Randomized comparison of distal protection with a filter-based catheter and a balloon occlusion and aspiration system during percutaneous intervention of diseased saphenous vein aorto-coronary bypass grafts.
BACKGROUND
The high rate of periprocedural complications resulting from atherothrombotic embolization after percutaneous intervention in diseased saphenous vein grafts is reduced by distal microcirculatory protection using a balloon occlusion and aspiration system. Whether filter-based catheters, which offer the inherent advantages of maintained perfusion and ease of use, are as effective for this purpose has not been established.


RESULTS
A total of 651 patients undergoing percutaneous intervention of 682 saphenous vein graft lesions were prospectively randomized to distal protection with the filter-based FilterWire EX versus the GuardWire balloon occlusion and aspiration system. Device success was 95.5% and 97.2% with the FilterWire EX and GuardWire, respectively (P=0.25). Postprocedural measures of epicardial flow and angiographic complications were similar between the 2 groups, although bailout IIb/IIIa inhibitors were required slightly less frequently in the FilterWire EX group (0% versus 1.5%, P=0.03). The primary end point, the composite incidence of death, myocardial infarction, or target vessel revascularization at 30 days, occurred in 9.9% of FilterWire EX patients and 11.6% of GuardWire patients (difference [95% CI]=-1.7% [-6.4%, 3.1%]; P for superiority=0.53, P for noninferiority=0.0008).


CONCLUSIONS
Distal protection with the FilterWire EX may be safely used as an adjunct to percutaneous intervention of diseased saphenous vein grafts and, compared with distal protection with the GuardWire balloon occlusion and aspiration system, results in similar rates of major adverse cardiac events at 30 days.
Stone
Gregg W
GW
Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, 55 E 59th St, 6th Floor, New York, NY 10022, USA. gstone@crf.org
Rogers
Campbell
C
Hermiller
James
J
Feldman
Robert
R
Hall
Patrick
P
Haber
Robert
R
Masud
A
A
Cambier
Patrick
P
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
D000368:Aged; D001161:Arteriosclerosis / Q000601:surgery; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation; D002170:Canada; D002404:Catheterization / Q000295:instrumentation* / Q000379:methods; D017023:Coronary Angiography; D001026:Coronary Artery Bypass / Q000009:adverse effects*; D003402:Creatine Kinase / Q000097:blood; D052279:Creatine Kinase, MB Form; D004562:Electrocardiography; D004617:Embolism / Q000517:prevention & control*; D005260:Female; D005374:Filtration / Q000295:instrumentation*; D006801:Humans; D007527:Isoenzymes / Q000097:blood; D008297:Male; D012501:Saphenous Vein / Q000601:surgery* / Q000637:transplantation; D015607:Stents; D013396:Suction; D016896:Treatment Outcome; D014481:United States
D007527:Isoenzymes; D003402:Creatine Kinase; D052279:Creatine Kinase, MB Form