November 15, 1995Circulation
Influence of Blockade at Specific Levels of the Coagulation Cascade on Restenosis in a Rabbit Atherosclerotic Femoral Artery Injury Model
Key result
DEGR-VIIa or TFPI increases minimal luminal diameter ~68% after arterial injury in rabbits.
- P=0.0001
- n=48
Why the study?
The relation among the coagulation cascade, its individual proteins, and the response to vascular injury is largely undefined.
Does blockade of specific levels of the coagulation cascade reduce restenosis and neointimal hyperplasia in a rabbit atherosclerotic femoral artery injury model?
Population
48 New Zealand White rabbits with atherosclerotic femoral artery injury
Comparison
DEGR-VIIa, TFPI, TAP, and hirudin treatments versus controls
Design
Experimental study with intravenous bolus and infusion treatments
Follow-up
21 days
Authors
Discussion
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Implication
Supports coagulation blockade to limit restenosis in rabbit models; leaves open translation to human post-angioplasty outcomes.
Structured PICO
Does blockade of specific levels of the coagulation cascade reduce restenosis and neointimal hyperplasia in a rabbit atherosclerotic femoral artery injury model?
P
Population
48 New Zealand White rabbits with focal femoral atherosclerosis induced by air-desiccation injury and hypercholesterolemic diet, followed by balloon angioplasty.
I
Intervention
Active-site inactivated factor VIIa (DEGR-VIIa) (1 mg/kg IV bolus followed by 50 micrograms/kg/h infusion for 3 days), recombinant tissue factor pathway inhibitor (TFPI) (1 mg/kg bolus followed by 15 micrograms/kg/min infusion for 3 days), recombinant tick anticoagulant peptide (TAP) (1 mg/kg bolus followed by 5 micrograms/kg/min infusion for 3 days), or hirudin (1 mg/kg bolus followed by 5 micrograms/kg/min infusion for 3 days).
C
Comparator
Control groups (e.g., 150 U heparin bolus followed by saline infusion at 50 microL/kg/min for the DEGR-VIIa group; separate controls for the TFPI, TAP, and hirudin groups).
O
Outcome
Minimal luminal diameter (MLD) by angiography at 21 days after balloon angioplasty, and ratio of neointimal cross-sectional area to the area of internal elastic lamina by quantitative histological analysis.surrogate
Main Result
Absolute Event Rate: 1.24% vs 0.74%
p-value: p=0.0001
Blockade of early initiators of the extrinsic coagulation pathway (factor VII and tissue factor) significantly reduces angiographic restenosis and neointimal hyperplasia in a rabbit model of arterial injury.
Cite This Study
Jang et al. (1995) studied Atherosclerotic arterial injury (restenosis model) (n=48). DEGR-VIIa or TFPI vs. Control (heparin bolus and saline infusion) was evaluated on Mean minimal luminal diameter (MLD) 21 days after balloon angioplasty (p=0.0001). Treatment with DEGR-VIIa or TFPI for 3 days in a rabbit atherosclerotic injury model significantly increased minimal luminal diameter at 21 days compared with controls (P=0.0001).