First results from BEST-CLI poised to reveal ‘very low’ quality of life for patients entering the trial, especially women

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Richard J. Powell

An analysis from the Best Endovascular versus Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial presented at the 2022 Vascular Annual Meeting (VAM) demonstrated patient-specific variables such as self-reported female gender, current smoking, impaired mobility and opioid use are associated with lower health-related quality of life (HR-QOL) as captured by multiple measurement tools.

Richard J. Powell, section chief of vascular surgery at Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, told Vascular Specialist@VAM this is a unique dataset that acquired information from three different patient-reported quality of life measures (VascQOL [Vascular Quality of Life Questionnaire], EQ-5D [EuroQoL 5D], and SF-12) and shed light on the baseline demographics of the 1,830 patients enrolled into the BEST-CLI randomized controlled trial that is set to be presented in fall 2022. Data were obtained from the majority of patients (94.9%, 95.8%, and 95.8% of subjects completed the VascQOL, EQ5D, and SF-12 instruments at baseline). “I think that is the power of it. It is not just one quality of life measure, so if you see these factors reproducing themselves across instruments, it is probably real,” he said. 

BEST-CLI is an ongoing, National Institutes of Health-sponsored, multicenter trial comparing revascularization strategies in patients with chronic limb-threatening ischemia (CLTI). The latest data was presented in a VAM 2022 (June 15–18) plenary session in Boston.

Powell outlined that there is limited evidence regarding the role of health-related quality of life (HRQOL) measures in patients with CLTI. Speaking particularly on female gender being associated with lower quality of life in multiple QOL measurement tools, he said: “This bears looking into as it is present with other disease processes as well. Are women less able to receive social support to weather the storm? Are they not being looked after in the same way as men? Do they present with later-or end-stage disease? These remain questions to be researched.” 

Powell is also categorical that while QOL scores assess perceptions of independence, mobility and mental sharpness and how “functional” patients are, they are not a direct indicator of happiness and that this is where is all gets “tricky.”

“If the patient is a golfer who can no longer play golf, because they’ve got a sore on the bottom of their foot, they may be very functional but they’re likely to be miserable. But if it’s a person who gets up in the morning and watches TV all day, they could have lost their leg and still be perfectly happy because they’re doing everything they want to do. And it’s the doctor’s role to keep people happy for as long as possible.” 

Vitally, this dataset allows physicians to look at the modifiable risk factors that cause patients to have low quality of life. “Smokers across the board have worse quality of life than non-smokers. So that’s a modifiable risk factor. Another is independence. So, trying to do everything possible to keep the patient working, and that might go along with things like making sure they have an orthotic or something to walk on and that they remain weight bearing [is really important]. But I think those sorts of patient modifiable factors have a direct impact on quality of life. And yet there are some non-modifiable risk factors like female gender and it is important for vascular specialists to be aware of this.” 

The mean (standard deviation) SF-12 physical and mental health reads for all patients in the study will be revealed to be significantly lower than the national SF-12 scores for the U.S. population over 60 years of age. Indeed, Powell emphasized that these BEST-CLI SF12 baseline population scores are similar to a population of patients with cancer and three to four additional chronic conditions—typically characterized by impaired mobility and chronic pain. “Interestingly, these scores are a little bit better than those reported by the BASIL trial, and significantly better than three previous trials, so it might be that we are doing a better job of medically managing patients’ associated comorbidities,” he said. 

Speaking to the wider interest that the dataset could garner, Powell stated that it could serve as a benchmark. “Other groups of people will find this useful if they are interested in planning a CLI trial, because they’ll be able to use this as a point of reference. The FDA could actually use it as a performance goal. So, if you know the average quality of life measure for CLI patients in these different scores, you could run a single-arm trial and use these data as a benchmark to simplify evidence generation,” he said. 

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