Bypass surgery favorable for initial treatment of chronic limb-threatening ischemia
Performing open bypass surgery to restore circulation for people with a severe form of peripheral artery disease (PAD) – a condition that limits blood flow to the legs and feet – resulted in better outcomes for specific patients compared to a less-invasive procedure, a National Institutes of Health-supported clinical research trial has found.
The findings were published in the New England Journal of Medicine and simultaneously presented at the American Heart Association’s Scientific Sessions 2022.
To better understand the effectiveness of two common treatments for CLTI, researchers enrolled 1,830 adults who were planning to have revascularization, a procedure used to restore blood flow in their blocked arteries, and who were eligible for both treatment strategies.
The first trial, defined as cohort 1, included 1,434 adults who were judged to be the best candidates for the bypass surgery because they had an adequate amount of an optimal vein (the single-segment great saphenous vein) preferred for the procedure. Participants were then randomly assigned to have either a surgical bypass or endovascular procedure. Researchers followed the trial participants for up to seven years.
The second trial, defined as cohort 2, included 396 adults who were not the best candidates for the open bypass because they did not have an adequate amount of the preferred saphenous vein. They were randomized to have either an endovascular procedure or a bypass that used alternate graft material instead of the saphenous vein. Researchers followed the trial participants for up to three years.
At the end of the trial, the researchers found that participants in cohort 1 who received the bypass were 32% less likely to have major medical events related to CLTI than those who had an endovascular procedure. This result was driven by a 65% reduction in major repeat surgeries or procedures to retain blood flow in the lower leg and a 27% reduction in major amputations. No differences were found in death rates between the participants who received the bypass surgery and those who received an endovascular procedure.
Adults in cohort 2 – those who did not have the optimal vein for the bypass – had no major differences in outcomes based on having had an open bypass or an endovascular procedure.
