Medizinische Universität Graz - Research portal
Navigation/Search
- Researchers
- Institutions
- Projects
- Publications
- Partners
- Sponsors
- Equipment
- Knowhow
- Fields of Research
"Faces" of the day:
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Mwipatayi, BP; Barry, IP; Brodmann, M; Zeller, T; Varcoe, RL; Moscovic, M; Chian, JWC; Christensen, JK; Yahaya, SA; Oshin, OA; Tepe, G, , BIOLUX, P-III, Global, Registry, Investigators.
Twenty-Four-Month Outcomes of Drug-Coated Balloon in Diabetic Patients in the BIOLUX P-III Registry: A Subgroup Analysis.
ANN VASC SURG. 2021; 75: 237-252.
Doi: 10.1016/j.avsg.2021.02.050
Web of Science
PubMed
FullText
FullText_MUG
- Co-authors Med Uni Graz
- Brodmann Marianne
- Altmetrics:
- Dimensions Citations:
- Plum Analytics:
- Scite (citation analytics):
- 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Adult - administration & dosage
- Aged - administration & dosage
- Aged, 80 and over - administration & dosage
- Amputation - administration & dosage
- Angioplasty, Balloon - adverse effects, instrumentation
- Asia - epidemiology
- Australia - epidemiology
- Coated Materials, Biocompatible - administration & dosage
- Diabetes Mellitus - diagnosis, epidemiology
- Europe - epidemiology
- Female - administration & dosage
- Humans - administration & dosage
- Limb Salvage - administration & dosage
- Lower Extremity - blood supply
- Male - administration & dosage
- Middle Aged - administration & dosage
- Multimorbidity - administration & dosage
- Peripheral Arterial Disease - diagnosis, epidemiology, therapy
- Prospective Studies - administration & dosage
- Registries - administration & dosage
- Risk Assessment - administration & dosage
- Risk Factors - administration & dosage
- Time Factors - administration & dosage
- Treatment Outcome - administration & dosage
- Vascular Access Devices - administration & dosage
- Young Adult - administration & dosage