Uninterrupted vs. interrupted periprocedural direct oral anticoagulants for catheter ablation of atrial fibrillation: a prospective randomized single-centre study on post-ablation thrombo-embolic and haemorrhagic events
Abstract Aims This prospective, randomized, single-centre study aimed to directly compare the safety and efficacy of uninterrupted and interrupted periprocedural anticoagulation protocols with direct oral anticoagulants (DOACs) in patients undergoing catheter ablation of non-valvular atrial fibrilla...
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| Veröffentlicht in: | Europace (London, England) England), 2019-02, Vol.21 (2), p.259-267 |
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| creator | Nakamura, Kohki Naito, Shigeto Sasaki, Takehito Take, Yutaka Minami, Kentaro Kitagawa, Yoshiyuki Motoda, Hiroyuki Inoue, Mitsuho Otsuka, Yoshimitsu Niijima, Katsura Yamashita, Eiji Sugai, Yoshinao Kumagai, Koji Koyama, Keiko Funabashi, Nobusada Oshima, Shigeru |
| description | Abstract
Aims
This prospective, randomized, single-centre study aimed to directly compare the safety and efficacy of uninterrupted and interrupted periprocedural anticoagulation protocols with direct oral anticoagulants (DOACs) in patients undergoing catheter ablation of non-valvular atrial fibrillation (NVAF).
Methods and results
We randomly assigned 846 NVAF patients receiving DOACs prior to ablation to uninterruption (n = 422) or interruption (n = 424) of the DOACs on the day of the procedure. The primary endpoint was a composite of symptomatic thromboembolisms and major bleeding events within 30 days after the ablation. Secondary endpoints included symptomatic and silent thromboembolisms and major and minor bleeding events. The primary endpoint occurred in 0.7% of the uninterrupted DOAC group [1 transient ischaemic attack (TIA) and 2 major bleeding events] and 1.2% of the interrupted DOAC group (1 TIA and 4 major bleeding events) (P = 0.480). The incidence of major and minor bleeding was comparable between the two groups (0.5% vs. 0.9%, P = 0.345; 5.9% vs. 5.4%, P = 0.753). Silent cerebral ischaemic lesions (SCILs) were observed in 138 (20.9%) of the 661 patients undergoing post-ablation magnetic resonance (MR) imaging. The uninterrupted and interrupted DOAC groups revealed a similar incidence of SCILs (19.8% vs. 22.0%, P = 0.484) and percentage of SCILs with disappearance on follow-up MR imaging (77.8% vs. 82.1%, P = 0.428).
Conclusion
Both the uninterrupted and interrupted DOAC protocols revealed a low risk of symptomatic thromboembolisms and major bleeding events and similar incidence of SCILs and minor bleeding events and may be feasible for periprocedural anticoagulation in NVAF patients undergoing catheter ablation. |
| doi_str_mv | 10.1093/europace/euy148 |
| format | Article |
| fullrecord | <record><control><sourceid>oup_TOX</sourceid><recordid>TN_cdi_crossref_primary_10_1093_europace_euy148</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><oup_id>10.1093/europace/euy148</oup_id><sourcerecordid>10.1093/europace/euy148</sourcerecordid><originalsourceid>FETCH-LOGICAL-c373t-49ed953715abb038f2046a934ca1b238f16500441c76ea6d8cb6ff950603dc0d3</originalsourceid><addsrcrecordid>eNqFkUtr3DAUhUVpaR7turuidcGJHrZn1F0JSVsIdNOszbV0PaNiW-JKHpj81f6ZanATsstGOlec80niMPZJiispjL7GhUIEi0UcZb19w85lo1WlhFFvixbGVI1U5oxdpPRHCLFRpnnPzpQxW9W06pz9fZj9nJFoiRkdP6Qr_nKOSD5SsOgWgpE7T2gzDycNc_Y2wG4Zi0p8CMQt5D2WMId-hOzDzMPAIZMv9sH35Mf1-CsHXqgpFpg_ICeYXZj8Y7kw-Xk3YmVxzoQ85cUdeeHEkHL1TM17ClMfKizL6G15iuN7wCkQ7WFXDvBQ8ukDezfAmPDj__2SPdzd_r75Ud3_-v7z5tt9ZfVG56o26EyjN7KBvhd6OyhRt2B0bUH2qsyybYSoa2k3LULrtrZvh8E0ohXaWeH0Jbteubb8KREOXSQ_AR07KbpTTd1TTd1aU0l8XhNx6Sd0z_6nXorhy2oIS3yV9g_T2Kie</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Uninterrupted