In the EdoxabaN versus warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation study (NCT 02072434), edoxaban showed similar efficacy and safety versus enoxaparin-warfarin in patients underwent electrical cardioversion of nonvalvular atrial fibrillation. In this ancillary analysis, we compared the primary efficacy (composite of stroke, systemic embolic event, myocardial infarction, cardiovascular death, and overall study period) and safety (composite of major and clinically relevant nonmajor bleeding, on-treatment) end points in relation to body mass index (BMI; <30 vs ≥30 kg/m2). We also compared cardioversion outcomes in relation to BMI. Of 2,199 patients enrolled, 1,095 were randomized to edoxaban and 1,104 to enoxaparin-warfarin. Mean age was 64 ± 10 and 64 ± 11 years and mean BMI 30.6 and 30.7 kg/m2, respectively. Cardiovascular and metabolic diseases were more prevalent in obese (n = 1067) than nonobese patients. Overall ischemic event rates were low; rates in the BMI <30 kg/m2 subgroup were numerically lower than the ≥30 kg/m2 subgroup, but not significantly different (odds ratio [OR], 0.74 [95% confidence interval 0.23, 2.24]). Composite major + clinically relevant nonmajor bleeding rates were low and numerically lower, but not significantly different (OR 0.88 [0.38, 2.04]), between the edoxaban and enoxaparin-warfarin arms and across weight categories. Successful cardioversion rate was higher in the BMI <30 versus ≥30 kg/m2 subgroup (73.9% vs 69.9%; OR 1.22 [1.01 to 1.48]). In EdoxabaN versus warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation, BMI did not significantly impact the relative efficacy and safety of edoxaban versus enoxaparin-warfarin. Nevertheless, the nonobese group had a higher rate of cardioversion success than the obese group.

Impact of Body Mass Index on Outcomes in the Edoxaban Versus Warfarin Therapy Groups in Patients Underwent Cardioversion of Atrial Fibrillation (from ENSURE-AF) / Lip, Gregory Y H; Merino, Jose L; Banach, Maciej; de Groot, Joris R; Maier, Lars S; Themistoclakis, Sakis; Boriani, Giuseppe; Jin, James; Melino, Michael; Winters, Shannon M; Goette, Andreas. - In: THE AMERICAN JOURNAL OF CARDIOLOGY. - ISSN 0002-9149. - 123:4(2019), pp. 592-597.

Impact of Body Mass Index on Outcomes in the Edoxaban Versus Warfarin Therapy Groups in Patients Underwent Cardioversion of Atrial Fibrillation (from ENSURE-AF)

Boriani, Giuseppe;
2019

Abstract

In the EdoxabaN versus warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation study (NCT 02072434), edoxaban showed similar efficacy and safety versus enoxaparin-warfarin in patients underwent electrical cardioversion of nonvalvular atrial fibrillation. In this ancillary analysis, we compared the primary efficacy (composite of stroke, systemic embolic event, myocardial infarction, cardiovascular death, and overall study period) and safety (composite of major and clinically relevant nonmajor bleeding, on-treatment) end points in relation to body mass index (BMI; <30 vs ≥30 kg/m2). We also compared cardioversion outcomes in relation to BMI. Of 2,199 patients enrolled, 1,095 were randomized to edoxaban and 1,104 to enoxaparin-warfarin. Mean age was 64 ± 10 and 64 ± 11 years and mean BMI 30.6 and 30.7 kg/m2, respectively. Cardiovascular and metabolic diseases were more prevalent in obese (n = 1067) than nonobese patients. Overall ischemic event rates were low; rates in the BMI <30 kg/m2 subgroup were numerically lower than the ≥30 kg/m2 subgroup, but not significantly different (odds ratio [OR], 0.74 [95% confidence interval 0.23, 2.24]). Composite major + clinically relevant nonmajor bleeding rates were low and numerically lower, but not significantly different (OR 0.88 [0.38, 2.04]), between the edoxaban and enoxaparin-warfarin arms and across weight categories. Successful cardioversion rate was higher in the BMI <30 versus ≥30 kg/m2 subgroup (73.9% vs 69.9%; OR 1.22 [1.01 to 1.48]). In EdoxabaN versus warfarin in subjectS UndeRgoing cardiovErsion of Atrial Fibrillation, BMI did not significantly impact the relative efficacy and safety of edoxaban versus enoxaparin-warfarin. Nevertheless, the nonobese group had a higher rate of cardioversion success than the obese group.
24-nov-2018
123
4
592
597
Impact of Body Mass Index on Outcomes in the Edoxaban Versus Warfarin Therapy Groups in Patients Underwent Cardioversion of Atrial Fibrillation (from ENSURE-AF) / Lip, Gregory Y H; Merino, Jose L; Banach, Maciej; de Groot, Joris R; Maier, Lars S; Themistoclakis, Sakis; Boriani, Giuseppe; Jin, James; Melino, Michael; Winters, Shannon M; Goette, Andreas. - In: THE AMERICAN JOURNAL OF CARDIOLOGY. - ISSN 0002-9149. - 123:4(2019), pp. 592-597.
Lip, Gregory Y H; Merino, Jose L; Banach, Maciej; de Groot, Joris R; Maier, Lars S; Themistoclakis, Sakis; Boriani, Giuseppe; Jin, James; Melino, Michael; Winters, Shannon M; Goette, Andreas
File in questo prodotto:
File Dimensione Formato  
1-s2.0-S0002914918321003-main.pdf

non disponibili

Tipologia: Versione dell'editore (versione pubblicata)
Dimensione 633.88 kB
Formato Adobe PDF
633.88 kB Adobe PDF   Visualizza/Apri   Richiedi una copia
Pubblicazioni consigliate

Caricamento pubblicazioni consigliate

Licenza Creative Commons
I metadati presenti in IRIS UNIMORE sono rilasciati con licenza Creative Commons CC0 1.0 Universal, mentre i file delle pubblicazioni sono rilasciati con licenza Attribuzione 4.0 Internazionale (CC BY 4.0), salvo diversa indicazione.
In caso di violazione di copyright, contattare Supporto Iris

Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11380/1168172
Citazioni
  • ???jsp.display-item.citation.pmc??? 3
  • Scopus 5
  • ???jsp.display-item.citation.isi??? 6
social impact