Published Online
on July 21, 2003

A more recent version of this article appeared on August 5, 2003

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Submitted on April 9, 2003
Revised on April 29, 2003
Accepted on May 5, 2003

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

Gregg W. Stone MD^*, Campbell Rogers MD, James Hermiller MD, Robert Feldman MD, Patrick Hall MD, Robert Haber MD, A. Masud MD, Patrick Cambier MD, Ron P. Caputo MD, Mark Turco MD, Richard Kovach MD, Bruce Brodie MD, Howard C. Herrmann MD, Richard E. Kuntz MD, Jeffrey J. Popma MD, Steve Ramee MD, David A. Cox MD, and for the FilterWire EX Randomized Evaluation (FIRE) Investigators

From the Cardiovascular Research Foundation and Lenox Hill Heart and Vascular Institute, New York, NY.

^* To whom correspondence should be addressed. E-mail: gstone{at}crf.org.

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.

Methods and 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.

Key words: grafting • stent • complications

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