Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention (2024)

Krishnan, P., Farhan, S., Schneider, P., Kamran, H., Iida, O., Brodmann, M., Micari, A., Sachar, R., Urasawa, K., Scheinert, D., Ando, K., Tarricone, A., Doros, G., Tepe, G., Yokoi, H., Laird, J., & Zeller, T. (2022). Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. Journal of the American College of Cardiology, 80(13), 1241-1250. https://doi.org/10.1016/j.jacc.2022.06.043

Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. / Krishnan, Prakash; Farhan, Serdar; Schneider, Peter et al.
In: Journal of the American College of Cardiology, Vol. 80, No. 13, 27.09.2022, p. 1241-1250.

Research output: Contribution to journal › Article › peer-review

Krishnan, P, Farhan, S, Schneider, P, Kamran, H, Iida, O, Brodmann, M, Micari, A, Sachar, R, Urasawa, K, Scheinert, D, Ando, K, Tarricone, A, Doros, G, Tepe, G, Yokoi, H, Laird, J & Zeller, T 2022, 'Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention', Journal of the American College of Cardiology, vol. 80, no. 13, pp. 1241-1250. https://doi.org/10.1016/j.jacc.2022.06.043

Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M et al. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. Journal of the American College of Cardiology. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043

Krishnan, Prakash ; Farhan, Serdar ; Schneider, Peter et al. / Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. In: Journal of the American College of Cardiology. 2022 ; Vol. 80, No. 13. pp. 1241-1250.

@article{9b0daaa1d4d64e5a8dfc5a70633ad7bf,

title = "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{\textregistered} 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",

keywords = "drug-coated balloon, drug-coated balloon failure, femoropopliteal artery, peripheral artery disease, restenosis",

author = "Prakash Krishnan and Serdar Farhan and Peter Schneider and Haroon Kamran and Osamu Iida and Marianne Brodmann and Antonio Micari and Ravish Sachar and Kasuki Urasawa and Dierk Scheinert and Kenji Ando and Arthur Tarricone and Gheorghe Doros and Gunnar Tepe and Hiroyoshi Yokoi and John Laird and Thomas Zeller",

note = "Publisher Copyright: {\textcopyright} 2022 The Authors",

year = "2022",

month = sep,

day = "27",

doi = "10.1016/j.jacc.2022.06.043",

language = "English (US)",

volume = "80",

pages = "1241--1250",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier USA",

number = "13",

}

TY - JOUR

T1 - Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention

AU - Krishnan, Prakash

AU - Farhan, Serdar

AU - Schneider, Peter

AU - Kamran, Haroon

AU - Iida, Osamu

AU - Brodmann, Marianne

AU - Micari, Antonio

AU - Sachar, Ravish

AU - Urasawa, Kasuki

AU - Scheinert, Dierk

AU - Ando, Kenji

AU - Tarricone, Arthur

AU - Doros, Gheorghe

AU - Tepe, Gunnar

AU - Yokoi, Hiroyoshi

AU - Laird, John

AU - Zeller, Thomas

N1 - Publisher Copyright:© 2022 The Authors

PY - 2022/9/27

Y1 - 2022/9/27

N2 - 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

AB - 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

KW - drug-coated balloon

KW - drug-coated balloon failure

KW - femoropopliteal artery

KW - peripheral artery disease

KW - restenosis

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DO - 10.1016/j.jacc.2022.06.043

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JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

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