SVS and SIR to Initiate Large-Scale PRESERVE Study of IVC Filters in 2015

November 12, 2014—The Society for Vascular Surgery (SVS) and Society of Interventional Radiology (SIR), on behalf of the Inferior Vena Cava (IVC) Filter Study Group Foundation, announced the planned 2015 commencement of the multicenter PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) study with the participation of seven IVC filter manufacturers. SVS and SIR collaboratively formed the IVC Filter Study Group Foundation, a 501(c)(3) not-for-profit entity that sponsors and oversees PRESERVE.

According to the societies, PRESERVE is the first large-scale, multispecialty, prospective clinical research trial to evaluate the use of IVC filters and related follow-up treatment in the United States. Initiated by SVS and SIR, the study is set to enroll the first patient in the spring of 2015.

The study’s protocol development has been completed. The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) study designation with HIPAA (Health Insurance Portability and Accountability Act) compliance. Members of the IVC Filter Study Group Foundation have been working with the contract research organization, New England Research Institutes Inc.

The societies stated that the PRESERVE study will directly address an August 2010 FDA medical alert detailing the possibility that retrievable IVC filters could move or break, potentially causing significant health risks for patients. The FDA recommendations are that physicians remove the filters, which are designed to be retrievable, once the threat of pulmonary embolism has passed. The FDA warning stated that all physicians were encouraged to consider the benefits and health risks of IVC filter removal for each patient.

As reported in Endovascular Today on May 7, 2014, the FDA issued a second safety communication, which contained no new safety concerns but updated the previously issued communication to include information on recently published research and postmarket surveillance studies for these devices (2014;5:10). The FDA issued the initial safety communication regarding removing retrievable IVC filters on August 9, 2010.

The goal of the PRESERVE study is to obtain a real-world view of the safety and effectiveness of most filters placed in the United States. The 5-year study will evaluate the overall safety and efficacy of filters placed by physicians and intends to enroll 2,100 patients at approximately 60 centers in the United States. There will be at least 300 patients enrolled for each participating manufacturer filter, and patients will be evaluated every 6 months postprocedure up to 24 months or filter retrieval.

The PRESERVE study principal investigators are Matthew S. Johnson, MD, Indiana University School of Medicine in Indianapolis, Indiana; and David L. Gillespie MD, Southcoast Health System in Fall River, Massachusetts. In the November 2012 issue of Endovascular Today, Dr. Johnson provided a preview of the PRESERVE study (2012;11:65­–68).

The societies advised that filter manufacturers are providing financial support to the IVC Filter Study Group Foundation to sponsor the PRESERVE study. The manufacturers and devices that will be included in the study are: ALN Implants Chirurgicaux (ALN vena cava filters); Argon Medical Devices, Inc. (Option Elite retrievable vena cava filter, which is designed and manufactured by Rex Medical); B. Braun Interventional Systems Inc. (VenaTech LP vena cava filter); Bard Peripheral Vascular, Inc. (Denali vena cava filter system); Cook Medical (Cook Günther Tulip vena cava filter); Cordis Corporation (Cordis OptEase retrievable vena cava filter and Cordis TrapEase vena cava filter); and Volcano Corporation (Crux vena cava filter system).

In the announcement, the IVC Filter Study Group Foundation’s President, John A. Kaufman, MD, commented, “Patient safety is imperative, which is why interventional radiologists and vascular surgeons are working together collaboratively to respond to FDA's concerns regarding filter safety and effectiveness."

Peter Lawrence, MD, Foundation Vice President, added, “The PRESERVE study will benefit patients by helping determine how well filters prevent pulmonary embolism and when retrievable filters should be removed.”

In addition to Dr. Kaufman and Dr. Lawrence, the IVC Filter Study Group Foundation Board of Directors is composed of SVS Executive Director Rebecca M. Maron (secretary); SIR Executive Director Susan E. Sedory Holzer (treasurer); Peter Gloviczki, MD (SVS representative); and Marshall E. Hicks, MD (SIR representative).