PMID- 16079449
OWN - NLM
STAT- MEDLINE
DCOM- 20050927
LR  - 20181201
IS  - 1042-3931 (Print)
IS  - 1042-3931 (Linking)
VI  - 17
IP  - 8
DP  - 2005 Aug
TI  - A safety and feasibility report of combined direct thrombin and GP IIb/IIIa 
      inhibition with bivalirudin and tirofiban in peripheral vascular disease 
      intervention: treating critical limb ischemia like acute coronary syndrome.
PG  - 427-32
AB  - BACKGROUND: The combination of glycoprotein (GP) IIb-IIIa inhibition and direct 
      thrombin inhibition (DTI) with bivalirudin (Angiomax, The Medicines Company, 
      Cambridge, Massachusetts) have shown ischemic and hemorrhagic outcomes benefit in 
      coronary interventions and may have similar benefits in percutaneous peripheral 
      interventions (PPI). The high incidence of diabetes, chronic renal disease, 
      platelet dysfunction, hypercoagulability, inflammation and a thrombus-rich 
      environment make a GP IIb-IIIa and DTI combination with tirofiban (Aggrastat 
      Merck and Company, Inc., Whitehouse Station, New Jersey) an attractive 
      anticoagulation strategy in the PPI treatment of critical limb ischemia (CLI). 
      METHODS: Between May 1, 2001 and January 31, 2003, a CLI treatment group of 149 
      patients received PPI with bivalirudin (0.75 mg per kg bolus with 1.75 mg per kg 
      per hour periprocedural infusion) and tirofiban (10 mcg per kg per minute bolus 
      with 12-hour 0.1 mcg per kg per minute infusion) as an anticoagulation and 
      antiplatelet strategy, and were compared to a matched unfractionated heparin 
      (UFH) control group without GP IIb-IIIa inhibitors. Clinical and hemostasis 
      outcomes were analyzed, including distal embolization (DE). RESULTS: Procedural 
      success was 95.9% and 97.3% in the UFH control group and DTI-GP IIb-IIIa group, 
      respectively. Significant differences were observed in the sheath removal time < 
      2 hours (60.5% UFH group versus 19.4% DTI-GP IIb-IIIa group; p = < 0.0001). 
      Vascular closure devices were used equally in both groups. No statistical 
      significance was observed in major and minor complications, femoral access 
      complications, acute (< 48 hours) or subacute (30 days) vessel thrombosis, and 
      6-month duplex ultrasound restenosis rate between the DTI-GP IIb-IIIa versus the 
      UFH group. A trend towards statistical significance was observed in the 6-month 
      secondary re-intervention and limb salvage rates (10.7% versus 18.8%; p = 0.0501 
      and 93.9% versus 88.5%; p = 0.053) in the DTI-GP IIb-IIIa versus the UFH group, 
      respectively. Angiographically relevant DE occurred in 4 of 149 (1.3%) and 8 of 
      149 (5.4%) of the bivalirudin-tirofiban and UFH groups, respectively. CONCLUSION: 
      The combination of DTI with bivalirudin and GP IIb-IIIa inhibition with tirofiban 
      is a safe and feasible alternative anticoagulation and antiplatelet strategy in 
      PPI, and may offer improved clinical and hemostasis outcomes in treating CLI. A 
      larger, prospective randomized trial is warranted.
FAU - Allie, David E
AU  - Allie DE
AD  - Cardiovascular Institute of the South, Houma, LA, USA. david.allie@cardio.com
FAU - Hebert, Chris J
AU  - Hebert CJ
FAU - Lirtzman, Mitchell D
AU  - Lirtzman MD
FAU - Wyatt, Charles H
AU  - Wyatt CH
FAU - Keller, V Antoine
AU  - Keller VA
FAU - Khan, Mohamed H
AU  - Khan MH
FAU - Khan, Muhammad A
AU  - Khan MA
FAU - Fail, Peter S
AU  - Fail PS
FAU - Vivekananthan, Krishnamoorthy
AU  - Vivekananthan K
FAU - Allie, Sonja E
AU  - Allie SE
FAU - Mitran, Elena V
AU  - Mitran EV
FAU - Chaisson, Gary
AU  - Chaisson G
FAU - Stagg, Samuel J 3rd
AU  - Stagg SJ 3rd
FAU - Allie, Adam A
AU  - Allie AA
FAU - McElderry, Michael W
AU  - McElderry MW
FAU - Barker, Esmond A
AU  - Barker EA
FAU - Walker, Craig M
AU  - Walker CM
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - United States
TA  - J Invasive Cardiol
JT  - The Journal of invasive cardiology
JID - 8917477
RN  - 0 (Anticoagulants)
RN  - 0 (Hirudins)
RN  - 0 (Peptide Fragments)
RN  - 0 (Platelet Aggregation Inhibitors)
RN  - 0 (Platelet Glycoprotein GPIIb-IIIa Complex)
RN  - 0 (Recombinant Proteins)
RN  - 42HK56048U (Tyrosine)
RN  - EC 3.4.21.5 (Thrombin)
RN  - GGX234SI5H (Tirofiban)
RN  - TN9BEX005G (bivalirudin)
SB  - IM
MH  - Acute Disease
MH  - Aged
MH  - Angioplasty, Balloon
MH  - Anticoagulants/adverse effects/*therapeutic use
MH  - Feasibility Studies
MH  - Female
MH  - Follow-Up Studies
MH  - Hirudins
MH  - Humans
MH  - Ischemia/blood/therapy
MH  - Leg/blood supply
MH  - Male
MH  - Myocardial Ischemia/blood/therapy
MH  - Peptide Fragments/*therapeutic use
MH  - Peripheral Vascular Diseases/blood/*therapy
MH  - Platelet Aggregation Inhibitors/*therapeutic use
MH  - Platelet Glycoprotein GPIIb-IIIa Complex/*antagonists & inhibitors/metabolism
MH  - Recombinant Proteins/therapeutic use
MH  - Retrospective Studies
MH  - Thrombin/*antagonists & inhibitors/metabolism
MH  - Tirofiban
MH  - Treatment Outcome
MH  - Tyrosine/*analogs & derivatives/therapeutic use
EDAT- 2005/08/05 09:00
MHDA- 2005/09/28 09:00
CRDT- 2005/08/05 09:00
PHST- 2005/08/05 09:00 [pubmed]
PHST- 2005/09/28 09:00 [medline]
PHST- 2005/08/05 09:00 [entrez]
PST - ppublish
SO  - J Invasive Cardiol. 2005 Aug;17(8):427-32.