COMPARE LAAO: Rationale and design of the randomized controlled trial “COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy”
Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking. To assess the efficacy a...
Gespeichert in:
| Veröffentlicht in: | The American heart journal 2022-08, Vol.250, p.45-56 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , , , , , , , , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 56 |
|---|---|
| container_issue | |
| container_start_page | 45 |
| container_title | The American heart journal |
| container_volume | 250 |
| creator | Huijboom, Marina Maarse, Moniek Aarnink, Errol van Dijk, Vincent Swaans, Martin van der Heijden, Jeroen IJsselmuiden, Sander Folkeringa, Richard Blaauw, Yuri Elvan, Arif Stevenhagen, Jeroen Vlachojannis, George van der Voort, Pepijn Westra, Sjoerd Chaldoupi, Marisevi Khan, Muchtiar de Groot, Joris van der Kley, Frank van Mieghem, Nicolas van Dijk, Ewoud Dijkgraaf, Marcel Tijssen, Jan Boersma, Lucas |
| description | Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking.
To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications.
This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands.
The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use.
NCT04676880 |
| doi_str_mv | 10.1016/j.ahj.2022.05.001 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2662546188</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0002870322000850</els_id><sourcerecordid>2675209597</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3391-69fb9127dad0c2b80b0dca735eb7d606ebc0a15ff521b08f36bd5f7888f160013</originalsourceid><addsrcrecordid>eNp9ksuO0zAUhgMCMWWYB2CDLLFhk2IntZPAKqrKRSoqGsHacuzj1J00ztjOSGU1DwIvN0-C2xQWLFj5ov__zjVJXhI8J5iwt7u52O7mGc6yOaZzjMnjZEZwVaSsWCyeJDOMcZaWBc4vkufe7-KTZSV7llzklOYFxfns0dVy8-Vrfb1C67revEPXIhjbiw6Q6BVS4E3bI6tR2AJy8cvuzQ9QSNo-ONt18RqcER16uP85gUzfopXWIIO5gx68P4G80BAOR9AadED1ZKqHAXolWkAbKbvRx8goWORDtAinjnIpHCBtHRKTRZvGma47ZYmGeEAfYoiAtqbdRqezNzFR429OYU0PnWlNE8uJ3NEDsi5CRB-MtKIdz5xYnBPD4eH-14vkqRadh6vzeZl8_7D6tvyUrjcfPy_rdSrzvCIpq3RTkaxQQmGZNSVusJKiyCk0hWKYQSOxIFRrmpEGlzpnjaK6KMtSExbHlF8mbybu4OztCD7wvfESYmE92NHzjLGMLhgpyyh9_Y90Z0cXR3RUFTTDFa2KqCKTSjrrvQPNB2f2wh04wfy4K3zH467w465wTPmUxKszeWz2oP46_ixHFLyfBBBbcWfAcS9jwyUo4-KAubLmP_jf5snUiw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2675209597</pqid></control><display><type>article</type><title>COMPARE LAAO: Rationale and design of the randomized controlled trial “COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy”</title><source>ScienceDirect Journals (5 years ago - present)</source><source>ProQuest Central UK/Ireland</source><creator>Huijboom, Marina ; Maarse, Moniek ; Aarnink, Errol ; van Dijk, Vincent ; Swaans, Martin ; van der Heijden, Jeroen ; IJsselmuiden, Sander ; Folkeringa, Richard ; Blaauw, Yuri ; Elvan, Arif ; Stevenhagen, Jeroen ; Vlachojannis, George ; van der Voort, Pepijn ; Westra, Sjoerd ; Chaldoupi, Marisevi ; Khan, Muchtiar ; de Groot, Joris ; van der Kley, Frank ; van Mieghem, Nicolas ; van Dijk, Ewoud ; Dijkgraaf, Marcel ; Tijssen, Jan ; Boersma, Lucas</creator><creatorcontrib>Huijboom, Marina ; Maarse, Moniek ; Aarnink, Errol ; van Dijk, Vincent ; Swaans, Martin ; van der Heijden, Jeroen ; IJsselmuiden, Sander ; Folkeringa, Richard ; Blaauw, Yuri ; Elvan, Arif ; Stevenhagen, Jeroen ; Vlachojannis, George ; van der Voort, Pepijn ; Westra, Sjoerd ; Chaldoupi, Marisevi ; Khan, Muchtiar ; de Groot, Joris ; van der Kley, Frank ; van Mieghem, Nicolas ; van Dijk, Ewoud ; Dijkgraaf, Marcel ; Tijssen, Jan ; Boersma, Lucas</creatorcontrib><description>Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking.
