Distal filter protection during saphenous vein graft stenting: technical and clinical correlates of efficacy

J Am Coll Cardiol. 2002 Nov 20;40(10):1882-8. doi: 10.1016/s0735-1097(02)02129-0.


Objectives: The aim of this study was to evaluate the clinical, angiographic, and technical factors related to successful stenting of diseased saphenous vein grafts (SVGs) using a novel filter-based distal protection device.

Background: Protection of the distal microvasculature with a balloon occlusion and aspiration system has been shown to reduce atherothrombotic embolization and peri-procedural myocardial infarction (MI) after percutaneous coronary intervention (PCI) in SVGs. The safety, efficacy, and technical factors relating to procedural success with filter-based distal protection devices are unknown.

Methods: Percutaneous coronary intervention was performed in 60 lesions in 48 patients undergoing SVG intervention with the FilterWire EX distal protection system in a phase I experience at six sites. A larger phase II study was then performed in 248 lesions in 230 SVGs at 65 U.S. centers.

Results: Cumulative adverse events to 30 days occurred in 21.3% of patients in phase I, including a 19.1% rate of MI. Numerous anatomic, device-specific, and operator-related contributors to these adverse events were identified, resulting in significant changes to the protocol and instructions for use. Subsequently, despite similar clinical and angiographic characteristics to the phase I patients, the 30-day adverse event rate in phase II was reduced to 11.3% (p = 0.09), due primarily to a lower incidence of peri-procedural Q-wave and non-Q-wave MI.

Conclusions: Distal protection during SVG PCI with the FilterWire EX is associated with a low rate of peri-procedural adverse events compared to historical controls. A unique set of anatomic, technical, and operator-related issues exist with distal filters which, if ignored, may reduce their effectiveness.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Aged
  • Blood Vessel Prosthesis Implantation
  • Device Removal
  • Equipment Design
  • Female
  • Filtration / instrumentation*
  • Humans
  • Male
  • Middle Aged
  • Myocardial Infarction / surgery
  • Prospective Studies
  • Saphenous Vein / transplantation*
  • Stents*
  • Treatment Outcome
  • United States