vs. interrupted periprocedural direct oral anticoagulants for catheter ablation of atrial fibrillation: a prospective randomized single-centre study on post-ablation thrombo-embolic and haemorrhagic events</title><source>Oxford Journals Open Access Collection</source><creator>Nakamura, Kohki ; Naito, Shigeto ; Sasaki, Takehito ; Take, Yutaka ; Minami, Kentaro ; Kitagawa, Yoshiyuki ; Motoda, Hiroyuki ; Inoue, Mitsuho ; Otsuka, Yoshimitsu ; Niijima, Katsura ; Yamashita, Eiji ; Sugai, Yoshinao ; Kumagai, Koji ; Koyama, Keiko ; Funabashi, Nobusada ; Oshima, Shigeru</creator><creatorcontrib>Nakamura, Kohki ; Naito, Shigeto ; Sasaki, Takehito ; Take, Yutaka ; Minami, Kentaro ; Kitagawa, Yoshiyuki ; Motoda, Hiroyuki ; Inoue, Mitsuho ; Otsuka, Yoshimitsu ; Niijima, Katsura ; Yamashita, Eiji ; Sugai, Yoshinao ; Kumagai, Koji ; Koyama, Keiko ; Funabashi, Nobusada ; Oshima, Shigeru</creatorcontrib><description>Abstract
Aims
This prospective, randomized, single-centre study aimed to directly compare the safety and efficacy of uninterrupted and interrupted periprocedural anticoagulation protocols with direct oral anticoagulants (DOACs) in patients undergoing catheter ablation of non-valvular atrial fibrillation (NVAF).
Methods and results
We randomly assigned 846 NVAF patients receiving DOACs prior to ablation to uninterruption (n = 422) or interruption (n = 424) of the DOACs on the day of the procedure. The primary endpoint was a composite of symptomatic thromboembolisms and major bleeding events within 30 days after the ablation. Secondary endpoints included symptomatic and silent thromboembolisms and major and minor bleeding events. The primary endpoint occurred in 0.7% of the uninterrupted DOAC group [1 transient ischaemic attack (TIA) and 2 major bleeding events] and 1.2% of the interrupted DOAC group (1 TIA and 4 major bleeding events) (P = 0.480). The incidence of major and minor bleeding was comparable between the two groups (0.5% vs. 0.9%, P = 0.345; 5.9% vs. 5.4%, P = 0.753). Silent cerebral ischaemic lesions (SCILs) were observed in 138 (20.9%) of the 661 patients undergoing post-ablation magnetic resonance (MR) imaging. The uninterrupted and interrupted DOAC groups revealed a similar incidence of SCILs (19.8% vs. 22.0%, P = 0.484) and percentage of SCILs with disappearance on follow-up MR imaging (77.8% vs. 82.1%, P = 0.428).
Conclusion
Both the uninterrupted and interrupted DOAC protocols revealed a low risk of symptomatic thromboembolisms and major bleeding events and similar incidence of SCILs and minor bleeding events and may be feasible for periprocedural anticoagulation in NVAF patients undergoing catheter ablation.</description><identifier>ISSN: 1099-5129</identifier><identifier>EISSN: 1532-2092</identifier><identifier>DOI: 10.1093/europace/euy148</identifier><identifier>PMID: 29982562</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Administration, Oral ; Aged ; Antithrombins - administration & dosage ; Antithrombins - adverse effects ; Atrial Fibrillation - complications ; Atrial Fibrillation - diagnosis ; Atrial Fibrillation - physiopathology ; Atrial Fibrillation - surgery ; Catheter Ablation - adverse effects ; Drug Administration Schedule ; Factor Xa Inhibitors - administration & dosage ; Female ; Hemorrhage - chemically induced ; Humans ; Ischemic Attack, Transient - diagnostic imaging ; Ischemic Attack, Transient - etiology ; Ischemic Attack, Transient - prevention & control ; Japan ; Male ; Middle Aged ; Prospective Studies ; Risk Factors ; Thromboembolism - diagnostic imaging ; Thromboembolism - etiology ; Thromboembolism - prevention & control ; Time Factors ; Treatment Outcome</subject><ispartof>Europace (London, England), 2019-02, Vol.21 (2), p.259-267</ispartof><rights>Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2018. For permissions, please email: journals.permissions@oup.com. 