To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications.
This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands.
The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use.
NCT04676880</description><identifier>ISSN: 0002-8703</identifier><identifier>EISSN: 1097-6744</identifier><identifier>DOI: 10.1016/j.ahj.2022.05.001</identifier><identifier>PMID: 35537503</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Anticoagulants ; Blood clots ; Cardiac arrhythmia ; Complications ; Contraindications ; Cost analysis ; Decision analysis ; Decision making ; Design ; Effectiveness ; Embolism ; Fibrillation ; Health risks ; Health services ; Heart surgery ; Hemorrhage ; Impact analysis ; Ischemia ; Occlusion ; Patients ; Population ; Risk ; Safety ; Standard of care ; Stroke ; Therapy ; Thromboembolism ; Transient ischemic attack</subject><ispartof>The American heart journal, 2022-08, Vol.250, p.45-56</ispartof><rights>2022 The Authors</rights><rights>Copyright © 2022. Published by Elsevier Inc.</rights><rights>2022. The Authors</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3391-69fb9127dad0c2b80b0dca735eb7d606ebc0a15ff521b08f36bd5f7888f160013</citedby><cites>FETCH-LOGICAL-c3391-69fb9127dad0c2b80b0dca735eb7d606ebc0a15ff521b08f36bd5f7888f160013</cites><orcidid>0000-0001-8751-3156</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2675209597?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3548,27923,27924,45994,64384,64386,64388,72240</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35537503$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Huijboom, Marina</creatorcontrib><creatorcontrib>Maarse, Moniek</creatorcontrib><creatorcontrib>Aarnink, Errol</creatorcontrib><creatorcontrib>van Dijk, Vincent</creatorcontrib><creatorcontrib>Swaans, Martin</creatorcontrib><creatorcontrib>van der Heijden, Jeroen</creatorcontrib><creatorcontrib>IJsselmuiden, Sander</creatorcontrib><creatorcontrib>Folkeringa, Richard</creatorcontrib><creatorcontrib>Blaauw, Yuri</creatorcontrib><creatorcontrib>Elvan, Arif</creatorcontrib><creatorcontrib>Stevenhagen, Jeroen</creatorcontrib><creatorcontrib>Vlachojannis, George</creatorcontrib><creatorcontrib>van der Voort, Pepijn</creatorcontrib><creatorcontrib>Westra, Sjoerd</creatorcontrib><creatorcontrib>Chaldoupi, Marisevi</creatorcontrib><creatorcontrib>Khan, Muchtiar</creatorcontrib><creatorcontrib>de Groot, Joris</creatorcontrib><creatorcontrib>van der Kley, Frank</creatorcontrib><creatorcontrib>van Mieghem, Nicolas</creatorcontrib><creatorcontrib>van Dijk, Ewoud</creatorcontrib><creatorcontrib>Dijkgraaf, Marcel</creatorcontrib><creatorcontrib>Tijssen, Jan</creatorcontrib><creatorcontrib>Boersma, Lucas</creatorcontrib><title>COMPARE LAAO: Rationale and design of the randomized controlled trial “COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy”</title><title>The American heart journal</title><addtitle>Am Heart J</addtitle><description>Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking.
To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications.
This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands.
The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use.
