Safety of Simultaneous Coronary Artery Bypass Grafting and Carotid Endarterectomy Versus Isolated Coronary Artery Bypass Grafting: A Randomized Clinical Trial
BACKGROUND AND PURPOSE—The optimal operative strategy in patients with severe carotid artery disease undergoing coronary artery bypass grafting (CABG) is unknown. We sought to investigate the safety and efficacy of synchronous combined carotid endarterectomy and CABG as compared with isolated CABG....
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| creator | Weimar, Christian Bilbilis, Konstantinos Rekowski, Jan Holst, Torulv Beyersdorf, Friedhelm Breuer, Martin Dahm, Manfred Diegeler, Anno Kowalski, Arne Martens, Sven Mohr, Friedrich W Ondrášek, Jiri Reiter, Beate Roth, Peter Seipelt, Ralf Siggelkow, Markus Steinhoff, Gustav Moritz, Anton Wilhelmi, Mathias Wimmer-Greinecker, Gerhard Diener, Hans-Christoph Jakob, Heinz Ose, Claudia Scherag, Andre Knipp, Stephan C |
| description | BACKGROUND AND PURPOSE—The optimal operative strategy in patients with severe carotid artery disease undergoing coronary artery bypass grafting (CABG) is unknown. We sought to investigate the safety and efficacy of synchronous combined carotid endarterectomy and CABG as compared with isolated CABG.
METHODS—Patients with asymptomatic high-grade carotid artery stenosis ≥80% according to ECST (European Carotid Surgery Trial) ultrasound criteria (corresponding to ≥70% NASCET [North American Symptomatic Carotid Endarterectomy Trial]) who required CABG surgery were randomly assigned to synchronous carotid endarterectomy+CABG or isolated CABG. To avoid unbalanced prognostic factor distributions, randomization was stratified by center, age, sex, and modified Rankin Scale. The primary composite end point was the rate of stroke or death at 30 days.
RESULTS—From 2010 to 2014, a total of 129 patients were enrolled at 17 centers in Germany and the Czech Republic. Because of withdrawal of funding after insufficient recruitment, enrolment was terminated early. At 30 days, the rate of any stroke or death in the intention-to-treat population was 12/65 (18.5%) in patients receiving synchronous carotid endarterectomy+CABG as compared with 6/62 (9.7%) in patients receiving isolated CABG (absolute risk reduction, 8.8%; 95% confidence interval, −3.2% to 20.8%; PWALD=0.12). Also for all secondary end points at 30 days and 1 year, there was no evidence for a significant treatment-group effect although patients undergoing isolated CABG tended to have better outcomes.
CONCLUSIONS—Although our results cannot rule out a treatment-group effect because of lack of power, a superiority of the synchronous combined carotid endarterectomy+CABG approach seems unlikely. Five-year follow-up of patients is still ongoing.
CLINICAL TRIAL REGISTRATION—URLhttps://www.controlled-trials.com. Unique identifierISRCTN13486906.Stroke is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution License (CC-BY), which permits use, distribution, and reproduction in any medium, provided the original work is properly cited. |
| doi_str_mv | 10.1161/STROKEAHA.117.017570 |
| format | Article |
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METHODS—Patients with asymptomatic high-grade carotid artery stenosis ≥80% according to ECST (European Carotid Surgery Trial) ultrasound criteria (corresponding to ≥70% NASCET [North American Symptomatic Carotid Endarterectomy Trial]) who required CABG surgery were randomly assigned to synchronous carotid endarterectomy+CABG or isolated CABG. To avoid unbalanced prognostic factor distributions, randomization was stratified by center, age, sex, and modified Rankin Scale. The primary composite end point was the rate of stroke or death at 30 days.
RESULTS—From 2010 to 2014, a total of 129 patients were enrolled at 17 centers in Germany and the Czech Republic. Because of withdrawal of funding after insufficient recruitment, enrolment was terminated early. At 30 days, the rate of any stroke or death in the intention-to-treat population was 12/65 (18.5%) in patients receiving synchronous carotid endarterectomy+CABG as compared with 6/62 (9.7%) in patients receiving isolated CABG (absolute risk reduction, 8.8%; 95% confidence interval, −3.2% to 20.8%; PWALD=0.12). Also for all secondary end points at 30 days and 1 year, there was no evidence for a significant treatment-group effect although patients undergoing isolated CABG tended to have better outcomes.
