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Participation In A Landmark Critical Limb Ischemia (CLI) Trial Is Inversely Correlated With Amputation Rate In CLI Patients
Alik Farber1, *Maria Fernanda Villarreal Rodriguez1, *Matthew Menard2, *Maxwell Van Over3, *Mark Cziraky3, *Kenneth Rosenfield4, Philip Goodney5
1Boston Medical Center, Boston, MA;2Brigham and Womens Hospital, Boston, MA;3Healthcore Inc, Watertown, MA;4Massachussets General Hospital, Boston, MA;5Dartmouth-Hitchcock Medical Center, Boston, MA

OBJECTIVES: There is limited evidence regarding the role of RCTs in management of peripheral arterial disease (PAD). The Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial (n=1843) is an ongoing, multicenter, NIH-sponsored, international RCT comparing revascularization strategies in patients with CLI. We sought to correlate amputation rate among CLI patients across the United States (US) with RCT participation, hypothesizing that regions with BEST-CLI participation have better outcomes. METHODS: As a surrogate measure of CLI prevalence we queried the CMS database (2007-2016) for patients with concurrent PAD and diabetes, then assessed how many had leg amputations. Correlation of regional amputation rates with distribution of BEST-CLI sites in 4 US geographical regions was calculated. RESULTS: Of 9,231,909 CLI patients, 342,406 underwent amputation. Amputation rates per 1000 CLI patients differed by region (South 40.4, Midwest 40.1, West 34.8, Northeast 31.1) (P<.0001). 117 US vascular centers participated in BEST-CLI with the following distribution; South (n=28, 24%), Midwest (n=26, 22%), West (n=30, 26%), and Northeast (n=33, 28%). There was a negative correlation between the proportion of Medicare CLI patients with amputation and the number of BEST-CLI sites in the region (Pearsonís correlation -0.95, p=0.50). CONCLUSION: Amputation rate among Medicare CLI patients is inversely correlated with US BEST-CLI site distribution. Higher participation in high profile RCTs may be a marker of optimal PAD management


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