NCT04676880</description><subject>Anticoagulants</subject><subject>Blood clots</subject><subject>Cardiac arrhythmia</subject><subject>Complications</subject><subject>Contraindications</subject><subject>Cost analysis</subject><subject>Decision analysis</subject><subject>Decision making</subject><subject>Design</subject><subject>Effectiveness</subject><subject>Embolism</subject><subject>Fibrillation</subject><subject>Health risks</subject><subject>Health services</subject><subject>Heart surgery</subject><subject>Hemorrhage</subject><subject>Impact analysis</subject><subject>Ischemia</subject><subject>Occlusion</subject><subject>Patients</subject><subject>Population</subject><subject>Risk</subject><subject>Safety</subject><subject>Standard of care</subject><subject>Stroke</subject><subject>Therapy</subject><subject>Thromboembolism</subject><subject>Transient ischemic attack</subject><issn>0002-8703</issn><issn>1097-6744</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9ksuO0zAUhgMCMWWYB2CDLLFhk2IntZPAKqrKRSoqGsHacuzj1J00ztjOSGU1DwIvN0-C2xQWLFj5ov__zjVJXhI8J5iwt7u52O7mGc6yOaZzjMnjZEZwVaSsWCyeJDOMcZaWBc4vkufe7-KTZSV7llzklOYFxfns0dVy8-Vrfb1C67revEPXIhjbiw6Q6BVS4E3bI6tR2AJy8cvuzQ9QSNo-ONt18RqcER16uP85gUzfopXWIIO5gx68P4G80BAOR9AadED1ZKqHAXolWkAbKbvRx8goWORDtAinjnIpHCBtHRKTRZvGma47ZYmGeEAfYoiAtqbdRqezNzFR429OYU0PnWlNE8uJ3NEDsi5CRB-MtKIdz5xYnBPD4eH-14vkqRadh6vzeZl8_7D6tvyUrjcfPy_rdSrzvCIpq3RTkaxQQmGZNSVusJKiyCk0hWKYQSOxIFRrmpEGlzpnjaK6KMtSExbHlF8mbybu4OztCD7wvfESYmE92NHzjLGMLhgpyyh9_Y90Z0cXR3RUFTTDFa2KqCKTSjrrvQPNB2f2wh04wfy4K3zH467w465wTPmUxKszeWz2oP46_ixHFLyfBBBbcWfAcS9jwyUo4-KAubLmP_jf5snUiw</recordid><startdate>20220801</startdate><enddate>20220801</enddate><creator>Huijboom, Marina</creator><creator>Maarse, Moniek</creator><creator>Aarnink, Errol</creator><creator>van Dijk, Vincent</creator><creator>Swaans, Martin</creator><creator>van der Heijden, Jeroen</creator><creator>IJsselmuiden, Sander</creator><creator>Folkeringa, Richard</creator><creator>Blaauw, Yuri</creator><creator>Elvan, Arif</creator><creator>Stevenhagen, Jeroen</creator><creator>Vlachojannis, George</creator><creator>van der Voort, Pepijn</creator><creator>Westra, Sjoerd</creator><creator>Chaldoupi, Marisevi</creator><creator>Khan, Muchtiar</creator><creator>de Groot, Joris</creator><creator>van der Kley, Frank</creator><creator>van Mieghem, Nicolas</creator><creator>van Dijk, Ewoud</creator><creator>Dijkgraaf, Marcel</creator><creator>Tijssen, Jan</creator><creator>Boersma, Lucas</creator><general>Elsevier Inc</general><general>Elsevier Limited</general><scope>6I.</scope><scope>AAFTH</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QO</scope><scope>7RV</scope><scope>7TS</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>P64</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-8751-3156</orcidid></search><sort><creationdate>20220801</creationdate><title>COMPARE LAAO: Rationale and design of the randomized controlled trial “COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy”</title><author>Huijboom, Marina ; Maarse, Moniek ; Aarnink, Errol ; van Dijk, Vincent ; Swaans, Martin ; van der Heijden, Jeroen ; IJsselmuiden, Sander ; Folkeringa, Richard ; Blaauw, Yuri ; Elvan, Arif ; Stevenhagen, Jeroen ; Vlachojannis, George ; van der Voort, Pepijn ; Westra, Sjoerd ; Chaldoupi, Marisevi ; Khan, Muchtiar ; de Groot, Joris ; van der Kley, Frank ; van Mieghem, Nicolas ; van Dijk, Ewoud ; Dijkgraaf, Marcel ; Tijssen, Jan ; Boersma, Lucas</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3391-69fb9127dad0c2b80b0dca735eb7d606ebc0a15ff521b08f36bd5f7888f160013</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Anticoagulants</topic><topic>Blood