CONCLUSIONS—Although our results cannot rule out a treatment-group effect because of lack of power, a superiority of the synchronous combined carotid endarterectomy+CABG approach seems unlikely. Five-year follow-up of patients is still ongoing.
CLINICAL TRIAL REGISTRATION—URLhttps://www.controlled-trials.com. Unique identifierISRCTN13486906.Stroke is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution License (CC-BY), which permits use, distribution, and reproduction in any medium, provided the original work is properly cited.</description><identifier>ISSN: 0039-2499</identifier><identifier>EISSN: 1524-4628</identifier><identifier>DOI: 10.1161/STROKEAHA.117.017570</identifier><identifier>PMID: 28916664</identifier><language>eng</language><publisher>United States: American Heart Association, Inc</publisher><subject>Aged ; Carotid Stenosis - diagnosis ; Carotid Stenosis - epidemiology ; Carotid Stenosis - surgery ; Coronary Artery Bypass - adverse effects ; Coronary Artery Bypass - standards ; Endarterectomy, Carotid - adverse effects ; Endarterectomy, Carotid - standards ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Original Contributions ; Patient Safety - standards ; Treatment Outcome</subject><ispartof>Stroke (1970), 2017-10, Vol.48 (10), p.2769-2775</ispartof><rights>2017 American Heart Association, Inc.</rights><rights>Copyright © 2017 The Author(s).</rights><rights>Copyright © 2017 The Author(s). 2017</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3600-b0b798b9beccfb2c6ac6432995327c30241f3559e54b2ee549581dcc1faf3d573</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,3674,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28916664$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Weimar, Christian</creatorcontrib><creatorcontrib>Bilbilis, Konstantinos</creatorcontrib><creatorcontrib>Rekowski, Jan</creatorcontrib><creatorcontrib>Holst, Torulv</creatorcontrib><creatorcontrib>Beyersdorf, Friedhelm</creatorcontrib><creatorcontrib>Breuer, Martin</creatorcontrib><creatorcontrib>Dahm, Manfred</creatorcontrib><creatorcontrib>Diegeler, Anno</creatorcontrib><creatorcontrib>Kowalski, Arne</creatorcontrib><creatorcontrib>Martens, Sven</creatorcontrib><creatorcontrib>Mohr, Friedrich W</creatorcontrib><creatorcontrib>Ondrášek, Jiri</creatorcontrib><creatorcontrib>Reiter, Beate</creatorcontrib><creatorcontrib>Roth, Peter</creatorcontrib><creatorcontrib>Seipelt, Ralf</creatorcontrib><creatorcontrib>Siggelkow, Markus</creatorcontrib><creatorcontrib>Steinhoff, Gustav</creatorcontrib><creatorcontrib>Moritz, Anton</creatorcontrib><creatorcontrib>Wilhelmi, Mathias</creatorcontrib><creatorcontrib>Wimmer-Greinecker, Gerhard</creatorcontrib><creatorcontrib>Diener, Hans-Christoph</creatorcontrib><creatorcontrib>Jakob, Heinz</creatorcontrib><creatorcontrib>Ose, Claudia</creatorcontrib><creatorcontrib>Scherag, Andre</creatorcontrib><creatorcontrib>Knipp, Stephan C</creatorcontrib><creatorcontrib>CABACS Trial Investigators</creatorcontrib><title>Safety of Simultaneous Coronary Artery Bypass Grafting and Carotid Endarterectomy Versus Isolated Coronary Artery Bypass Grafting: A Randomized Clinical Trial</title><title>Stroke (1970)</title><addtitle>Stroke</addtitle><description>BACKGROUND AND PURPOSE—The optimal operative strategy in patients with severe carotid artery disease undergoing coronary artery bypass grafting (CABG) is unknown. We sought to investigate the safety and efficacy of synchronous combined carotid endarterectomy and CABG as compared with isolated CABG.
