Academic Research Consortium High Bleeding Risk Criteria associated with 2-year bleeding events and mortality after transcatheter aortic valve replacement discharge: a Japanese Multicentre Prospective OCEAN-TAVI Registry Study
Aims To investigate the ability of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria and ARC-HBR score to predict 2-year bleeding and mortality in patients undergoing transcatheter aortic valve replacement (TAVR). Methods and results We enrolled 2514 patients who underwent s...
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| Veröffentlicht in: | European heart journal open 2021-11, Vol.1 (3), p.oeab036-oeab036 |
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| creator | Mizutani, Kazuki Nakazawa, Gaku Yamaguchi, Tomohiro Ogawa, Mana Okai, Tsukasa Yashima, Fumiaki Naganuma, Toru Yamanaka, Futoshi Tada, Norio Takagi, Kensuke Yamawaki, Masahiro Ueno, Hiroshi Tabata, Minoru Shirai, Shinichi Watanabe, Yusuke Yamamoto, Masanori Hayashida, Kentaro |
| description | Aims
To investigate the ability of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria and ARC-HBR score to predict 2-year bleeding and mortality in patients undergoing transcatheter aortic valve replacement (TAVR).
Methods and results
We enrolled 2514 patients who underwent successful TAVR during 2013–17. In this study, we used the ARC-HBR score for further HBR-risk stratification, and the ARC-HBR score was calculated as follows: each major criterion was 2 points and each minor criterion was 1 point. The impact of the ARC-HBR criteria and increasing ARC-HBR score on the incidence of moderate/severe bleeding events, mortality, and ischaemic stroke in the first 2 years were evaluated. We used survival classification and regression tree (CART) analysis for 2-year moderate or severe bleeding events, and patients were statistically classified into HBR low- (ARC-HBR score ≤1), intermediate- (ARC-HBR score = 2–4), or high-risk (ARC-HBR score ≥5) groups, and 91.4% were at HBR (ARC-HBR score ≥2). The rates of 2-year moderate/severe bleeding events and all-cause mortality were higher in the ARC-HBR group and highest in the HBR high-risk group. An increased HBR score was significantly associated with moderate/severe bleeding events [hazard ratio (HR) 1.19, 95% confidence interval (CI) 1.07–1.31; P = 0.001] and all-cause mortality (adjusted HR 1.24, 95% CI 1.17–1.32; P < 0.001).
Conclusions
The ARC-HBR criteria identify patients at HBR after TAVR; an increased ARC-HBR score is associated with 2-year moderate/severe bleeding events and mortality.
Graphical Abstract
Graphical Abstract |
| doi_str_mv | 10.1093/ehjopen/oeab036 |
| format | Article |
| fullrecord | <record><control><sourceid>gale_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_9263883</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><galeid>A761154607</galeid><oup_id>10.1093/ehjopen/oeab036</oup_id><sourcerecordid>A761154607</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3876-f851f7bb381ede0c151a637a548aeccbb6a16af7463f62c674ec7c6fd0801f593</originalsourceid><addsrcrecordid>eNqFkk1v1DAQhiMEolXpmaslLggpXTvZ2AkHpGVVaFGhqBSu1sQZJy5JHGxn0f5dfgledkFUQuLkj3ne1zPjSZKnjJ4xWuUL7O7shOPCItQ05w-S40wUWbpkFXv41_4oOfX-jlKalbSsGH2cHOVFxaqyLI6THysFDQ5GkRv0CE51ZG1Hb10w80AuTNuR1z1iY8aW3Bj_laydCegMEPDeKgMBG_LdhI5k6TbqSf2bxg2OwRMYGzJEO-hN2BLQUUyCg9ErCB3uTrB7TJEN9BskDqceFA5RSxrjVQeuxZcEyDuYYIwpkvdzH_EYd0g-OusnVMFE5fX6fPUhvV19uYyltMYHtyWfwtxsnySPNPQeTw_rSfL5zfnt-iK9un57uV5dpSovBU91WTAt6jovGTZIFSsY8FxAsSwBlaprDoyDFkuea54pLpaohOK6oSVluqjyk-TV3nea6wGbXylCLydnBnBbacHI-5HRdLK1G1llPC_LPBo8Pxg4-21GH-QQO4B9Hwu3s5cZrwQXvMiLiD7boy30KM2obXRUO1yuBGesWHIqInX2DwoOP25H1Cbe3xMs9gIVG-sd6j_ZMyp3MycPMycPMxcVL_YKO0__hX8CzcXfcA</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2697676535</pqid></control><display><type>article</type><title>Academic Research Consortium High Bleeding Risk Criteria associated with 2-year bleeding events and mortality after transcatheter aortic valve replacement discharge: a Japanese Multicentre Prospective OCEAN-TAVI Registry Study</title><source>Oxford Journals Open Access Collection</source><source>DOAJ Directory of Open Access Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><creator>Mizutani, Kazuki ; Nakazawa, Gaku ; Yamaguchi, Tomohiro ; Ogawa, Mana ; Okai, Tsukasa ; Yashima, Fumiaki ; Naganuma, Toru ; Yamanaka, Futoshi ; Tada, Norio ; Takagi, Kensuke ; Yamawaki, Masahiro ; Ueno, Hiroshi ; Tabata, Minoru ; Shirai, Shinichi ; Watanabe, Yusuke ; Yamamoto, Masanori ; Hayashida, Kentaro</creator><creatorcontrib>Mizutani, Kazuki ; Nakazawa, Gaku ; Yamaguchi, Tomohiro ; Ogawa, Mana ; Okai, Tsukasa ; Yashima, Fumiaki ; Naganuma, Toru ; Yamanaka, Futoshi ; Tada, Norio ; Takagi, Kensuke ; Yamawaki, Masahiro ; Ueno, Hiroshi ; Tabata, Minoru ; Shirai, Shinichi ; Watanabe, Yusuke ; Yamamoto, Masanori ; Hayashida, Kentaro</creatorcontrib><description>Aims
To investigate the ability of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria and ARC-HBR score to predict 2-year bleeding and mortality in patients undergoing transcatheter aortic valve replacement (TAVR).
Methods and results
We enrolled 2514 patients who underwent successful TAVR during 2013–17. In this study, we used the ARC-HBR score for further HBR-risk stratification, and the ARC-HBR score was calculated as follows: each major criterion was 2 points and each minor criterion was 1 point. The impact of the ARC-HBR criteria and increasing ARC-HBR score on the incidence of moderate/severe bleeding events, mortality, and ischaemic stroke in the first 2 years were evaluated. We used survival classification and regression tree (CART) analysis for 2-year moderate or severe bleeding events, and patients were statistically classified into HBR low- (ARC-HBR score ≤1), intermediate- (ARC-HBR score = 2–4), or high-risk (ARC-HBR score ≥5) groups, and 91.4% were at HBR (ARC-HBR score ≥2). The rates of 2-year moderate/severe bleeding events and all-cause mortality were higher in the ARC-HBR group and highest in the HBR high-risk group. An increased HBR score was significantly associated with moderate/severe bleeding events [hazard ratio (HR) 1.19, 95% confidence interval (CI) 1.07–1.31; P = 0.001] and all-cause mortality (adjusted HR 1.24, 95% CI 1.17–1.32; P < 0.001).
Conclusions
The ARC-HBR criteria identify patients at HBR after TAVR; an increased ARC-HBR score is associated with 2-year moderate/severe bleeding events and mortality.
