Twenty-Four-Month Outcomes of Drug-Coated Balloon in Diabetic Patients in the BIOLUX P-III Registry: A Subgroup Analysis

Mwipatayi BP 1 , Barry IP 2 , Brodmann M 3 , Zeller T 4 , Varcoe RL 5 , Moscovic M 6 Show all authors , Chian JWC 7 , Christensen JK 8 , Yahaya SA 9 , Oshin OA 2 , Tepe G 10 , BIOLUX P-III Global Registry Investigators

Affiliations 

  • 1 University of Western Australia, School of Surgery, Perth, Australia; Department of Vascular Surgery, Royal Perth Hospital, Perth, Australia. Electronic address: bibombe@iinet.net.au
  • 2 Department of Vascular Surgery, Royal Perth Hospital, Perth, Australia
  • 3 Department of Angiology, Medical University Graz, Graz, Austria
  • 4 Clinic Cardiology and Angiology II, Universitäts-Herzzentrum Freiburg, Freiburg, Germany
  • 5 Faculty of Medicine, University of New South Wales, Sydney, Australia; Department of Surgery, Prince of Wales Hospital, Sydney, Australia; The Vascular Institute, Prince of Wales Hospital, Sydney, Australia
  • 6 Department of Angiology, Institute of Cardiovascular Diseases, Kosice, Slovakia
  • 7 Department of Vascular Surgery, Singapore General Hospital, Singapore
  • 8 Department of Radiology, Kolding Hospital, Kolding, Denmark
  • 9 Cardiology Department, Institute Jantung Negara, Kuala Lumpur, Malaysia
  • 10 Department of Diagnostic and Interventional Radiology, Klinikum Rosenheim, Rosenheim, Germany
Ann Vasc Surg, 2021 Aug;75:237-252.
PMID: 33831519 DOI: 10.1016/j.avsg.2021.02.050

Abstract

OBJECTIVES: This study aims to assess the use of drug-coated balloon (DCB) in a large patient population under real-world conditions and, specifically, analyse the impact of diabetes mellitus on long term outcomes following DCB utilisation.

METHODS: BIOLUX P-III is a prospective, international, multicentre, registry that was conducted at 41 centres. The present study is a 24-month subgroup analysis of patients with diabetes mellitus having infrainguinal lesions treated with the Passeo-18 Lux DCB. The primary endpoints were freedom from major adverse events (MAEs) within 6 months of intervention and freedom from clinically driven target lesion revascularisation (CD-TLR) within 12 months of intervention.

RESULTS: Of the 882 patients in the registry, 418 had diabetes (516 lesions). Most diabetics had concomitant hypertension (88.8%) and hyperlipidaemia (70.3%). Insulin dependence was observed in 48.8% of diabetics. Moreover, smoking (62.2%) and chronic renal insufficiency (41.9%) were also found to be common in this cohort. Chronic limb threatening ischemia (Rutherford class ≥4) was present in 53.1% of all patients. 22.9% of lesions were infrapopliteal, while 22.5% of lesions were treated for in-stent restenosis. The mean target lesion length was 85.6 ± 73.2 mm, and 79.4% of lesions were calcified (of which 17.9% were heavily calcified). Overall, device success was 99.7%. Freedom from MAEs was 90.5% (95% confidence interval (95% CI): 87.2-93.0) at 6 months, 85.4% (95% CI: 81.5-88.6) at 12 months and 80% (95% CI: 75.5-83.8) at 24 months. Freedom from CD-TLR was 95.9% (95% CI: 93.8-97.4), 91.6% (95% CI: 88.7-93.8), and 87.1% (95% CI: 83.5-89.9) at 6, 12, and 24 months, respectively. All-cause mortality at 24 months in diabetics was 16.0% (95% CI: 12.6-20.2), and major target limb amputation was 6.1% (95% CI: 4.1-8.9), which was significantly higher than in non-diabetics (8.4% (95% CI: 6.0-11.6), P = 0.0005 and 1.2% (95% CI: 0.5-2.9), P <0.0001, respectively). At 24 months, 82.0% of patients had improved by ≥1 Rutherford class.

CONCLUSION: Treatment of a real-world diabetic patient population with the Passeo-18 Lux DCB resulted in high efficacy and low complication rates, despite the fact that diabetic patients usually suffer from a multitude of concomitant comorbidities.

CLINICAL TRIAL REGISTRATION: NCT02276313.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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