Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention

Abstract

Background: Drug-coated balloons (DCB) are frequently used to treat femoropopliteal artery disease. However, patency loss occurs in ≥10% of patients within 12 months posttreatment with poor understanding of the underlying mechanisms.

Objectives: The authors sought to investigate the determinants of DCB failure in femoropopliteal disease.

Methods: Data from randomized clinical trials (IN.PACT SFA, MDT-2113 SFA Japan) and 2 prespecified imaging cohorts of the IN.PACT Global Clinical Study were included. Influential procedural characteristics were evaluated by an independent angiographic core laboratory. The primary endpoint was DCB failure (patency loss during follow-up). Additional endpoints were binary restenosis and clinically driven target lesion revascularization. Multivariable analyses evaluated the clinical, anatomical, and procedural predictors of DCB failure.

Results: Included were 557 participants with single lesions and 12-month core laboratory-adjudicated duplex ultrasonography. Key clinical characteristics were as follows: mean age 68.8 years, 67.5% male, 87.6% with hypertension, 76.9% with hyperlipidemia, 40.5% with diabetes mellitus, 90.5% in Rutherford Classification Category (RCC) 2 to 3, and 9.5% in RCC 4 to 5. Average length and reference vessel diameter (RVD) were 16.37 cm and 4.66 mm, respectively; 49.7% of lesions were totally occluded. In multivariable analysis, only residual stenosis >30% was associated with patency loss, whereas residual stenosis >30% and smaller preprocedure RVD were associated with increased binary restenosis risk. RCC >3 and residual stenosis >30% were associated with increased 12-month clinically driven target lesion revascularization risk.

Conclusions: Patency loss after DCB treatment was influenced by procedural and clinical factors. Residual stenosis >30%, smaller preprocedure RVD, and higher RCC may be considered predictors of increased risk of DCB failure and its components in femoropopliteal artery disease. (Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease [INPACT SFA I]; NCT01175850; IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery [SFA] and Proximal Popliteal Artery [PPA] [INPACT SFA II]; NCT01566461; MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery [MDT-2113 SFA]; NCT01947478; IN.PACT Global Clinical Study; NCT01609296).

Keywords: drug-coated balloon; drug-coated balloon failure; femoropopliteal artery; peripheral artery disease; restenosis.

Conflict of interest statement

Funding Support and Author Disclosures The clinical studies included in this analysis were sponsored and funded by Medtronic. Data were transferred for independent analysis to the Baim Institute for Clinical Research, and the analysis was funded by Medtronic. Dr Krishnan has served as a consultant to Abbott and Medtronic. Dr Schneider has served as a member of the advisory board for Philips, Boston Scientific, and Medtronic; and has served as a consultant for Cagent, Cardiovascular Systems, Inc, Intact Vascular, Medtronic, Profusa, Silk Road Medical, and Surmodics. Dr Brodmann has received speaker honoraria from Bard Peripheral Vascular, Biotronik, Medtronic, Spectranetics, and VIVA Physicians; and is a consultant for Bard Peripheral Vascular, Biotronik, Medtronic, and Spectranetics. Dr Micari is a compensated consultant for Medtronic and Boston Scientific. Dr Sachar has served as a consultant for, an advisory board member for, and has received compensation for educational programs from Boston Scientific and Medtronic; has received funds for research or clinical trials from Abbott Vascular, Bard Peripheral Vascular, Cook Medical, W.L. Gore and Associates, Medtronic, Terumo, and Veryan; and is a major shareholder of Contego Medical. Dr Scheinert is a compensated consultant for Abbott, Acotec, Alvimedica, Bayer, Boston Scientific, Cook Medical, Cardionovum, CR Baird, Gardia Medical/Allium, Medtronic, Phillips, and Upstream Peripheral Technologies. Dr Doros is an employee of the Baim Institute for Clinical Research, which was funded by Medtronic to conduct the present analysis. Dr Tepe has received research grants from Medtronic; and is a compensated advisory board member for Medtronic. Dr Laird is an employee of Medtronic; has served on the advisory board for Abbott Vascular and Boston Scientific; has served as a consultant for Abbott Vascular, Bard/Becton Dickinson, Boston Scientific, Medtronic, and Philips; and has received speaker fees from Medtronic. Dr Zeller has received speaking honoraria from Abbott Vascular, Bard Peripheral Vascular, Biotronik, Boston Scientific, Cook Medical, Cordis, GLG, W.L. Gore & Associates, Medtronic, Philips, Spectranetics, Straub Medical, TriReme, Veryan, and VIVA Physicians; is a consultant for Abbott Vascular, Bard Peripheral Vascular, Boston Scientific, 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. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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