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 Breall, Aland Fernandez, Eugene Heyman, Christopher Metzger

Research output: Contribution to journalArticle

70 Citations (Scopus)

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
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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Saphenous Vein
Transplants
Embolic Protection Devices
Acer
Therapeutics
Control Groups
Ischemia
Outcome Assessment (Health Care)
Confidence Intervals
Safety
Incidence

ASJC Scopus subject areas

  • Nursing(all)

Cite this

Randomized evaluation of the triactiv balloon-protection flush and extraction system for the treatment of saphenous vein graft disease. / Carrozza, Joseph P.; Mumma, Michael; Breall, Jeffrey; Fernandez, Aland; Heyman, Eugene; Metzger, Christopher.

In: Journal of the American College of Cardiology, Vol. 46, No. 9, 01.11.2005, p. 1677-1683.

Research output: Contribution to journalArticle

Carrozza, Joseph P. ; Mumma, Michael ; Breall, Jeffrey ; Fernandez, Aland ; Heyman, Eugene ; Metzger, Christopher. / Randomized evaluation of the triactiv balloon-protection flush and extraction system for the treatment of saphenous vein graft disease. In: Journal of the American College of Cardiology. 2005 ; Vol. 46, No. 9. pp. 1677-1683.
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