DOAC Score for Predicting Clinical Outcomes After Left Atrial Appendage Closure
Background: The direct-acting oral anticoagulant (DOAC) score has been validated for assessing the bleeding risk in patients with atrial fibrillation (AF). However, data on DOAC scores in patients undergoing percutaneous left atrial appendage closure (LAAC) is limited. This study aimed to evaluate t...
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2025-04-01
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| author | Masahiko Asami, MD Yu Horiuchi, MD Jun Tanaka, MD Daiki Yoshiura, MD Masanori Taniwaki, MD Kota Komiyama, MD, PhD Hitomi Yuzawa, MD, PhD Kengo Tanabe, MD, PhD Mitsuru Sago, CE Shuhei Tanaka, MD, PhD Ryuki Chatani, MD Toru Naganuma, MD Yohei Ohno, MD, PhD Tomoyuki Tani, MD Hideharu Okamatsu, MD Kazuki Mizutani, MD, PhD Yusuke Watanabe, MD, PhD Masaki Izumo, MD, PhD Mike Saji, MD, PhD Shingo Mizuno, MD Daisuke Hachinohe, MD Hiroshi Ueno, MD, PhD Shunsuke Kubo, MD Shinichi Shirai, MD Masaki Nakashima, MD Masanori Yamamoto, MD, PhD Kentaro Hayashida, MD, PhD |
| author_facet | Masahiko Asami, MD Yu Horiuchi, MD Jun Tanaka, MD Daiki Yoshiura, MD Masanori Taniwaki, MD Kota Komiyama, MD, PhD Hitomi Yuzawa, MD, PhD Kengo Tanabe, MD, PhD Mitsuru Sago, CE Shuhei Tanaka, MD, PhD Ryuki Chatani, MD Toru Naganuma, MD Yohei Ohno, MD, PhD Tomoyuki Tani, MD Hideharu Okamatsu, MD Kazuki Mizutani, MD, PhD Yusuke Watanabe, MD, PhD Masaki Izumo, MD, PhD Mike Saji, MD, PhD Shingo Mizuno, MD Daisuke Hachinohe, MD Hiroshi Ueno, MD, PhD Shunsuke Kubo, MD Shinichi Shirai, MD Masaki Nakashima, MD Masanori Yamamoto, MD, PhD Kentaro Hayashida, MD, PhD |
| author_sort | Masahiko Asami, MD |
| collection | DOAJ |
| description | Background: The direct-acting oral anticoagulant (DOAC) score has been validated for assessing the bleeding risk in patients with atrial fibrillation (AF). However, data on DOAC scores in patients undergoing percutaneous left atrial appendage closure (LAAC) is limited. This study aimed to evaluate the predictive impact of the DOAC score on clinical events following LAAC and compare it with that of the HAS-BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio [INR], Elderly [age ≥65 years], Drugs and alcohol concomitantly) score. Methods: In this prospective, multicenter, observational study, patients with nonvalvular AF (NVAF) undergoing LAAC were categorized by the DOAC score into higher (HBR) and lower bleeding risk groups. The primary endpoints of all-cause death, stroke, and bleeding were evaluated at 3 months and 1 year. Results: Among 1464 patients (mean age 77.1 years; 67.6% male), the HBR group (923 patients) had a lower body mass index, more frequent comorbidities, and higher risk profiles for bleeding and stroke. The device, technical, and procedural success rates were high and similar between groups. At 1 year, the primary endpoint was higher in the HBR group (17.6% vs 12.4%, P = 0.01), influenced by differences in bleeding events (10.9% vs 7.6%, P = 0.045). The DOAC score showed superior predictive value for the primary endpoint compared with the HAS-BLED score. Conclusions: The DOAC score is a reliable predictor of composite outcomes, including death, stroke, and bleeding, in patients undergoing LAAC, demonstrating superior utility compared with the HAS-BLED score. This scoring system may improve risk stratification and patient management in daily clinical practice. Clinical Trial Registration: UMIN-ID: UMIN000038498 (OCEAN-LAAC registry). Résumé: Contexte: Le score d'anticoagulants oraux directs (AOD) a été validé pour évaluer le risque hémorragique chez les patients atteints de fibrillation auriculaire (FA). Cependant, les données sur les scores AOD chez les patients subissant une fermeture percutanée de l'appendice auriculaire gauche (FAAG) sont limitées. Cette étude visait à évaluer l'impact prédictif du score AOD sur les événements cliniques après une FAAG et à le comparer à celui du score de prédiction du risque d'hémorragie en cas de FA : HAS-BLED (hypertension, fonctions rénale et hépatique anormales, accident vasculaire cérébral (AVC), antécédents ou prédisposition aux saignements, rapport international normalisé [INR] instable, personne âgée [âge ≥65 ans], prise concomitante de médicaments et d'alcool). Méthodes: Dans cette étude prospective, multicentrique et observationnelle, les patients atteints de FA non valvulaire subissant une FAAG ont été classés selon le score AOD dans des groupes à risque hémorragique élevé (RHE) et faible. Les principaux critères d'évaluation, à savoir le décès toutes causes confondues, l'AVC et l'hémorragie, ont été évalués à 3 mois et à 1 an. Résultats: Parmi les 1 464 patients (âge moyen 77,1 ans ; 67,6 % d'hommes), le groupe RHE (923 patients) avait un indice de masse corporelle plus bas, des comorbidités plus fréquentes et des profils de risque plus élevés pour les saignements et les AVC. Les taux de réussite du dispositif, de la technique et de la procédure étaient élevés et similaires entre les groupes. À un an, le critère d'évaluation principal était plus élevé dans le groupe RHE (17,6 % contre 12,4 %, p = 0,01), influencé par des différences dans les événements hémorragiques (10,9 % contre 7,6 %, p = 0,045). Le score AOD a montré une valeur prédictive supérieure pour le critère d'évaluation principal par rapport au score HAS-BLED. Conclusions: Le score AOD est un prédicteur fiable des résultats composites, y compris le décès, l'AVC et l'hémorragie, chez les patients subissant une FAAG, démontrant une utilité supérieure à celle du score HAS-BLED. Ce système de notation peut améliorer la stratification des risques et la prise en charge des patients dans la pratique clinique quotidienne. Numéro d'enregistrement de l'essai clinique: UMIN-ID : UMIN000038498 (registre OCEAN-LAAC). |
| format | Article |
| id | doaj-art-4a5f699f32fa40f0a637a2b1b20419ee |
| institution | DOAJ |
| issn | 2589-790X |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Elsevier |
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| series | CJC Open |
| spelling | doaj-art-4a5f699f32fa40f0a637a2b1b20419ee2025-08-20T03:06:05ZengElsevierCJC Open2589-790X2025-04-017442042810.1016/j.cjco.2025.01.009DOAC Score for Predicting Clinical Outcomes After Left Atrial Appendage ClosureMasahiko Asami, MD0Yu Horiuchi, MD1Jun Tanaka, MD2Daiki Yoshiura, MD3Masanori Taniwaki, MD4Kota Komiyama, MD, PhD5Hitomi Yuzawa, MD, PhD6Kengo Tanabe, MD, PhD7Mitsuru Sago, CE8Shuhei Tanaka, MD, PhD9Ryuki Chatani, MD10Toru Naganuma, MD11Yohei Ohno, MD, PhD12Tomoyuki Tani, MD13Hideharu Okamatsu, MD14Kazuki Mizutani, MD, PhD15Yusuke Watanabe, MD, PhD16Masaki Izumo, MD, PhD17Mike Saji, MD, PhD18Shingo Mizuno, MD19Daisuke Hachinohe, MD20Hiroshi Ueno, MD, PhD21Shunsuke Kubo, MD22Shinichi Shirai, MD23Masaki Nakashima, MD24Masanori Yamamoto, MD, PhD25Kentaro Hayashida, MD, PhD26Division of Cardiology, Mitsui Memorial Hospital, Tokyo, Japan; Corresponding author: Dr Masahiko Asami, Division of Cardiology, Mitsui Memorial Hospital, 1 Kanda-Izumicho, Chiyoda-ku, Tokyo, 101-8643, Japan. Tel.: +81-3-3863-9111; fax: +81-3-5687-9765.Division of Cardiology, Mitsui Memorial Hospital, Tokyo, JapanDivision of Cardiology, Mitsui Memorial Hospital, Tokyo, JapanDivision of Cardiology, Mitsui Memorial Hospital, Tokyo, JapanDivision of