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Factor V Leiden and the Risk of Bleeding in Patients With Acute Coronary Syndromes Treated With Antiplatelet Therapy: Pooled Analysis of 3 Randomized Clinical Trials

BACKGROUND: Whether factor V Leiden is associated with lower bleeding risk in patients with acute coronary syndromes using (dual) antiplatelet therapy has yet to be investigated. METHODS AND RESULTS: We pooled data from 3 randomized clinical trials, conducted in patients with acute coronary syndrome...

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Autores principales: Mahmoodi, Bakhtawar K., Eriksson, Niclas, Ross, Stephanie, Claassens, Daniel M. F., Asselbergs, Folkert W., Meijer, Karina, Siegbahn, Agneta, James, Stefan, Pare, Guillaume, Wallentin, Lars, ten Berg, Jurriën M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8649290/
https://www.ncbi.nlm.nih.gov/pubmed/34459239
http://dx.doi.org/10.1161/JAHA.120.021115
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author Mahmoodi, Bakhtawar K.
Eriksson, Niclas
Ross, Stephanie
Claassens, Daniel M. F.
Asselbergs, Folkert W.
Meijer, Karina
Siegbahn, Agneta
James, Stefan
Pare, Guillaume
Wallentin, Lars
ten Berg, Jurriën M.
author_facet Mahmoodi, Bakhtawar K.
Eriksson, Niclas
Ross, Stephanie
Claassens, Daniel M. F.
Asselbergs, Folkert W.
Meijer, Karina
Siegbahn, Agneta
James, Stefan
Pare, Guillaume
Wallentin, Lars
ten Berg, Jurriën M.
author_sort Mahmoodi, Bakhtawar K.
collection PubMed
description BACKGROUND: Whether factor V Leiden is associated with lower bleeding risk in patients with acute coronary syndromes using (dual) antiplatelet therapy has yet to be investigated. METHODS AND RESULTS: We pooled data from 3 randomized clinical trials, conducted in patients with acute coronary syndromes, with adjudicated bleeding outcomes. Cox regression models were used to obtain overall and cause‐specific hazard ratios (HRs) to account for competing risk of atherothrombotic outcomes (ie, composite of ischemic stroke, myocardial infarction, and cardiovascular death) in each study. Estimates from the individual studies were pooled using fixed effect meta‐analysis. The 3 studies combined included 17 623 patients of whom 969 (5.5%) were either heterozygous or homozygous (n=23) carriers of factor V Leiden. During 1 year of follow‐up, a total of 1289 (7.3%) patients developed major (n=559) or minor bleeding. Factor V Leiden was associated with a lower risk of combined major and minor bleeding (adjusted cause‐specific HR, 0.75; 95% CI, 0.56–1.00; P=0.046; I(2)=0%) but a comparable risk of major bleeding (adjusted cause‐specific HR, 0.93; 95% CI, 0.62–1.39; P=0.73; I(2)=0%). Adjusted pooled cause‐specific HRs for the association of factor V Leiden with atherothrombotic events alone and in combination with bleeding events were 0.75 (95% CI, 0.55–1.02; P=0.06; I(2)=0%) and 0.75 (95% CI, 0.61–0.92; P=0.007; I(2)=0%), respectively. CONCLUSIONS: Given that the lower risk of bleeding conferred by factor V Leiden was not counterbalanced by a higher risk of atherothrombotic events, these findings warrant future assessment for personalized medicine such as selecting patients for extended or intensive antiplatelet therapy.
