Six-month outcomes after percutaneous intervention for lesions in aortocoronary saphenous vein grafts using distal protection devices: results from the FIRE trial.
BACKGROUND
The filter-based FilterWire EX (Boston Scientific, Natick, MA) embolic protection system and the GuardWire (Medtronic, Santa Rosa, CA) balloon occlusion and aspiration device have been previously shown to reduce periprocedural complication rates of percutaneous coronary intervention for saphenous vein graft (SVG) disease and are considered the standard of care in this setting. The late clinical course after treatment with these devices has not been reported.


METHODS
In the FIRE trial, 651 patients undergoing SVG intervention were randomized to either the FilterWire EX or GuardWire. Six-month rates of the primary end point (composite major adverse cardiac events [MACE]) and its components (death, myocardial infarction [MI], or target vessel revascularization) were studied.


RESULTS
MACE at 30 days occurred in 9.9% of patients randomized to the FilterWire EX compared with 11.6% with the GuardWire, P = .53. By 6 months, MACE had increased to 19.3% and 21.9% in FilterWire EX and GuardWire groups, respectively, (relative risk 0.88, 95% CI 0.65-1.19; P = .44). All-cause 6-month mortality in the entire population was 3.5% (3.0% with FilterWire EX vs 4.1% with GuardWire, P = .53, with all deaths occurring after hospital discharge). MI occurred in 12.0% of patients at 6 months (12.1% vs 11.9% with the FilterWire EX and GuardWire, respectively, P = .99), and target vessel revascularization was required in 9.1% (8.2% vs 10.0%, respectively, P = .42).


CONCLUSIONS
SVG intervention with the FilterWire EX and GuardWire distal protection devices resulted in similar outcomes at 6 months, although the clinical course after hospital discharge was not benign, with significant rates of death, MI, and repeat intervention.
Cardiovascular Research Foundation, New York, NY 10022, USA.
Amir
A
Halkin
A Zaki
AZ
Masud
Campbell
C
Rogers
James
J
Hermiller
Robert
R
Feldman
Patrick
P
Hall
Robert H
RH
Haber
Patrick A
PA
Cambier
Ron P
RP
Caputo
Mark
M
Turco
Richard
R
Kovach
Bruce
B
Brodie
Howard C
HC
Herrmann
Richard E
RE
Kuntz
Jeffrey J
JJ
Popma
Steve
S
Ramee
David A
DA
Cox
Roxana
R
Mehran
Gregg W
GW
Stone
D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects; D017023:Coronary Angiography; D003327:Coronary Disease / Q000628:therapy*; D005260:Female; D005374:Filtration; D006801:Humans; D008297:Male; D015999:Multivariate Analysis; D019736:Prostheses and Implants; D016032:Randomized Controlled Trials as Topic; D012501:Saphenous Vein / Q000637:transplantation*; D015607:Stents; D016896:Treatment Outcome