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Linn, YL; Wang, JCC; Pua, U; Yahaya, SAB; Choke, ETC; Chong, TT; Brodmann, M; Tang, TY.
Utility of paclitaxel-coated balloons for the treatment of infrainguinal disease in the Asian population-24-month outcome data from the BIOLUX P-III Global Registry 24-month Asian outcomes of BIOLUX P-III
VASCULAR. 2022; 17085381221081969
Doi: 10.1177/17085381221081969
Web of Science
PubMed
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- Co-authors Med Uni Graz
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Brodmann Marianne
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- Abstract:
- Background Results from the BIOLUX P-III registry have demonstrated favourable outcomes of Passeo-18 Lux (TM) (Biotronik (R), Buelach, Switzerland) drug-coated balloon in treating obstructive infrainguinal peripheral artery disease, but it has not been established if Asians would benefit to the same extent as non-Asians. Methods A subgroup analysis was performed on the 24-month data comparing the Asian cohort (AC) to non-Asian cohort (NAC). Results AC included 49 patients with 77 lesions. AC was significantly younger (65.6 vs 70.3 years, p < 0.05), had more diabetes (87.8% vs 45.3%, p < 0.05), and was more likely to present with CLTI (73.5% vs 35.3%, p < 0.001) compared to NAC. They had significantly longer mean target lesions (115 vs 86.9 mm, p = 0.006), and received significantly higher paclitaxel doses (10.7 vs 7.2 mg, p = 0.0005). Device, technical and procedural successes were 125/125(100%), 95/97(97.5%) and 45/49(91.8%), respectively. There was no significant difference in target lesion revascularization rates between groups (10.5% vs 12%, p = 0.91). However, the AC had more major adverse events (30.2% vs 16.1%, p = 0.001), amputations (26.3% vs 6.2%, p < 0.05) and mortality (37.9% vs 10.6%, p < 0.05) at 24 months. Conclusion Passeo-18 Lux (TM) use was efficacious in Asians, but was associated with higher adverse events, amputations and mortality rates, likely attributable to poorer patient comorbidities and more extensive PAD.
- Find related publications in this database (Keywords)
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paclitaxel-coated balloon
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infrainguinal disease
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chronic limb ischaemia
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peripheral arterial disease
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Asian