Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort
-
Published:2020-06-25
Issue:5
Volume:27
Page:693-705
-
ISSN:1526-6028
-
Container-title:Journal of Endovascular Therapy
-
language:en
-
Short-container-title:J Endovasc Ther
Author:
Torsello Giovanni1ORCID, Stavroulakis Konstantinos12ORCID, Brodmann Marianne3, Micari Antonio4, Tepe Gunnar5ORCID, Veroux Pierfrancesco6ORCID, Benko Andrew7, Choi Donghoon8, Vermassen Frank E. G.9, Jaff Michael R.10, Guo Jia11, Dobranszki Reka12, Zeller Thomas13ORCID, Zeller Thomas, Torsello Giovanni, Tepe Gunnar, Peeters Patrick, Scheinert Dierk, Bosiers Marc, Maene Lieven, Micari Antonio, Do Dai-Do, Hendriks Jeroen, Keirse Koen, Brodmann Marianne, Merkely Bela, Lardenoije Jan-Willem, Ruzsa Zoltan, Vogel Britta, Veroux Pierfrancesco, Albuquerque e Castro Joao, Periard Daniel, Ludyga Tomasz, Midy Dominique, Choi Donghoon, Lansink Wouter, Ketelsen Dominik, Dubenec Steven, Banyai Martin, Chakfe Nabil, Xaver Roithinger Franz, Trani Carlo, Mansour Hossam, Rha Seung-Woon, Vermassen Frank, Belenky Alexander, Spak Lubomir, Chalmers Nicholas, Benko Andrew, Kum Steven, Won Je Hwan, Vozar Matej, Teng Tan Kong, Labib Mamdouh, Borst Gert-Jan de, Do Young-Soo, Teijink Joep, Gomez Juan Fernando, Falkowski Aleksander, Ferreira Luis, Matela Jozef, Lee Seung-Whan, Verhoeven Bart, Mannheim Dalit, Nessi Franco, Vulev Ivan, Vries Jean-Paul de, Maly Radovan, Kavteladze Zaza, Turner Douglas, Mendiz Oscar, Kolvenbach Ralf, Karnabatidis Dimitrios, Cuellar Cesar, Venermo Maarit, Velicka Linas, Lundberg Goran
Affiliation:
1. Department of Vascular Surgery, St Franziskus-Hospital Münster, Germany 2. Department of Vascular Surgery, Ludwig-Maximilians-University Hospital Munich, Germany 3. Department of Internal Medicine, Medical University, Graz, Austria 4. Department of Cardiology, Humanitas Gavazzeni Hospital, Bergamo, Italy 5. Institute of Diagnostic and Interventional Radiology, RoMed Klinikum, Rosenheim, Germany 6. Vascular Surgery and Transplant Unit, University of Catania, Italy 7. Division of Interventional Radiology, Faculté de Medecine, Université de Sherbrooke, Quebec, Canada 8. Department of Internal Medicine, Yonsei University Hospital, Seoul, South Korea 9. Department of Vascular Surgery, Ghent University Hospital, Gent, Belgium 10. Harvard Medical School, Boston, MA, USA 11. Medtronic, Minneapolis, MN, USA 12. Medtronic, Bakken Research Center BV, Maastricht, Netherlands 13. Universitäts-Herzzentrum Freiburg–Bad Krozingen, Bad Krozingen, Germany
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.
Publisher
SAGE Publications
Subject
Cardiology and Cardiovascular Medicine,Radiology Nuclear Medicine and imaging,Surgery
Cited by
36 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献
|
|