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. 2023 May 8;16(9):1065-1078.
doi: 10.1016/j.jcin.2023.03.032.

5-Year Outcomes of Drug-Coated Balloons for Peripheral Artery In-Stent Restenosis, Long Lesions, and CTOs

Gunnar Tepe  1 , Marianne Brodmann  2 , Antonio Micari  3 , Dierk Scheinert  4 , Donghoon Choi  5 , Jeremiah Menk  6 , Thomas Zeller  7 ; IN.PACT Global Study Investigators
Affiliations
Free article

5-Year Outcomes of Drug-Coated Balloons for Peripheral Artery In-Stent Restenosis, Long Lesions, and CTOs

Gunnar Tepe et al. JACC Cardiovasc Interv. .
Free article

Abstract

Background: Long-term data on drug-coated balloon (DCB) outcomes in complex femoropopliteal atherosclerotic lesions are limited.

Objectives: The authors sought to report 5-year safety and effectiveness outcomes of a paclitaxel DCB for the treatment of de novo in-stent restenosis (ISR), long lesions (LL), or chronic total occlusions (CTOs) in the prespecified imaging cohorts of the IN.PACT Global Study.

Methods: The IN.PACT Global study was a prospective, international single-arm study. Assessments through 5 years included freedom from clinically driven target lesion revascularization (CD-TLR), a safety composite (freedom from device- and procedure-related death to 30 days, and freedom from major target limb amputation and freedom from clinically driven target vessel revascularization within 60 months), and major adverse events.

Results: The prespecified imaging cohorts enrolled 132 de novo ISR, 158 LL, and 127 CTO participants. Kaplan-Meier estimates of freedom from CD-TLR through 5 years were 58.0% (ISR), 67.3% (LL), and 69.8% (CTO). The cumulative incidences of the composite safety endpoint were 56.0% (ISR), 65.7% (LL), and 69.8% (CTO). The 5-year freedom from all-cause mortality with vital status update were 81.4% (ISR), 75.2% (LL), and 78.2% (CTO). Within the ISR cohort, 15.9% of participants experienced 2 or more TLRs, compared with 9.5% and 5.5% in the LL and CTO groups, respectively.

Conclusions: Results demonstrate long-term safety and effectiveness of this DCB in all 3 cohorts, with low reintervention rates in the LL and CTO cohorts and no safety issues. These results support the inclusion of this DCB into the treatment algorithm for complex femoropopliteal disease.

Keywords: chronic total occlusions; claudication; femoropopliteal disease; in-stent restenosis; peripheral arterial disease.

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Conflict of interest statement

Funding Support and Author Disclosures This study was sponsored by Medtronic. Prof Tepe has received study support from Bard Boston Scientific, Gore, Medtronic, CSI, Philips, and Shockwave; grants or contracts from B Braun, Biotronik, Bayer, Veryan, Gore, Shockwave, and Philips; is on the Global Advisory Board of Medtronic, Boston Scientific, B Braun, and Philips; has received payment or honoraria for presentations from Boston Scientific, Biotronik, B Braun, Veryan, Gore, and Shockwave; and has a leadership or fiduciary role in CX London. Dr Brodmann has received speaker honoraria from Bard Peripheral Vascular, Biotronik, Medtronic, Philips, and VIVA Physicians; and is a consultant for Bard Peripheral Vascular, Biotronik, Medtronic, and Philips. Dr Micari is on the advisory board for Medtronic; is a consultant for Boston Scientific and Terumo; and has received support for attending meetings from Medtronic, Boston Scientific, and Terumo. Dr Scheinert has received consulting fees and/or speaker honoraria from Abbott, Acotec, Alvimedica, Bayer, Boston Scientific, Cook Medical, Cardionovum, CR Bard, IVascular, Gardia Medical/Allium, Medtronic, Phillips, and Upstream Peripheral Technologies; and has received payment for participation on a data safety monitory board or advisory board for Boston Scientific. Mr Menk is an employee of Medtronic; and holds Medtronic stock. Dr Zeller has received honoraria/consulting fees from Abbott Vascular, BIBA Medical, Shockwave, Biotronik, Cook Medical, Efemoral, Philips, CSI, Intact Vascular, and Bayer; has received grants or contracts from Bard, Biotronik, Veryan, Cook, Gore & Associates, Medtronic, Philips, Terumo, Trireme, Shockwave, MedAlliance, B Braun, Intact Vascular, Boston Scientific, University of Jena, Pluristem, PQ Bypass, Reflow Medical, Ablative Solutions, and Surmodics; participated on a data safety monitoring board or advisory board for Medtronic, Boston Scientific, Gore, Veryan, Vesper Medical, and VentureMed. Dr Choi has reported that he has no relationships relevant to the contents of this paper to disclose.

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