More than 200 million people globally suffer from peripheral artery disease (PAD), a condition characterized by the narrowing of arteries to the lower limbs, causing pain during walking. Approximately 10% of these cases escalate to chronic limb-threatening ischemia (CLTI), an advanced stage of PAD. Individuals with CLTI often experience intense pain even while resting due to fatty plaque buildup that blocks blood flow, primarily to the legs or feet. This severe stage increases the risk of amputation, cardiovascular disease, and early death. Research on how CLTI affects quality of life is lacking. Typically, CLTI patients eligible for surgical intervention face a choice between surgical bypass (Bypass)—where blocked vessels are reconstructed to restore blood flow—or endovascular therapy (Endo), which involves inserting a stent or catheter to open the blockage. Now, a new study has revealed diminished quality of life among patients with chronic limb-threatening ischemia and has emphasized the benefits of revascularization on their well-being.

Following their previous study highlighting the clinical results of the BEST-CLI trial, investigators from Mass General Brigham (Boston, MA, USA) assessed patient health-related quality of life before and after revascularization treatment. The BEST-CLI trial involved more than 1,800 patients with CLTI from 150 research sites in the U.S., Canada, Finland, Italy, and New Zealand between August of 2014 and October of 2019. The researchers divided 1,528 participants into two groups: the first consisted of 1,193 patients with an accessible, high-quality, single-segment great saphenous vein (SSGSV), previously identified as optimal for Bypass; the second group comprised 335 patients lacking an available SSGSV. The team examined differences in clinical outcomes and quality of life between the two revascularization methods.

Participants in both groups were randomized to receive either Bypass or Endo. Quality of life was measured through voluntary surveys that queried pain levels, daily activities, disease symptoms, physical activity, and mental health, including anxiety and depression. These surveys were conducted at baseline, 30 days post-procedure, three months, twelve months, and annually until the study concluded. Results highlighted that CLTI patients generally endure a significantly lower quality of life compared to many other chronic conditions. The findings affirmed that revascularization substantially enhances quality of life by restoring adequate blood flow to the legs, underscoring the essential role of these procedures not only in prolonging life but also in improving patients' wellbeing. Future research by the team will evaluate the cost-effectiveness of these treatments and how factors like cost influence patient quality of life and overall health outcomes.

“The next step is to integrate quality-of-life measures into a more sophisticated care plan to account for the clinical status of the patient and the cost-effectiveness of treatment options, both for the patient and the viability of the healthcare system,” said co-principal investigator Alik Farber, MD, MBA. 

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