Patent foramen ovale closure or medical therapy for cryptogenic ischemic stroke: an updated meta-analysis of randomized controlled trials
Background Previous randomized controlled trials (RCT) failed to demonstrate benefits of patent foramen ovale (PFO) closure (PFO-C) over medical therapy (MT) for secondary prevention of cryptogenic ischemic stroke. Three recently published RCTs, however, turned out positive for PFO-C and warrant an...
Gespeichert in:
| Veröffentlicht in: | Clinical research in cardiology 2018-09, Vol.107 (9), p.745-755 |
|---|---|
| Hauptverfasser: | , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 755 |
|---|---|
| container_issue | 9 |
| container_start_page | 745 |
| container_title | Clinical research in cardiology |
| container_volume | 107 |
| creator | Schulze, Volker Lin, Yingfeng Karathanos, Athanasios Brockmeyer, Maximilian Zeus, Tobias Polzin, Amin Perings, Stefan Kelm, Malte Wolff, Georg |
| description | Background
Previous randomized controlled trials (RCT) failed to demonstrate benefits of patent foramen ovale (PFO) closure (PFO-C) over medical therapy (MT) for secondary prevention of cryptogenic ischemic stroke. Three recently published RCTs, however, turned out positive for PFO-C and warrant an updated meta-analysis.
Methods
Data from all available RCTs on PFO-C vs. MT for secondary prevention of cryptogenic ischemic stroke up until October 2017 were abstracted and analyzed in a comprehensive meta-analysis. Clinical efficacy outcomes were recurrent stroke, recurrent TIA, and their combination; safety outcomes were mortality, major bleeding, venous thromboembolism (VTE), and new-onset atrial fibrillation/flutter (NOAF).
Results
Five trials including a total of 3440 patients were included in the meta-analysis. PFO-C significantly reduced recurrent stroke [odds ratio (OR) 0.41, 95% confidence interval (CI) 0.19–0.90;
p
= 0.03] and the combination of recurrent stroke + TIA (OR 0.53, CI 0.36–0.80;
p
= 0.002) compared to MT; recurrent TIA alone showed no differences (OR 0.77; CI 0.51–1.14;
p
= 0.19). NOAF was significantly more frequent after PFO-C (OR 5.75, CI 3.09–10.70;
p
|
| doi_str_mv | 10.1007/s00392-018-1224-4 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2010372137</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2009767353</sourcerecordid><originalsourceid>FETCH-LOGICAL-c372t-f730dc880f822aa8d9034b023202f9f9d1497fee0a0b576d1b93ee8083d6315b3</originalsourceid><addsrcrecordid>eNp1kcFu1TAQRS0EoqXwAWyQJTZsQsd2EjvsUAW0UiVYwNpy7Emb4sTBTpBe_4C_7jy9UiSkrmasOfdaM5ex1wLeCwB9WgBUJysQphJS1lX9hB0L04oK2k4-fehNfcRelHID0AhQ9XN2JLuGHq05Zn--uRXnlQ8puwlnnn67iNzHVLaMPGU-YRi9i3y9xuyW3R7kPu-WNV3hPHo-Fn-NEzVlzeknfuBu5tsSyDWQdnWVm13clbHwNPDs5pCm8ZZmPs0kiJHaNY8ulpfs2UAFX93XE_bj86fvZ-fV5dcvF2cfLyuvtFyrQSsI3hgYjJTOmdDRSj1IJUEO3dAFUXd6QAQHfaPbIPpOIRowKrRKNL06Ye8OvktOvzYsq51oB4zRzZi2YiXQkbQUShP69j_0Jm2Z9tlT0OlWq0YRJQ6Uz6mUjINd8ji5vLMC7D4ne8jJUk52n5OtSfPm3nnr6cIPir_BECAPQKHRfIX539ePu94BboafNw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2009767353</pqid></control><display><type>article</type><title>Patent foramen ovale closure or medical therapy for cryptogenic ischemic stroke: an updated meta-analysis of randomized controlled trials</title><source>SpringerLink Journals</source><creator>Schulze, Volker ; Lin, Yingfeng ; Karathanos, Athanasios ; Brockmeyer, Maximilian ; Zeus, Tobias ; Polzin, Amin ; Perings, Stefan ; Kelm, Malte ; Wolff, Georg</creator><creatorcontrib>Schulze, Volker ; Lin, Yingfeng ; Karathanos, Athanasios ; Brockmeyer, Maximilian ; Zeus, Tobias ; Polzin, Amin ; Perings, Stefan ; Kelm, Malte ; Wolff, Georg</creatorcontrib><description>Background
Previous randomized controlled trials (RCT) failed to demonstrate benefits of patent foramen ovale (PFO) closure (PFO-C) over medical therapy (MT) for secondary prevention of cryptogenic ischemic stroke. Three recently published RCTs, however, turned out positive for PFO-C and warrant an updated meta-analysis.
