ArticleVascular health and risk management2026
Five-Year Outcomes of Paclitaxel-Coated Balloons in Patients with Diabetes from the BIOLUX P-III Single-Arm Study.
Article in Vascular health and risk management, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02276313 (BIOTRONIK - A Prospective, International, Mulit-centre, Post-market All-comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III), which is not on this map. Not yet cited in PubMed.
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BIOTRONIK - A Prospective, International, Mulit-centre, Post-market All-comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries - III
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Abstract
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%; 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).
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