Abstract
Background - High-risk patient characteristics and complexity of percutaneous peripheral intervention (PPI) procedures suggest a need for predictable and reliable anticoagulation. We undertook this study to assess the safety and efficacy of bivalirudin as the procedural anticoagulant in patients undergoing PPI of the renal, iliac, or femoral artery. Methods - This was a prospective, open-label, single arm study in patients undergoing PPI of the renal, iliac, or femoral vessels to assess bivalirudin as the sole procedural anticoagulant (0.75 mg/kg bolus/1.75 mg/kg/hr infusion). The primary endpoint was procedural success defined as residual stenosis ≤ 20%. Secondary endpoints included ischemic events (death, myocardial infarction, unplanned revascularization, and amputation), and bleeding complications, as well as ACT values and times to sheath removal, ambulation, and discharge. Results - 505 patients were enrolled at 26 sites. Procedural success was achieved in 95.0% of patients. Ischemic events were low (1.4%) and similar between vessel types. Protocol-defined major hemorrhage and TIMI major hemorrhage rates were 2.2% and 0.4%, respectively. Mean ACTs were similar among treatment groups (renal 353.8 seconds(s); iliac 335.9s, femoral, 343.5s). Conclusion - Bivalirudin provided consistent anticoagulation and similar outcomes in all vessel types treated at the dose tested. Ischemic and bleeding event rates were low, demonstrating the safe use of bivalirudin as a procedural anticoagulant in PPI.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 651-656 |
| Number of pages | 6 |
| Journal | Journal of Invasive Cardiology |
| Volume | 16 |
| Issue number | 11 |
| State | Published - Nov 2004 |
| Externally published | Yes |
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Keywords
- Anticoagulation
- Femoral artery
- Iliac artery
- Percutaneous peripheral intervention
- Renal intervention
- Unfractionated heparin
ASJC Scopus subject areas
- Cardiology and Cardiovascular Medicine
Cite this
The Angiomax Peripheral Procedure Registry of Vascular Events Trial (APPROVE) : In-hospital and 30-day results. / Allie, David; Hall, Patrick; Shammas, Nicolas W.; Safian, Robert; Laird, John R.; Young, John J.; Virmani, Ajay.
In: Journal of Invasive Cardiology, Vol. 16, No. 11, 11.2004, p. 651-656.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The Angiomax Peripheral Procedure Registry of Vascular Events Trial (APPROVE)
T2 - In-hospital and 30-day results
AU - Allie, David
AU - Hall, Patrick
AU - Shammas, Nicolas W.
AU - Safian, Robert
AU - Laird, John R.
AU - Young, John J.
AU - Virmani, Ajay
PY - 2004/11
Y1 - 2004/11
N2 - Background - High-risk patient characteristics and complexity of percutaneous peripheral intervention (PPI) procedures suggest a need for predictable and reliable anticoagulation. We undertook this study to assess the safety and efficacy of bivalirudin as the procedural anticoagulant in patients undergoing PPI of the renal, iliac, or femoral artery. Methods - This was a prospective, open-label, single arm study in patients undergoing PPI of the renal, iliac, or femoral vessels to assess bivalirudin as the sole procedural anticoagulant (0.75 mg/kg bolus/1.75 mg/kg/hr infusion). The primary endpoint was procedural success defined as residual stenosis ≤ 20%. Secondary endpoints included ischemic events (death, myocardial infarction, unplanned revascularization, and amputation), and bleeding complications, as well as ACT values and times to sheath removal, ambulation, and discharge. Results - 505 patients were enrolled at 26 sites. Procedural success was achieved in 95.0% of patients. Ischemic events were low (1.4%) and similar between vessel types. Protocol-defined major hemorrhage and TIMI major hemorrhage rates were 2.2% and 0.4%, respectively. Mean ACTs were similar among treatment groups (renal 353.8 seconds(s); iliac 335.9s, femoral, 343.5s). Conclusion - Bivalirudin provided consistent anticoagulation and similar outcomes in all vessel types treated at the dose tested. Ischemic and bleeding event rates were low, demonstrating the safe use of bivalirudin as a procedural anticoagulant in PPI.
AB - Background - High-risk patient characteristics and complexity of percutaneous peripheral intervention (PPI) procedures suggest a need for predictable and reliable anticoagulation. We undertook this study to assess the safety and efficacy of bivalirudin as the procedural anticoagulant in patients undergoing PPI of the renal, iliac, or femoral artery. Methods - This was a prospective, open-label, single arm study in patients undergoing PPI of the renal, iliac, or femoral vessels to assess bivalirudin as the sole procedural anticoagulant (0.75 mg/kg bolus/1.75 mg/kg/hr infusion). The primary endpoint was procedural success defined as residual stenosis ≤ 20%. Secondary endpoints included ischemic events (death, myocardial infarction, unplanned revascularization, and amputation), and bleeding complications, as well as ACT values and times to sheath removal, ambulation, and discharge. Results - 505 patients were enrolled at 26 sites. Procedural success was achieved in 95.0% of patients. Ischemic events were low (1.4%) and similar between vessel types. Protocol-defined major hemorrhage and TIMI major hemorrhage rates were 2.2% and 0.4%, respectively. Mean ACTs were similar among treatment groups (renal 353.8 seconds(s); iliac 335.9s, femoral, 343.5s). Conclusion - Bivalirudin provided consistent anticoagulation and similar outcomes in all vessel types treated at the dose tested. Ischemic and bleeding event rates were low, demonstrating the safe use of bivalirudin as a procedural anticoagulant in PPI.
KW - Anticoagulation
KW - Femoral artery
KW - Iliac artery
KW - Percutaneous peripheral intervention
KW - Renal intervention
KW - Unfractionated heparin
UR - http://www.scopus.com/inward/record.url?scp=8844241452&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=8844241452&partnerID=8YFLogxK
M3 - Article
C2 - 15550739
AN - SCOPUS:8844241452
VL - 16
SP - 651
EP - 656
JO - Journal of Invasive Cardiology
JF - Journal of Invasive Cardiology
SN - 1042-3931
IS - 11
ER -