1. Major amputation and all-cause mortality were higher in the vein bypass group compared to the best endovascular treatment group.
2. Cardiovascular and respiratory-related events contributed to most morbidity and mortality cases.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Chronic limb ischemia is the most severe form of peripheral arterial disease which often requires invasive interventions such as angioplasty, bypass grafting, and amputation. Despite successful revascularization, patients with chronic limb ischemia require multiple procedures and frequent hospital readmissions. This randomized controlled trial aimed to compare the safety and efficacy of vein bypass with the best endovascular treatment in patients with chronic limb-threatening ischemia. The primary outcome was amputation-free survival and death while key secondary outcomes included time to major amputation or revascularization. According to study results, best endovascular treatment was associated with better amputation-free survival compared to the vein bypass strategy. Although this study was well-done, it was largely skewed toward male patients who are known to have fewer complications of limb ischemia compared to female patients.
Click to read the study in The Lancet
Relevant Reading: Transcatheter Arterialization of Deep Veins in Chronic Limb-Threatening Ischemia
In-depth [randomized-controlled trial]: Between Jul 22, 2014, and Nov 30, 2020, 345 patients were screened for eligibility across 41 vascular surgery units in the UK, Sweden, and Denmark. Included were patients with chronic limb-threatening ischemia who underwent revascularization to restore limb perfusion. Altogether, 345 patients (172 in the vein bypass group and 173 in the endovascular treatment group) were included in the intention-to-treat analysis. The primary outcome of major amputation was higher in the vein bypass group (63%) compared to the best endovascular treatment group (53%; adjusted hazard ratio [aHR] 1.35, 95% confidence interval [CI] 1.02-1.80, p=0.037). This was also the case for all-cause mortality (53% in vein bypass group vs. 45% in endovascular treatment group, aHR 1.37, 95% CI 1.00-1.87). Most morbidity and mortality cases were attributable to cardiovascular (110 cases) and respiratory (48 cases) causes. Findings from this study suggest that the best endovascular treatment strategy was associated with better survival compared to vein bypass strategy.
Image: PD
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