1. Three-Year Sustained Clinical Efficacy of Drug-Coated Balloon Angioplasty in a Real-World Femoropopliteal Cohort
- Author
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Torsello, Giovanni, Stavroulakis, Konstantinos, Brodmann, Marianne, Micari, Antonio, Tepe, Gunnar, Veroux, Pierfrancesco, Benko, Andrew, Choi, Donghoon, Vermassen, Frank E. G., Jaff, Michael R., Guo, Jia, Dobranszki, Reka, Zeller, Thomas, 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, and Lundberg, Goran
- Abstract
Purpose:To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study (ClinicalTrials.govidentifier 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.
- Published
- 2020
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