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Intravascular Lithotripsy for Peripheral Artery Calcification: Mid-term Outcomes From the Randomized Disrupt PAD III Trial.
Tepe, Gunnar; Brodmann, Marianne; Bachinsky, William; Holden, Andrew; Zeller, Thomas; Mangalmurti, Sarang; Nolte-Ernsting, Claus; Virmani, Renu; Parikh, Sahil A; Gray, William A.
Afiliación
  • Tepe G; Department of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany.
  • Brodmann M; Division of Angiology, Medical University Graz, Graz, Austria.
  • Bachinsky W; UPMC Heart and Vascular Institute, UPMC-Pinnacle Health, Harrisburg, Pennsylvania.
  • Holden A; Department of Interventional Radiology, Auckland City Hospital, Auckland, New Zealand.
  • Zeller T; Division of Angiology, Department of Internal Medicine, Universitäts-Herzzentrum Freiburg & Bad Krozingen, Bad Krozingen, Germany.
  • Mangalmurti S; Department of Interventional Cardiology, Main Line Hospitals, Bryn Mawr, Pennsylvania.
  • Nolte-Ernsting C; Department of Radiology, Evangelisches Krankenhaus Mülheim an der Ruhr, Mülheim an der Ruhr, Germany.
  • Virmani R; CVPath Institute, Inc, Gaithersburg, Maryland.
  • Parikh SA; Center for Interventional Vascular Therapy, NewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York.
  • Gray WA; Division of Cardiology, Main Line Health, Wynnewood, Pennsylvania.
J Soc Cardiovasc Angiogr Interv ; 1(4): 100341, 2022.
Article en En | MEDLINE | ID: mdl-39131928
ABSTRACT

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 treated with intravascular lithotripsy (IVL) vs percutaneous transluminal angioplasty (PTA). The present study evaluates primary patency after 1 and 2 years in this randomized population.

Methods:

The Disrupt PAD III RCT enrolled 306 patients with moderately-to-severely calcified femoropopliteal arteries treated with IVL (n = 153) or PTA (n = 153) prior to DCB treatment or stenting. The powered secondary effectiveness endpoint was primary patency at 1 year, defined as freedom from clinically driven target lesion revascularization plus freedom from restenosis determined by duplex ultrasound. Acute PTA failure requiring stent placement during the index procedure was prespecified as a loss of primary patency.

Results:

Primary patency at 1 year was significantly greater in the IVL arm (80.5% vs 68.0%, P = .017). The requirement for provisional stenting was significantly lower in the IVL group (4.6% vs 18.3%, P < .0001). Freedom from clinically driven target lesion revascularization (IVL 95.7% vs PTA 98.3%, P = .94) and restenosis rates (IVL 90.0% vs PTA 88.8%, P = .48) were similar between the 2 groups at 1 year. At 2 years, primary patency remained significantly greater in the IVL arm (70.3% vs 51.3%, P = .003).

Conclusions:

The Disrupt PAD III RCT secondary endpoint of superior 1-year primary patency was achieved, confirming the consistent safety and effectiveness of IVL followed by DCB treatment to facilitate a durable approach for patients with heavily calcified femoropopliteal arteries largely without stent requirement.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Soc Cardiovasc Angiogr Interv Año: 2022 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: J Soc Cardiovasc Angiogr Interv Año: 2022 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Estados Unidos