Distal embolic protection during percutaneous intervention of aorto-coronary venous bypass grafts: the FIRST Trial.
OBJECTIVE
Interventions in aorto-coronary venous bypass grafts (CABG) can cause acute procedural complications due to distal embolization of debris. In the FIRST (First European Investigation Regarding the Systematic use of the TriActiv device) multicenter trial the distal endovascular protection system TriActiv (Kensey Nash) was evaluated during intervention of CABG.


METHODS
195 patients in 17 centers in Germany with significant disease of a vein graft were enrolled. Inclusion and exclusion criteria were comparable to the SAFER trial.


RESULTS
Acute procedural success was achieved in 98% of cases. Aspirated debris was found in 96.5% of patients. Primary endpoints (MACE at 30 days) occurred in 8.7% of all pts. (ITT). No patient died and 7.2% of patients suffered from MI. The rate of early revascularization was 1.5%. Secondary endpoints (MACCE at 30 days) were found in 9.2% and at hospital discharge in 8.7% of patients.


CONCLUSIONS
The TriActiv system is safe and effective. Normal post procedural flow can be preserved and the MACE rate is with 8.7% considerably low. The FIRST trial supports the growing belief that PCI of CABG should be performed with protection systems.
Lins
M
M
University Clinic Schleswig-Holstein, Campus Kiel, Department of Cardiology, Schittenhelmstrasse 12, 24105 Kiel, Germany.
Heuer
H
H
Haude
M
M
Braun
P
P
Stahl
F
F
Franz
N
N
Simon
R
R
D000368:Aged; D001011:Aorta / Q000601:surgery*; D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000379:methods*; D004617:Embolism / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*
Am Heart J. 2005 Jun;149(6):1136
15976802
Circulation. 2002 Dec 10;106(24):3063-7
12473552
Circulation. 1999 Dec 14;100(24):2400-5
10595951
J Am Coll Cardiol. 2005 Oct 18;46(8):1434-45
16226166
J Am Coll Cardiol. 1998 Feb;31(2):241-51
9462562
N Engl J Med. 1994 Feb 24;330(8):523-8
8043066
Circulation. 2002 Mar 19;105(11):1285-90
11901037
Circulation. 1994 Jun;89(6):2514-8
8205658
J Am Coll Cardiol. 2005 Nov 1;46(9):1677-83
16256868
Circulation. 2000 Feb 8;101(5):570-80
10662756
J Am Coll Cardiol. 1999 Aug;34(2):468-75
10440161
Circulation. 2003 Aug 5;108(5):548-53
12874191
Circulation. 2003 Jul 8;108(1):37-42
12821546