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.
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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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