Kooperation mit Universitätsklinikum Essen: Westdeutsches Herz- und Gefäßzentrum (Dr. Knipp)
Patients with high-grade carotid stenosis undergoing coronary artery bypass graft (CABG) surgery have an increased risk of stroke and cardiovascular complications. Treatment options include combined synchronous CABG and carotid endarterectomy (CEA), staged CABG / CEA or carotid angioplasty with stenting (CAS), or isolated CABG. Although combined CABG and CEA is advocated by many cardiothoracic surgeons, optimal surgical management in these patients remains unknown. In fact, there seems to be little evidence to justify prophylactic CEA or CAS in patients with asymptomatic carotid disease undergoing CABG. This multidisciplinay trial of cardiothoracic surgeons and neurologists aims to randomize 1,160 patients (minimum to be analyzed n=1100) with high-grade carotid stenosis to either isolated CABG or combined CABG and CEA. Thus, a 4.5% absolute difference in the 30-day risk of the composite vascular endpoint can be detected with 80% power. Predefined subgroup analyses which are not part of the confirmatory testing will furthermore investigate operative techniques (in particular off-pump CABG + CEA), degree of stenosis as well as gender differences. The study will have a DMSB, an executive steering committee, an adjudication committee and an independent monitoring and will be performed in about 30 German centers. Thus, we believe that it will be possible to randomize 1,160 patients within three years. The expected results based on randomized controlled trial evidence will be of major importance for surgical management in cardiovascular patients with asymptomatic carotid stenosis.
|Tatsächlicher Beginn/-es Ende||01.01.11 → 19.01.16|