Clinical outcomes of bypass-first versus endovascular-first strategy in patients with chronic limb-threatening ischemia due to infrageniculate arterial disease

Abstract

Background: Chronic limb-threatening ischemia (CLTI), defined as ischemic rest pain or tissue loss secondary to arterial insufficiency, is caused by multilevel arterial disease with frequent, severe infrageniculate disease. The rise in CLTI is in part the result of increasing worldwide prevalence of diabetes, renal insufficiency, and advanced aging of the population. The aim of this study was to compare a bypass-first with an endovascular-first revascularization strategy in patients with CLTI due to infrageniculate arterial disease.Methods: We reviewed the American College of Surgeons National Surgical Quality Improvement Program targeted lower extremity revascularization database from 2012 to 2015 to identify patients with CLTI and isolated infrageniculate arterial disease who underwent primary infrageniculate bypass or endovascular intervention. We excluded patients with a history of ipsilateral revascularization and proximal interventions. The end points were major adverse limb event (MALE), major adverse cardiovascular event (MACE), amputation at 30 days, reintervention, patency, and mortality. Multivariable logistic regression was used to determine the association of a bypass-first or an endovascular-first intervention with outcomes.Results: There were 1355 CLTI patients undergoing first-time revascularization to the infrageniculate arteries (821 endovascular-first revascularizations and 534 bypass-first revascularizations) identified. There was no significant difference in adjusted rate of 30-day MALE in the bypass-first vs endovascular-first revascularization cohort (9% vs 11.2%; odds ratio [OR], 0.73; 95% confidence interval [CI], 0.50-1.08). However, the incidence of transtibial or proximal amputation was lower in the bypass-first cohort (4.3% vs 7.4%; OR, 0.60; CI, 0.36-0.98). Patients with bypass-first revascularization had higher wound complication rates (9.7% vs 3.7%; OR, 2.75; CI, 1.71-4.42) compared with patients in the endovascular-first cohort. Compared with the endovascular-first cohort, the incidence of 30-day MACE was significantly higher in bypass-first patients (6.9% vs 2.6%; adjusted OR, 3.88; CI, 2.18-6.88), and 30-day mortality rates were 3.23% vs 1.8% (adjusted OR, 2.77; CI, 1.26-6.11). There was no difference in 30-day untreated loss of patency, reintervention of treated arterial segment, readmissions, and reoperations between the two cohorts. In subgroup analysis after exclusion of dialysis patients, there was also no significant difference in MALE or amputation between the bypass-first and endovascular-first cohorts.Conclusions: CLTI patients with isolated infrageniculate arterial disease treated by a bypass-first approach have a significantly lower 30-day amputation. However, this benefit was not observed when dialysis patients were excluded. The bypass-first cohort had a higher incidence of MACE compared with an endovascular-first strategy. These results reaffirm the need for randomized controlled trials, such as the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL-2)...

Risk of Death and Amputation with Use of Paclitaxel-Coated Balloons in the Infrapopliteal Arteries for Treatment of Critical Limb Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

“…Both endovascular and surgical revascularization are valid treatment options, and individualized decisions for optimal therapy by a multidisciplinary team of physicians are recommended (2,3). Endovascular therapies of infrapopliteal arterial occlusions are often preferred considering their inherently less invasive nature and because of multiple patient background comorbidities or absence of a suitable vein conduit (4). Hence, percutaneous revascularization has been developed as mainstream treatment of below-the-knee arterial occlusive disease, offering long-term clinical outcomes comparable to open bypass surgery (5).…”

Long-Term Outcomes of Extra-Anatomic Femoro-Tibial Bypass Reconstructions in Chronic Limb-Threating Ischemia

“…The role of endovascular versus surgery first in the infrapopliteal segment is still under discussion [ 3 ]. Whereas better results as to patency and short-term amputation-free survival for bypass grafts [ 24 , 25 ] have been described, similar long-term outcomes as to amputation–free survival are reported for both approaches [ 3 ]; nevertheless, such comparisons are biased by high heterogeneity in terms of patient and lesion characteristics and especially by the fact that no long-segment occlusions are included in endovascular therapy studies [ 3 , 4 ]. Against this background, we may conclude that an individualized approach is essential in these patients and that tibial and pedal bypass grafts remain crucial therapy tools in CLTI and in the presence of long-segment occlusions of the infrapopliteal arteries.…”

Bypass Surgery versus Endovascular Therapy for Lower Limb Ischemia Due to Infragenicular Lesions

“…The United Kingdom multicenter bypass versus angioplasty in severe ischemia of the leg (SIL) trial remains the only randomized controlled trial (RCT) to compare a bypassfirst with an endovascular-first revascularization strategy for infrainguinal arterial occlusive disease. However, this study did not specifically address the effectiveness of treatment for the infrageniculate arteries (2) . For the aortoiliac and femoropopliteal arterial areas, the therapeutic results of lower limb enodovascular therapy (EVT) including long-term outcomes have improved and became equivalent to those of bypass surgery (3) .…”