METHODS—Patients with asymptomatic high-grade carotid artery stenosis ≥80% according to ECST (European Carotid Surgery Trial) ultrasound criteria (corresponding to ≥70% NASCET [North American Symptomatic Carotid Endarterectomy Trial]) who required CABG surgery were randomly assigned to synchronous carotid endarterectomy+CABG or isolated CABG. To avoid unbalanced prognostic factor distributions, randomization was stratified by center, age, sex, and modified Rankin Scale. The primary composite end point was the rate of stroke or death at 30 days.
RESULTS—From 2010 to 2014, a total of 129 patients were enrolled at 17 centers in Germany and the Czech Republic. Because of withdrawal of funding after insufficient recruitment, enrolment was terminated early. At 30 days, the rate of any stroke or death in the intention-to-treat population was 12/65 (18.5%) in patients receiving synchronous carotid endarterectomy+CABG as compared with 6/62 (9.7%) in patients receiving isolated CABG (absolute risk reduction, 8.8%; 95% confidence interval, −3.2% to 20.8%; PWALD=0.12). Also for all secondary end points at 30 days and 1 year, there was no evidence for a significant treatment-group effect although patients undergoing isolated CABG tended to have better outcomes.
CONCLUSIONS—Although our results cannot rule out a treatment-group effect because of lack of power, a superiority of the synchronous combined carotid endarterectomy+CABG approach seems unlikely. Five-year follow-up of patients is still ongoing.
CLINICAL TRIAL REGISTRATION—URLhttps://www.controlled-trials.com. Unique identifierISRCTN13486906.Stroke is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution License (CC-BY), which permits use, distribution, and reproduction in any medium, provided the original work is properly cited.</description><subject>Aged</subject><subject>Carotid Stenosis - diagnosis</subject><subject>Carotid Stenosis - epidemiology</subject><subject>Carotid Stenosis - surgery</subject><subject>Coronary Artery Bypass - adverse effects</subject><subject>Coronary Artery Bypass - standards</subject><subject>Endarterectomy, Carotid - adverse effects</subject><subject>Endarterectomy, Carotid - standards</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Original Contributions</subject><subject>Patient Safety - standards</subject><subject>Treatment Outcome</subject><issn>0039-2499</issn><issn>1524-4628</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkdFuFCEUhonR2G31DYzh0pupwAAzeGEybta2sUmT7uotYRimizLDCozN9mF8VtlM3eiN3nBC-M7HyfkBeIXROcYcv11vbm8-rZrLJl-rc4QrVqEnYIEZoQXlpH4KFgiVoiBUiBNwGuNXhBApa_YcnJBaYM45XYCfa9WbtIe-h2s7TC6p0fgpwqUPflRhD5uQTC4f9jsVI7wIqk92vINq7OBSBZ9sB1djpw6U0ckPe_jFhJgNV9E7lUz3P9U72MDbrPODfTjQzo5WKwc3wSr3AjzrlYvm5WM9A58_rjbLy-L65uJq2VwXuuQIFS1qK1G3ojVa9y3RXGlOSyIEK0mlS0Qo7kvGhGG0JSafgtW40xr3qi87VpVn4P3s3U3tYDptxhSUk7tghzy59MrKv19Gu5V3_odkHCPGURa8eRQE_30yMcnBRm2cm_cpsaAIMUIYzSidUR18jMH0x28wkodo5THafK3kHG1ue_3niMem31lmoJ6Be-_youM3N92bILdGubT9t_sXJ9W2oA</recordid><startdate>20171001</startdate><enddate>20171001</enddate><creator>Weimar, Christian</creator><creator>Bilbilis, Konstantinos</creator><creator>Rekowski, Jan</creator><creator>Holst, Torulv</creator><creator>Beyersdorf, Friedhelm</creator><creator>Breuer, Martin</creator><creator>Dahm, Manfred</creator><creator>Diegeler, Anno</creator><creator>Kowalski, Arne</creator><creator>Martens, Sven</creator><creator>Mohr, Friedrich W</creator><creator>Ondrášek, Jiri</creator><creator>Reiter, Beate</creator><creator>Roth, Peter</creator><creator>Seipelt, Ralf</creator><creator>Siggelkow, Markus</creator><creator>Steinhoff, Gustav</creator><creator>Moritz, Anton</creator><creator>Wilhelmi, Mathias</creator><creator>Wimmer-Greinecker, Gerhard</creator><creator>Diener, Hans-Christoph</creator><creator>Jakob, Heinz</creator><creator>Ose, Claudia</creator><creator>Scherag, Andre</creator><creator>Knipp, Stephan