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spelling pubmed-86492902022-01-14 Factor V Leiden and the Risk of Bleeding in Patients With Acute Coronary Syndromes Treated With Antiplatelet Therapy: Pooled Analysis of 3 Randomized Clinical Trials Mahmoodi, Bakhtawar K. Eriksson, Niclas Ross, Stephanie Claassens, Daniel M. F. Asselbergs, Folkert W. Meijer, Karina Siegbahn, Agneta James, Stefan Pare, Guillaume Wallentin, Lars ten Berg, Jurriën M. J Am Heart Assoc Original Research BACKGROUND: Whether factor V Leiden is associated with lower bleeding risk in patients with acute coronary syndromes using (dual) antiplatelet therapy has yet to be investigated. METHODS AND RESULTS: We pooled data from 3 randomized clinical trials, conducted in patients with acute coronary syndromes, with adjudicated bleeding outcomes. Cox regression models were used to obtain overall and cause‐specific hazard ratios (HRs) to account for competing risk of atherothrombotic outcomes (ie, composite of ischemic stroke, myocardial infarction, and cardiovascular death) in each study. Estimates from the individual studies were pooled using fixed effect meta‐analysis. The 3 studies combined included 17 623 patients of whom 969 (5.5%) were either heterozygous or homozygous (n=23) carriers of factor V Leiden. During 1 year of follow‐up, a total of 1289 (7.3%) patients developed major (n=559) or minor bleeding. Factor V Leiden was associated with a lower risk of combined major and minor bleeding (adjusted cause‐specific HR, 0.75; 95% CI, 0.56–1.00; P=0.046; I(2)=0%) but a comparable risk of major bleeding (adjusted cause‐specific HR, 0.93; 95% CI, 0.62–1.39; P=0.73; I(2)=0%). Adjusted pooled cause‐specific HRs for the association of factor V Leiden with atherothrombotic events alone and in combination with bleeding events were 0.75 (95% CI, 0.55–1.02; P=0.06; I(2)=0%) and 0.75 (95% CI, 0.61–0.92; P=0.007; I(2)=0%), respectively. CONCLUSIONS: Given that the lower risk of bleeding conferred by factor V Leiden was not counterbalanced by a higher risk of atherothrombotic events, these findings warrant future assessment for personalized medicine such as selecting patients for extended or intensive antiplatelet therapy. John Wiley and Sons Inc. 2021-08-28 /pmc/articles/PMC8649290/ /pubmed/34459239 http://dx.doi.org/10.1161/JAHA.120.021115 Text en © 2021 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Original Research
Mahmoodi, Bakhtawar K.
Eriksson, Niclas
Ross, Stephanie
Claassens, Daniel M. F.
Asselbergs, Folkert W.
Meijer, Karina
Siegbahn, Agneta
James, Stefan
Pare, Guillaume
Wallentin, Lars
ten Berg, Jurriën M.
Factor V Leiden and the Risk of Bleeding in Patients With Acute Coronary Syndromes Treated With Antiplatelet Therapy: Pooled Analysis of 3 Randomized Clinical Trials
title Factor V Leiden and the Risk of Bleeding in Patients With Acute Coronary Syndromes Treated With Antiplatelet Therapy: Pooled Analysis of 3 Randomized Clinical Trials
title_full Factor V Leiden and the Risk of Bleeding in Patients With Acute Coronary Syndromes Treated With Antiplatelet Therapy: Pooled Analysis of 3 Randomized Clinical Trials
title_fullStr Factor V Leiden and the Risk of Bleeding in Patients With Acute Coronary Syndromes Treated With Antiplatelet Therapy: Pooled Analysis of 3 Randomized Clinical Trials
title_full_unstemmed Factor V Leiden and the Risk of Bleeding in Patients With Acute Coronary Syndromes Treated With Antiplatelet Therapy: Pooled Analysis of 3 Randomized Clinical Trials
title_short Factor V Leiden and the Risk of Bleeding in Patients With Acute Coronary Syndromes Treated With Antiplatelet Therapy: Pooled Analysis of 3 Randomized Clinical Trials
title_sort factor v leiden and the risk of bleeding in patients with acute coronary syndromes treated with antiplatelet therapy: pooled analysis of 3 randomized clinical trials
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8649290/
https://www.ncbi.nlm.nih.gov/pubmed/34459239
http://dx.doi.org/10.1161/JAHA.120.021115
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