A prospective randomized trial comparing the safety and efficacy of three commercially available closure devices (Angioseal, Vasoseal and Duett).
OBJECTIVE
We compared the safety and efficacy of three closure devices (Angioseal, Vasoseal and Duett) used to close arterial puncture sites in patients who underwent coronary percutaneous procedures.


METHODS
A prospective randomized, single-center trial was carried out of consecutive patients who underwent coronary angiography [705 patients: Angioseal (243),Vasoseal (228) and Duett (234)] or angioplasty [146 patients:Angioseal (47), Vasoseal (52) and Duett (47)].


RESULTS
In the angiography patients the device deployment rates were similar, with the Angioseal been significantly slower in achieving hemostasis (p = 0.0001) but resulting in earlier ambulation (p = 0.0001). In the coronary angioplasty patients the deployment rates were similar to those for angiography: time to hemostasis was longer for the Angioseal (p = 0.003), while ambulation times were not different, although prolonged compared with angiography (p = 0.0001). The three devices had similar major complication rates. The Vasoseal had a higher major complication rate after angioplasty than after angiography (p = 0.004). The incidence rate of peripheral embolization was lower when the Angioseal was utilized. Severe complications were mainly seen in patients who received abciximab.


CONCLUSIONS
The three closure devices had high rates of successful deployment and were relatively safe. The Angioseal resulted in earlier ambulation after angiography. Utilization of closure devices after abciximab administration possibly increased the complications.
Michalis
Lampros K
LK
Cardiac Department, University Hospital of Ioannina, Ioannina, Greece. lmihalis@cc.uoi.gr
Rees
Michael R
MR
Patsouras
Demetrios
D
Katsouras
Christos S
CS
Goudevenos
John
J
Pappas
Spyridon
S
Sourla
Eleni
E
Kolettis
Theophilos
T
Sioros
Lampros
L
Zotou
Paraskevi
P
Gartzou-Matsouka
Panoraia
P
Sideris
Dimitris A
DA
D000077284:Abciximab; D000704:Analysis of Variance; D017130:Angioplasty / Q000009:adverse effects*; D000911:Antibodies, Monoclonal / Q000009:adverse effects; D000925:Anticoagulants / Q000009:adverse effects; D017023:Coronary Angiography / Q000009:adverse effects*; D004434:Early Ambulation; D004868:Equipment Failure; D005260:Female; D006489:Hemostatic Techniques / Q000009:adverse effects* / Q000295:instrumentation*; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011677:Punctures / Q000009:adverse effects; D015641:Radiography, Interventional / Q000009:adverse effects / Q000295:instrumentation
D000911:Antibodies, Monoclonal; D000925:Anticoagulants; D007140:Immunoglobulin Fab Fragments; D000077284:Abciximab