Eric Van Belle1, Christian Hengstenberg2, Thierry Lefevre3, Christian Kupatt4, Nicolas Debry1, Oliver Husser5, François Pontana6, Grégory Kuchcinski6, Efthymios N Deliargyris7, Roxana Mehran8, Debra Bernstein7, Prodromos Anthopoulos9, George D Dangas10. 1. Department of Cardiology, Centre Hospitalier Régional Universitaire (CHRU) Lille and Unité Mixte de Recherche (UMR1011), Lille, France. 2. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany; Deutsches Zentrum für Herz-Kreislauf-Forschung E.V. (DZHK), partner site Munich Heart Alliance, Munich, Germany. 3. Institut Cardio Vasculaire Paris Sud, Paris, France. 4. Ludwig Maximilian University of Munich (LMU) Munich, Munich, Germany. 5. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. 6. Department of Radiology, CHRU Lille, Lille, France. 7. The Medicines Company, Parsippany, New Jersey. 8. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. 9. The Medicines Company, Zurich, Switzerland. 10. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: George.Dangas@mountsinai.org.
Abstract
BACKGROUND:Cerebral embolization is a frequent complication after transcatheter aortic valve replacement (TAVR). We hypothesized that cerebral embolization may be reduced by anticoagulation with bivalirudin during TAVR. OBJECTIVES: This study sought to determine the proportion of patients with new cerebral embolus after TAVR and to investigate whether parenteral procedural anticoagulation strategies affect cerebral embolization. METHODS: The BRAVO (Effect of Bivalirudin on Aortic Valve Intervention Outcomes)-3 randomized trial compared bivalirudin with unfractionated heparin in patients undergoing transfemoral TAVR. A prospective cerebral magnetic resonance imaging (MRI) substudy was conducted in 4 sites; 60 patients were imaged with brain MRI after TAVR. Primary endpoint was proportion of patients with new cerebral emboli on MRI. Secondary endpoints included quantitative MRI analyses of cerebral lesions and neurological outcomes at 48 h and 30 days. RESULTS: Patients were randomized to bivalirudin (n = 29) versus heparin (n = 31). The proportion of patients with new cerebral emboli on MRI did not differ between bivalirudin and heparin groups (65.5% vs. 58.1%; p = 0.55). Groups were similar for median number of emboli per patient (1 [interquartile range (IQR): 0 to 3] vs. 1 [IQR: 0 to 1]; p = 0.08), total volume of emboli (45 [IQR: 0 to 175] mm(3) vs. 33 [IQR: 0 to 133] mm(3); p = 0.86), or proportion of patients with a clinical neurological deficit at 48 h or 30 days. All patients who presented clinically with stroke had evidence of new emboli on MRI. CONCLUSIONS: This study documented cerebral embolization in nearly two-thirds of patients during contemporary TAVR. There were no significant differences in cerebral embolization for bivalirudin versus heparin anticoagulation during TAVR. (Open-Label, Randomized Trial in Patients Undergoing TAVR to Determine Safety and Efficacy of Bivalrudin vs. UFH [BRAVO-2/3]; NCT01651780).
RCT Entities:
BACKGROUND: Cerebral embolization is a frequent complication after transcatheter aortic valve replacement (TAVR). We hypothesized that cerebral embolization may be reduced by anticoagulation with bivalirudin during TAVR. OBJECTIVES: This study sought to determine the proportion of patients with new cerebral embolus after TAVR and to investigate whether parenteral procedural anticoagulation strategies affect cerebral embolization. METHODS: The BRAVO (Effect of Bivalirudin on Aortic Valve Intervention Outcomes)-3 randomized trial compared bivalirudin with unfractionated heparin in patients undergoing transfemoral TAVR. A prospective cerebral magnetic resonance imaging (MRI) substudy was conducted in 4 sites; 60 patients were imaged with brain MRI after TAVR. Primary endpoint was proportion of patients with new cerebral emboli on MRI. Secondary endpoints included quantitative MRI analyses of cerebral lesions and neurological outcomes at 48 h and 30 days. RESULTS:Patients were randomized to bivalirudin (n = 29) versus heparin (n = 31). The proportion of patients with new cerebral emboli on MRI did not differ between bivalirudin and heparin groups (65.5% vs. 58.1%; p = 0.55). Groups were similar for median number of emboli per patient (1 [interquartile range (IQR): 0 to 3] vs. 1 [IQR: 0 to 1]; p = 0.08), total volume of emboli (45 [IQR: 0 to 175] mm(3) vs. 33 [IQR: 0 to 133] mm(3); p = 0.86), or proportion of patients with a clinical neurological deficit at 48 h or 30 days. All patients who presented clinically with stroke had evidence of new emboli on MRI. CONCLUSIONS: This study documented cerebral embolization in nearly two-thirds of patients during contemporary TAVR. There were no significant differences in cerebral embolization for bivalirudin versus heparin anticoagulation during TAVR. (Open-Label, Randomized Trial in Patients Undergoing TAVR to Determine Safety and Efficacy of Bivalrudin vs. UFH [BRAVO-2/3]; NCT01651780).
Authors: Ozan M Demir; Gianmarco Iannopollo; Antonio Mangieri; Marco B Ancona; Damiano Regazzoli; Satoru Mitomo; Antonio Colombo; Giora Weisz; Azeem Latib Journal: Front Cardiovasc Med Date: 2018-10-23