SVS Encourages More Participation in PRESERVE Study of IVC Filters
November 8, 2016—The Society for Vascular Surgery (SVS) recently announced updated information on enrollment in the PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) study. PRESERVE is a large-scale, multispecialty, prospective clinical research trial evaluating the real-world safety and effectiveness of retrievable inferior vena cava (IVC) filters. SVS advised it is seeking to encourage its membership to participate in the study. More information is available at the study’s website, www.preservetrial.com.
According to the SVS, the PRESERVE trial has enrolled 356 patients at 32 sites and is designed to enroll 1,800 patients at up to 60 sites. Each of the six filters in the study, all from different manufacturers, will be studied in 300 patients. The society announced the commencement of the trial in December 2015.
The study, sponsored by the IVC Filter Study Group Foundation, is a collaboration of the SVS, the Society of Interventional Radiology (SIR), the US Food and Drug Administration (FDA), and six IVC filter manufacturers. Because of the number of patients experiencing complications from IVC filters, the FDA mandated that all manufacturers complete further studies to demonstrate their safety and efficacy. As an alternative, the SVS and SIR collaborated to create the investigator-initiated PRESERVE study.
The society noted that investigators in the trial have the opportunity to help create standards, track patients who need IVC filters removed, and, ultimately, set guidelines for the treatment of thromboembolism through participating in this national study on the real-world use of the filters. Vascular surgeon David Gillespie, MD, is Coprincipal Investigator for PRESERVE. Interventional radiologist Matthew S. Johnson, MD, is also Coprincipal Investigator.
Commenting on behalf of the SVS in the society’s notification, Dr. Gillespie stated, “I would love to see more vascular surgeon-led sites participate and more physicians participate more fully.” He urged his fellow SVS members to participate and “take ownership of the treatment of DVT and PE with filters. We certainly do with treatment of DVT using thrombolysis and venous stenting.”
Members will benefit through the specialty setting standards of care and for setting guidelines for the treatment of thromboembolism, Dr. Gillespie said. Additionally, data from PRESERVE will “highlight more specifically the complication rate of all these filters and compare them. Then members can make their own decision about which filter to use.” The PRESERVE study, he said, will “basically populate a dataset that could be used for research and publication for years to come.”
A significant problem is that, for a variety of reasons, IVC filters were placed under the assumption that they would be removed but were not. Trauma patients most likely receive emergency treatment and may not follow-up with their physicians for filter removal. With that lack of follow-through on the part of physicians, plus an increasing rate of implantations, the number of patients experiencing filter complications increased. “Even if the rate is low, with an exponential number being implanted, that number becomes a real number of patients,” Dr. Gillespie said.