The Angiomax Peripheral Procedure Registry of Vascular Events Trial (APPROVE): in-hospital and 30-day results.
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 inpatients undergoing PPI of the renal, iliac, or femoral vessels to assessbivalirudin 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).


CONCLUSIONS
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.
Allie
David E
DE
Cardiovascular Institute of the South - Lafayette, 2730 Ambassador Caffery Parkway, Lafayette, LA 70506, USA.
Hall
Patrick
P
Shammas
Nicolas W
NW
Safian
Robert
R
Laird
John R
JR
Young
John J
JJ
Virmani
Ajay
A
D000368:Aged; D000800:Angioplasty, Balloon / Q000379:methods*; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D002406:Catheterization, Peripheral; D003131:Combined Modality Therapy; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006629:Hirudins / Q000031:analogs & derivatives*; D006801:Humans; D007083:Iliac Artery; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D010446:Peptide Fragments / Q000627:therapeutic use*; D016491:Peripheral Vascular Diseases / Q000175:diagnosis / Q000401:mortality / Q000628:therapy; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use*; D012078:Renal Artery Obstruction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy; D018570:Risk Assessment; D016037:Single-Blind Method; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency / Q000502:physiology
D006629:Hirudins; D010446:Peptide Fragments; D011994:Recombinant Proteins; C074619:bivalirudin