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CLINICAL RESEARCH

Randomized Evaluation of the TriActiv Balloon-Protection Flush and Extraction System for the Treatment of Saphenous Vein Graft Disease

Joseph P. Carrozza, Jr, MD, FACC^_*,_*, Michael Mumma, MD, FACC, Jeffrey A. Breall, MD, PhD, FACC, Aland Fernandez, MD, FACC, Eugene Heyman, PhD^||, Christopher Metzger, MD, FACC^¶ for the PRIDE Study Investigators

^_* Section of Interventional Cardiology-Beth Israel Deaconess Medical Center, Boston, Massachusetts USA
Sarasota Memorial Hospital, Sarasota, Florida USA
Krannert Institute of Cardiology, Indiana University of Medicine, Indianapolis, Indiana USA
Morton Plant Hospital, Clearwater Cardiovascular & Interventional Consultants, Clearwater, Florida USA
^|| Montgomery Village, Maryland USA
^¶ Wellmont Holston Valley Medical Center, Kingsport, Tennessee USA

Manuscript received February 28, 2005; revised manuscript received June 17, 2005, accepted June 21, 2005.

^_* Reprint requests and correspondence: Dr. Joseph P. Carrozza, Jr., Section of Interventional Cardiology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, Massachusetts 02215 (Email: jcarrozz{at}bidmc.harvard.edu).

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.

Abbreviations and Acronyms   FIRE = FilterWire EX Randomized Evaluation   MACE = major adverse cardiac events   MI = myocardial infarction   PCI = percutaneous coronary intervention   PRIDE = Protection During Saphenous Vein Graft Intervention to Prevent Distal Embolization trial   SAFER = Saphenous Vein Graft Angioplasty Free of Emboli, Randomized study   SVG = saphenous vein/venous graft   TIMI = Thrombolysis In Myocardial Infarction   TLR = target lesion revascularization   TVR = target vessel revascularization

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