Asymptomatic Cerebral Infarction During Catheter Ablation for Atrial Fibrillation: Comparing Uninterrupted Rivaroxaban and Warfarin (ASCERTAIN)

Takehiro Kimura, Shin Kashimura, Takahiko Nishiyama, Yoshinori Katsumata, Kohei Inagawa, Yukinori Ikegami, Nobuhiro Nishiyama, Kotaro Fukumoto, Yoko Tanimoto, Yoshiyasu Aizawa, Kojiro Tanimoto, Keiichi Fukuda, Seiji Takatsuki

Research output: Contribution to journalArticle

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Abstract

Objectives: This randomized study compared uninterrupted rivaroxaban therapy with warfarin therapy as prophylaxis against catheter ablation (CA)-induced asymptomatic cerebral infarction (ACI) and identified the risk factors of rivaroxaban. Background: The reported incidence of ACI during CA for atrial fibrillation (AF) remains at 10% to 30%, and periprocedural oral anticoagulation could affect this incidence. Methods: Patients with nonvalvular AF undergoing radiofrequency CA were randomly assigned to receive either uninterrupted rivaroxaban or warfarin as periprocedural anticoagulation therapy. CA was performed after at least 1 month of adequate anticoagulation. Cerebral magnetic resonance imaging (MRI) was performed within 2 weeks before and 1 day after CA to detect ACI. Results: A total 132 patients were enrolled; 127 (median: 60.0 years of age; 83.5% males; 64.6% incidence of paroxysmal AF) complied with the study protocol and were analyzed; 64 patients received rivaroxaban, and 63 patients received warfarin. The rates of CA-induced ACI in the rivaroxaban group (15.6% [10 of 64 patients]) were similar to those in the warfarin group (15.9% [10 of 63 patients]; p = 1.000). No thromboembolic events developed; no differences in major or nonmajor bleeding rates were observed between the 2 drug groups (3.1% vs. 1.6%, respectively, or 18.8% vs. 19.0%, respectively). Multiple regression analysis indicated that the presence of deep and subcortical white matter hyperintensity (p = 0.002; odds ratio [OR]: 5.323) and the frequency of cardioversions (p = 0.016; OR: 1.250) were associated with the incidence of ACI. Conclusions: No notable differences were found between the incidence of CA-induced ACI in the rivaroxaban group and that in the warfarin group in this randomized study.

Original languageEnglish
Pages (from-to)1598-1609
Number of pages12
JournalJACC: Clinical Electrophysiology
Volume4
Issue number12
DOIs
Publication statusPublished - 2018 Dec 1

Fingerprint

Catheter Ablation
Cerebral Infarction
Warfarin
Atrial Fibrillation
Incidence
Odds Ratio
Electric Countershock
Rivaroxaban
Therapeutics
Regression Analysis
Magnetic Resonance Imaging
Hemorrhage
Pharmaceutical Preparations

Keywords

  • ablation
  • anticoagulation
  • asymptomatic cerebral infarction
  • atrial fibrillation
  • cardiac magnetic resonance imaging
  • rivaroxaban

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Asymptomatic Cerebral Infarction During Catheter Ablation for Atrial Fibrillation : Comparing Uninterrupted Rivaroxaban and Warfarin (ASCERTAIN). / Kimura, Takehiro; Kashimura, Shin; Nishiyama, Takahiko; Katsumata, Yoshinori; Inagawa, Kohei; Ikegami, Yukinori; Nishiyama, Nobuhiro; Fukumoto, Kotaro; Tanimoto, Yoko; Aizawa, Yoshiyasu; Tanimoto, Kojiro; Fukuda, Keiichi; Takatsuki, Seiji.

In: JACC: Clinical Electrophysiology, Vol. 4, No. 12, 01.12.2018, p. 1598-1609.

Research output: Contribution to journalArticle

Kimura, T, Kashimura, S, Nishiyama, T, Katsumata, Y, Inagawa, K, Ikegami, Y, Nishiyama, N, Fukumoto, K, Tanimoto, Y, Aizawa, Y, Tanimoto, K, Fukuda, K & Takatsuki, S 2018, 'Asymptomatic Cerebral Infarction During Catheter Ablation for Atrial Fibrillation: Comparing Uninterrupted Rivaroxaban and Warfarin (ASCERTAIN)', JACC: Clinical Electrophysiology, vol. 4, no. 12, pp. 1598-1609. https://doi.org/10.1016/j.jacep.2018.08.003
Kimura, Takehiro ; Kashimura, Shin ; Nishiyama, Takahiko ; Katsumata, Yoshinori ; Inagawa, Kohei ; Ikegami, Yukinori ; Nishiyama, Nobuhiro ; Fukumoto, Kotaro ; Tanimoto, Yoko ; Aizawa, Yoshiyasu ; Tanimoto, Kojiro ; Fukuda, Keiichi ; Takatsuki, Seiji. / Asymptomatic Cerebral Infarction During Catheter Ablation for Atrial Fibrillation : Comparing Uninterrupted Rivaroxaban and Warfarin (ASCERTAIN). In: JACC: Clinical Electrophysiology. 2018 ; Vol. 4, No. 12. pp. 1598-1609.
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abstract = "Objectives: This randomized study compared uninterrupted rivaroxaban therapy with warfarin therapy as prophylaxis against catheter ablation (CA)-induced asymptomatic cerebral infarction (ACI) and identified the risk factors of rivaroxaban. Background: The reported incidence of ACI during CA for atrial fibrillation (AF) remains at 10{\%} to 30{\%}, and periprocedural oral anticoagulation could affect this incidence. Methods: Patients with nonvalvular AF undergoing radiofrequency CA were randomly assigned to receive either uninterrupted rivaroxaban or warfarin as periprocedural anticoagulation therapy. CA was performed after at least 1 month of adequate anticoagulation. Cerebral magnetic resonance imaging (MRI) was performed within 2 weeks before and 1 day after CA to detect ACI. Results: A total 132 patients were enrolled; 127 (median: 60.0 years of age; 83.5{\%} males; 64.6{\%} incidence of paroxysmal AF) complied with the study protocol and were analyzed; 64 patients received rivaroxaban, and 63 patients received warfarin. The rates of CA-induced ACI in the rivaroxaban group (15.6{\%} [10 of 64 patients]) were similar to those in the warfarin group (15.9{\%} [10 of 63 patients]; p = 1.000). No thromboembolic events developed; no differences in major or nonmajor bleeding rates were observed between the 2 drug groups (3.1{\%} vs. 1.6{\%}, respectively, or 18.8{\%} vs. 19.0{\%}, respectively). Multiple regression analysis indicated that the presence of deep and subcortical white matter hyperintensity (p = 0.002; odds ratio [OR]: 5.323) and the frequency of cardioversions (p = 0.016; OR: 1.250) were associated with the incidence of ACI. Conclusions: No notable differences were found between the incidence of CA-induced ACI in the rivaroxaban group and that in the warfarin group in this randomized study.",
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T2 - Comparing Uninterrupted Rivaroxaban and Warfarin (ASCERTAIN)

