Comparison of specialties participating in the BEST-CLI trial to specialists treating peripheral arterial disease nationally

Abstract

Background: The Best Endovascular vs Best Surgical Therapy for Patients with Critical Limb Ischemia (BEST-CLI) trial compares open surgery and endovascular therapy for the treatment of critical limb ischemia (CLI). This report describes the types and proportion of investigators participating in BEST-CLI and determines how these compare with those specialists treating peripheral artery disease (PAD) outside of the trial.

Methods: To be credentialed to enroll in BEST-CLI, investigators must be approved by the Surgical and Interventional Management Committee to have sufficient experience and skill in the management of patients with CLI. Investigators must attest to having completed at least 12 below-knee interventions in the last 2 years on CLI patients for endovascular approval and 10 lower extremity below-knee bypass procedures in the last 2 years for open surgical treatment. Investigators who met these criteria but were within their first year of practice were conditionally approved to do procedures under the oversight of a fully approved investigator. The type and proportion of specialists credentialed in BEST-CLI were compared with those treating PAD on a national basis by auditing 10% of Medicare claims for PAD.

Results: As of September 2017, a total of 865 physicians were credentialed to enroll in the BEST-CLI trial. Of these, 596 (69%) are vascular surgeons, 128 (15%) are interventional cardiologists, 123 (14%) are interventional radiologists, 7 (1%) are vascular medicine specialists, and 11 (1%) are other. Of the 596 vascular surgeons enrolling in the trial, 113 (19%) are credentialed for open surgery only, 409 (69%) are credentialed for both open surgery and endovascular therapy, and 3 (1%) are credentialed for only endovascular therapy. The remaining 71 participating vascular surgeons were conditionally approved. Of the 136 centers enrolling patients, multispecialty involvement is present in 98 (72%). In 38 (28%), vascular surgery alone is the service enrolling CLI patients. Endovascular treatment by specialty in BEST-CLI vs national Medicare claims is as follows: vascular surgery, 55% vs 51%; interventional cardiology, 17% vs 13%; interventional radiology, 16% vs 25%; and other, 2% vs 10%.

Conclusions: BEST-CLI contains a diverse group of specialists enrolling and treating patients with CLI. Whereas a majority of the participating practitioners are vascular surgeons who do both open and endovascular procedures, a broad variety of specialists are represented in BEST-CLI in a pattern that represents national treatment patterns outside of the BEST-CLI trial. These treatment patterns will help ensure that findings from BEST-CLI are applicable to the real-world practice of treatments for PAD.

Trial registration: ClinicalTrials.gov NCT02060630.

Keywords: Critical limb ischemia.

Copyright © 2018. Published by Elsevier Inc.