A Prospective, Randomized, Controlled Trial of Distal Protection With the Third Generation Mednova Emboshield Compared to the GuardWire or FilterWire - CAPTIVE

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

Description:

This study evaluated the safety and efficacy of distal protection the Emboshield filter device compared to the Guardwire balloon occlusion system for percutanous intervention on saphenous vein grafts.

Hypothesis:

Distal protection using the Emboshield distal protection device would be superior to no distal protection and noninferior to distal protection using the Guardwire.

Study Design

Study Design:

Patients Enrolled: 1011

Patient Populations:

Patient is a candidate for ischemia driven stent placement in a saphenous vein graft with baseline TIMI 2 flow or greater and reference vessel diameter between 3.0 and 6.0 mm.

Exclusions:

MI within 24 hours of enrollment, total CK more than 2 times upper limit normal, LVEF <30%, ostial lesion, lesion in arterial conduit or lesion without sufficient space from end of filter to place stent.

Primary Endpoints:

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

Secondary Endpoints:

In-hospital MACE, Technical success and presence of visible embolic material within filter upon retrieval.

Drug/Procedures Used:

Saphenous vein graft intervention using the Emboshield protection system.

Principal Findings:

The initial 197 patients randomized to the Emboshield (n=96) or no distal protection (n=101) did not provide sufficient statistical power to make conclusions regarding the efficacy of the Emboshield relative to placebo. After the protocol was revised to reflect the widespread usage of distal protection in saphenous vein graft intervention, 652 patients were randomized to the Emboshield (n=334) or control with distal protection using the Guardwire device(n=318) with the goal of demonstrating noninferiority. MACE rates at 30 days were 11.4% in the Emboshield group and 9.1% in the Guardwire group. This absolute difference was not statistically significant and did not achieve the the stastical threshold for noninferiority. Utilizing a prespecified modified intention to treat analysis, patients who did not receive the assigned treatment were excluded. Reanalysis showed the MACE rate in the Emboshield group to be 10.1% and 8.8% in the Guardwire group (p=0.022).

Interpretation:

Among saphenous vein graft patients undegoing percutaneous intervention, the Emboshield filter device did not prove statistictical noninferiority when compared to the Guardwire balloon / aspiration device. Event rates in this trial were low (<12%) in comparison to prior studies. Further studies are necessary to evaluate whether the next generation Emboshield device is noninferior compared to currently approved distal protection devices for saphenous vein graft intervention.

References:

Holmes, DR. A prospective randomized, controlled trial of distal protection with the Emboshield compared to the Guardwire. Presented at Transcatheter Therapeutics 2004, Sept. 28. Washington, DC.

Keywords: Coronary Artery Disease, Balloon Occlusion, Saphenous Vein, Intention to Treat Analysis, Stents


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