title: 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.
abstract: 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.
authors.affiliation: Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, 55 E 59th St, 6th Floor, New York, NY 10022, USA. gstone@crf.org
authors.forename: Gregg W
authors.initials: GW
authors.lastname: Stone
authors.forename: Campbell
authors.initials: C
authors.lastname: Rogers
authors.forename: James
authors.initials: J
authors.lastname: Hermiller
authors.forename: Robert
authors.initials: R
authors.lastname: Feldman
authors.forename: Patrick
authors.initials: P
authors.lastname: Hall
authors.forename: Robert
authors.initials: R
authors.lastname: Haber
authors.forename: A
authors.initials: A
authors.lastname: Masud
authors.forename: Patrick
authors.initials: P
authors.lastname: Cambier
authors.forename: Ron P
authors.initials: RP
authors.lastname: Caputo
authors.forename: Mark
authors.initials: M
authors.lastname: Turco
authors.forename: Richard
authors.initials: R
authors.lastname: Kovach
authors.forename: Bruce
authors.initials: B
authors.lastname: Brodie
authors.forename: Howard C
authors.initials: HC
authors.lastname: Herrmann
authors.forename: Richard E
authors.initials: RE
authors.lastname: Kuntz
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.forename: Steve
authors.initials: S
authors.lastname: Ramee
authors.forename: David A
authors.initials: DA
authors.lastname: Cox
mesh_terms: 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
chemical_list: D007527:Isoenzymes; D003402:Creatine Kinase; D052279:Creatine Kinase, MB Form