clots</topic><topic>Cardiac arrhythmia</topic><topic>Complications</topic><topic>Contraindications</topic><topic>Cost analysis</topic><topic>Decision analysis</topic><topic>Decision making</topic><topic>Design</topic><topic>Effectiveness</topic><topic>Embolism</topic><topic>Fibrillation</topic><topic>Health risks</topic><topic>Health services</topic><topic>Heart surgery</topic><topic>Hemorrhage</topic><topic>Impact analysis</topic><topic>Ischemia</topic><topic>Occlusion</topic><topic>Patients</topic><topic>Population</topic><topic>Risk</topic><topic>Safety</topic><topic>Standard of care</topic><topic>Stroke</topic><topic>Therapy</topic><topic>Thromboembolism</topic><topic>Transient ischemic attack</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Huijboom, Marina</creatorcontrib><creatorcontrib>Maarse, Moniek</creatorcontrib><creatorcontrib>Aarnink, Errol</creatorcontrib><creatorcontrib>van Dijk, Vincent</creatorcontrib><creatorcontrib>Swaans, Martin</creatorcontrib><creatorcontrib>van der Heijden, Jeroen</creatorcontrib><creatorcontrib>IJsselmuiden, Sander</creatorcontrib><creatorcontrib>Folkeringa, Richard</creatorcontrib><creatorcontrib>Blaauw, Yuri</creatorcontrib><creatorcontrib>Elvan, Arif</creatorcontrib><creatorcontrib>Stevenhagen, Jeroen</creatorcontrib><creatorcontrib>Vlachojannis, George</creatorcontrib><creatorcontrib>van der Voort, Pepijn</creatorcontrib><creatorcontrib>Westra, Sjoerd</creatorcontrib><creatorcontrib>Chaldoupi, Marisevi</creatorcontrib><creatorcontrib>Khan, Muchtiar</creatorcontrib><creatorcontrib>de Groot, Joris</creatorcontrib><creatorcontrib>van der Kley, Frank</creatorcontrib><creatorcontrib>van Mieghem, Nicolas</creatorcontrib><creatorcontrib>van Dijk, Ewoud</creatorcontrib><creatorcontrib>Dijkgraaf, Marcel</creatorcontrib><creatorcontrib>Tijssen, Jan</creatorcontrib><creatorcontrib>Boersma, Lucas</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</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>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</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>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>The American heart journal</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Huijboom, Marina</au><au>Maarse, Moniek</au><au>Aarnink, Errol</au><au>van Dijk, Vincent</au><au>Swaans, Martin</au><au>van der Heijden, Jeroen</au><au>IJsselmuiden, Sander</au><au>Folkeringa, Richard</au><au>Blaauw, Yuri</au><au>Elvan, Arif</au><au>Stevenhagen, Jeroen</au><au>Vlachojannis, George</au><au>van der Voort, Pepijn</au><au>Westra, Sjoerd</au><au>Chaldoupi, Marisevi</au><au>Khan, Muchtiar</au><au>de Groot, Joris</au><au>van der Kley, Frank</au><au>van Mieghem, Nicolas</au><au>van Dijk, Ewoud</au><au>Dijkgraaf, Marcel</au><au>Tijssen, Jan</au><au>Boersma, Lucas</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>COMPARE LAAO: Rationale and design of the randomized controlled trial “COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy”</atitle><jtitle>The American heart journal</jtitle><addtitle>Am Heart J</addtitle><date>2022-08-01</date><risdate>2022</risdate><volume>250</volume><spage>45</spage><epage>56</epage><pages>45-56</pages><issn>0002-8703</issn><eissn>1097-6744</eissn><abstract>Left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for stroke prevention in patients with atrial fibrillation (AF). In patients with a long-term or permanent contraindication for OAC randomized controlled trial (RCT) data is lacking.
