Three-year sustained clinical efficacy of drug-coated balloon angioplasty in a real-world femoropopliteal cohort
In: JOURNAL OF ENDOVASCULAR THERAPY ; ISSN: 1526-6028 ; ISSN: 1545-1550, 2020
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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 ...
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Three-year sustained clinical efficacy of drug-coated balloon angioplasty in a real-world femoropopliteal cohort
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Autor/in / Beteiligte Person: | Torsello, Giovanni ; Stavroulakis, Konstantinos ; Brodmann, Marianne ; Micari, Antonio ; Tepe, Gunnar ; Veroux, Pierfrancesco ; Benko, Andrew ; Choi, Donghoon ; Vermassen, Frank ; Jaff, Michael R. ; Guo, Jia ; Dobranszki, Reka ; Zeller, Thomas |
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Zeitschrift: | JOURNAL OF ENDOVASCULAR THERAPY ; ISSN: 1526-6028 ; ISSN: 1545-1550, 2020 |
Veröffentlichung: | 2020 |
Medientyp: | academicJournal |
ISSN: | 1526-6028 |
DOI: | 10.1177/1526602820931477 |
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