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

Autor: Biolux P-Iii Global Registry Investigators, Gunnar Tepe, Ramon L. Varcoe, Marianne Brodmann, Matej Moscovic, Ian P Barry, Olufemi Oshin, Bibombe P. Mwipatayi, John Wang Chaw Chian, Shaiful Azmi Yahaya, Johnny Kent Christensen, Thomas Zeller
Rok vydání: 2020
Předmět:
Target lesion
Male
Time Factors
030204 cardiovascular system & hematology
030218 nuclear medicine & medical imaging
0302 clinical medicine
Coated Materials
Biocompatible
Risk Factors
Prospective Studies
Registries
Aged
80 and over
education.field_of_study
Diabetes
Passeo-18 Lux
General Medicine
Middle Aged
Limb Salvage
Europe
Treatment Outcome
Lower Extremity
Cohort
Female
Cardiology and Cardiovascular Medicine
Vascular Access Devices
Adult
medicine.medical_specialty
Asia
Population
Subgroup analysis
Risk Assessment
Amputation
Surgical
03 medical and health sciences
Peripheral Arterial Disease
Young Adult
Internal medicine
Diabetes mellitus
medicine
Diabetes Mellitus
Humans
Drug-eluting balloon
education
Aged
Peripheral artery disease
business.industry
Australia
Multimorbidity
medicine.disease
Confidence interval
Concomitant
Surgery
Drug-coated balloon
business
Complication
Angioplasty
Balloon
Zdroj: BIOLUX P-III Global Registry Investigators 2021, ' Twenty-Four-Month Outcomes of Drug-Coated Balloon in Diabetic Patients in the BIOLUX P-III Registry : A Subgroup Analysis ', Annals of Vascular Surgery, vol. 75, pp. 237-252 . https://doi.org/10.1016/j.avsg.2021.02.050
ISSN: 1615-5947
0227-6313
DOI: 10.1016/j.avsg.2021.02.050
Popis: 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
Databáze: OpenAIRE
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