TY - JOUR
T1 - Clinical risk predictors in atrial fibrillation patients following successful coronary stenting: ENTRUST-AF PCI sub-analysis
AU - Goette, Andreas
AU - Eckardt, Lars
AU - Valgimigli, Marco
AU - Lewalter, Thorsten
AU - Laeis, Petra
AU - Reimitz, Paul-Egbert
AU - Smolnik, R. diger
AU - Zierhut, Wolfgang
AU - Tijssen, Jan G.
AU - Vranckx, Pascal
N1 - Funding Information: Open Access funding enabled and organized by Projekt DEAL. This study was supported by Daiichi Sankyo Europe GmbH, Munich, Germany. Acknowledgements Funding Information: Andreas Goette discloses honoraria and speaker fees from Astra Zeneca, Bayer Health Care, Berlin-Chemie, Bristol-Myers Squibb/Pfizer, Boehringer Ingelheim, Boston Scientific, Daiichi Sankyo, Medtronic, Novartis, and Omeicos. Research has been supported by Josef-Freitag Stiftung and Deutsche Herzstiftung e.V. outside the submitted work. Thorsten Lewalter reports personal fees from Abbott, Boston Scientific, Bayer, Boehringer, Daiichi Sankyo, and Pfizer outside the submitted work. Marco Valgimigli reports grants and personal fees from Abbott, Alvimedica, Amgen, Bayer, Bristol-Myers Squibb SA, Coreflow, Daiichi Sankyo, Vifor, Idorsia, Terumo, and iVascular; grants and personal fees from grants from AstraZeneca and Medicure, outside the submitted work. Lars Eckardt discloses consultant fees, speaking honoraria, and travel expenses from Abbott, Bayer Healthcare, Biosense Webster, Biotronik, Boehringer, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Medtronic, Pfizer, and Sanofi Aventis. Research has been supported by German Research Foundation (DFG) and German Heart Foundation outside the submitted work. Petra Laeis, Paul-Egbert Reimitz, Rüdiger Smolnik and Wolfgang Zierhut are employees of Daiichi Sankyo Europe GmbH, Munich, Germany. Jan G. Tijssen reports personal fees from AstraZeneca, Bayer, and Boehringer Ingelheim outside the submitted work. Pascal Vranckx discloses personal fees from Daiichi Sankyo during the conduct of the study; and personal fees from AstraZeneca, Bayer Health Care, CLS Behring, and Terumo outside the submitted work. Publisher Copyright: © 2020, The Author(s).
PY - 2021/6
Y1 - 2021/6
N2 - Aims: This subgroup analysis of the ENTRUST-AF PCI trial (ClinicalTrials.gov Identifier: NCT02866175; Date of registration: August 2016) evaluated type of AF, and CHA2DS2-VASc score parameters as predictors for clinical outcome. Methods: Patients were randomly assigned after percutaneous coronary intervention (PCI) to either edoxaban (60 mg/30 mg once daily [OD]; n = 751) plus a P2Y12 inhibitor for 12 months or a vitamin K antagonist [VKA] (n = 755) plus a P2Y12 inhibitor and aspirin (100 mg OD, for 1–12 months). The primary outcome was a composite of major/clinically relevant non-major bleeding (CRNM) within 12 months. The composite efficacy endpoint consisted of cardiovascular death, stroke, systemic embolic events, myocardial infarction (MI), and definite stent thrombosis. Results: Major/CRNM bleeding event rates were 20.7%/year and 25.6%/year with edoxaban and warfarin, respectively (HR [95% CI]: 0.83 [0.654–1.047]). The event rates of composite outcome were 7.26%/year and 6.86%/year, respectively (HR [95% CI]): 1.06 [0.711–1.587]), and of overall net clinical benefit were 12.48%/year and 12.80%/year, respectively (HR [(95% CI]: 0.99 [(0.730; 1.343]). Increasing CHA2DS2-VASc score was associated with increased rates of all outcomes. CHA2DS2-VASc score ≥ 5 was a marker for stent thrombosis. Paroxysmal AF was associated with a higher occurrence of MI (4.87% versus 2.01%, p = 0.0024). Conclusion: After PCI in AF patients, increasing CHA2DS2-VASc score was associated with increased bleeding rates and CHA2DS2-VASc score (≥ 5) predicted the occurrence of stent thrombosis. Paroxysmal AF was associated with MI. These findings may have important clinical implications in AF patients.
AB - Aims: This subgroup analysis of the ENTRUST-AF PCI trial (ClinicalTrials.gov Identifier: NCT02866175; Date of registration: August 2016) evaluated type of AF, and CHA2DS2-VASc score parameters as predictors for clinical outcome. Methods: Patients were randomly assigned after percutaneous coronary intervention (PCI) to either edoxaban (60 mg/30 mg once daily [OD]; n = 751) plus a P2Y12 inhibitor for 12 months or a vitamin K antagonist [VKA] (n = 755) plus a P2Y12 inhibitor and aspirin (100 mg OD, for 1–12 months). The primary outcome was a composite of major/clinically relevant non-major bleeding (CRNM) within 12 months. The composite efficacy endpoint consisted of cardiovascular death, stroke, systemic embolic events, myocardial infarction (MI), and definite stent thrombosis. Results: Major/CRNM bleeding event rates were 20.7%/year and 25.6%/year with edoxaban and warfarin, respectively (HR [95% CI]: 0.83 [0.654–1.047]). The event rates of composite outcome were 7.26%/year and 6.86%/year, respectively (HR [95% CI]): 1.06 [0.711–1.587]), and of overall net clinical benefit were 12.48%/year and 12.80%/year, respectively (HR [(95% CI]: 0.99 [(0.730; 1.343]). Increasing CHA2DS2-VASc score was associated with increased rates of all outcomes. CHA2DS2-VASc score ≥ 5 was a marker for stent thrombosis. Paroxysmal AF was associated with a higher occurrence of MI (4.87% versus 2.01%, p = 0.0024). Conclusion: After PCI in AF patients, increasing CHA2DS2-VASc score was associated with increased bleeding rates and CHA2DS2-VASc score (≥ 5) predicted the occurrence of stent thrombosis. Paroxysmal AF was associated with MI. These findings may have important clinical implications in AF patients.
KW - Atrial fibrillation
KW - CHA DS -VASc
KW - Coronary stenting
KW - Edoxaban
KW - NOACs
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85093507187&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/33098470
U2 - https://doi.org/10.1007/s00392-020-01760-4
DO - https://doi.org/10.1007/s00392-020-01760-4
M3 - Article
C2 - 33098470
SN - 1861-0684
VL - 110
SP - 831
EP - 840
JO - Clinical research in cardiology
JF - Clinical research in cardiology
IS - 6
ER -