Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort

Carlo Trani, Giovanni Torsello, Konstantinos Stavroulakis, Marianne Brodmann, Antonio Micari, Gunnar Tepe, Pierfrancesco Veroux, Andrew Benko, Donghoon Choi, Frank E. G. Vermassen, Michael R. Jaff, Jia Guo, Reka Dobranszki, Thomas Zeller, Thomas Zeller, Giovanni Torsello, Gunnar Tepe, Patrick Peeters, Dierk Scheinert, Marc BosiersLieven Maene, Antonio Micari, Dai-Do Do, Jeroen Hendriks, Koen Keirse, Marianne Brodmann, Bela Merkely, Jan-Willem Lardenoije, Zoltan Ruzsa, Britta Vogel, Pierfrancesco Veroux, Joao Albuquerque E Castro, Daniel Periard, Tomasz Ludyga, Dominique Midy, Donghoon Choi, Wouter Lansink, Dominik Ketelsen, Steven Dubenec, Martin Banyai, Nabil Chakfe, Franz Xaver Roithinger, Hossam Mansour, Seung-Woon Rha, Frank Vermassen, Alexander Belenky, Lubomir Spak, Nicholas Chalmers, Andrew Benko, Steven Kum, Je Hwan Won, Matej Vozar, Kong Teng Tan, Mamdouh Labib, Gert-Jan De Borst, Young-Soo Do, Joep Teijink, Juan Fernando Gomez, Aleksander Falkowski, Luis Ferreira, Jozef Matela, Seung-Whan Lee, Bart Verhoeven, Dalit Mannheim, Franco Nessi, Ivan Vulev, Jean-Paul De Vries, Radovan Maly, Zaza Kavteladze, Douglas Turner, Oscar Mendiz, Ralf Kolvenbach, Dimitrios Karnabatidis, Cesar Cuellar, Maarit Venermo, Linas Velicka, Goran Lundberg

Risultato della ricerca: Contributo in rivistaArticolo in rivista

6 Citazioni (Scopus)

Abstract

Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p<0.001). Predictors of CD-TLR through 36 months included increased lesion length, reference vessel diameter ≤4.5 mm, in-stent restenosis, bilateral disease, CLTI, and hyperlipidemia. Conclusion: DCB angioplasty with the IN.PACT Admiral DCB for femoropopliteal disease in a diverse and complex real-world population is associated with sustained clinical efficacy and low rates of reinterventions at 3 years after the initial procedure.
Lingua originaleEnglish
pagine (da-a)693-705
Numero di pagine13
RivistaJournal of Endovascular Therapy
Volume27
DOI
Stato di pubblicazionePubblicato - 2020

Keywords

  • angioplasty
  • drug-coated balloon
  • femoropopliteal segment
  • mortality
  • peripheral artery disease
  • popliteal artery
  • superficial femoral artery
  • target lesion revascularization

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