Patients with diffuse multi-level peripheral arterial disease have achieved disappointing results following complete surgical or endovascular revascularization (1–3) and account for approximately 30% (4). Iliac-only revascularization strategy (5) can improve collateral circulation, via the patent profunda femoris artery (either pre-existing or re-established by endovascular intervention), to the ischemic lower limb in cases of both iliac artery and superficial femoral artery (SFA) occlusive disease. On the one hand, the deep femoral artery (DFA), which acts as a collateral pathway, plays a critical role in the irrigation of the limbs when the SFA is severely stenosized or occluded (6). On the other hand, the iliac artery and DFA lesion are less susceptible to atherosclerosis than the SFA lesion in patients with diffuse multilevel peripheral arterial disease (PAD), and prior studies have demonstrated that endovascular treatments have a greater long-term primary patency for the iliac artery and DFA lesion compared with SFA lesion (7–9). Therefore, SFA revascularization is not always justified in multifocal arterial disease, as some patients can solely achieve symptom relief and limb salvage by using the iliac-only revascularization strategy (5, 6, 10). However, for the treatment of concomitant iliac and SFA occlusive disease, there has been a few published discussions about the complete multi-level vs. iliac-only revascularization. Considering the above knowledge, the objective of this study is to compare the efficacy and safety of complete multi-level vs. iliac-only revascularization for the treatment of concomitant iliac and SFA occlusive disease.

This retrospective study was approved by the hospital's medical ethics committee, and a written informed consent was obtained from all eligible patients. A total of 139 consecutive adult patients with concomitant iliac and SFA occlusive disease with Rutherford classes of 2–5 underwent multi-level and iliac-only revascularization at the Department of Intervention Vascular Surgery, Peking University Third Hospital, and Aerospace Center Hospital, between March 2015 and June 2017. Patients’ data, such as demographics, comorbidities, lesion characteristics, procedural details, and outcome variables, were collected from the hospital’s electronic medical records. The patients were required to have the patent profunda femoris artery (either pre-existing or re-established by endovascular intervention) and at least one healthy outflow tract of the infrapopliteal artery. The exclusion criteria were patients with acute limb ischemia or anastomosis stenosis, limited life expectancy or limited walking, pregnancy, or lactation. The intervention strategies were based on the surgeon's preference and patients’ selection. The details of the endovascular procedures were obtained from the electronic patient records. The lesion characteristics were evaluated by the Trans-Atlantic Inter-Society Consensus II classification.

For patients with concomitant iliac and SFA occlusive disease, vascular surgeons are probably reluctant to perform a complete multi-level reconstruction in light of the prolonged operation time, operative complication, or poor prognosis (11). In another way, revascularization from an iliac artery to the DFA without repair of the SFA has been performed to achieve relatively good results through either surgical or endovascular treatment (5, 6, 10–13). To the best of our knowledge, no comparative data were found regarding the relative efficacy of complete multi-level vs. iliac-only revascularization. In the present study, the improvement in Rutherford category (P = 0.809) and the limb salvage rate (93.1% vs. 91.3%, P = 0.781) were similar between the two groups. This indicated that the improvement of conditions, for the patients with both iliac and SFA lesions, and the presence of at least one healthy outflow tract of the infrapopliteal artery were observed in the majority of patients through either complete multi-level or iliac-only revascularization. A possible explanation is that the blood flow through the isolated patent DFA in the iliac-only group was equal to the flow through both patent SFA and DFA in the multi-level group (14). Furthermore, home-based walking exercise might accelerate the blood restoration of chronic critical limb ischemia and promote the formation of collateral vessels in SFA occlusive disease (15, 16). Therefore, multi-level revascularization is not always justified in patients with iliac and SFA lesions, considering that in most of these patients iliac-only intervention is required (Figures 5).

In theory, poor runoff is one of the main risk predictors of iliac arterial stent failure. Mousa et al. (17) advocate a hybrid therapy of combined percutaneous iliac angioplasty and infrainguinal surgical reconstruction in patients with multisegmental arterial occlusive disease. However, Timaran et al. (2) failed to demonstrate that concomitant infrainguinal arterial revascularization improves the patency of the iliac stent. Kudo et al. (18) reported that angioplasty for occluded SFA disease did not improve primary patency and clinical outcomes following percutaneous transluminal angioplasty of the iliac arteries. The patency of the iliac artery stent (84.0% vs. 79.1%, P = 0.717) was comparable between the two groups. The results suggest that SFA patency does not adversely interfere with the primary failure of endovascular intervention for iliac arterial disease. Similarly, de Athayde Soares et al. (6) evaluated the importance of SFA and PFA after endovascular treatment of chronic aortoiliac occlusive disease, and the PFA in conjunction with its collateral circulation may have a great value in primary patency (80.2% vs. 82.3%; P = 0.80) and limb salvage rate (91.3% vs. 86.1%; P = 0.60) after endovascular aorta-iliac intervention compared with patent SFA. Therefore, it is not indispensable to simultaneously cope with iliac and SFA lesions to prevent iliac stent failure.

The SFA is the site of common atherosclerotic lesion involvement, and endovascular strategies are the recommended first-line choice (19). At present, nevertheless, there are still many challenges in the revascularization of complex SFA disease, especially considering the long lesion, chronic total occlusion, heavy calcium, and in-stent restenosis. Through the advent of a new conception with “leaving nothing behind” and the application of a drug-coated device, the efficacy and safety of endovascular interventions are less robust in complex SFA disease which concerned about the failure of the provisional stenting rate as high as 40%–46% (20, 21) and increased all-cause mortality (22). Higher levels of the neutrophil–lymphocyte ratio before surgery, reflecting the severity of peripheral arterial disease, were associated with poor outcomes after lower extremity procedures (23). No significant differences in the neutrophil–lymphocyte ratio and the platelet–lymphocyte ratio were observed in the two groups. Symptoms sometimes worsen after angioplasty and SFA stents. The complete multi-level revascularization group is associated with higher overall perioperative major adverse events (33.8% vs. 27.9%, P = 0.455) and length of hospital stay [7.0 (6.0, 11.0) vs. 7.0 (5.0, 8.0), P = 0.037]. A possible interpretation is that SFA is one of the most hostile vascular environments among the human body and vascular endothelium damage inevitably caused by endovascular treatments, associated with the occurrence of perioperative complications and vessel restenosis and unsatisfactory clinical benefit. Another explanation is that the coverage of collateral pathways possibly deteriorates clinical outcome after failed endografts.

There were several limitations in the study. First, the retrospective observational study with potential bias affected the results of this trial. Second, data on pharmacological and pain management were not completely noted in both groups, particularly in participants with limb-threatening ischemia; thereby it may affect the strength of the conclusions. Third, the present study did not compare the ankle–brachial index between the multi-level and iliac-only groups. Nonetheless, Pandey et al. (24) suggest that ankle–brachial index is probably not a decision-making tool for selecting therapeutic strategies but an appropriate screening tool to detect patients with lower-extremity peripheral artery disease.

For concomitant iliac and SFA occlusive disease, iliac-only revascularization has favorable efficacy and safety results compared with complete multi-level revascularization in selected patients with patent profunda femoris artery and at least one healthy outflow tract of the infrapopliteal artery.