Functional and clinical outcomes of nitinol stenting with and without abciximab for complex superficial femoral artery disease: a randomized trial.
OBJECTIVE
To evaluate the effect of glycoprotein IIb/IIIa inhibition during nitinol stenting, of superficial femoral occlusive disease.


BACKGROUND
Stent implantation in the superficial femoral artery has been associated with suboptimal results while Glycoprotein IIb/IIIa inhibitors have shown improved procedural results during coronary intervention. We evaluated abciximab infusion during (Smart Stent) implantation in superficial femoral obstructions.


METHODS
We conducted a randomized placebo controlled trial. The two primary end points include: (1) 9-month restenosis defined as a decrease in ankle brachial index and in-stent duplex ultrasound restenosis: (2) adverse events defined as death (30 days) or repeat revascularization within 9 months.


RESULTS
Twenty-seven patients were randomized to abciximab and 24 patients to control (placebo). The primary end point of cumulative restenosis occurred in 15.4% of patients administered abciximab and in 12% administered placebo (P = 0.873). The primary restenosis endpoint in diabetics and total occlusions were similar at 14.3% and 15.4% respectively. The composite end point of 30-day mortality and 9-month revascularization occurred in 5.8% abciximab and 0% (P = 0.274) placebo with no 30-day deaths. Graded treadmill time and Rutherford class were all significantly improved in both groups, but the abciximab group did not appear to demonstrate any identifiable effect.


CONCLUSIONS
(Smart Stent) nitinol stenting of the superficial femoral artery was associated with favorable functional outcomes at 9 months. Adjunctive abciximab did not appear to demonstrate any identifiable effect.
Ansel
Gary M
GM
Section of Cardiology, Riverside Methodist Hospital, Columbus, Ohio, USA. gansel@mocvc.com
Silver
Mitchell J
MJ
Botti
Charles F
CF
Rocha-Singh
Krishna
K
Bates
Mark C
MC
Rosenfield
Kenneth
K
Schainfeld
Robert M
RM
Laster
Steven B
SB
Zander
Carol
C
D000077284:Abciximab; D000368:Aged; D000369:Aged, 80 and over; D000497:Alloys; D000792:Angiography; D000800:Angioplasty, Balloon; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D001157:Arterial Occlusive Diseases / Q000628:therapy*; D016009:Chi-Square Distribution; D005260:Female; D005263:Femoral Artery; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000628:therapy*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D015607:Stents; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex
D000497:Alloys; D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; C013616:nitinol; D000077284:Abciximab