Background Device-detected subclinical atrial fibrillation (AF) refers to infrequent, short-lasting, asymptomatic AF that is detected only with long-term continuous monitoring. Subclinical AF is common and associated with an increased risk of stroke; however, the risk of stroke with subclinical AF is lower than for clinical AF, and very few patients with subclinical AF alone have been included in large AF anticoagulation trials. The net benefit of anticoagulation in patients with subclinical AF is unknown. Design ARTESiA is a prospective, multicenter, double-blind, randomized controlled trial, recruiting patients with subclinical AF detected by an implanted pacemaker, defibrillator, or cardiac monitor, and who have additional risk factors for stroke. Patients with clinical AF documented by surface electrocardiogram will be excluded from the study. Participants will be randomized to receive either apixaban (according to standard AF dosing) or aspirin 81 mg daily. The primary outcome is the composite of stroke, transient ischemic attack with diffusion-weighted magnetic resonance imaging evidence of cerebral infarction, and systemic embolism. Approximately 4,000 patients will be enrolled from around 230 clinical sites, with an anticipated mean follow-up of 36 months until 248 adjudicated primary outcome events have occurred. Summary ARTESiA will determine whether oral anticoagulation therapy with apixaban compared with aspirin reduces the risk of stroke or systemic embolism in patients with subclinical AF and additional risk factors.

Rationale and design of the Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation (ARTESiA) trial / Lopes, Renato D; Alings, Marco; Connolly, Stuart J.; Beresh, Heather; Granger, Christopher B.; Mazuecos, Juan Benezet; Boriani, Giuseppe; Nielsen, Jens C.; Conen, David; Hohnloser, Stefan H.; Mairesse, Georges H.; Mabo, Philippe; Camm, A. John; Healey, Jeffrey S.. - In: AMERICAN HEART JOURNAL. - ISSN 0002-8703. - 189:(2017), pp. 137-145. [10.1016/j.ahj.2017.04.008]

Rationale and design of the Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation (ARTESiA) trial

BORIANI, Giuseppe;
2017

Abstract

Background Device-detected subclinical atrial fibrillation (AF) refers to infrequent, short-lasting, asymptomatic AF that is detected only with long-term continuous monitoring. Subclinical AF is common and associated with an increased risk of stroke; however, the risk of stroke with subclinical AF is lower than for clinical AF, and very few patients with subclinical AF alone have been included in large AF anticoagulation trials. The net benefit of anticoagulation in patients with subclinical AF is unknown. Design ARTESiA is a prospective, multicenter, double-blind, randomized controlled trial, recruiting patients with subclinical AF detected by an implanted pacemaker, defibrillator, or cardiac monitor, and who have additional risk factors for stroke. Patients with clinical AF documented by surface electrocardiogram will be excluded from the study. Participants will be randomized to receive either apixaban (according to standard AF dosing) or aspirin 81 mg daily. The primary outcome is the composite of stroke, transient ischemic attack with diffusion-weighted magnetic resonance imaging evidence of cerebral infarction, and systemic embolism. Approximately 4,000 patients will be enrolled from around 230 clinical sites, with an anticipated mean follow-up of 36 months until 248 adjudicated primary outcome events have occurred. Summary ARTESiA will determine whether oral anticoagulation therapy with apixaban compared with aspirin reduces the risk of stroke or systemic embolism in patients with subclinical AF and additional risk factors.
2017
24-apr-2017
189
137
145
Rationale and design of the Apixaban for the Reduction of Thrombo-Embolism in Patients With Device-Detected Sub-Clinical Atrial Fibrillation (ARTESiA) trial / Lopes, Renato D; Alings, Marco; Connolly, Stuart J.; Beresh, Heather; Granger, Christopher B.; Mazuecos, Juan Benezet; Boriani, Giuseppe; Nielsen, Jens C.; Conen, David; Hohnloser, Stefan H.; Mairesse, Georges H.; Mabo, Philippe; Camm, A. John; Healey, Jeffrey S.. - In: AMERICAN HEART JOURNAL. - ISSN 0002-8703. - 189:(2017), pp. 137-145. [10.1016/j.ahj.2017.04.008]
Lopes, Renato D; Alings, Marco; Connolly, Stuart J.; Beresh, Heather; Granger, Christopher B.; Mazuecos, Juan Benezet; Boriani, Giuseppe; Nielsen, Jen...espandi
File in questo prodotto:
File Dimensione Formato  
lopes2017.pdf

Accesso riservato

Tipologia: Versione pubblicata dall'editore
Dimensione 378.84 kB
Formato Adobe PDF
378.84 kB Adobe PDF   Visualizza/Apri   Richiedi una copia
j.ahj.2017.04.008.pdf

Open access

Tipologia: Versione dell'autore revisionata e accettata per la pubblicazione
Dimensione 642.39 kB
Formato Adobe PDF
642.39 kB Adobe PDF Visualizza/Apri
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: https://hdl.handle.net/11380/1139421
Citazioni
  • ???jsp.display-item.citation.pmc??? 102
  • Scopus 243
  • ???jsp.display-item.citation.isi??? 236
social impact