Vascular health and risk management · 2026
Five-Year Outcomes of Paclitaxel-Coated Balloons in Patients with Diabetes from the BIOLUX P-III Single-Arm Study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Dodd James, Stratford Gabrielle, Brodmann Marianne, Moscovic Matej, Wang John Chaw Chian, Nano Giovanni, Zeller Thomas, Christensen Johnny Kent, Tepe Gunnar, Mwipatayi Bibombe Patrice, BIOLUX P-III Global Registry, BIOLUX P-III Global Registry Investigators:, BIOLUX P-III Global Registry Investigators:
Аннотация
PURPOSE: Long-term outcomes of paclitaxel-coated drug-coated balloons (DCBs) in patients with diabetes mellitus (DM) and infrainguinal peripheral arterial disease (PAD) are incompletely defined. In the current study, we evaluated 5-year outcomes in the diabetic cohort of BIOLUX P-III.
PATIENTS AND METHODS: BIOLUX P-III was a prospective, international, multicenter, post-market, single-arm study evaluating the Passeo-18 Lux DCB in routine practice. Between October 2014 and January 2017, 877 patients with infrainguinal lesions were treated at 47 centers, of whom 418 (47.7%) had DM. The primary clinical endpoint was 6-month freedom from major adverse events (MAEs), defined as freedom from procedure- or device-related death through 30 days, major target-limb amputation, or clinically driven target-lesion revascularization (CD-TLR). The primary performance endpoint was 12-month freedom from CD-TLR. Time-to-event outcomes were analyzed using Kaplan-Meier methods and the Log rank test.
RESULTS: Among 877 treated patients, 418 had DM. Follow-up completion was 81.6%, 86.4%, 82.3%, and 31.3% at 6, 12, 24, and 60 months, respectively. At 5 years, freedom from MAE was lower in patients with DM than in those without DM (71.2% vs 74.7%; P = 0.0359), whereas freedom from CD-TLR was similar between groups (79.8% vs 79.6%; P = 0.535). Patients with DM also had lower overall survival (56.3% vs 73.8%; P < 0.0001), lower freedom from major target-limb amputation (92.4% vs 98.8%; P < 0.0001), and lower amputation-free survival (53.0% vs 73.6%; P < 0.0001).
CONCLUSION: In this real-world registry, the Passeo-18 Lux DCB was associated with durable freedom from reintervention through 5 years, with similar CD-TLR rates in patients with and without DM. Patients with DM had poorer long-term survival and limb outcomes. However, these findings should be interpreted in the context of baseline between-group differences and limited 60-month follow-up (ClinicalTrials.gov number, NCT02276313).
PATIENTS AND METHODS: BIOLUX P-III was a prospective, international, multicenter, post-market, single-arm study evaluating the Passeo-18 Lux DCB in routine practice. Between October 2014 and January 2017, 877 patients with infrainguinal lesions were treated at 47 centers, of whom 418 (47.7%) had DM. The primary clinical endpoint was 6-month freedom from major adverse events (MAEs), defined as freedom from procedure- or device-related death through 30 days, major target-limb amputation, or clinically driven target-lesion revascularization (CD-TLR). The primary performance endpoint was 12-month freedom from CD-TLR. Time-to-event outcomes were analyzed using Kaplan-Meier methods and the Log rank test.
RESULTS: Among 877 treated patients, 418 had DM. Follow-up completion was 81.6%, 86.4%, 82.3%, and 31.3% at 6, 12, 24, and 60 months, respectively. At 5 years, freedom from MAE was lower in patients with DM than in those without DM (71.2% vs 74.7%; P = 0.0359), whereas freedom from CD-TLR was similar between groups (79.8% vs 79.6%; P = 0.535). Patients with DM also had lower overall survival (56.3% vs 73.8%; P < 0.0001), lower freedom from major target-limb amputation (92.4% vs 98.8%; P < 0.0001), and lower amputation-free survival (53.0% vs 73.6%; P < 0.0001).
CONCLUSION: In this real-world registry, the Passeo-18 Lux DCB was associated with durable freedom from reintervention through 5 years, with similar CD-TLR rates in patients with and without DM. Patients with DM had poorer long-term survival and limb outcomes. However, these findings should be interpreted in the context of baseline between-group differences and limited 60-month follow-up (ClinicalTrials.gov number, NCT02276313).
Предметные рубрики MeSH
HumansPaclitaxelPeripheral Arterial DiseaseFemaleTime FactorsCoated Materials, BiocompatibleCardiovascular AgentsAgedProspective StudiesMaleRisk FactorsAmputation, SurgicalAngioplasty, BalloonVascular Access DevicesProgression-Free SurvivalLimb SalvageMiddle AgedEquipment DesignTreatment OutcomeVascular PatencyAged, 80 and overDiabetes MellitusDiabetic Angiopathies