TY - JOUR
T1 - Five-Year Outcomes after Paclitaxel Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Diabetic and Chronic Limb-Threatening Ischemia Cohorts
T2 - IN.PACT Global Study Post Hoc Analysis
AU - Reijnen, Michel M.P.J.
AU - van Wijck, Iris
AU - Brodmann, Marianne
AU - Micari, Antonio
AU - Torsello, Giovanni
AU - Rha, Seung Woon
AU - Menk, Jeremiah
AU - Zeller, Thomas
AU - On behalf of the IN.PACT Global Study Investigators
N1 - Funding Information:
The authors would like to acknowledge Sangeeta Yendrembam, PhD (Medtronic) for medical writing assistance; Stefanie Deckers, MS and Giulia Gatta, MS (Medtronic) for clinical support; and Kristin Hood, PhD (Medtronic) for technical review in accordance with Good Publication Practice guidelines (Battisti et al., Ann Intern Med. 2015;163:461-4).
Funding Information:
Open access funding provided by Rijnstate. This study was funded by Medtronic. The funder of the study was involved in the study design, data collection, data analysis, data interpretation, and provided medical writing support. The authors had full access to all the data, interpretation, manuscript writing and had full and final responsibility for the decision to submit for publication. Authors received no specific funding for preparation of the manuscript.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/10
Y1 - 2023/10
N2 - Purpose: To summarize the 5-year outcomes of drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with diabetes mellitus (DM) or chronic limb-threatening ischemia (CLTI) compared to non-DM and intermittent claudication (IC).Methods: The IN.PACT Global study was a real-world prospective, multicenter, international, single-arm study that enrolled 1535 participants. Post hoc analyses were conducted for participants with DM (n = 560) versus non-DM (n = 842) and CLTI (n = 156) versus IC (n = 1246). Assessments included freedom from clinically driven target lesion revascularization (CD-TLR) through 60 months, a composite safety outcome (freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and freedom from CD-target vessel revascularization within 60 months), and major adverse events (MAEs).Results: Kaplan–Meier estimates of 60-month freedom from CD-TLR were 67.7% and 70.5% (p = 0.25) in the DM and non-DM cohorts; and 60.7% and 70.5% (p = 0.006) in the CLTI and IC cohorts. The Kaplan–Meier 60-month composite safety outcomes were 65.1% DM versus 68.9% non-DM (p = 0.12); 53.2% CLTI versus 69.1% IC (p < 0.001). Between DM and non-DM, MAE rates were not significantly different through 60 months except for all-cause mortality which was higher in DM (23.8% versus 16.6%; p < 0.001). Participants with CLTI had a higher cumulative incidence of major target limb amputation (6.8% versus 1.1%; p < 0.001) and all-cause mortality (37.4% versus 17.4%; p < 0.001) through 60 months compared to IC.Conclusions: In this real-world study, 5-year reintervention rates following DCB angioplasty were similar between DM and non-DM, but mortality rates were expectedly higher in patients with DM. Reintervention, mortality, and amputation rates were all higher in CLTI patients compared to IC, which is consistent with the known frailty of this patient population. Level of Evidence: Level 3, Non-randomized controlled cohort/follow-up study.
AB - Purpose: To summarize the 5-year outcomes of drug-coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with diabetes mellitus (DM) or chronic limb-threatening ischemia (CLTI) compared to non-DM and intermittent claudication (IC).Methods: The IN.PACT Global study was a real-world prospective, multicenter, international, single-arm study that enrolled 1535 participants. Post hoc analyses were conducted for participants with DM (n = 560) versus non-DM (n = 842) and CLTI (n = 156) versus IC (n = 1246). Assessments included freedom from clinically driven target lesion revascularization (CD-TLR) through 60 months, a composite safety outcome (freedom from device- and procedure-related death through 30 days, and freedom from major target limb amputation and freedom from CD-target vessel revascularization within 60 months), and major adverse events (MAEs).Results: Kaplan–Meier estimates of 60-month freedom from CD-TLR were 67.7% and 70.5% (p = 0.25) in the DM and non-DM cohorts; and 60.7% and 70.5% (p = 0.006) in the CLTI and IC cohorts. The Kaplan–Meier 60-month composite safety outcomes were 65.1% DM versus 68.9% non-DM (p = 0.12); 53.2% CLTI versus 69.1% IC (p < 0.001). Between DM and non-DM, MAE rates were not significantly different through 60 months except for all-cause mortality which was higher in DM (23.8% versus 16.6%; p < 0.001). Participants with CLTI had a higher cumulative incidence of major target limb amputation (6.8% versus 1.1%; p < 0.001) and all-cause mortality (37.4% versus 17.4%; p < 0.001) through 60 months compared to IC.Conclusions: In this real-world study, 5-year reintervention rates following DCB angioplasty were similar between DM and non-DM, but mortality rates were expectedly higher in patients with DM. Reintervention, mortality, and amputation rates were all higher in CLTI patients compared to IC, which is consistent with the known frailty of this patient population. Level of Evidence: Level 3, Non-randomized controlled cohort/follow-up study.
KW - Chronic limb-threatening ischemia
KW - Clinically driven target lesion revascularization
KW - Diabetes mellitus
KW - Drug-coated balloon
KW - UT-Hybrid-D
UR - https://www.scopus.com/pages/publications/85166277944
U2 - 10.1007/s00270-023-03478-y
DO - 10.1007/s00270-023-03478-y
M3 - Article
C2 - 37526706
AN - SCOPUS:85166277944
SN - 0174-1551
VL - 46
SP - 1329
EP - 1345
JO - CardioVascular and Interventional Radiology
JF - CardioVascular and Interventional Radiology
ER -
SDG 3 Good Health and Well-being