Korean Journal of Radiology

The Korean Society of Radiology (대한영상의학회)
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Safety and Effectiveness of Passeo-18 Lux Drug-Coated Balloon Catheter in Infrainguinal Endovascular Revascularization in the Korean Population: A Multicenter Post-Market Surveillance Study

  • Tae Won Choi (Department of Radiology, Ajou University Hospital, Ajou University School of Medicine) ;
  • Je Hwan Won (Department of Radiology, Ajou University Hospital, Ajou University School of Medicine) ;
  • Hwan Jun Jae (Department of Radiology, Seoul National University Hospital, Seoul National University College of Medicine) ;
  • Yong Sun Jeon (Department of Radiology, Inha University Hospital, Inha University School of Medicine) ;
  • Sang Woo Park (Department of Radiology, Konkuk University Hospital, Konkuk University School of Medicine) ;
  • Gi-Young Ko (Department of Radiology, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Nam Yeol Yim (Department of Radiology, Chonnam National University Hospital, Chonnam National University Medical School) ;
  • Jong Yun Won (Department of Radiology, Severance Hospital, Yonsei University College of Medicine) ;
  • Chang Won Kim (Department of Radiology, Pusan National University Hospital, Pusan National University College of Medicine) ;
  • Jinoo Kim (Department of Radiology, Ajou University Hospital, Ajou University School of Medicine)
  • Received : 2023.11.18
  • Accepted : 2024.04.04
  • Published : 2024.06.01
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Abstract

Objective: To evaluate the safety and clinical outcomes of the Passeo-18 Lux drug-coated balloon (DCB) in endovascular revascularization procedures under real-world conditions in a Korean population with atherosclerotic disease of the infrainguinal arteries, including below-the-knee (BTK) arteries. Materials and Methods: Eight institutions in the Republic of Korea participated in this prospective, multicenter, single-arm, post-market surveillance study. Two hundred patients with Rutherford class 2-5 peripheral arterial disease and infrainguinal lesions suitable for endovascular treatment were competitively enrolled. Data were collected at baseline, the time of intervention, discharge, and 1-, 6-, 12-, and 24-month follow-up visits. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months (except when limiting the time frame for procedure- or device-related mortality to within 30 days), and the primary effectiveness endpoint was freedom from clinically driven target lesion revascularization (CD-TLR) within 12 months after the procedure. Results: A total of 197 patients with 332 target lesions were analyzed. Two-thirds of the patients had diabetes mellitus, and 41.6% had chronic limb-threatening ischemia. The median target lesion length was 100 mm (interquartile range: 56-133 mm). Of the target lesions, 35.2% were occlusions, and 14.8% were located in the BTK arteries. Rate of freedom from MAE was 97.9% at 6 months, and the rate of freedom from CD-TLR was 95.0% and 92.2% at 12 and 24 months, respectively. Subgroup analysis of 43 patients and 49 target lesions involving the BTK arteries showed rate of freedom from MAE of 92.8% at 6 months and rates of freedom from CD-TLR of 88.8% and 84.4% at 12 and 24 months, respectively. Conclusion: The results of the present study, including the BTK subgroup analysis, showed outcomes comparable to those of other DCB studies, confirming the safety and effectiveness of Passeo-18 Lux DCB in the Korean population.

Keywords

Acknowledgement

The present study was supported by BIOTRONIK through the research grant number G1714. The funding source was not involved in collecting, monitoring, or analyzing study data and writing the manuscript.

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