In-hospital safety and effectiveness of bivalirudin in percutaneous peripheral interventions: data from a real-world registry.
OBJECTIVE
To present real-world data to evaluate the safety and effectiveness of bivalirudin, a direct thrombin inhibitor, in an unselected group of patients undergoing percutaneous peripheral interventions (PPI).


METHODS
Data were extracted from a prospectively collected peripheral vascular registry developed for quality assurance measures at 2 centers. Of 398 consecutive patients (195 men; mean age 69.4+/-11.3 years) who underwent PPI in a 2-year period, 369 (92.7%) received bivalirudin (0.75 mg/kg bolus followed by a 1.75 mg/kg/h infusion) and 29 (7.3%) received unfractionated heparin (UFH). In the bivalirudin sample, critical limb ischemia was present in 28.0% of patients, TASC D lesion in 29.5%, and angiographic thrombus in 7.8% of vessels. Demographic, clinical, procedural, and angiographic variables and in-hospital complications were analyzed. All in-hospital adverse events were independently adjudicated.


RESULTS
Procedural success (<30% residual narrowing) was achieved in 359 (97.3%) patients receiving bivalirudin. Adverse events included stroke (1, 0.3%), acute renal failure (1, 0.3%), major bleeding (3, 0.8%), distal embolization (11, 3.0%), vascular access complications (2, 0.5%), and minor amputation (2, 0.5%).


CONCLUSIONS
Bivalirudin had an excellent safety profile in a real-life cohort of patients undergoing PPI, including high-risk patients with critical limb ischemia and TASC D lesions. In-hospital major bleeding and other adverse events were infrequent. A randomized trial of bivalirudin versus UFH is needed to verify these results and establish bivalirudin as a standard anticoagulant in PPI.
Shammas
Nicolas W
NW
Midwest Cardiovascular Research Foundation, Cardiovascular Medicine, PC, 1236 E Rusholme, Suite 300, Davenport, IA 52803 USA. shammas@mchsi.com
Shammas
Gail A
GA
Jerin
Michael
M
Dippel
Eric J
EJ
Shammas
Andrew N
AN
D000368:Aged; D000369:Aged, 80 and over; D017130:Angioplasty / Q000009:adverse effects; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003251:Constriction, Pathologic; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006629:Hirudins / Q000009:adverse effects; D006801:Humans; D007297:Inpatients / Q000706:statistics & numerical data; D007484:Iowa; D007511:Ischemia / Q000000981:diagnostic imaging / Q000209:etiology / Q000628:therapy*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000009:adverse effects / Q000627:therapeutic use*; D016491:Peripheral Vascular Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D011859:Radiography; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000925:Anticoagulants; D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; D006493:Heparin; C074619:bivalirudin