Methods
Data from all available RCTs on PFO-C vs. MT for secondary prevention of cryptogenic ischemic stroke up until October 2017 were abstracted and analyzed in a comprehensive meta-analysis. Clinical efficacy outcomes were recurrent stroke, recurrent TIA, and their combination; safety outcomes were mortality, major bleeding, venous thromboembolism (VTE), and new-onset atrial fibrillation/flutter (NOAF).
Results
Five trials including a total of 3440 patients were included in the meta-analysis. PFO-C significantly reduced recurrent stroke [odds ratio (OR) 0.41, 95% confidence interval (CI) 0.19–0.90;
p
= 0.03] and the combination of recurrent stroke + TIA (OR 0.53, CI 0.36–0.80;
p
= 0.002) compared to MT; recurrent TIA alone showed no differences (OR 0.77; CI 0.51–1.14;
p
= 0.19). NOAF was significantly more frequent after PFO-C (OR 5.75, CI 3.09–10.70;
p
< 0.00001). Mortality (OR 0.80, CI 0.39–1.67), major bleeding (OR 0.96, CI 0.48–1.92), and VTE (OR 2.45, CI 0.75–7.99) remained neutral. Trials with superior patient selection for PFO-C showed advantageous results compared to MT.
Conclusions
PFO-C after cryptogenic ischemic stroke is safe and effective to reduce the risk of recurrent stroke and recurrent stroke + TIA, albeit with an increased risk for NOAF.</description><identifier>ISSN: 1861-0684</identifier><identifier>EISSN: 1861-0692</identifier><identifier>DOI: 10.1007/s00392-018-1224-4</identifier><identifier>PMID: 29500568</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>Bleeding ; Cardiology ; Clinical trials ; Confidence intervals ; Data processing ; Fibrillation ; Flutter ; Health risk assessment ; Health risks ; Ischemia ; Medicine ; Medicine & Public Health ; Meta-analysis ; Mortality ; Original Paper ; Prevention ; Randomization ; Stroke ; Therapy ; Thromboembolism</subject><ispartof>Clinical research in cardiology, 2018-09, Vol.107 (9), p.745-755</ispartof><rights>Springer-Verlag GmbH Germany, part of Springer Nature 2018</rights><rights>Clinical Research in Cardiology is a copyright of Springer, (2018). All Rights Reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c372t-f730dc880f822aa8d9034b023202f9f9d1497fee0a0b576d1b93ee8083d6315b3</citedby><cites>FETCH-LOGICAL-c372t-f730dc880f822aa8d9034b023202f9f9d1497fee0a0b576d1b93ee8083d6315b3</cites><orcidid>0000-0002-1734-6177</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00392-018-1224-4$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00392-018-1224-4$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29500568$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Schulze, Volker</creatorcontrib><creatorcontrib>Lin, Yingfeng</creatorcontrib><creatorcontrib>Karathanos, Athanasios</creatorcontrib><creatorcontrib>Brockmeyer, Maximilian</creatorcontrib><creatorcontrib>Zeus, Tobias</creatorcontrib><creatorcontrib>Polzin, Amin</creatorcontrib><creatorcontrib>Perings, Stefan</creatorcontrib><creatorcontrib>Kelm, Malte</creatorcontrib><creatorcontrib>Wolff, Georg</creatorcontrib><title>Patent foramen ovale closure or medical therapy for cryptogenic ischemic stroke: an updated meta-analysis of randomized controlled trials</title><title>Clinical research in cardiology</title><addtitle>Clin Res Cardiol</addtitle><addtitle>Clin Res Cardiol</addtitle><description>Background
Previous randomized controlled trials (RCT) failed to demonstrate benefits of patent foramen ovale (PFO) closure (PFO-C) over medical therapy (MT) for secondary prevention of cryptogenic ischemic stroke. Three recently published RCTs, however, turned out positive for PFO-C and warrant an updated meta-analysis.
Methods
Data from all available RCTs on PFO-C vs. MT for secondary prevention of cryptogenic ischemic stroke up until October 2017 were abstracted and analyzed in a comprehensive meta-analysis. Clinical efficacy outcomes were recurrent stroke, recurrent TIA, and their combination; safety outcomes were mortality, major bleeding, venous thromboembolism (VTE), and new-onset atrial fibrillation/flutter (NOAF).
