A significant proportion of patients enrolled in the BEST-CLI trial did not meet optimal medical therapy (OMT) guideline-based recommendations at the time of their entry into the study, co-principal investigator Matthew Menard, MD, told the 2022 New England Society for Vascular Surgery (NESVS) annual meeting in Newport, Rhode Island (Oct. 14–16).
The investigators were looking to understand the utilization of OMT at the inception point, with baseline data—post-consent, prior to revascularization—showing that 87% of patients enrolled had hypertension, 74% had hyperlipidemia, 69% diabetes, and 36% were active smokers, Menard told attendees.
“How did we do?” he pondered. “Not so well. The data show those who had controlled blood pressure was 64%, “so just shy of two thirds,” said Menard. The number of those still smoking was greater than one third, he continued, with those on at least one lipid-lowering medication “a little better at 72%,” while those on at least one antiplatelet medication was 73%.
He further revealed how just a quarter met all four OMT criteria, with 2% not meeting any of the stated components. Some 38% met three, another quarter two, and 11% just one of the criteria.
Multivariate analysis showed Hispanic ethnicity, prior or existing coronary artery disease, stroke and diabetes were among positive predictors of a higher optimal medical therapy score, while Black race and participation in Cohort 1 were negative predictors.
“Patients in this BEST-CLI dataset had utilization rates of defined optimal medical therapy well below recommended at the time of presentation,” Menard said.
“Where do we go from here? The most important work is to turn participation in the trial into improved utilization of optimal medical therapy.”
Changes from baseline utilization of optimal medical therapy over the course of BEST-CLI and associated impacts on clinical outcomes and quality of life are to be further assessed, Menard added.
