Article ; Online: Sex-Related Outcomes Following Drug Balloon Angioplasty in Patients from the BIOLUX P-III Registry: A Subgroup Analysis.
Cardiovascular and interventional radiology
2022 Volume 45, Issue 7, Page(s) 918–928
Abstract: ... The BIOLUX P-III is a prospective, international, multi-centre, registry of patients with infra-inguinal ...
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. |
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MeSH term(s) | Angioplasty, Balloon/adverse effects ; Cardiovascular Agents/adverse effects ; Coated Materials, Biocompatible ; Female ; Femoral Artery ; Humans ; Limb Salvage ; Male ; Paclitaxel/adverse effects ; Peripheral Arterial Disease/complications ; Peripheral Arterial Disease/diagnostic imaging ; Peripheral Arterial Disease/therapy ; Popliteal Artery ; Prospective Studies ; Registries ; Treatment Outcome ; Vascular Patency |
Chemical Substances | Cardiovascular Agents ; Coated Materials, Biocompatible ; Paclitaxel (P88XT4IS4D) |
Language | English |
Publishing date | 2022-04-20 |
Publishing country | United States |
Document type | Journal Article |
ZDB-ID | 603082-8 |
ISSN | 1432-086X ; 0342-7196 ; 0174-1551 |
ISSN (online) | 1432-086X |
ISSN | 0342-7196 ; 0174-1551 |
DOI | 10.1007/s00270-022-03135-w |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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