Results
Five trials including a total of 3440 patients were included in the meta-analysis. PFO-C significantly reduced recurrent stroke [odds ratio (OR) 0.41, 95% confidence interval (CI) 0.19–0.90;
p
= 0.03] and the combination of recurrent stroke + TIA (OR 0.53, CI 0.36–0.80;
p
= 0.002) compared to MT; recurrent TIA alone showed no differences (OR 0.77; CI 0.51–1.14;
p
= 0.19). NOAF was significantly more frequent after PFO-C (OR 5.75, CI 3.09–10.70;
p
< 0.00001). Mortality (OR 0.80, CI 0.39–1.67), major bleeding (OR 0.96, CI 0.48–1.92), and VTE (OR 2.45, CI 0.75–7.99) remained neutral. Trials with superior patient selection for PFO-C showed advantageous results compared to MT.
Conclusions
PFO-C after cryptogenic ischemic stroke is safe and effective to reduce the risk of recurrent stroke and recurrent stroke + TIA, albeit with an increased risk for NOAF.</description><subject>Bleeding</subject><subject>Cardiology</subject><subject>Clinical trials</subject><subject>Confidence intervals</subject><subject>Data processing</subject><subject>Fibrillation</subject><subject>Flutter</subject><subject>Health risk assessment</subject><subject>Health risks</subject><subject>Ischemia</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Meta-analysis</subject><subject>Mortality</subject><subject>Original Paper</subject><subject>Prevention</subject><subject>Randomization</subject><subject>Stroke</subject><subject>Therapy</subject><subject>Thromboembolism</subject><issn>1861-0684</issn><issn>1861-0692</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>BENPR</sourceid><recordid>eNp1kcFu1TAQRS0EoqXwAWyQJTZsQsd2EjvsUAW0UiVYwNpy7Emb4sTBTpBe_4C_7jy9UiSkrmasOfdaM5ex1wLeCwB9WgBUJysQphJS1lX9hB0L04oK2k4-fehNfcRelHID0AhQ9XN2JLuGHq05Zn--uRXnlQ8puwlnnn67iNzHVLaMPGU-YRi9i3y9xuyW3R7kPu-WNV3hPHo-Fn-NEzVlzeknfuBu5tsSyDWQdnWVm13clbHwNPDs5pCm8ZZmPs0kiJHaNY8ulpfs2UAFX93XE_bj86fvZ-fV5dcvF2cfLyuvtFyrQSsI3hgYjJTOmdDRSj1IJUEO3dAFUXd6QAQHfaPbIPpOIRowKrRKNL06Ye8OvktOvzYsq51oB4zRzZi2YiXQkbQUShP69j_0Jm2Z9tlT0OlWq0YRJQ6Uz6mUjINd8ji5vLMC7D4ne8jJUk52n5OtSfPm3nnr6cIPir_BECAPQKHRfIX539ePu94BboafNw</recordid><startdate>20180901</startdate><enddate>20180901</enddate><creator>Schulze, Volker</creator><creator>Lin, Yingfeng</creator><creator>Karathanos, Athanasios</creator><creator>Brockmeyer, Maximilian</creator><creator>Zeus, Tobias</creator><creator>Polzin, Amin</creator><creator>Perings, Stefan</creator><creator>Kelm, Malte</creator><creator>Wolff, Georg</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M7Z</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-1734-6177</orcidid></search><sort><creationdate>20180901</creationdate><title>Patent foramen ovale closure or medical therapy for cryptogenic ischemic stroke: an updated meta-analysis of randomized controlled trials</title><author>Schulze, Volker ; Lin, Yingfeng ; Karathanos, Athanasios ; Brockmeyer, Maximilian ; Zeus, Tobias ; Polzin, Amin ; Perings, Stefan ; Kelm, Malte ; Wolff, Georg</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c372t-f730dc880f822aa8d9034b023202f9f9d1497fee0a0b576d1b93ee8083d6315b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Bleeding</topic><topic>Cardiology</topic><topic>Clinical trials</topic><topic>Confidence intervals</topic><topic>Data processing</topic><topic>Fibrillation</topic><topic>Flutter</topic><topic>Health risk assessment</topic><topic>Health risks</topic><topic>Ischemia</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Meta-analysis</topic><topic>Mortality</topic><topic>Original Paper</topic><topic>Prevention</topic><topic>Randomization</topic><topic>Stroke</topic><topic>Therapy</topic><topic>Thromboembolism</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Schulze, Volker</creatorcontrib><creatorcontrib>Lin, Yingfeng</creatorcontrib><creatorcontrib>Karathanos, Athanasios</creatorcontrib><creatorcontrib>Brockmeyer, Maximilian</creatorcontrib><creatorcontrib>Zeus, Tobias</creatorcontrib><creatorcontrib>Polzin, Amin</creatorcontrib><creatorcontrib>Perings, Stefan</creatorcontrib><creatorcontrib>Kelm, Malte</creatorcontrib><creatorcontrib>Wolff, Georg</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biochemistry