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Home > Vascular Annual Meeting^® > RR36. Prospective Randomized Study Comparing...

RR36. Prospective Randomized Study Comparing the Clinical Outcomes Between IVC Greenfield Filter and TrapEase Filter

Fred Usoh, Anil Hingorani, Enrico Ascher, Natalie Marks, Alexander Shiferson, Nirav Patel, Kapil Gopal, Theresa Jacob
Maimonides Medical Center, Brooklyn, NY

OBJECTIVES: Although anticoagulation remains the mainstay of treatment for DVT, the utilization of vena cava interruption devices in patients who have failed or in whom anticoagulation is contraindicated remains a safe and effective treatment. In this regards, Greenfield and Trapease filters are arguably the most popular filtration devices. Despite the popularity of the above mentioned filters, there are no good guidelines in place to help determine which filter to use in any given situation. Therefore, we prospectively compared the clinical outcomes between the above-mentioned filters in a randomized fashion.

METHODS: Between July 2006 and November 2008, 156 patients (63 males, 93 females; mean age of 75 years [range, 38-101 years±13 (sd]) were randomized to either Greenfield (n=84) or TrapEase (n=72) IVC filters. During this same period, 349 patients (143 males, 206 females, mean age 75 years±15(sd), range 24-96 years) were not randomized. Other demographics were: randomized group (malignancy=26.9%, PE=17.3%) non-randomized group (malignancy=16.9%, PE=17.2%). Follow -up consisted of serial lower extremity and iliac/IVC duplex at post-op day 1, 1st week, every 3 month for the first year, and every 6months for the second year, and clinic visits.

RESULTS: Indications for filter placement in the randomized group were (GI bleeding=37, intracranial hemorrhage=12, free floating clot=19, failure of anticoagulation=29, PE=27, prophylactic=4, others=32) and non-randomized (GI bleeding=78, intracranial hemorrhage=26, free floating clot=31, failure of anticoagulation=51, PE=60, prophylactic 31, others=77). During a mean follow-up of 7±7 months (sd) (range 0-24 months), 5 patients (6.94%) developed symptomatic IVC/iliac thrombosis in the TrapEase group and none in the Greenfield group (p-value=0.019). Overall mortality was 32.7% (51 patients) and 30 day mortality was 13.5% (21 patients: 10 in TF and 11 in GF group respectively). 78.2% underwent duplex follow-up. The study was initially designed to recruit 360 patients but was prematurely concluded due the results.

CONCLUSIONS: There is a higher rate of symptomatic IVC filter thrombosis associated with Trapease filter placement. This is the first randomized prospective study comparing IVC filters since their inception in 1967 with the Mobin-Uddin filter.

AUTHOR DISCLOSURES: F. Usoh, None; A. Hingorani, None; E. Ascher, None; N. Marks, None; A. Shiferson, None; N. Patel, None; K. Gopal, None; T. Jacob, None.