Sex-Related Outcomes Following Drug Balloon Angioplasty in Patients from the BIOLUX P-III Registry: A Subgroup Analysis.
Cardiovasc Intervent Radiol
; 45(7): 918-928, 2022 Jul.
Article
em En
| MEDLINE
| ID: mdl-35445317
ABSTRACT
PURPOSE:
To evaluate the use of drug-coated balloons in a real-world patient population with peripheral arterial disease and analyse the impact of sex on mid-term outcomes following their utilisation.METHODS:
The BIOLUX P-III is a prospective, international, multi-centre, registry of patients with infra-inguinal lesions treated using the Passeo-18 Lux, a drug-coated balloon. Our study is a 24-month subgroup analysis of these patients; primary endpoints were freedom from major adverse events and clinically driven target lesion re-vascularisation within 12 months post-intervention.RESULTS:
Of the 877 patients in the registry, 561 (64.0%) were male and 316 (36.0%) were female. Chronic limb threatening ischaemia (Rutherford class ≥ 4) occurred in 35.7% of males and 40.6% of females. Rates of freedom from major adverse events and clinically driven target lesion re-vascularisation at 12 months were 87.3% (95% confidence interval [CI] 84.2-89.9) and 90.4% (95% CI 86.5-93.3), and 92.3% (95% CI 89.9-94.1) and 92.9% (95% CI 89.7-95.1) in males and females, respectively. All-cause mortality at 24 months was 12.0% (95% CI 9.4-15.3) in males and 11.9% (95% CI 8.6-16.5) in females. The major target limb amputation rate at 24 months was 9.1% (95% CI 6.9-11.9) in males and 4.0% (95% CI 2.3-7.0) in females.CONCLUSION:
Treatment with the Passeo-18 Lux DCB demonstrated high efficacy and low complication rates. Despite the greater proportion of chronic limb threatening ischaemia observed in females, males were at a greater risk of ipsilateral major limb amputation and major adverse events following drug-coated balloon utilisation. CLINICAL TRIAL REGISTRATION NCT02276313. LEVEL OF EVIDENCE Level 4.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Fármacos Cardiovasculares
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Angioplastia com Balão
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Doença Arterial Periférica
Tipo de estudo:
Observational_studies
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Risk_factors_studies
Limite:
Female
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Humans
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Male
Idioma:
En
Revista:
Cardiovasc Intervent Radiol
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Austrália