A Prospective, Randomized, Controlled Trial of Distal Protection With the Kensey-Nash TriActiv System Compared to the GuardWire or FilterWire - PRIDE

Nov 08, 2004
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Date Presented:
01/01/2004
Date Published:
01/01/2005
Date Updated:
11/08/2004
Original Posted Date:
11/08/2004
References

Description:

This was a study evaluating the use of the Triactiv distal occlusion system to current the standard therapy for percutaneous intervention in saphenous vein grafts (SVGs). The Triactive system is a distal balloon occlusion device with continous active removal of debris using a motorized pump with saline infusion and the angioplasty guiding catheter.

Hypothesis:

The Tractiv distal protection system would be superior to no distal protection and non-inferior to distal protection with the Guardwire or Filterwire.

Study Design

Patients Enrolled: 894
Mean Follow Up: 30 days

Patient Populations:

Saphenous vein graft lesions between 3.0 and 5.0 mm in diameter with no limit on lesion length.

Exclusions:

Age less than 21 years, immediate treatment of one or more native vessels, treatment of more than 2 SVGs, CK-MB elevation more than two times upper limit normal within 24 hours of enrollment, pre-treatment with atherectomy, lesion less than 2.0 cm from distal anastomosis, Y graft lesions unless lesion is more than 2.0 cm from the branch, graft age <6 months, LVEF <25%, allergy to latex, aspirin, or clopidogrel/ticlodipine, life expectancy <6 months.

Primary Endpoints:

Major adverse cardiac events at 30 days (death, MI, emergent CABG, or target vessel revascularization)

Secondary Endpoints:

Final TIMI 3 flow, in-hospital MACE, stroke in-hospital and at 30-days, major vascular complications, and need for transfusion.

Drug/Procedures Used:

Percutaneous intervention using the Triactive distal protection system in SVGs.

Concomitant Medications:

Patients were stratified according to usage of Glycoprotein IIB/IIIA receptor antagonists

Principal Findings:

An initial cohort of patients (n=62) was enrolled prior to approval of the Filterwire and the routine usage of distal protection. The remaining cohort (n=631) was randomized between the Tractiv system and the standard distal protection using the Guardwire or Filter Wire. Periprocedureal CPK elevations occurred in approximately 27% of patients. No significant differences were noted among the groups. The rates of the primary endpoint of MACE was 10.1% in the control group and 11.2% in the Tractiv group. The absolute difference of 1.1% led to a 5.2% one-sided 95% confidence interval fulfilling the criteria for noninferiority. There was no significant interaction with these results and the usage of Glycoprotein IIB/IIA receptor antagonists. Increased rates of hemorrhagic/vascular complications were seen in patients undergoing intervention using the Triactive system 11.8% v. 6.6%; p=0.02). Further analysis revealed that these complications occurred more frequently in Triactiv patients when 8 French guiding catheters were used (15.1% v. 4.0%), while no difference was noted when the Triactiv system was used with a 7 French system (6.3% v. 6.1%).

Interpretation:

Among patients undergoing SVG intervention, no conclusions can be made regarding the efficacy of the Triactiv device vs. use of no distal protection device due to small numbers of patients (n=62) in the Tractiv vs. no distal protection arms. The Triactiv system was not inferior with regard to efficacy when compared to the Guardwire or Filterwire and may be regarded as an acceptable alternative for use during percutaneous vein graft intervention. There were no differences in post treatment angiographic complications including no-reflow, perforation or dissection. TIMI-3 flow was present at the end of the case in over 98% of patients. Increased hemorrhagic complications occur when 8 French systems are used and efforts should be made to use 7 French guiding catheters when utilizing the Triativ distal protection system.

References:

Carrozza JP Jr, Mumma M, Breall JA, Fernandez A, Heyman E, Metzger C; PRIDE Study Investigators. Randomized evaluation of the TriActiv balloon-protection flush and extraction system for the treatment of saphenous vein graft disease. J Am Coll Cardiol. 2005 Nov 1;46(9):1677-83.

Carrozza JP. A multicenter, randomized trial of PRotection during saphenous vein graft Intervention to prevent Distal Embolization. Presented at Transcatheter Therapeutics 2004, Sept. 28. Washington, D.C.

Keywords: Balloon Occlusion, Saphenous Vein, Coronary Disease, Confidence Intervals, Coronary Artery Bypass, Angioplasty, Graft Occlusion, Vascular, Stents


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