PMID- 37526706 OWN - NLM STAT- Publisher LR - 20231006 IS - 1432-086X (Electronic) IS - 0174-1551 (Print) IS - 0174-1551 (Linking) VI - 46 IP - 10 DP - 2023 Oct TI - Five-Year Outcomes after Paclitaxel Drug-Coated Balloon Treatment of Femoropopliteal Lesions in Diabetic and Chronic Limb-Threatening Ischemia Cohorts: IN.PACT Global Study Post Hoc Analysis. PG - 1329-1345 LID - 10.1007/s00270-023-03478-y [doi] 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. CI - (c) 2023. The Author(s). FAU - Reijnen, Michel M P J AU - Reijnen MMPJ AUID- ORCID: 0000-0002-5021-1768 AD - Department of Vascular Surgery, Rijnstate, Arnhem, The Netherlands. MReijnen@rijnstate.nl. AD - Multi-Modality Medical Imaging Group, TechMed Centre, University of Twente, Enschede, The Netherlands. MReijnen@rijnstate.nl. FAU - van Wijck, Iris AU - van Wijck I AD - Department of Vascular Surgery, Rijnstate, Arnhem, The Netherlands. FAU - Brodmann, Marianne AU - Brodmann M AD - Department of Internal Medicine, Division of Angiology, Medical University, Graz, Austria. FAU - Micari, Antonio AU - Micari A AD - Cardiology Unit, University of Messina, Messina, Italy. FAU - Torsello, Giovanni AU - Torsello G AD - Institute for Vascular Research, St Franziskus-Hospital, Munster, Germany. FAU - Rha, Seung-Woon AU - Rha SW AD - Cardiovascular Center, Korea University Guro Hospital, Seoul, Korea. FAU - Menk, Jeremiah AU - Menk J AD - , Medtronic, Minneapolis, MN, USA. FAU - Zeller, Thomas AU - Zeller T AD - Universitats-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany. CN - IN.PACT Global Study Investigators LA - eng PT - Journal Article DEP - 20230801 PL - United States TA - Cardiovasc Intervent Radiol JT - Cardiovascular and interventional radiology JID - 8003538 SB - IM PMC - PMC10547845 OTO - NOTNLM OT - Chronic limb-threatening ischemia OT - Clinically driven target lesion revascularization OT - Diabetes mellitus OT - Drug-coated balloon COIS- Michel M. P. J. Reijnen, MD, PhD, is a consultant for Bentley Innomed, Medtronic, Terumo Aortic, and W.L. Gore and Associates. Iris Van Wijck, MD, has nothing to disclose. Marianne Brodmann, MD, received speaking honoraria from Bard Peripheral Vascular, Biotronik, Medtronic, Spectranetics, and VIVA Physicians and is a consultant for Bard Peripheral Vascular, Biotronik, Medtronic, and Spectranetics. Antonio Micari, MD, PhD, is a compensated consultant for Medtronic and Boston Scientific Corp. Giovanni Torsello, MD, received grants and speaking honoraria from Biotronik, Boston Scientific Corp., Cordis, W.L. Gore & Associates and Medtronic. Seung-Woon Rha, MD, PhD, has nothing to disclose. Jeremiah Menk, MS, is a full-time employee of Medtronic. Thomas Zeller, MD, PhD, received speaking honoraria from Abbott Vascular, Bard Peripheral Vascular, Biotronik, Boston Scientific Corp, Cook Medical, Cordis, GLG, W.L. Gore & Associates, Medtronic, Philips, Spectranetics, Straub Medical, TriReme, Veryan, and VIVA Physicians; he is a consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific Corp, Cook Medical, W.L. Gore & Associates, Medtronic, and Spectranetics; and his clinic has received study funds or funds for research or clinical trials from 480 Biomedical, Abbott Vascular, B. Braun, Bard Peripheral Vascular, Bayer Pharma, Biotronik, Caveo Med, Contego Medical, Cook Medical, CSI, W.L. Gore & Associates, Innora, Intact Vascular, Medtronic, Mercator, Philips, Pluristem, Shockwave, Spectranetics, Terumo, TriReme, and Veryan. EDAT- 2023/08/01 13:09 MHDA- 2023/08/01 13:09 PMCR- 2023/08/01 CRDT- 2023/08/01 11:05 PHST- 2023/01/19 00:00 [received] PHST- 2023/05/24 00:00 [accepted] PHST- 2023/08/01 13:09 [pubmed] PHST- 2023/08/01 13:09 [medline] PHST- 2023/08/01 11:05 [entrez] PHST- 2023/08/01 00:00 [pmc-release] AID - 10.1007/s00270-023-03478-y [pii] AID - 3478 [pii] AID - 10.1007/s00270-023-03478-y [doi] PST - ppublish SO - Cardiovasc Intervent Radiol. 2023 Oct;46(10):1329-1345. doi: 10.1007/s00270-023-03478-y. Epub 2023 Aug 1.