TY - JOUR
T1 - Outcomes of drug-coated balloon angioplasty in patients with dyslipidemia in the BIOLUX P-III registry
T2 - A subgroup analysis
AU - Dodd, James Evan
AU - Hanna, Joseph
AU - Brodmann, Marianne
AU - Golledge, Jonathan
AU - Zeller, Thomas
AU - Moscovic, Matej
AU - Dahm, Johannes
AU - Troisi, Nicola
AU - Tepe, Gunnar
AU - Wong, Jacqueline
AU - Ward, Natalie C.
AU - Mwipatayi, Bibombe Patrice
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/8/19
Y1 - 2024/8/19
N2 - Objectives: The aim of this study was to assess the mid-term outcomes of the use of drug-coated balloons (DCBs) to treat infrainguinal peripheral arterial disease (PAD) in patients with dyslipidemia. Methods: BIOLUX P-III is a prospective, international, multicenter, all-comers registry-based study that was conducted at 44 sites with follow-ups at 6, 12 and 24 months. The present study is a subgroup analysis comparing the outcomes associated with endovascular revascularization with those associated with Passeo-18 lux DCBs in patients with and without dyslipidemia. The proportions of patients free from major adverse events (defined as device- or procedure-related mortality within 30 days, clinically driven target lesion revascularization (CD-TLR) and major target limb amputation), target vessel revascularization, and patient-reported outcomes within 24 months postintervention were compared between the two groups. Results: A total of 876 patients with symptomatic PAD who underwent peripheral revascularization with DCBs and had information on their dyslipidemia status were included; 588 of those patients had dyslipidemia. There was no difference in the proportion of patients free from MAEs between the groups. The percentages of patients who were 6, 12 and 24 months free from CD-TLR were significantly lower in the dyslipidemia group than in the nondyslipidemia group (86.3% vs 91.9% at 2 years, p =.0183). Similarly, the percentage of patients free from target vessel revascularization was lower in the dyslipidemia group at all timepoints (83.3% vs 89.3% at 2 years, p =.0203). There was no difference in mortality or major or minor limb amputation rates. Other secondary outcomes were similar between the groups. Conclusions: Compared to those without dyslipidemia, patients with symptomatic PAD and dyslipidemia who underwent revascularization with a Passeo-18 lux DCB had greater rates of CD-TLR and TVR. However, having dyslipidemia did not increase the risk of mortality or limb amputation. Clinical Trial Registration: NCT02276313.
AB - Objectives: The aim of this study was to assess the mid-term outcomes of the use of drug-coated balloons (DCBs) to treat infrainguinal peripheral arterial disease (PAD) in patients with dyslipidemia. Methods: BIOLUX P-III is a prospective, international, multicenter, all-comers registry-based study that was conducted at 44 sites with follow-ups at 6, 12 and 24 months. The present study is a subgroup analysis comparing the outcomes associated with endovascular revascularization with those associated with Passeo-18 lux DCBs in patients with and without dyslipidemia. The proportions of patients free from major adverse events (defined as device- or procedure-related mortality within 30 days, clinically driven target lesion revascularization (CD-TLR) and major target limb amputation), target vessel revascularization, and patient-reported outcomes within 24 months postintervention were compared between the two groups. Results: A total of 876 patients with symptomatic PAD who underwent peripheral revascularization with DCBs and had information on their dyslipidemia status were included; 588 of those patients had dyslipidemia. There was no difference in the proportion of patients free from MAEs between the groups. The percentages of patients who were 6, 12 and 24 months free from CD-TLR were significantly lower in the dyslipidemia group than in the nondyslipidemia group (86.3% vs 91.9% at 2 years, p =.0183). Similarly, the percentage of patients free from target vessel revascularization was lower in the dyslipidemia group at all timepoints (83.3% vs 89.3% at 2 years, p =.0203). There was no difference in mortality or major or minor limb amputation rates. Other secondary outcomes were similar between the groups. Conclusions: Compared to those without dyslipidemia, patients with symptomatic PAD and dyslipidemia who underwent revascularization with a Passeo-18 lux DCB had greater rates of CD-TLR and TVR. However, having dyslipidemia did not increase the risk of mortality or limb amputation. Clinical Trial Registration: NCT02276313.
KW - angioplasty
KW - drug-coated balloon
KW - drug-eluting balloon
KW - dyslipidemia
KW - Peripheral arterial disease
KW - stenosis
UR - http://www.scopus.com/inward/record.url?scp=85201578145&partnerID=8YFLogxK
U2 - 10.1177/17085381241275795
DO - 10.1177/17085381241275795
M3 - Article
C2 - 39158589
AN - SCOPUS:85201578145
SN - 1708-5381
JO - Vascular
JF - Vascular
ER -