Abstracts 1</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical research in cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Schulze, Volker</au><au>Lin, Yingfeng</au><au>Karathanos, Athanasios</au><au>Brockmeyer, Maximilian</au><au>Zeus, Tobias</au><au>Polzin, Amin</au><au>Perings, Stefan</au><au>Kelm, Malte</au><au>Wolff, Georg</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Patent foramen ovale closure or medical therapy for cryptogenic ischemic stroke: an updated meta-analysis of randomized controlled trials</atitle><jtitle>Clinical research in cardiology</jtitle><stitle>Clin Res Cardiol</stitle><addtitle>Clin Res Cardiol</addtitle><date>2018-09-01</date><risdate>2018</risdate><volume>107</volume><issue>9</issue><spage>745</spage><epage>755</epage><pages>745-755</pages><issn>1861-0684</issn><eissn>1861-0692</eissn><abstract>Background
Previous randomized controlled trials (RCT) failed to demonstrate benefits of patent foramen ovale (PFO) closure (PFO-C) over medical therapy (MT) for secondary prevention of cryptogenic ischemic stroke. Three recently published RCTs, however, turned out positive for PFO-C and warrant an updated meta-analysis.
Methods
Data from all available RCTs on PFO-C vs. MT for secondary prevention of cryptogenic ischemic stroke up until October 2017 were abstracted and analyzed in a comprehensive meta-analysis. Clinical efficacy outcomes were recurrent stroke, recurrent TIA, and their combination; safety outcomes were mortality, major bleeding, venous thromboembolism (VTE), and new-onset atrial fibrillation/flutter (NOAF).
Results
Five trials including a total of 3440 patients were included in the meta-analysis. PFO-C significantly reduced recurrent stroke [odds ratio (OR) 0.41, 95% confidence interval (CI) 0.19–0.90;
p
= 0.03] and the combination of recurrent stroke + TIA (OR 0.53, CI 0.36–0.80;
p
= 0.002) compared to MT; recurrent TIA alone showed no differences (OR 0.77; CI 0.51–1.14;
p
= 0.19). NOAF was significantly more frequent after PFO-C (OR 5.75, CI 3.09–10.70;
p
< 0.00001). Mortality (OR 0.80, CI 0.39–1.67), major bleeding (OR 0.96, CI 0.48–1.92), and VTE (OR 2.45, CI 0.75–7.99) remained neutral. Trials with superior patient selection for PFO-C showed advantageous results compared to MT.
Conclusions
PFO-C after cryptogenic ischemic stroke is safe and effective to reduce the risk of recurrent stroke and recurrent stroke + TIA, albeit with an increased risk for NOAF.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>29500568</pmid><doi>10.1007/s00392-018-1224-4</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-1734-6177</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1861-0684 |
| ispartof | Clinical research in cardiology, 2018-09, Vol.107 (9), p.745-755 |
| issn | 1861-0684 1861-0692 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2010372137 |
| source | SpringerLink Journals |
| subjects | Bleeding Cardiology Clinical trials Confidence intervals Data processing Fibrillation Flutter Health risk assessment Health risks Ischemia Medicine Medicine & Public Health Meta-analysis Mortality Original Paper Prevention Randomization Stroke Therapy Thromboembolism |
| title | Patent foramen ovale closure or medical therapy for cryptogenic ischemic stroke: an updated meta-analysis of randomized controlled trials |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-09T07%3A19%3A46IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Patent%20foramen%20ovale%20closure%20or%20medical%20therapy%20for%20cryptogenic%20ischemic%20stroke:%20an%20updated%20meta-analysis%20of%20randomized%20controlled%20trials&rft.jtitle=Clinical%20research%20in%20cardiology&rft.au=Schulze,%20Volker&rft.date=2018-09-01&rft.volume=107&rft.issue=9&rft.spage=745&rft.epage=755&rft.pages=745-755&rft.issn=1861-0684&rft.eissn=1861-0692&rft_id=info:doi/10.1007/s00392-018-1224-4&rft_dat=%3Cproquest_cross%3E2009767353%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2009767353&rft_id=info:pmid/29500568&rfr_iscdi=true |