Artikel
The Coronary Artery Bypass Graft Surgery in Patients with Asymptomatic Carotid Stenosis (CABACS) Trial
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Autoren
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Stephan Knipp
- Westdeutsches Herzzentrum, Thorax- und Kardiovaskuläre Chirurgie, Essen
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Andre Scherag
- Institut für Medizinische Biometrie, Zentrum für Klinische Studien, Essen
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Hans-Christoph Diener
- Universitätsklinikum Essen, Neurologische Klinik, Essen
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Heinz Jakob
- Westdeutsches Herzzentrum, Thorax- und Kardiovaskuläre Chirurgie, Essen
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Christian Weimar
- Universitätsklinikum Essen, Neurologische Klinik, Essen
| Veröffentlicht: | 20. Mai 2011 |
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Gliederung
Text
Introduction: Annually, more than 60,000 coronary artery bypass graft (CABG) procedures are performed in Germany. Significant carotid stenosis is present in 6-8% of these patients and is associated with an increased risk of stroke and cardiovascular complications during and after CABG. In these patients, treatment is handled controversially. Options include combined synchronous CABG (on- or off-pump) and carotid endarterectomy (CEA), staged or reverse staged CABG + CEA, staged or reverse staged CABG + carotid artery angioplasty and stenting, and isolated CABG. Although synchronous CABG and CEA still constitutes the current standard of care by many cardiothoracic surgeons, no proven gold standard is known in these patients. Conversely, no randomized trial has assessed whether a combined synchronous or staged procedure confers any benefit at all compared to isolated CABG. Aim of the study was to compare the safety and efficacy of isolated CABG with synchronous CABG and CEA in patients with asymptomatic high-grade (≥80% ECST) carotid stenosis.
Materials and methods: Patients with asymptomatic, high-grade carotid stenosis scheduled for elective CABG will be assigned to either isolated CABG or synchronous CABG and CEA by 1:1 block stratified randomization with 3 different stratification factors (age, sex, modified Rankin scale). Primary efficacy endpoint is the number of strokes and deaths from any cause (whatever occurs first) at 30 days after intervention. With 1,160 patients to be randomized, a 4.5% absolute difference in the 30-day rate of the above endpoints can be detected with 80% power. Follow-up will be 1 year with an additional telephone follow-up for 4 years. The trial is expected to start in July 2010 in 30 German cardiothoracic centers. The study is funded by the Deutsche Forschungsgemeinschaft (WE 2858-3/1).
Results:
Conclusion: CABACS is the first randomized controlled clinical trial to compare CABG with and without CEA in patients with concomitant coronary and high-grade carotid stenosis. The results of this trial will be of major importance for surgical management in coronary patients with asymptomatic carotid stenosis.
