Five-Year Results of Coronary Artery Bypass Grafting With or Without Carotid Endarterectomy in Patients With Asymptomatic Carotid Artery Stenosis: CABACS RCT

Author:

Knipp Stephan C.1ORCID,Holst Torulv2ORCID,Bilbilis Konstantinos3,von Velsen Otgonzul3ORCID,Ose Claudia3ORCID,Diener Hans-Christoph4,Jakob Heinz1ORCID,Ruhparwar Arjang1ORCID,Jöckel Karl-Heinz34,Weimar Christian45,Beyersdorf Friedhelm,Breuer Martin,Dahm Manfred,Diegeler Anno,Kowalski Arne,Martens Sven,Mohr Friedrich-Wilhelm,Moritz Anton,Ondrášek Jiri,Reiter Beate,Roth Peter,Seipelt Ralf,Siggelkow Markus,Steinhoff Gustav,Stock Ulrich,Wilhelmi Mathias,Wimmer-Greinecker Gerhard

Affiliation:

1. Department of Thoracic and Cardiovascular Surgery, University Hospital Essen, Germany (S.C.K., H.J., A.R.).

2. Department of Cardiac Surgery, Medical Faculty and University Hospital Duesseldorf, Heinrich-Heine-University Duesseldorf, Germany (T.H.).

3. Center for Clinical Trials Essen (ZKSE), c/o Institute for Medical Informatics, Biometry and Epidemiology (IMIBE), University Hospital Essen, Germany (K.B., O.V.V., C.O., K.-H.J.).

4. Institute for Medical Informatics, Biometry and Epidemiology (IMIBE), University Hospital Essen, Germany (H.-C.D., K.-H.J., C.W.).

5. BDH Clinic Elzach GmbH, Germany (C.W.).

Abstract

Background: In patients with coronary artery disease and concomitant asymptomatic severe carotid stenosis, combined simultaneous coronary artery bypass grafting (CABG) and carotid endarterectomy (CEA) has been widely performed despite lack of evidence from randomized trials. We recently showed that the risk of stroke or death within 30 days was higher following CABG+CEA compared with CABG alone. Here, we report long-term outcomes following CABG with versus without CEA. Methods: The CABACS (Coronary Artery Bypass Graft Surgery in Patients With Asymptomatic Carotid Stenosis Study) is a randomized, controlled, multicenter, open trial. Patients with asymptomatic severe (≥70%) carotid stenosis undergoing CABG were allocated either CABG+CEA or CABG alone, and follow-up was 5 years. Major secondary end points included nonfatal stroke or death, any death and any nonfatal stroke. Due to low recruitment, the study was stopped prematurely after randomization of 127 patients in 17 centers. Results: By 5 years, the rate of stroke or death did not significantly differ between groups (CABG+CEA 40.6% [95% CI, 0.285–0.536], CABG alone 35.0% [95% CI, 0.231–0.484]; P =0.58). Higher albeit statistically nonsignificant rates of nonfatal strokes occurred at any time following CABG+CEA versus CABG alone (1 year: 19.3% versus 7.1%, P =0.09; 5 years: 29.4% versus 18.8%, P =0.25). All-cause mortality up to 5 years was similar in both groups (CABG+CEA: 25.4% versus CABG alone: 23.3%, hazard ratio, 1.148 [95% CI, 0.560–2.353]; P =0.71). Subgroup analyses did not reveal any significant effect of age, sex, preoperative modified Rankin Scale and center on outcome events. Conclusions: During 5-years follow-up, combined simultaneous CABG+CEA was associated with a higher albeit statistically nonsignificant rate of stroke or death compared with CABG alone. This was mainly due to a nonsignificantly higher perioperative risk following CABG+CEA. Since the power of our study was not sufficient, no significant effect of either procedure could be observed at any time during follow-up. Registration: URL: http://www.controlled-trials.com ; Unique identifier: ISRCTN13486906.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Advanced and Specialized Nursing,Cardiology and Cardiovascular Medicine,Neurology (clinical)

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