C</creator><general>American Heart Association, Inc</general><general>Lippincott Williams & Wilkins</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><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20171001</creationdate><title>Safety of Simultaneous Coronary Artery Bypass Grafting and Carotid Endarterectomy Versus Isolated Coronary Artery Bypass Grafting: A Randomized Clinical Trial</title><author>Weimar, Christian ; Bilbilis, Konstantinos ; Rekowski, Jan ; Holst, Torulv ; Beyersdorf, Friedhelm ; Breuer, Martin ; Dahm, Manfred ; Diegeler, Anno ; Kowalski, Arne ; Martens, Sven ; Mohr, Friedrich W ; Ondrášek, Jiri ; Reiter, Beate ; Roth, Peter ; Seipelt, Ralf ; Siggelkow, Markus ; Steinhoff, Gustav ; Moritz, Anton ; Wilhelmi, Mathias ; Wimmer-Greinecker, Gerhard ; Diener, Hans-Christoph ; Jakob, Heinz ; Ose, Claudia ; Scherag, Andre ; Knipp, Stephan C</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3600-b0b798b9beccfb2c6ac6432995327c30241f3559e54b2ee549581dcc1faf3d573</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Aged</topic><topic>Carotid Stenosis - diagnosis</topic><topic>Carotid Stenosis - epidemiology</topic><topic>Carotid Stenosis - surgery</topic><topic>Coronary Artery Bypass - adverse effects</topic><topic>Coronary Artery Bypass - standards</topic><topic>Endarterectomy, Carotid - adverse effects</topic><topic>Endarterectomy, Carotid - standards</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Original Contributions</topic><topic>Patient Safety - standards</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Weimar, Christian</creatorcontrib><creatorcontrib>Bilbilis, Konstantinos</creatorcontrib><creatorcontrib>Rekowski, Jan</creatorcontrib><creatorcontrib>Holst, Torulv</creatorcontrib><creatorcontrib>Beyersdorf, Friedhelm</creatorcontrib><creatorcontrib>Breuer, Martin</creatorcontrib><creatorcontrib>Dahm, Manfred</creatorcontrib><creatorcontrib>Diegeler, Anno</creatorcontrib><creatorcontrib>Kowalski, Arne</creatorcontrib><creatorcontrib>Martens, Sven</creatorcontrib><creatorcontrib>Mohr, Friedrich W</creatorcontrib><creatorcontrib>Ondrášek, Jiri</creatorcontrib><creatorcontrib>Reiter, Beate</creatorcontrib><creatorcontrib>Roth, Peter</creatorcontrib><creatorcontrib>Seipelt, Ralf</creatorcontrib><creatorcontrib>Siggelkow, Markus</creatorcontrib><creatorcontrib>Steinhoff, Gustav</creatorcontrib><creatorcontrib>Moritz, Anton</creatorcontrib><creatorcontrib>Wilhelmi, Mathias</creatorcontrib><creatorcontrib>Wimmer-Greinecker, Gerhard</creatorcontrib><creatorcontrib>Diener, Hans-Christoph</creatorcontrib><creatorcontrib>Jakob, Heinz</creatorcontrib><creatorcontrib>Ose, Claudia</creatorcontrib><creatorcontrib>Scherag, Andre</creatorcontrib><creatorcontrib>Knipp, Stephan C</creatorcontrib><creatorcontrib>CABACS Trial Investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Stroke (1970)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Weimar, Christian</au><au>Bilbilis, Konstantinos</au><au>Rekowski, Jan</au><au>Holst, Torulv</au><au>Beyersdorf, Friedhelm</au><au>Breuer, Martin</au><au>Dahm, Manfred</au><au>Diegeler, Anno</au><au>Kowalski, Arne</au><au>Martens, Sven</au><au>Mohr, Friedrich W</au><au>Ondrášek, Jiri</au><au>Reiter, Beate</au><au>Roth, Peter</au><au>Seipelt, Ralf</au><au>Siggelkow, Markus</au><au>Steinhoff, Gustav</au><au>Moritz, Anton</au><au>Wilhelmi, Mathias</au><au>Wimmer-Greinecker, Gerhard</au><au>Diener, Hans-Christoph</au><au>Jakob, Heinz</au><au>Ose, Claudia</au><au>Scherag, Andre</au><au>Knipp, Stephan