Graphical Abstract
Graphical Abstract</description><identifier>ISSN: 2752-4191</identifier><identifier>EISSN: 2752-4191</identifier><identifier>DOI: 10.1093/ehjopen/oeab036</identifier><identifier>PMID: 35919885</identifier><language>eng</language><publisher>Oxford University Press</publisher><subject>Aortic valve stenosis ; Care and treatment ; Diagnosis ; Heart valve replacement ; Hemorrhage ; Original ; Patient outcomes ; Prevention ; Risk factors</subject><ispartof>European heart journal open, 2021-11, Vol.1 (3), p.oeab036-oeab036</ispartof><rights>The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology. 2021</rights><rights>COPYRIGHT 2021 Oxford University Press</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3876-f851f7bb381ede0c151a637a548aeccbb6a16af7463f62c674ec7c6fd0801f593</citedby><cites>FETCH-LOGICAL-c3876-f851f7bb381ede0c151a637a548aeccbb6a16af7463f62c674ec7c6fd0801f593</cites><orcidid>0000-0001-7206-4538 ; 0000-0003-3999-8536 ; 0000-0002-1304-5836 ; 0000-0002-4501-1358 ; 0000-0002-6721-1342</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9263883/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9263883/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,1598,27901,27902,53766,53768</link.rule.ids></links><search><creatorcontrib>Mizutani, Kazuki</creatorcontrib><creatorcontrib>Nakazawa, Gaku</creatorcontrib><creatorcontrib>Yamaguchi, Tomohiro</creatorcontrib><creatorcontrib>Ogawa, Mana</creatorcontrib><creatorcontrib>Okai, Tsukasa</creatorcontrib><creatorcontrib>Yashima, Fumiaki</creatorcontrib><creatorcontrib>Naganuma, Toru</creatorcontrib><creatorcontrib>Yamanaka, Futoshi</creatorcontrib><creatorcontrib>Tada, Norio</creatorcontrib><creatorcontrib>Takagi, Kensuke</creatorcontrib><creatorcontrib>Yamawaki, Masahiro</creatorcontrib><creatorcontrib>Ueno, Hiroshi</creatorcontrib><creatorcontrib>Tabata, Minoru</creatorcontrib><creatorcontrib>Shirai, Shinichi</creatorcontrib><creatorcontrib>Watanabe, Yusuke</creatorcontrib><creatorcontrib>Yamamoto, Masanori</creatorcontrib><creatorcontrib>Hayashida, Kentaro</creatorcontrib><title>Academic Research Consortium High Bleeding Risk Criteria associated with 2-year bleeding events and mortality after transcatheter aortic valve replacement discharge: a Japanese Multicentre Prospective OCEAN-TAVI Registry Study</title><title>European heart journal open</title><description>Aims
To investigate the ability of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria and ARC-HBR score to predict 2-year bleeding and mortality in patients undergoing transcatheter aortic valve replacement (TAVR).
Methods and results
We enrolled 2514 patients who underwent successful TAVR during 2013–17. In this study, we used the ARC-HBR score for further HBR-risk stratification, and the ARC-HBR score was calculated as follows: each major criterion was 2 points and each minor criterion was 1 point. The impact of the ARC-HBR criteria and increasing ARC-HBR score on the incidence of moderate/severe bleeding events, mortality, and ischaemic stroke in the first 2 years were evaluated. We used survival classification and regression tree (CART) analysis for 2-year moderate or severe bleeding events, and patients were statistically classified into HBR low- (ARC-HBR score ≤1), intermediate- (ARC-HBR score = 2–4), or high-risk (ARC-HBR score ≥5) groups, and 91.4% were at HBR (ARC-HBR score ≥2). The rates of 2-year moderate/severe bleeding events and all-cause mortality were higher in the ARC-HBR group and highest in the HBR high-risk group. An increased HBR score was significantly associated with moderate/severe bleeding events [hazard ratio (HR) 1.19, 95% confidence interval (CI) 1.07–1.31; P = 0.001] and all-cause mortality (adjusted HR 1.24, 95% CI 1.17–1.32; P < 0.001).
Conclusions
The ARC-HBR criteria identify patients at HBR after TAVR; an increased ARC-HBR score is associated with 2-year moderate/severe bleeding events and mortality.
