Randomized evaluation of the triactiv balloon-protection flush and extraction system for the treatment of saphenous vein graft disease

Joseph P. Carrozza, Michael Mumma, Jeffrey A. Breall, Aland Fernandez, Eugene Heyman, Christopher Metzger

Research output: Contribution to journalArticle

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Abstract

OBJECTIVES: The Protection During Saphenous Vein Graft Intervention to Prevent Distal Embolization (PRIDE) study compared outcomes with the TriActiv System (Kensey Nash Corp., Exton, Pennsylvania), a balloon-protection flush and extraction device, with an embolic protection group during treatment of saphenous venous grafts (SVGs). BACKGROUND: Treatment of SVGs with embolic protection reduces adverse cardiac events. METHODS: We conducted a prospective trial randomizing 631 patients with coronary ischemia and lesions in SVGs to embolic protection with the TriActiv System or control group (Guardwire System [Medtronic AVE, Santa Rosa, California] or Filterwire EX [Boston Scientific Corp., Maple Grove, Minnesota]). RESULTS: The incidence of major adverse cardiac events at 30 days was 11.2% for the TriActiv group and 10.1% for the control group (relative risk = 1.1%; 95% confidence interval 0.67 to 1.76; p = 0.65; p = 0.02 for non-inferiority). Safety and efficacy end points were similar between groups except that patients randomized to the TriActiv System had more hemorrhagic complications (10.9% vs. 5.4%; p = 0.01). CONCLUSIONS: The TriActiv System was not inferior to approved embolic protection devices for the treatment of diseased SVGs.

Original languageEnglish (US)
Pages (from-to)1677-1683
Number of pages7
JournalJournal of the American College of Cardiology
Volume46
Issue number9
DOIs
StatePublished - Nov 1 2005

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ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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