To assess the efficacy and safety of LAAO in AF patients who are ineligible to use OAC. The co-primary efficacy endpoint is (1) time to first occurrence of stroke (ischemic, hemorrhagic, or undetermined) and (2) time to first occurrence of the composite of stroke, transient ischemic attack (TIA), and systemic embolism (SE). The primary safety endpoint is the 30-day rate of peri-procedural complications.
This is a multicenter, investigator-initiated, open-label, blinded endpoint (PROBE), superiority-driven RCT. Patients with AF, a CHA₂DS₂-VASc score ≥2 for men and ≥3 for women and a long-term or permanent contraindication for OAC will be randomized in a 2:1 fashion to the device- or control arm. Patients in the device arm will undergo percutaneous LAAO and will receive post-procedural dual antiplatelet therapy (DAPT) per protocol, while those in the control arm will continue their current treatment consisting of no antithrombotic therapy or (D)APT as deemed appropriate by the primary responsible physician. In this endpoint-driven trial design, assuming a 50% lower stroke risk of LAAO compared to conservative treatment, 609 patients will be followed for a minimum of 1 and a maximum of 5 years. Cost-effectiveness and budget impact analyses will be performed to allow decision-making on reimbursement of LAAO for the target population in the Netherlands.
The COMPARE LAAO trial will investigate the clinical superiority in preventing thromboembolic events and cost-effectiveness of LAAO in AF patients with a high thromboembolic risk and a contraindication for OAC use.
NCT04676880</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>35537503</pmid><doi>10.1016/j.ahj.2022.05.001</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0001-8751-3156</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0002-8703 |
| ispartof | The American heart journal, 2022-08, Vol.250, p.45-56 |
| issn | 0002-8703 1097-6744 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2662546188 |
| source | ScienceDirect Journals (5 years ago - present); ProQuest Central UK/Ireland |
| subjects | Anticoagulants Blood clots Cardiac arrhythmia Complications Contraindications Cost analysis Decision analysis Decision making Design Effectiveness Embolism Fibrillation Health risks Health services Heart surgery Hemorrhage Impact analysis Ischemia Occlusion Patients Population Risk Safety Standard of care Stroke Therapy Thromboembolism Transient ischemic attack |
| title | COMPARE LAAO: Rationale and design of the randomized controlled trial “COMPARing Effectiveness and safety of Left Atrial Appendage Occlusion to standard of care for atrial fibrillation patients at high stroke risk and ineligible to use oral anticoagulation therapy” |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-11T06%3A29%3A47IST&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=COMPARE%20LAAO:%20Rationale%20and%20design%20of%20the%20randomized%20controlled%20trial%20%E2%80%9CCOMPARing%20Effectiveness%20and%20safety%20of%20Left%20Atrial%20Appendage%20Occlusion%20to%20standard%20of%20care%20for%20atrial%20fibrillation%20patients%20at%20high%20stroke%20risk%20and%20ineligible%20to%20use%20oral%20anticoagulation%20therapy%E2%80%9D&rft.jtitle=The%20American%20heart%20journal&rft.au=Huijboom,%20Marina&rft.date=2022-08-01&rft.volume=250&rft.spage=45&rft.epage=56&rft.pages=45-56&rft.issn=0002-8703&rft.eissn=1097-6744&rft_id=info:doi/10.1016/j.ahj.2022.05.001&rft_dat=%3Cproquest_cross%3E2675209597%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=2675209597&rft_id=info:pmid/35537503&rft_els_id=S0002870322000850&rfr_iscdi=true |