Cardiology, Mitsui Memorial Hospital, Tokyo, JapanDivision of Cardiology, Mitsui Memorial Hospital, Tokyo, JapanDivision of Cardiology, Mitsui Memorial Hospital, Tokyo, JapanDivision of Cardiology, Mitsui Memorial Hospital, Tokyo, JapanDepartment of Cardiology, Toyohashi Heart Center, Aichi, JapanDepartment of Cardiology, Toyama University Hospital, Toyama, JapanDepartment of Cardiology, Kurashiki Central Hospital, Okayama, JapanDepartment of Cardiology, New Tokyo Hospital, Chiba, JapanDepartment of Cardiology, Tokai University School of Medicine, Kanagawa, JapanDepartment of Cardiology, Sapporo Higashi Tokushukai Hospital, Hokkaido, JapanDepartment of Cardiology, Saiseikai Kumamoto Hospital, Kumamoto, JapanDepartment of Cardiology, Kinki University School of Medicine, Osaka, JapanDepartment of Cardiology, Teikyo University School of Medicine, Tokyo, JapanDepartment of Cardiology, St Marianna University School of Medicine, Kanagawa, JapanDepartment of Cardiology, Sakakibara Heart Institute, Tokyo, Japan; Department of Cardiovascular Medicine, Toho University Faculty of Medicine, Tokyo, JapanDepartment of Cardiology, Shonan Kamakura General Hospital, Kanagawa, JapanDepartment of Cardiology, Sapporo Heart Center, Sapporo Cardio Vascular Clinic, Hokkaido, JapanDepartment of Cardiology, Toyama University Hospital, Toyama, JapanDepartment of Cardiology, Kurashiki Central Hospital, Okayama, JapanDepartment of Cardiology, Kokura Memorial Hospital, Fukuoka, JapanDepartment of Cardiology, Sendai Kousei Hospital, Miyagi, JapanDepartment of Cardiology, Toyohashi Heart Center, Aichi, Japan; Department of Cardiology, Nagoya Heart Center, Aichi, Japan; Department of Cardiology, Gifu Heart Center, Gifu, JapanDepartment of Cardiology, Keio University School of Medicine, Tokyo, JapanBackground: The direct-acting oral anticoagulant (DOAC) score has been validated for assessing the bleeding risk in patients with atrial fibrillation (AF). However, data on DOAC scores in patients undergoing percutaneous left atrial appendage closure (LAAC) is limited. This study aimed to evaluate the predictive impact of the DOAC score on clinical events following LAAC and compare it with that of the HAS-BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio [INR], Elderly [age ≥65 years], Drugs and alcohol concomitantly) score. Methods: In this prospective, multicenter, observational study, patients with nonvalvular AF (NVAF) undergoing LAAC were categorized by the DOAC score into higher (HBR) and lower bleeding risk groups. The primary endpoints of all-cause death, stroke, and bleeding were evaluated at 3 months and 1 year. Results: Among 1464 patients (mean age 77.1 years; 67.6% male), the HBR group (923 patients) had a lower body mass index, more frequent comorbidities, and higher risk profiles for bleeding and stroke. The device, technical, and procedural success rates were high and similar between groups. At 1 year, the primary endpoint was higher in the HBR group (17.6% vs 12.4%, P = 0.01), influenced by differences in bleeding events (10.9% vs 7.6%, P = 0.045). The DOAC score showed superior predictive value for the primary endpoint compared with the HAS-BLED score. Conclusions: The DOAC score is a reliable predictor of composite outcomes, including death, stroke, and bleeding, in patients undergoing LAAC, demonstrating superior utility compared with the HAS-BLED score. This scoring system may improve risk stratification and patient management in daily clinical practice. Clinical Trial Registration: UMIN-ID: UMIN000038498 (OCEAN-LAAC registry). Résumé: Contexte: Le score d'anticoagulants oraux directs (AOD) a été validé pour évaluer le risque hémorragique