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c373t-49ed953715abb038f2046a934ca1b238f16500441c76ea6d8cb6ff950603dc0d3</citedby><cites>FETCH-LOGICAL-c373t-49ed953715abb038f2046a934ca1b238f16500441c76ea6d8cb6ff950603dc0d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,1604,27924,27925</link.rule.ids><linktorsrc>$$Uhttps://dx.doi.org/10.1093/europace/euy148$$EView_record_in_Oxford_University_Press$$FView_record_in_$$GOxford_University_Press</linktorsrc><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29982562$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Nakamura, Kohki</creatorcontrib><creatorcontrib>Naito, Shigeto</creatorcontrib><creatorcontrib>Sasaki, Takehito</creatorcontrib><creatorcontrib>Take, Yutaka</creatorcontrib><creatorcontrib>Minami, Kentaro</creatorcontrib><creatorcontrib>Kitagawa, Yoshiyuki</creatorcontrib><creatorcontrib>Motoda, Hiroyuki</creatorcontrib><creatorcontrib>Inoue, Mitsuho</creatorcontrib><creatorcontrib>Otsuka, Yoshimitsu</creatorcontrib><creatorcontrib>Niijima, Katsura</creatorcontrib><creatorcontrib>Yamashita, Eiji</creatorcontrib><creatorcontrib>Sugai, Yoshinao</creatorcontrib><creatorcontrib>Kumagai, Koji</creatorcontrib><creatorcontrib>Koyama, Keiko</creatorcontrib><creatorcontrib>Funabashi, Nobusada</creatorcontrib><creatorcontrib>Oshima, Shigeru</creatorcontrib><title>Uninterrupted vs. interrupted periprocedural direct oral anticoagulants for catheter ablation of atrial fibrillation: a prospective randomized single-centre study on post-ablation thrombo-embolic and haemorrhagic events</title><title>Europace (London, England)</title><addtitle>Europace</addtitle><description>Abstract
Aims
This prospective, randomized, single-centre study aimed to directly compare the safety and efficacy of uninterrupted and interrupted periprocedural anticoagulation protocols with direct oral anticoagulants (DOACs) in patients undergoing catheter ablation of non-valvular atrial fibrillation (NVAF).
Methods and results
We randomly assigned 846 NVAF patients receiving DOACs prior to ablation to uninterruption (n = 422) or interruption (n = 424) of the DOACs on the day of the procedure. The primary endpoint was a composite of symptomatic thromboembolisms and major bleeding events within 30 days after the ablation. Secondary endpoints included symptomatic and silent thromboembolisms and major and minor bleeding events. The primary endpoint occurred in 0.7% of the uninterrupted DOAC group [1 transient ischaemic attack (TIA) and 2 major bleeding events] and 1.2% of the interrupted DOAC group (1 TIA and 4 major bleeding events) (P = 0.480). The incidence of major and minor bleeding was comparable between the two groups (0.5% vs. 0.9%, P = 0.345; 5.9% vs. 5.4%, P = 0.753). Silent cerebral ischaemic lesions (SCILs) were observed in 138 (20.9%) of the 661 patients undergoing post-ablation magnetic resonance (MR) imaging. The uninterrupted and interrupted DOAC groups revealed a similar incidence of SCILs (19.8% vs. 22.0%, P = 0.484) and percentage of SCILs with disappearance on follow-up MR imaging (77.8% vs. 82.1%, P = 0.428).
