Joseph P. Carrozza, MD, chief of interventional cardiology at the Beth Israel Deaconess Medical Center, Boston presented that the PRIDE (Protection during Saphenous Vein Graft Intervention to Prevent Distal Embolization) trial showed that the TriActiv System (Kensey Nash) was not inferior to the GuardWire (Medtronic) or the FilterWire (Boston Scientific) for the adjunctive treatment of diseased saphenous veins. Both the GuardWire and the FilterWire systems acted as controls. Clinicians had high device, lesion and procedure success rates.
A measurement of major adverse cardiac events at 30 days showed an 11.2% rate in the TriActiv arm and a 10.1% rate in the control group (¥Ä 1.1%).
Procedure-related major adverse cardiac events, determined by a blinded clinical events committee at 30 days, were 10.2% in the TriActiv group and 10.1% in the control group. TriActiv patients had a higher rate of hemorrhagic/vascular complications than controls (15.1% vs. 4%), but this difference was not present in those patients who were using guiding catheters less than 8 F (6.3% in TriActiv patients vs. 6.1% in the control group).
PRIDE researchers enrolled 894 patients from 68 U.S. and 10 European sites. The first 62 patients were randomized to TriActiv or no embolic protection in a superiority design, but this protocol was soon altered to reflect best clinical practice. Another 631 patients were randomized in a non-inferiority design to TriActiv or a control arm of GuardWire or FilterWire.