chez les patients atteints de fibrillation auriculaire (FA). Cependant, les données sur les scores AOD chez les patients subissant une fermeture percutanée de l'appendice auriculaire gauche (FAAG) sont limitées. Cette étude visait à évaluer l'impact prédictif du score AOD sur les événements cliniques après une FAAG et à le comparer à celui du score de prédiction du risque d'hémorragie en cas de FA : HAS-BLED (hypertension, fonctions rénale et hépatique anormales, accident vasculaire cérébral (AVC), antécédents ou prédisposition aux saignements, rapport international normalisé [INR] instable, personne âgée [âge ≥65 ans], prise concomitante de médicaments et d'alcool). Méthodes: Dans cette étude prospective, multicentrique et observationnelle, les patients atteints de FA non valvulaire subissant une FAAG ont été classés selon le score AOD dans des groupes à risque hémorragique élevé (RHE) et faible. Les principaux critères d'évaluation, à savoir le décès toutes causes confondues, l'AVC et l'hémorragie, ont été évalués à 3 mois et à 1 an. Résultats: Parmi les 1 464 patients (âge moyen 77,1 ans ; 67,6 % d'hommes), le groupe RHE (923 patients) avait un indice de masse corporelle plus bas, des comorbidités plus fréquentes et des profils de risque plus élevés pour les saignements et les AVC. Les taux de réussite du dispositif, de la technique et de la procédure étaient élevés et similaires entre les groupes. À un an, le critère d'évaluation principal était plus élevé dans le groupe RHE (17,6 % contre 12,4 %, p = 0,01), influencé par des différences dans les événements hémorragiques (10,9 % contre 7,6 %, p = 0,045). Le score AOD a montré une valeur prédictive supérieure pour le critère d'évaluation principal par rapport au score HAS-BLED. Conclusions: Le score AOD est un prédicteur fiable des résultats composites, y compris le décès, l'AVC et l'hémorragie, chez les patients subissant une FAAG, démontrant une utilité supérieure à celle du score HAS-BLED. Ce système de notation peut améliorer la stratification des risques et la prise en charge des patients dans la pratique clinique quotidienne. Numéro d'enregistrement de l'essai clinique: UMIN-ID : UMIN000038498 (registre OCEAN-LAAC).http://www.sciencedirect.com/science/article/pii/S2589790X2500037X |
| spellingShingle | Masahiko Asami, MD Yu Horiuchi, MD Jun Tanaka, MD Daiki Yoshiura, MD Masanori Taniwaki, MD Kota Komiyama, MD, PhD Hitomi Yuzawa, MD, PhD Kengo Tanabe, MD, PhD Mitsuru Sago, CE Shuhei Tanaka, MD, PhD Ryuki Chatani, MD Toru Naganuma, MD Yohei Ohno, MD, PhD Tomoyuki Tani, MD Hideharu Okamatsu, MD Kazuki Mizutani, MD, PhD Yusuke Watanabe, MD, PhD Masaki Izumo, MD, PhD Mike Saji, MD, PhD Shingo Mizuno, MD Daisuke Hachinohe, MD Hiroshi Ueno, MD, PhD Shunsuke Kubo, MD Shinichi Shirai, MD Masaki Nakashima, MD Masanori Yamamoto, MD, PhD Kentaro Hayashida, MD, PhD DOAC Score for Predicting Clinical Outcomes After Left Atrial Appendage Closure CJC Open |
| title | DOAC Score for Predicting Clinical Outcomes After Left Atrial Appendage Closure |
| title_full | DOAC Score for Predicting Clinical Outcomes After Left Atrial Appendage Closure |
| title_fullStr | DOAC Score for Predicting Clinical Outcomes After Left Atrial Appendage Closure |
| title_full_unstemmed | DOAC Score for Predicting Clinical Outcomes After Left Atrial Appendage Closure |
| title_short | DOAC Score for Predicting Clinical Outcomes After Left Atrial Appendage Closure |
| title_sort | doac score for predicting clinical outcomes after left atrial appendage closure |
| url | http://www.sciencedirect.com/science/article/pii/S2589790X2500037X |
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