Thomas Albrecht1,2, Antonia Ukrow3, Michael Werk4, Gunnar Tepe5, Thomas Zeller6, Dirk-Roelfs Meyer7, Maren Kutschera8, Ulrich Speck8, Matthias Waliszewski9,10. 1. Department of Radiology and Interventional Therapy, Vivantes Klinikum Neukölln, Berlin, Germany. Thomas.albrecht@vivantes.de. 2. Institut für Radiologie und Interventionelle Therapie, Vivantes Klinikum Neukölln, Rudower Str. 48, 12351, Berlin, Germany. Thomas.albrecht@vivantes.de. 3. Department of Radiology and Interventional Therapy, Vivantes Klinikum Neukölln, Berlin, Germany. 4. Department of Radiology, Martin-Luther-Hospital, Berlin, Germany. 5. Department of Radiology, RoMed Klinikum Rosenheim, Rosenheim, Germany. 6. Department of Angiology, Herzzentrum Bad Krozingen, Bad Krozingen, Germany. 7. Department of Diagnostic and Interventional Radiology, Hubertus Hospital, Berlin, Germany. 8. Experimental Radiology, Department of Radiology, Charité, Berlin, Germany. 9. Medical Scientific Affairs, B.Braun Melsungen AG, Berlin, Germany. 10. Department of Internal Medicine and Cardiology, Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany.
Abstract
OBJECTIVES: The principal objective of this pooled analysis was to investigate various patient and lesion characteristics on late lumen loss (LLL) after drug-coated balloon (DCB) angioplasty. BACKGROUND: Four randomized controlled trials (THUNDER, FEMPAC, PACIFIER, CONSEQUENT) were pooled to investigate the influence of various patient and lesion characteristics on DCB angioplasty and on plain old balloon angioplasty (POBA) in patients with femoropopliteal artery disease. METHODS: Angiographic data from 355 patients were pooled to assess the impact of patient (demographics, cardiovascular risk factors, cardiovascular co-morbidities, Rutherford stages) and lesion-/procedure-related (location, occlusion, length, restenosis, calcification, subintimal crossing, post-dilatation, dissection, stenting) characteristics on LLL. Linear regression models were utilized with LLL as the dependent variable to determine the predictive value of cardiovascular and lesion-/procedure-related factors. RESULTS: Observational statistics revealed that LLL was lower in the DCB group as compared to POBA independent of all tested patient variables. LLL after DCB was also independent of most lesion and procedural characteristics except for lesion length and bailout stenting. LLL increased with lesion length in both treatment groups. Bailout stenting did not improve LLL in the DCB group but did so in the POBA group (0.74 ± 1.07 mm vs. 1.22 ± 1.36 mm, p = 0.043). CONCLUSIONS:DCB was superior to POBA for all tested patient subgroups and lesion subgroups. Our results suggest that all patients and lesions benefit to a similar degree from the use of DCB. DCB-PTA should therefore be preferred to POBA in all patients with steno-occlusive femoropopliteal lesions.
RCT Entities:
OBJECTIVES: The principal objective of this pooled analysis was to investigate various patient and lesion characteristics on late lumen loss (LLL) after drug-coated balloon (DCB) angioplasty. BACKGROUND: Four randomized controlled trials (THUNDER, FEMPAC, PACIFIER, CONSEQUENT) were pooled to investigate the influence of various patient and lesion characteristics on DCB angioplasty and on plain old balloon angioplasty (POBA) in patients with femoropopliteal artery disease. METHODS: Angiographic data from 355 patients were pooled to assess the impact of patient (demographics, cardiovascular risk factors, cardiovascular co-morbidities, Rutherford stages) and lesion-/procedure-related (location, occlusion, length, restenosis, calcification, subintimal crossing, post-dilatation, dissection, stenting) characteristics on LLL. Linear regression models were utilized with LLL as the dependent variable to determine the predictive value of cardiovascular and lesion-/procedure-related factors. RESULTS: Observational statistics revealed that LLL was lower in the DCB group as compared to POBA independent of all tested patient variables. LLL after DCB was also independent of most lesion and procedural characteristics except for lesion length and bailout stenting. LLL increased with lesion length in both treatment groups. Bailout stenting did not improve LLL in the DCB group but did so in the POBA group (0.74 ± 1.07 mm vs. 1.22 ± 1.36 mm, p = 0.043). CONCLUSIONS:DCB was superior to POBA for all tested patient subgroups and lesion subgroups. Our results suggest that all patients and lesions benefit to a similar degree from the use of DCB. DCB-PTA should therefore be preferred to POBA in all patients with steno-occlusive femoropopliteal lesions.
Entities:
Keywords:
Drug-coated balloon angioplasty; Femoropopliteal lesions; Late lumen loss; Pooled data analyses
Authors: John A Laird; Peter A Schneider; Michael R Jaff; Marianne Brodmann; Thomas Zeller; D Chris Metzger; Prakash Krishnan; Dierk Scheinert; Antonio Micari; Hong Wang; Michele Masters; Gunnar Tepe Journal: Circ Cardiovasc Interv Date: 2019-06-14 Impact factor: 6.546