Graphical Abstract
Graphical Abstract</description><subject>Aortic valve stenosis</subject><subject>Care and treatment</subject><subject>Diagnosis</subject><subject>Heart valve replacement</subject><subject>Hemorrhage</subject><subject>Original</subject><subject>Patient outcomes</subject><subject>Prevention</subject><subject>Risk factors</subject><issn>2752-4191</issn><issn>2752-4191</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><recordid>eNqFkk1v1DAQhiMEolXpmaslLggpXTvZ2AkHpGVVaFGhqBSu1sQZJy5JHGxn0f5dfgledkFUQuLkj3ne1zPjSZKnjJ4xWuUL7O7shOPCItQ05w-S40wUWbpkFXv41_4oOfX-jlKalbSsGH2cHOVFxaqyLI6THysFDQ5GkRv0CE51ZG1Hb10w80AuTNuR1z1iY8aW3Bj_laydCegMEPDeKgMBG_LdhI5k6TbqSf2bxg2OwRMYGzJEO-hN2BLQUUyCg9ErCB3uTrB7TJEN9BskDqceFA5RSxrjVQeuxZcEyDuYYIwpkvdzH_EYd0g-OusnVMFE5fX6fPUhvV19uYyltMYHtyWfwtxsnySPNPQeTw_rSfL5zfnt-iK9un57uV5dpSovBU91WTAt6jovGTZIFSsY8FxAsSwBlaprDoyDFkuea54pLpaohOK6oSVluqjyk-TV3nea6wGbXylCLydnBnBbacHI-5HRdLK1G1llPC_LPBo8Pxg4-21GH-QQO4B9Hwu3s5cZrwQXvMiLiD7boy30KM2obXRUO1yuBGesWHIqInX2DwoOP25H1Cbe3xMs9gIVG-sd6j_ZMyp3MycPMycPMxcVL_YKO0__hX8CzcXfcA</recordid><startdate>20211101</startdate><enddate>20211101</enddate><creator>Mizutani, Kazuki</creator><creator>Nakazawa, Gaku</creator><creator>Yamaguchi, Tomohiro</creator><creator>Ogawa, Mana</creator><creator>Okai, Tsukasa</creator><creator>Yashima, Fumiaki</creator><creator>Naganuma, Toru</creator><creator>Yamanaka, Futoshi</creator><creator>Tada, Norio</creator><creator>Takagi, Kensuke</creator><creator>Yamawaki, Masahiro</creator><creator>Ueno, Hiroshi</creator><creator>Tabata, Minoru</creator><creator>Shirai, Shinichi</creator><creator>Watanabe, Yusuke</creator><creator>Yamamoto, Masanori</creator><creator>Hayashida, Kentaro</creator><general>Oxford University Press</general><scope>TOX</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-7206-4538</orcidid><orcidid>https://orcid.org/0000-0003-3999-8536</orcidid><orcidid>https://orcid.org/0000-0002-1304-5836</orcidid><orcidid>https://orcid.org/0000-0002-4501-1358</orcidid><orcidid>https://orcid.org/0000-0002-6721-1342</orcidid></search><sort><creationdate>20211101</creationdate><title>Academic Research Consortium High Bleeding Risk Criteria associated with 2-year bleeding events and mortality after transcatheter aortic valve replacement discharge: a Japanese Multicentre Prospective OCEAN-TAVI Registry Study</title><author>Mizutani, Kazuki ; Nakazawa, Gaku ; Yamaguchi, Tomohiro ; Ogawa, Mana ; Okai, Tsukasa ; Yashima, Fumiaki ; Naganuma, Toru ; Yamanaka, Futoshi ; Tada, Norio ; Takagi, Kensuke ; Yamawaki, Masahiro ; Ueno, Hiroshi ; Tabata, Minoru ; Shirai, Shinichi ; Watanabe, Yusuke ; Yamamoto, Masanori ; Hayashida, Kentaro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3876-f851f7bb381ede0c151a637a548aeccbb6a16af7463f62c674ec7c6fd0801f593</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Aortic valve stenosis</topic><topic>Care and treatment</topic><topic>Diagnosis</topic><topic>Heart valve replacement</topic><topic>Hemorrhage</topic><topic>Original</topic><topic>Patient outcomes</topic><topic>Prevention</topic><topic>Risk factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mizutani, Kazuki</creatorcontrib><creatorcontrib>Nakazawa, Gaku</creatorcontrib><creatorcontrib>Yamaguchi, Tomohiro</creatorcontrib><creatorcontrib>Ogawa, Mana</creatorcontrib><creatorcontrib>Okai, Tsukasa</creatorcontrib><creatorcontrib>Yashima, Fumiaki</creatorcontrib><creatorcontrib>Naganuma, Toru</creatorcontrib><creatorcontrib>Yamanaka, Futoshi</creatorcontrib><creatorcontrib>Tada, Norio</creatorcontrib><creatorcontrib>Takagi, Kensuke</creatorcontrib><creatorcontrib>Yamawaki, Masahiro</creatorcontrib><creatorcontrib>Ueno, Hiroshi</creatorcontrib><creatorcontrib>Tabata, Minoru</creatorcontrib><creatorcontrib>Shirai, Shinichi</creatorcontrib><creatorcontrib>Watanabe, Yusuke</creatorcontrib><creatorcontrib>Yamamoto, Masanori</creatorcontrib><creatorcontrib>Hayashida, Kentaro</creatorcontrib><collection>Oxford