Randomized evaluation of the TriActiv balloon-protection flush and extraction system for the treatment of saphenous vein graft disease.
OBJECTIVE
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.
Carrozza
Joseph P
JP
Section of Interventional Cardiology-Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, USA. jcarrozz@bidmc.harvard.edu
Mumma
Michael
M
Breall
Jeffrey A
JA
Fernandez
Aland
A
Heyman
Eugene
E
Metzger
Christopher
C
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D021721:Balloon Occlusion / Q000295:instrumentation*; D005260:Female; D006083:Graft Occlusion, Vascular / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000628:therapy*; D011446:Prospective Studies; D012501:Saphenous Vein / Q000637:transplantation*