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

BIOLUX P-III Global Registry Investigators, Bibombe Patrice Mwipatayi, Ian Patrick Barry, Marianne Brodmann, Thomas Zeller, Ramon L. Varcoe, Matej Moscovic, John Wang Chaw Chian, Johnny Kent Christensen, Shaiful Azmi Yahaya, Olufemi Ayoadeleke Oshin, Gunnar Tepe

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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

Original languageEnglish
Pages (from-to)237-252
Number of pages16
JournalAnnals of vascular surgery
Volume75
DOIs
Publication statusPublished - Aug 2021

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