A recent study has uncovered a decline in the quality of life among individuals suffering from chronic limb-threatening ischemia, a severe manifestation of peripheral artery disease. The research underscores the advantages of revascularization in improving overall well-being.
Globally, more than 200 million people grapple with peripheral artery disease (PAD), a condition resulting from the narrowing of blood vessels supplying the lower limbs from the heart, causing pain during physical activity. Approximately 1 in 10 individuals with PAD progress to chronic limb-threatening ischemia (CLTI), an advanced stage of the disease.
Individuals afflicted with CLTI often experience persistent discomfort, even at rest, due to the accumulation of fatty plaques that impede blood circulation, commonly affecting the leg or foot. They face heightened risks of amputation, cardiovascular issues, and premature mortality. Despite these challenges, there is a scarcity of research on how CLTI impacts the quality of life.
Researchers from Brigham and Women’s Hospital (BWH), Massachusetts General Hospital (MGH), and Boston Medical Center (BMC) collaborated to address this knowledge gap. Building on their prior investigation that focused on the clinical outcomes of the BEST-CLI trial (Best Endovascular versus Best Surgical Therapy for Patients with Critical Limb Ischemia) published in the New England Journal of Medicine (NEJM), the team evaluated changes in patients’ health-related quality of life following revascularization treatment. The results are detailed in a publication in Circulation.
Dr. Matthew Menard, co-director of the Endovascular Surgery Program at BWH and co-principal investigator of BEST-CLI, highlighted, “Our study indicates that individuals with CLTI exhibit a significantly diminished quality of life compared to those with many other chronic conditions.” He added, “Our findings underscore the substantial enhancement in quality of life resulting from revascularization, which reinstates adequate blood flow to the legs. This underscores the pivotal role of revascularization not only in prolonging patients’ lives but also in optimizing their well-being.”
Patients with CLTI who are eligible for surgical intervention typically have two treatment options: surgical bypass (Bypass) or endovascular therapy (Endo). The former involves reconstructing the blocked vessel to restore blood flow to the lower limb, while the latter entails inserting a stent or catheter into the artery to alleviate blockages.
The BEST-CLI trial enrolled over 1,800 CLTI patients from various research sites across the United States, Canada, Finland, Italy, and New Zealand between August 2014 and October 2019. The researchers compared clinical outcomes and quality of life metrics between the two revascularization techniques.
Dr. Kenneth Rosenfield, head of the Section of Vascular Medicine and Intervention in the Division of Cardiology at MGH, emphasized the shift towards a patient-centric healthcare model, emphasizing the importance of considering individual patient needs and evidence-based practices. He stated, “Quality of life serves as a crucial factor in this decision-making process.”
The participants were divided into two cohorts: one comprising patients with an available, high-quality single-segment great saphenous vein (SSGSV) optimal for Bypass, and the other consisting of patients lacking this vein. Both cohorts underwent either Bypass or Endo procedures, with researchers evaluating quality of life through voluntary surveys covering pain levels, daily activities, disease symptoms, physical and mental health. Surveys were conducted at different intervals throughout the study period.
Dr. Alik Farber, interim chair of the Department of Surgery at BMC, stressed the significance of patient-reported outcome measures in enhancing understanding of the patient experience and improving CLTI treatment outcomes.
While previous clinical outcomes from the trial indicated fewer major amputations and lower rates of repeat procedures for Bypass compared to Endo, there was no significant difference in quality of life between the two treatments. Survey results revealed substantial improvements in quality of life post-treatment for participants across both cohorts, irrespective of the revascularization method. Importantly, patients expressed low quality of life levels upon trial entry, underscoring the profound impact of the disease on their well-being.
The study acknowledged limitations, such as the timing of quality-of-life assessments not aligning with significant health events and the overall lack of quality-of-life research in PAD patients. Moving forward, the team aims to explore the cost-effectiveness of these procedures and how costs influence patient quality of life and health outcomes.
Dr. Farber emphasized the need to integrate measures into a comprehensive care plan that considers patient clinical status and treatment cost-effectiveness, ensuring optimal outcomes for both patients and the healthcare system.
The study, led by Matthew T. Menard et al., sheds light on the potential enhancement of quality of life for patients with chronic limb-threatening ischemia through revascularization, as published in Circulation.