Safety of Simultaneous Coronary Artery Bypass Grafting and Carotid Endarterectomy Versus Isolated Coronary Artery Bypass Grafting: A Randomized Clinical Trial
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Safety of Simultaneous Coronary Artery Bypass Grafting and Carotid Endarterectomy Versus Isolated Coronary Artery Bypass Grafting: A Randomized Clinical Trial. / 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; CABACS Trial Investigators.
In: STROKE, Vol. 48, No. 10, 10.2017, p. 2769-2775.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Safety of Simultaneous Coronary Artery Bypass Grafting and Carotid Endarterectomy Versus Isolated Coronary Artery Bypass Grafting: A Randomized Clinical Trial
AU - Weimar, Christian
AU - Bilbilis, Konstantinos
AU - Rekowski, Jan
AU - Holst, Torulv
AU - Beyersdorf, Friedhelm
AU - Breuer, Martin
AU - Dahm, Manfred
AU - Diegeler, Anno
AU - Kowalski, Arne
AU - Martens, Sven
AU - Mohr, Friedrich W
AU - Ondrášek, Jiri
AU - Reiter, Beate
AU - Roth, Peter
AU - Seipelt, Ralf
AU - Siggelkow, Markus
AU - Steinhoff, Gustav
AU - Moritz, Anton
AU - Wilhelmi, Mathias
AU - Wimmer-Greinecker, Gerhard
AU - Diener, Hans-Christoph
AU - Jakob, Heinz
AU - Ose, Claudia
AU - Scherag, Andre
AU - Knipp, Stephan C
AU - CABACS Trial Investigators
N1 - Copyright © 2017 The Author(s).
PY - 2017/10
Y1 - 2017/10
N2 - 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: URL: https://www.controlled-trials.com. Unique identifier: ISRCTN13486906.
AB - 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: URL: https://www.controlled-trials.com. Unique identifier: ISRCTN13486906.
KW - Aged
KW - Carotid Stenosis/diagnosis
KW - Coronary Artery Bypass/adverse effects
KW - Endarterectomy, Carotid/adverse effects
KW - Female
KW - Follow-Up Studies
KW - Humans
KW - Male
KW - Middle Aged
KW - Patient Safety/standards
KW - Treatment Outcome
U2 - 10.1161/STROKEAHA.117.017570
DO - 10.1161/STROKEAHA.117.017570
M3 - SCORING: Journal article
C2 - 28916664
VL - 48
SP - 2769
EP - 2775
JO - STROKE
JF - STROKE
SN - 0039-2499
IS - 10
ER -
