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November 17, 2014

Enrollment Underway in BEST-CLI Randomized Trial

November 17, 2014—Earlier this fall, investigators began enrolling patients in BEST-CLI, a prospective, multicenter, randomized trial comparing “best endovascular” versus “best surgical” options for treating critical limb ischemia (CLI). The trial is funded by the National Institutes of Health and aims to enroll 2,100 patients at 120 centers in North America over the next 4 years. 

Speaking with Endovascular Today at the recent Vascular InterVentional Advances (VIVA) meeting in Las Vegas, Principal Investigators Alik Farber, MD; Matthew T. Menard, MD; and Kenneth Rosenfield, MD, emphasized the importance of a comparative effectiveness trial in CLI at this time while acknowledging the challenges of the undertaking. In addition to a comprehensive design focusing on both clinical outcomes and cost-effectiveness, the investigators noted that multispecialty input from the trial’s Executive Committee and participation in enrollment and patient care are essential in providing an accurate view of modern CLI therapies. 

Representatives from vascular surgery, interventional cardiology, interventional radiology, and vascular medicine are all represented in the Executive Committee, and the trial has been endorsed by the US Food and Drug Administration, the Society for Vascular Surgery, the Society for Cardiovascular Angiography & Interventions, the Society of Interventional Radiology, the Society of Vascular Medicine, the Vascular Disease Foundation, and VIVA. 

Although there are numerous options now on the market for treating CLI patients, and “endovascular-first” strategies have gained popularity, the data available in the CLI population are largely limited to nonrandomized studies (each focusing on a single device) and one randomized trial that did not include results using many of today’s more commonly utilized therapies. Each previous dataset is important due to its contributions to the vascular community’s understanding of the safety and efficacy of a particular product on its own, achievement of regulatory milestones, or decision-making when it comes to bypass versus angioplasty alone. But, the investigators point out, comparative effectiveness data are increasingly sought after from payers and practitioners alike, with Medicare and insurance providers seeking to ensure strained health care resources are maximally cost-effective and physicians aiming to ideally match therapies to the unique needs of each patient. 

In an attempt to represent the modern clinical scenario as closely as possible, patients randomized to BEST-CLI’s endovascular arm can be treated using nearly any commercially available device and approach according to the preference of the enrolling investigator. Similarly, physicians treating patients enrolled in the open surgical arm can employ the surgical bypass technique or any type of conduit of their choosing. In order to mitigate the possibility that the trial could become dated before it is even complete due to the emergence of newly approved therapies in the coming years, therapies not currently in the trial will be reviewed and evaluated for suitability for inclusion as they emerge. 

The trial will enroll 1,620 patients who have adequate single-segment saphenous vein and 480 who do not. Upon enrollment into each group, the patients will then be randomized in a 1:1 fashion to either endovascular therapy or surgical bypass. The primary endpoint is major adverse limb event–free survival, an endpoint that includes both above-ankle amputation and major reintervention. Secondary endpoints include evaluation of minor reinterventions, hemodynamic success, and clinical success. In addition to the cost-effectiveness component, patients will be assessed for functional status and quality of life. 

For more information on BEST-CLI, please visit www.BESTCLI.com or contact best@neriscience.commmenard@partners.org; alik.farber@bmc.org; and krosenfield1@mgh.harvard.edu, and look for further coverage on the trial and a discussion with the investigators in an upcoming edition of Endovascular Today.

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