occurred more frequently in the PTA group (1.4% vs. 6.8%; p = 0.03). Post-dilatation (5.2% vs. 17.0%; p = 0.001) and stent placement (4.6% vs. 18.3%; p < 0.001) were also greater in the PTA group. The rates of major adverse events (IVL: 0% vs. PTA: 1.3%; p = 0.16) and clinically driven target lesion revascularization (IVL: 0.7% vs. PTA: 0.7%; p = 1.0) at 30 days were comparable between groups.

Conclusions: IVL is an effective vessel preparation strategy that facilitates definitive endovascular treatment in calcified femoropopliteal arteries in patients with peripheral artery disease. (Shockwave Medical Peripheral Lithoplasty System Study for PAD [Disrupt PAD III]; NCT02923193).

Keywords: calcification; drug-coated balloon; femoropopliteal artery; intravascular lithotripsy; peripheral artery disease.

Conflict of interest statement

Funding Support and Author Disclosures Shockwave Medical (Santa Clara, California) provided financial support for this research. Dr. Tepe has served on the advisory board for B. Braun, BSC, and Medtronic; and has received study support by Bayer Health Care, B. Braun, Biotronik, Bard, BSC, Gore, Medtronic, Verian, and Shockwave Medical. Dr. Brodmann has served on the advisory board for Medtronic, BD Bard, Philipps Spectranetics, Intact Vascular, Boston Scientific, Biotronik, Shockwave Medical, Cagent, Profusa, and Bayer Healthcare. Dr. Werner has received honoraria from Philips, Boston Scientific, Trireme Medical, and Shockwave Medical. Dr. Bachinsky has received research grant support and is a consultant for Abbott Vascular, Boston Scientific, BD Bard Vascular, Medtronic, and Shockwave Medical. Dr. Holden has served on the advisory board for Medtronic, Boston Scientific, Gore Medical, Philips, Shockwave Medical, Abbott, Intact Vascular, and Cagent; and has served as a Clinical investigator for Reflow Medical, LimFlow, Surmodics, and Shape Memory. Dr. Zeller has received honoraria from Abbott Vascular, BIBA Medical, Biotronik, Boston Scientific, Cook Medical, Efemoral Medical, W.L. Gore and Associates, Medtronic, Philips-Spectranetics, Shockwave, and Veryan; has served as a consultant for Boston Scientific, CSI, W.L. Gore and Associates, Medtronic, Veryan, Intact Vascular, Shockwave, Bayer, and Vesper Medical; has received institutional research grant, clinical trial, or drug study funds from Bard Peripheral Vascular, Veryan, Biotronik, Cook Medical, W.L. Gore and Associates, Medtronic, Philips, Terumo, TriReme, Shockwave, Med Alliance, Intact Vascular, B. Braun, CSI, Boston Scientific, University of Jena, Pluristem, Philips, and PQ Bypass; and holds common stock from QT Medical. Dr. Mangalmurti has served as a consultant for Shockwave Medical, Philips, Cardiovascular Systems, and Medtronic. Dr. Nolte-Ernsting has received honoraria from Medtronic, Biotronik, and Penumbra; and has served on advisory boards of Shockwave Medical, Medtronic, and W.L. Gore and Associates. Dr. Scheinert has received institutional research support from Shockwave Medical. Dr. Gray has served as a consultant for and received institutional research support from Shockwave Medical. Dr. Bertolet has reported that he has no relationships relevant to the contents of this paper to disclose.

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