PMID- 20199263
OWN - NLM
STAT- MEDLINE
DCOM- 20100520
LR  - 20161125
IS  - 1545-1550 (Electronic)
IS  - 1526-6028 (Linking)
VI  - 17
IP  - 1
DP  - 2010 Feb
TI  - In-hospital safety and effectiveness of bivalirudin in percutaneous peripheral 
      interventions: data from a real-world registry.
PG  - 31-6
LID - 10.1583/09-2810.1 [doi]
AB  - PURPOSE: 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%). 
      CONCLUSION: 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.
FAU - Shammas, Nicolas W
AU  - Shammas NW
AD  - Midwest Cardiovascular Research Foundation, Cardiovascular Medicine, PC, 1236 E 
      Rusholme, Suite 300, Davenport, IA 52803 USA. shammas@mchsi.com
FAU - Shammas, Gail A
AU  - Shammas GA
FAU - Jerin, Michael
AU  - Jerin M
FAU - Dippel, Eric J
AU  - Dippel EJ
FAU - Shammas, Andrew N
AU  - Shammas AN
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Endovasc Ther
JT  - Journal of endovascular therapy : an official journal of the International 
      Society of Endovascular Specialists
JID - 100896915
RN  - 0 (Anticoagulants)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Recombinant Proteins)
RN  - 9005-49-6 (Heparin)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
CIN - J Endovasc Ther. 2010 Feb;17(1):37-8. PMID: 20199264
MH  - Aged
MH  - Aged, 80 and over
MH  - *Angioplasty/adverse effects
MH  - Anticoagulants/adverse effects/*therapeutic use
MH  - Chi-Square Distribution
MH  - Constriction, Pathologic
MH  - Female
MH  - Hemorrhage/chemically induced
MH  - Heparin/adverse effects/*therapeutic use
MH  - Hirudins/adverse effects
MH  - Humans
MH  - *Inpatients/statistics & numerical data
MH  - Iowa
MH  - Ischemia/diagnostic imaging/etiology/*therapy
MH  - Logistic Models
MH  - Male
MH  - Middle Aged
MH  - Peptide Fragments/adverse effects/*therapeutic use
MH  - Peripheral Vascular Diseases/complications/diagnostic imaging/*therapy
MH  - Radiography
MH  - Recombinant Proteins/adverse effects/therapeutic use
MH  - Registries
MH  - Retrospective Studies
MH  - Risk Assessment
MH  - Risk Factors
MH  - Severity of Illness Index
MH  - Treatment Outcome
EDAT- 2010/03/05 06:00
MHDA- 2010/05/21 06:00
CRDT- 2010/03/05 06:00
PHST- 2010/03/05 06:00 [entrez]
PHST- 2010/03/05 06:00 [pubmed]
PHST- 2010/05/21 06:00 [medline]
AID - 10.1583/09-2810.1 [doi]
PST - ppublish
SO  - J Endovasc Ther. 2010 Feb;17(1):31-6. doi: 10.1583/09-2810.1.