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.
Halkin
Amir
A
Cardiovascular Research Foundation, New York, NY 10022, USA.
Masud
A Zaki
AZ
Rogers
Campbell
C
Hermiller
James
J
Feldman
Robert
R
Hall
Patrick
P
Haber
Robert H
RH
Cambier
Patrick A
PA
Caputo
Ron P
RP
Turco
Mark
M
Kovach
Richard
R
Brodie
Bruce
B
Herrmann
Howard C
HC
Kuntz
Richard E
RE
Popma
Jeffrey J
JJ
Ramee
Steve
S
Cox
David A
DA
Mehran
Roxana
R
Stone
Gregg W
GW
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