Nejvíce citovaný článek - PubMed ID 11991687
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.
- Klíčová slova
- carotid stenosis, coronary artery bypass, endarterectomy, carotid, randomized controlled trial, stroke,
- MeSH
- bezpečnost pacientů normy MeSH
- karotická endarterektomie škodlivé účinky normy MeSH
- koronární bypass škodlivé účinky normy MeSH
- lidé středního věku MeSH
- lidé MeSH
- následné studie MeSH
- senioři MeSH
- stenóza arteria carotis diagnóza epidemiologie chirurgie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
Here, we examined whether intraoperative sonolysis can alter the risk of new ischemic lesions in the insonated brain artery territory during coronary artery bypass grafting (CABG) or valve surgery.Silent brain ischemic lesions could be detected in as many as two-thirds of patients after CABG or valve surgery.Patients indicated for CABG or valve surgery were allocated randomly to sonolysis (60 patients, 37 males; mean age, 65.3 years) of the right middle cerebral artery (MCA) during cardiac surgery and control group (60 patients, 37 males; mean age, 65.3 years). Neurologic examination, cognitive function tests, and brain magnetic resonance imaging (MRI) were conducted before intervention as well as 24 to 72 hours and 30 days after surgery.New ischemic lesions on control diffusion-weighted MRI in the insonated MCA territory ≥0.5 mL were significantly less frequent in the sonolysis group than in the control group (13.3% vs 26.7%, P = 0.109). The sonolysis group exhibited significantly reduced median volume of new brain ischemic lesions (P = 0.026). Stenosis of the internal carotid artery ≥50% and smoking were independent predictors of new brain ischemic lesions ≥0.5 mL (odds ratio = 5.685 [1.272-25.409], P = 0.023 and 4.698 [1.092-20.208], P = 0.038, respectively). Stroke or transient ischemic attack occurred only in 2 control patients (P = 0.496). No significant differences were found in scores for postintervention cognitive tests (P > 0.05).This study provides class-II evidence that sonolysis during CABG or valve surgery reduces the risk of larger, new ischemic lesions in the brain.www.clinicaltrials.gov (NCT01591018).
- MeSH
- arteria cerebri media diagnostické zobrazování MeSH
- difuzní magnetická rezonance MeSH
- kognitivní dysfunkce diagnóza etiologie prevence a kontrola MeSH
- koronární bypass škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- mozkový infarkt diagnostické zobrazování etiologie prevence a kontrola MeSH
- neuropsychologické testy MeSH
- neurozobrazování MeSH
- peroperační komplikace diagnostické zobrazování etiologie prevence a kontrola MeSH
- prospektivní studie MeSH
- senioři MeSH
- ultrasonografie dopplerovská MeSH
- ultrazvuková terapie * MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH