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1000 Titel
  • Multivariable Regression Analysis of Clinical Data from the Randomized-Controlled EffPac Trial: Efficacy of Femoropopliteal Drug-Coated Balloon Angioplasty
1000 Autor/in
  1. Mietz, Selma |
  2. Lehmann, Thomas |
  3. Teichgräber, Ulf |
1000 Erscheinungsjahr 2020
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2020-04-01
1000 Erschienen in
1000 Quellenangabe
  • 43(6):840-849
1000 Copyrightjahr
  • 2020
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1007/s00270-020-02452-2 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7225207/ |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • Purpose!#!The post-hoc multivariable analysis of EffPac study data aimed to identify explanatory variables for efficacy of femoropopliteal artery angioplasty.!##!Methods!#!In the prospective, randomized, controlled EffPac study, patients were allocated to either DCB or plain old balloon angioplasty. Multivariable regression including interaction analysis was conducted to assess the impact of selected variables on the outcome measures of late lumen loss (LLL) at 6 months, and on binary restenosis, target lesion revascularization (TLR), clinical improvement, and hemodynamic improvement at 12 months.!##!Results!#!A total of 171 patients (69 ± 8 years, 111 men) were treated at 11 German centers. Hypertension increased, and advanced age decreased LLL (B coefficient [B]: 0.7 [95% CI - 0.04 to 1.3], p = 0.06 and - 0.3 per 10 years [95% CI - 0.5 to 0.01], p = 0.06, respectively). DCB angioplasty decreased odds of 12-month TLR and binary restenosis (OR 0.4 [95% CI 0.2 to 0.8], p = 0.01 and OR 0.1 [95% CI 0.01 to 0.6], p = 0.02, respectively). Lesion length and severe calcification decreased clinical improvement (B: - 0.1 per 10 mm [95% CI - 0.1 to - 0.03], p = 0.001 and - 0.1 [95% CI - 1.7 to - 0.1], p = 0.03, respectively). DCB angioplasty in former smokers improved ABI (0.2 [95% CI 0.01 to 0.5], p = 0.04).!##!Conclusion!#!DCB angioplasty decreased the incidence of 12-month restenosis and TLR. Increasing lesion length and severe calcification reduced clinical improvement. Hypertension is suspected to facilitate, and advanced age to mitigate LLL. DCB improved ABI most in former smokers.
1000 Sacherschließung
lokal Femoral Artery/surgery [MeSH]
lokal Female [MeSH]
lokal Clinical Investigation
lokal Aged [MeSH]
lokal Humans [MeSH]
lokal Prospective Studies [MeSH]
lokal Peripheral Arterial Disease/surgery [MeSH]
lokal Treatment Outcome [MeSH]
lokal Drug-coated balloon angioplasty
lokal Arterial Interventions
lokal Regression analysis
lokal Time Factors [MeSH]
lokal Male [MeSH]
lokal Germany [MeSH]
lokal Coated Materials, Biocompatible/therapeutic use [MeSH]
lokal Angioplasty, Balloon/methods [MeSH]
lokal Equipment Design [MeSH]
lokal Regression Analysis [MeSH]
lokal Femoropopliteal lesions
lokal Popliteal Artery/surgery [MeSH]
lokal Angioplasty, Balloon/instrumentation [MeSH]
lokal Hypertension
1000 Liste der Beteiligten
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1000 Erstellt am 2023-11-18T03:57:26.322+0100
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