Journals Open Access Collection</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>European heart journal open</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mizutani, Kazuki</au><au>Nakazawa, Gaku</au><au>Yamaguchi, Tomohiro</au><au>Ogawa, Mana</au><au>Okai, Tsukasa</au><au>Yashima, Fumiaki</au><au>Naganuma, Toru</au><au>Yamanaka, Futoshi</au><au>Tada, Norio</au><au>Takagi, Kensuke</au><au>Yamawaki, Masahiro</au><au>Ueno, Hiroshi</au><au>Tabata, Minoru</au><au>Shirai, Shinichi</au><au>Watanabe, Yusuke</au><au>Yamamoto, Masanori</au><au>Hayashida, Kentaro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Academic Research Consortium High Bleeding Risk Criteria associated with 2-year bleeding events and mortality after transcatheter aortic valve replacement discharge: a Japanese Multicentre Prospective OCEAN-TAVI Registry Study</atitle><jtitle>European heart journal open</jtitle><date>2021-11-01</date><risdate>2021</risdate><volume>1</volume><issue>3</issue><spage>oeab036</spage><epage>oeab036</epage><pages>oeab036-oeab036</pages><issn>2752-4191</issn><eissn>2752-4191</eissn><abstract>Aims
To investigate the ability of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria and ARC-HBR score to predict 2-year bleeding and mortality in patients undergoing transcatheter aortic valve replacement (TAVR).
Methods and results
We enrolled 2514 patients who underwent successful TAVR during 2013–17. In this study, we used the ARC-HBR score for further HBR-risk stratification, and the ARC-HBR score was calculated as follows: each major criterion was 2 points and each minor criterion was 1 point. The impact of the ARC-HBR criteria and increasing ARC-HBR score on the incidence of moderate/severe bleeding events, mortality, and ischaemic stroke in the first 2 years were evaluated. We used survival classification and regression tree (CART) analysis for 2-year moderate or severe bleeding events, and patients were statistically classified into HBR low- (ARC-HBR score ≤1), intermediate- (ARC-HBR score = 2–4), or high-risk (ARC-HBR score ≥5) groups, and 91.4% were at HBR (ARC-HBR score ≥2). The rates of 2-year moderate/severe bleeding events and all-cause mortality were higher in the ARC-HBR group and highest in the HBR high-risk group. An increased HBR score was significantly associated with moderate/severe bleeding events [hazard ratio (HR) 1.19, 95% confidence interval (CI) 1.07–1.31; P = 0.001] and all-cause mortality (adjusted HR 1.24, 95% CI 1.17–1.32; P < 0.001).
Conclusions
The ARC-HBR criteria identify patients at HBR after TAVR; an increased ARC-HBR score is associated with 2-year moderate/severe bleeding events and mortality.
Graphical Abstract
Graphical Abstract</abstract><pub>Oxford University Press</pub><pmid>35919885</pmid><doi>10.1093/ehjopen/oeab036</doi><orcidid>https://orcid.org/0000-0001-7206-4538</orcidid><orcidid>https://orcid.org/0000-0003-3999-8536</orcidid><orcidid>https://orcid.org/0000-0002-1304-5836</orcidid><orcidid>https://orcid.org/0000-0002-4501-1358</orcidid><orcidid>https://orcid.org/0000-0002-6721-1342</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Oxford Journals Open Access Collection; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central |
| subjects | Aortic valve stenosis Care and treatment Diagnosis Heart valve replacement Hemorrhage Original Patient outcomes Prevention Risk factors |
| title | Academic Research Consortium High Bleeding Risk Criteria associated with 2-year bleeding events and mortality after transcatheter aortic valve replacement discharge: a Japanese Multicentre Prospective OCEAN-TAVI Registry Study |
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