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• W3023908565 abstract "To assess the efficacy of drug-eluting balloon (DEB) compared with uncoated, non-stenting balloon angioplasty in patients with symptomatic lower-extremity peripheral arterial disease (PAD). A Cochrane systematic review and meta-analysis was carried out of all published randomized- controlled trials that compared DEBs with nonstenting balloon angioplasty for PAD. Eleven trials that randomized 1838 participants met the study inclusion criteria. DEBs were associated with better outcomes for up to 2 years in primary vessel patency (odds ratio [OR], 3.84; 95% confidence interval [CI], 1.43-10.31 at 6 months; OR, 1.92; 95% CI, 1.45-2.56 at 12 months; OR, 3.51; 95% CI, 2.26-5.46 at 2 years) and late lumen loss (mean difference [MD], −0.64 mm; 95% CI, −1.00 to −0.28 at 6 months; MD, −1.10 mm; 95% CI, −1.41 to −0.79 at 12 months; MD, −0.80 mm; 95% CI, −1.44 to −0.16 at 2 years). DEB were also superior to uncoated balloon angioplasty for up to 5 years in target lesion revascularization (OR, 0.28; 95% CI, 0.17 to 0.47 at 6 months; OR, 0.40; 95% CI, 0.31-0.51 at 12 months; OR, 0.28; 95% CI, 0.18-0.44 at 2 years; OR, 0.21; 95% CI, 0.09-0.51 at 5 years) and binary restenosis rate (OR, 0.44; 95% CI, 0.29-0.67 at 6 months; OR, 0.38; 95% CI, 0.15-0.98 at 12 months; OR, 0.26; 95% CI, 0.10-0.66 at 2 years; OR, 0.12; 95% CI, 0.05-0.30 at 5 years). There was no significant difference between DEB and uncoated angioplasty in amputation, patient mortality, ankle-brachial index measurements, change in Rutherford category and quality of life (QoL) scores, or treadmill walking distance, although none of the trials were powered to detect a significant difference in these clinical end points. Two subgroup analyses were carried out to examine outcomes in femoropopliteal and tibial interventions as well as in patients with critical limb ischemia (≥4 Rutherford class), and showed no advantage for DEBs at 6 and 12 months compared with uncoated balloon angioplasty. There is an advantage for DEBs compared with uncoated balloon angioplasty in several anatomic end points, but no significant advantage in clinical endpoints such as amputation or QoL. Well-designed studies with long-term follow-up are needed to adequately compare DEB with uncoated balloon angioplasty for both anatomic and clinical study end points before the widespread use of this expensive technology can be justified." @default.
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• W3023908565 date "2016-06-01" @default.
• W3023908565 modified "2023-09-30" @default.
• W3023908565 title "IP165. Drug-Eluting Balloon Angioplasty vs Nonstenting Balloon Angioplasty for Peripheral Arterial Disease of the Lower Limbs" @default.
• W3023908565 doi "https://doi.org/10.1016/j.jvs.2016.03.120" @default.
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