Conclusion
Both the uninterrupted and interrupted DOAC protocols revealed a low risk of symptomatic thromboembolisms and major bleeding events and similar incidence of SCILs and minor bleeding events and may be feasible for periprocedural anticoagulation in NVAF patients undergoing catheter ablation.</description><subject>Administration, Oral</subject><subject>Aged</subject><subject>Antithrombins - administration & dosage</subject><subject>Antithrombins - adverse effects</subject><subject>Atrial Fibrillation - complications</subject><subject>Atrial Fibrillation - diagnosis</subject><subject>Atrial Fibrillation - physiopathology</subject><subject>Atrial Fibrillation - surgery</subject><subject>Catheter Ablation - adverse effects</subject><subject>Drug Administration Schedule</subject><subject>Factor Xa Inhibitors - administration & dosage</subject><subject>Female</subject><subject>Hemorrhage - chemically induced</subject><subject>Humans</subject><subject>Ischemic Attack, Transient - diagnostic imaging</subject><subject>Ischemic Attack, Transient - etiology</subject><subject>Ischemic Attack, Transient - prevention & control</subject><subject>Japan</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Risk Factors</subject><subject>Thromboembolism - diagnostic imaging</subject><subject>Thromboembolism - etiology</subject><subject>Thromboembolism - prevention & control</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>1099-5129</issn><issn>1532-2092</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkUtr3DAUhUVpaR7turuidcGJHrZn1F0JSVsIdNOszbV0PaNiW-JKHpj81f6ZanATsstGOlec80niMPZJiispjL7GhUIEi0UcZb19w85lo1WlhFFvixbGVI1U5oxdpPRHCLFRpnnPzpQxW9W06pz9fZj9nJFoiRkdP6Qr_nKOSD5SsOgWgpE7T2gzDycNc_Y2wG4Zi0p8CMQt5D2WMId-hOzDzMPAIZMv9sH35Mf1-CsHXqgpFpg_ICeYXZj8Y7kw-Xk3YmVxzoQ85cUdeeHEkHL1TM17ClMfKizL6G15iuN7wCkQ7WFXDvBQ8ukDezfAmPDj__2SPdzd_r75Ud3_-v7z5tt9ZfVG56o26EyjN7KBvhd6OyhRt2B0bUH2qsyybYSoa2k3LULrtrZvh8E0ohXaWeH0Jbteubb8KREOXSQ_AR07KbpTTd1TTd1aU0l8XhNx6Sd0z_6nXorhy2oIS3yV9g_T2Kie</recordid><startdate>20190201</startdate><enddate>20190201</enddate><creator>Nakamura, Kohki</creator><creator>Naito, Shigeto</creator><creator>Sasaki, Takehito</creator><creator>Take, Yutaka</creator><creator>Minami, Kentaro</creator><creator>Kitagawa, Yoshiyuki</creator><creator>Motoda, Hiroyuki</creator><creator>Inoue, Mitsuho</creator><creator>Otsuka, Yoshimitsu</creator><creator>Niijima, Katsura</creator><creator>Yamashita, Eiji</creator><creator>Sugai, Yoshinao</creator><creator>Kumagai, Koji</creator><creator>Koyama, Keiko</creator><creator>Funabashi, Nobusada</creator><creator>Oshima, Shigeru</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope></search><sort><creationdate>20190201</creationdate><title>Uninterrupted vs. interrupted periprocedural direct oral anticoagulants for catheter ablation of atrial fibrillation: a prospective randomized single-centre study on post-ablation thrombo-embolic and haemorrhagic events</title><author>Nakamura, Kohki ; Naito, Shigeto ; Sasaki, Takehito ; Take, Yutaka ; Minami, Kentaro ; Kitagawa, Yoshiyuki ; Motoda, Hiroyuki ; Inoue, Mitsuho ; Otsuka, Yoshimitsu ; Niijima, Katsura ; Yamashita, Eiji ; Sugai, Yoshinao ; Kumagai, Koji ; Koyama, Keiko ; Funabashi, Nobusada ; Oshima, Shigeru</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c373t-49ed953715abb038f2046a934ca1b238f16500441c76ea6d8cb6ff950603dc0d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Administration, Oral</topic><topic>Aged</topic><topic>Antithrombins - administration & dosage</topic><topic>Antithrombins - adverse effects</topic><topic>Atrial Fibrillation - complications</topic><topic>Atrial Fibrillation - diagnosis</topic><topic>Atrial Fibrillation - physiopathology</topic><topic>Atrial Fibrillation - surgery</topic><topic>Catheter Ablation - adverse effects</topic><topic>Drug Administration Schedule</topic><topic>Factor Xa Inhibitors - administration & dosage</topic><topic>Female</topic><topic>Hemorrhage - chemically induced</topic><topic>Humans</topic><topic>Ischemic Attack, Transient - diagnostic imaging</topic><topic>Ischemic Attack, Transient - etiology</topic><topic>Ischemic Attack, Transient - prevention & control</topic><topic>Japan</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Risk Factors</topic><topic>Thromboembolism - diagnostic imaging</topic><topic>Thromboembolism - etiology</topic><topic>Thromboembolism - prevention & control</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Nakamura, Kohki</creatorcontrib><creatorcontrib>Naito, Shigeto</creatorcontrib><creatorcontrib>Sasaki, Takehito</creatorcontrib><creatorcontrib>Take, Yutaka</creatorcontrib><creatorcontrib>Minami, Kentaro</creatorcontrib><creatorcontrib>Kitagawa, Yoshiyuki</creatorcontrib><creatorcontrib>Motoda, Hiroyuki</creatorcontrib><creatorcontrib>Inoue, Mitsuho</creatorcontrib><creatorcontrib>Otsuka, Yoshimitsu</creatorcontrib><creatorcontrib>Niijima, Katsura</creatorcontrib><creatorcontrib>Yamashita, Eiji</creatorcontrib><creatorcontrib>Sugai, Yoshinao</creatorcontrib><creatorcontrib>Kumagai, Koji</creatorcontrib><creatorcontrib>Koyama, Keiko</creatorcontrib><creatorcontrib>Funabashi, Nobusada</creatorcontrib><creatorcontrib>Oshima, Shigeru</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Europace (London, England)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>Nakamura, Kohki</au><au>Naito, Shigeto</au><au>Sasaki, Takehito</au><au>Take, Yutaka</au><au>Minami, Kentaro</au><au>Kitagawa, Yoshiyuki</au><au>Motoda, Hiroyuki</au><au>Inoue, Mitsuho</au><au>Otsuka, Yoshimitsu</au><au>Niijima, Katsura</au><au>Yamashita, Eiji</au><au>Sugai, Yoshinao</au><au>Kumagai, Koji</au><au>Koyama, Keiko</au><au>Funabashi, Nobusada</au><au>Oshima, Shigeru</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Uninterrupted vs. interrupted periprocedural direct oral anticoagulants for catheter ablation of atrial fibrillation: a prospective randomized single-centre study on post-ablation thrombo-embolic and haemorrhagic events</atitle><jtitle>Europace (London, England)</jtitle><addtitle>Europace</addtitle><date>2019-02-01</date><risdate>2019</risdate><volume>21</volume><issue>2</issue><spage>259</spage><epage>267</epage><pages>259-267</pages><issn>1099-5129</issn><eissn>1532-2092</eissn><abstract>Abstract
Aims
This prospective, randomized, single-centre study aimed to directly compare the safety and efficacy of uninterrupted and interrupted periprocedural anticoagulation protocols with direct oral anticoagulants (DOACs) in patients undergoing catheter ablation of non-valvular atrial fibrillation (NVAF).
Methods and results
We randomly assigned 846 NVAF patients receiving DOACs prior to ablation to uninterruption (n = 422) or interruption (n = 424) of the DOACs on the day of the procedure. The primary endpoint was a composite of symptomatic thromboembolisms and major bleeding events within 30 days after the ablation. Secondary endpoints included symptomatic and silent thromboembolisms and major and minor bleeding events. The primary endpoint occurred in 0.7% of the uninterrupted DOAC group [1 transient ischaemic attack (TIA) and 2 major bleeding events] and 1.2% of the interrupted DOAC group (1 TIA and 4 major bleeding events) (P = 0.480). The incidence of major and minor bleeding was comparable between the two groups (0.5% vs. 0.9%, P = 0.345; 5.9% vs. 5.4%, P = 0.753). Silent cerebral ischaemic lesions (SCILs) were observed in 138 (20.9%) of the 661 patients undergoing post-ablation magnetic resonance (MR) imaging. The uninterrupted and interrupted DOAC groups revealed a similar incidence of SCILs (19.8% vs. 22.0%, P = 0.484) and percentage of SCILs with disappearance on follow-up MR imaging (77.8% vs. 82.1%, P = 0.428).
Conclusion
Both the uninterrupted and interrupted DOAC protocols revealed a low risk of symptomatic thromboembolisms and major bleeding events and similar incidence of SCILs and minor bleeding events and may be feasible for periprocedural anticoagulation in NVAF patients undergoing catheter ablation.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>29982562</pmid><doi>10.1093/europace/euy148</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Europace (London, England), 2019-02, Vol.21 (2), p.259-267 |
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| source | Oxford Journals Open Access Collection |
| subjects | Administration, Oral Aged Antithrombins - administration & dosage Antithrombins - adverse effects Atrial Fibrillation - complications Atrial Fibrillation - diagnosis Atrial Fibrillation - physiopathology Atrial Fibrillation - surgery Catheter Ablation - adverse effects Drug Administration Schedule Factor Xa Inhibitors - administration & dosage Female Hemorrhage - chemically induced Humans Ischemic Attack, Transient - diagnostic imaging Ischemic Attack, Transient - etiology Ischemic Attack, Transient - prevention & control Japan Male Middle Aged Prospective Studies Risk Factors Thromboembolism - diagnostic imaging Thromboembolism - etiology Thromboembolism - prevention & control Time Factors Treatment Outcome |
| title | Uninterrupted vs. interrupted periprocedural direct oral anticoagulants for catheter ablation of atrial fibrillation: a prospective randomized single-centre study on post-ablation thrombo-embolic and haemorrhagic events |
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