Restoring blood flow to the legs – through surgery or less invasive modalities – reduces pain and enhances quality of life in people with peripheral artery disease (PAD), according to a preliminary study presented at the American Heart Association’s Scientific Sessions 2022.
“This is the first-ever randomized controlled trial of this scale, and it is a landmark effort in its breadth and depth,” said lead study author Matthew Menard, M.D., an associate professor of surgery at Harvard Medical School, and co-director of endovascular surgery at the Brigham and Women’s Hospital, both in Boston via a press release. “The large body of high-quality evidence that guides treatment of heart disease and stroke does not exist for PAD, and until now, there has been almost no data to inform the care of CLTI patients. Our hope is that this study may serve as a benchmark for future efforts in treating this particularly vulnerable patient population.”
In this study, called Best Endovascular versus Best Surgical Therapy for Patients with Chronic Limb Threatening Ischemia (BEST-CLI) Trial, Dr. Menard and colleagues enrolled 1,830 people (average age, 67, 28% female, 72% white, 36% smokers, 69% with diabetes, 11% with end-stage kidney disease) with severe PAD at 150 centers across the U.S., Canada, Italy, Finland and New Zealand.
The first part of the trial focused on safety, the need for repeat procedures and amputations between patients who underwent endovascular procedure and those who had bypass surgery. According to the findings of the first portion of the study, patients who received bypass surgery with their own leg vein as the bypass vessel had better outcomes compared to those who had an endovascular procedure.
To assess for health-related quality of life, the investigators surveyed participants at the beginning of the study and at six follow-up visits over the four years following surgery/procedure. The surveys inquired about pain, daily activities, disease symptoms and severity, physical activity levels, and mental health.
The findings showed that quality-of-life scores were low at the beginning of the study, suggesting poor health status and well-being of patients with chronic limb-threatening ischemia (CLTI), and high pain levels. However, subsequent to surgery or an endovascular procedure, pain scores markedly decreased, and and quality-of-life scores increased.
“We anticipated low levels of quality of life at the beginning of the study due to the pain and other life-altering symptoms associated with chronic limb-threatening ischemia,” said Menard. “Improvement in health-related quality-of-life measures regardless of the type of procedure is very encouraging and highlights the importance of timely restoration of blood flow to the leg and foot.“