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

Gregg W. Stone, Campbell Rogers, Steve Ramee, Christopher White, Richard E. Kuntz, Jeffrey J. Popma, John George, Steve Almany, Steve Bailey

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)1882-1888
Number of pages7
JournalJournal of the American College of Cardiology
Volume40
Issue number10
DOIs
Publication statusPublished - Nov 20 2002

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ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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