Carotid stenting and bivalirudin with and without vascular closure: 3-year analysis of procedural outcomes.
OBJECTIVE
The purpose of this study was to examine the outcome of carotid stenting using bivalirudin and the influence of vascular closure devices (VCD) on the incidence and severity of peri-procedural hypotension.


BACKGROUND
Bivalirudin, a short-acting direct thrombin inhibitor, has been shown to be an effective anticoagulant in coronary interventions, with less risk of bleeding compared with heparin. Routine use of VCD has become the standard of care, facilitating patient ambulation after percutaneous carotid and coronary interventions. The combined use of these two therapies (bivalirudin and VCD) may improve outcomes in carotid interventions where prolonged patient immobilization may exacerbate hypotension following stenting.


METHODS
A total of 514 patients underwent 536 carotid stenting procedures in the 3-year period from September 2004 to September 2007. All patients received adjunctive bivalirudin, with and without VCD. This cohort was analyzed for peri-procedural and 30-day clinical outcomes and length of hospitalization.


RESULTS
Thirty-day stroke and death rate was 1.7%. A total of 83 patients (15.4%) experienced intra- or post-procedural hypotension (systolic BP < 80 mm Hg). There were four (0.7%) major bleeding complications requiring transfusion, and length of stay was delayed more than 24 hr in five patients (0.93%), all of whom were in the manual compression group.


CONCLUSIONS
This was a negative study, with no significant difference on prolonged hypotensive events in patients with vascular closure device and bivalirudin, compared with those with manual compression and bivalirudin. Vascular closure devices were safe and effective with a low incidence of complications. In carotid artery stenting, bivalirudin is safe with low incidence of major bleeding and acceptable 30-day adverse event rates (stroke and death).
Schneider
Laurence M
LM
Department of Cardiovascular Medicine, Lenox Hill Heart and Vascular Institute, 130 E. 77th Street, New York, NY 10065, USA.
Polena
Sotir
S
Roubin
Gary
G
Iyer
Sriram
S
Vitek
Jiri
J
Panagopoulos
Georgia
G
Mussap
Christian J
CJ
Vitellas
Michael
M
Mahdavi
Ramyar
R
Brennan
Christina
C
D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use*; D016893:Carotid Stenosis / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D006489:Hemostatic Techniques / Q000009:adverse effects / Q000295:instrumentation*; D006629:Hirudins; D006801:Humans; D007022:Hypotension / Q000209:etiology; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use; D015607:Stents; D016896:Treatment Outcome
D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; C074619:bivalirudin