AU - Kimura, Takehiro

AU - Kashimura, Shin

AU - Nishiyama, Takahiko

AU - Katsumata, Yoshinori

AU - Inagawa, Kohei

AU - Ikegami, Yukinori

AU - Nishiyama, Nobuhiro

AU - Fukumoto, Kotaro

AU - Tanimoto, Yoko

AU - Aizawa, Yoshiyasu

AU - Tanimoto, Kojiro

AU - Fukuda, Keiichi

AU - Takatsuki, Seiji

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N2 - Objectives: This randomized study compared uninterrupted rivaroxaban therapy with warfarin therapy as prophylaxis against catheter ablation (CA)-induced asymptomatic cerebral infarction (ACI) and identified the risk factors of rivaroxaban. Background: The reported incidence of ACI during CA for atrial fibrillation (AF) remains at 10% to 30%, and periprocedural oral anticoagulation could affect this incidence. Methods: Patients with nonvalvular AF undergoing radiofrequency CA were randomly assigned to receive either uninterrupted rivaroxaban or warfarin as periprocedural anticoagulation therapy. CA was performed after at least 1 month of adequate anticoagulation. Cerebral magnetic resonance imaging (MRI) was performed within 2 weeks before and 1 day after CA to detect ACI. Results: A total 132 patients were enrolled; 127 (median: 60.0 years of age; 83.5% males; 64.6% incidence of paroxysmal AF) complied with the study protocol and were analyzed; 64 patients received rivaroxaban, and 63 patients received warfarin. The rates of CA-induced ACI in the rivaroxaban group (15.6% [10 of 64 patients]) were similar to those in the warfarin group (15.9% [10 of 63 patients]; p = 1.000). No thromboembolic events developed; no differences in major or nonmajor bleeding rates were observed between the 2 drug groups (3.1% vs. 1.6%, respectively, or 18.8% vs. 19.0%, respectively). Multiple regression analysis indicated that the presence of deep and subcortical white matter hyperintensity (p = 0.002; odds ratio [OR]: 5.323) and the frequency of cardioversions (p = 0.016; OR: 1.250) were associated with the incidence of ACI. Conclusions: No notable differences were found between the incidence of CA-induced ACI in the rivaroxaban group and that in the warfarin group in this randomized study.

AB - Objectives: This randomized study compared uninterrupted rivaroxaban therapy with warfarin therapy as prophylaxis against catheter ablation (CA)-induced asymptomatic cerebral infarction (ACI) and identified the risk factors of rivaroxaban. Background: The reported incidence of ACI during CA for atrial fibrillation (AF) remains at 10% to 30%, and periprocedural oral anticoagulation could affect this incidence. Methods: Patients with nonvalvular AF undergoing radiofrequency CA were randomly assigned to receive either uninterrupted rivaroxaban or warfarin as periprocedural anticoagulation therapy. CA was performed after at least 1 month of adequate anticoagulation. Cerebral magnetic resonance imaging (MRI) was performed within 2 weeks before and 1 day after CA to detect ACI. Results: A total 132 patients were enrolled; 127 (median: 60.0 years of age; 83.5% males; 64.6% incidence of paroxysmal AF) complied with the study protocol and were analyzed; 64 patients received rivaroxaban, and 63 patients received warfarin. The rates of CA-induced ACI in the rivaroxaban group (15.6% [10 of 64 patients]) were similar to those in the warfarin group (15.9% [10 of 63 patients]; p = 1.000). No thromboembolic events developed; no differences in major or nonmajor bleeding rates were observed between the 2 drug groups (3.1% vs. 1.6%, respectively, or 18.8% vs. 19.0%, respectively). Multiple regression analysis indicated that the presence of deep and subcortical white matter hyperintensity (p = 0.002; odds ratio [OR]: 5.323) and the frequency of cardioversions (p = 0.016; OR: 1.250) were associated with the incidence of ACI. Conclusions: No notable differences were found between the incidence of CA-induced ACI in the rivaroxaban group and that in the warfarin group in this randomized study.

KW - ablation

KW - anticoagulation

KW - asymptomatic cerebral infarction

KW - atrial fibrillation

KW - cardiac magnetic resonance imaging

KW - rivaroxaban

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