C</au><aucorp>CABACS Trial Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety of Simultaneous Coronary Artery Bypass Grafting and Carotid Endarterectomy Versus Isolated Coronary Artery Bypass Grafting: A Randomized Clinical Trial</atitle><jtitle>Stroke (1970)</jtitle><addtitle>Stroke</addtitle><date>2017-10-01</date><risdate>2017</risdate><volume>48</volume><issue>10</issue><spage>2769</spage><epage>2775</epage><pages>2769-2775</pages><issn>0039-2499</issn><eissn>1524-4628</eissn><abstract>BACKGROUND AND PURPOSE—The optimal operative strategy in patients with severe carotid artery disease undergoing coronary artery bypass grafting (CABG) is unknown. We sought to investigate the safety and efficacy of synchronous combined carotid endarterectomy and CABG as compared with isolated CABG.
METHODS—Patients with asymptomatic high-grade carotid artery stenosis ≥80% according to ECST (European Carotid Surgery Trial) ultrasound criteria (corresponding to ≥70% NASCET [North American Symptomatic Carotid Endarterectomy Trial]) who required CABG surgery were randomly assigned to synchronous carotid endarterectomy+CABG or isolated CABG. To avoid unbalanced prognostic factor distributions, randomization was stratified by center, age, sex, and modified Rankin Scale. The primary composite end point was the rate of stroke or death at 30 days.
RESULTS—From 2010 to 2014, a total of 129 patients were enrolled at 17 centers in Germany and the Czech Republic. Because of withdrawal of funding after insufficient recruitment, enrolment was terminated early. At 30 days, the rate of any stroke or death in the intention-to-treat population was 12/65 (18.5%) in patients receiving synchronous carotid endarterectomy+CABG as compared with 6/62 (9.7%) in patients receiving isolated CABG (absolute risk reduction, 8.8%; 95% confidence interval, −3.2% to 20.8%; PWALD=0.12). Also for all secondary end points at 30 days and 1 year, there was no evidence for a significant treatment-group effect although patients undergoing isolated CABG tended to have better outcomes.
CONCLUSIONS—Although our results cannot rule out a treatment-group effect because of lack of power, a superiority of the synchronous combined carotid endarterectomy+CABG approach seems unlikely. Five-year follow-up of patients is still ongoing.
CLINICAL TRIAL REGISTRATION—URLhttps://www.controlled-trials.com. Unique identifierISRCTN13486906.Stroke is published on behalf of the American Heart Association, Inc., by Wolters Kluwer Health, Inc. This is an open access article under the terms of the Creative Commons Attribution License (CC-BY), which permits use, distribution, and reproduction in any medium, provided the original work is properly cited.</abstract><cop>United States</cop><pub>American Heart Association, Inc</pub><pmid>28916664</pmid><doi>10.1161/STROKEAHA.117.017570</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; American Heart Association Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection; Journals@Ovid Complete |
| subjects | Aged Carotid Stenosis - diagnosis Carotid Stenosis - epidemiology Carotid Stenosis - surgery Coronary Artery Bypass - adverse effects Coronary Artery Bypass - standards Endarterectomy, Carotid - adverse effects Endarterectomy, Carotid - standards Female Follow-Up Studies Humans Male Middle Aged Original Contributions Patient Safety - standards Treatment Outcome |
| title | Safety of Simultaneous Coronary Artery Bypass Grafting and Carotid Endarterectomy Versus Isolated Coronary Artery Bypass Grafting: A Randomized Clinical Trial |
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