Efficacy of endoluminal interventional therapy in diabetic peripheral arterial occlusive disease: a retrospective trial

The hyperglycemia and lipid metabolic abnormality not only lead to injury of the vascular endothelial cells, but also initiate and promote the process of atherosclerosis in diabetes. Some protective cytokines, such as adiponectin and osteoprotegerin, could relieve the progression of PAOD. Adiponectin exhibits anti-inflammatory and atheroprotective actions and osteoprotegerin protects vascular endothelial cells and inhibits atherosclerosis. Lower plasma levels of adiponectin and higher osteoprotegerin were found in diabetic patients with PAOD [9‐11]. In fact, the incidence of atherosclerosis in diabetes was significantly higher than that in non-diabetic patients, and the lesion in diabetes was more serious and diffuse. For diabetes, atherosclerosis usually involved the below-knee arteries; the severe vascular lesions and their wide range often lead to less effective intervention; on the other hand, initial hyperplasia or smooth muscle cell proliferation and the progression of atherosclerosis was more serious in diabetes than that in non-diabetes after revascularization.

Patients with PAOD have a poor clinical course. During the first year of diagnosis, mortality is 20%-30%, and an equivalent number undergo amputations or suffer from persistent pain [12]. Lower extremity bypass has been applied very successfully even in difficult clinical cases, including the treatment of patients with diabetic foot gangrene and other conditions which carry a high risk of amputation [13]. But bypass surgery can only be performed to a minority of patients because of poor runoff, advanced age, and cardiac co-morbidities. Surgical treatment is often withheld from those patients who would benefit. Surgical complications include death (1.3%-6%), myocardial infarction (1.9%-3.4%), wound infections (10%-30%), leg edema (50%-100%), and early graft failure rates (6%-49%) requiring repeat surgery [12, 14].

Angioplasty for critical limb ischemia was reported nearly 50 years ago [15]. Hanna et al. [16] reported a 21% procedural complication rate, including embolization and thrombosis in patients with critical limb ischemia undergoing balloon angioplasty, whereas Dorros et al. [17] demonstrated that PTA of below-knee arteries could be performed with relative safety and with satisfactory results.

The mortality and major morbidity in patients treated for limb-threatening disease with percutaneous interventions was only 0 and 8.1%, respectively, compared with usual mortalities and morbidities of 5% and 30% for open surgical bypass [12]. To some extent, it appears that the short-term advantages of minimally invasive vascular therapies are often counterbalanced by diminished durability. Percutaneous therapy for limb-threatening lower extremity vascular disease with or without diabetes has no exception, with primary patency rates at 36 months of 46.5% and 60.9%. However, secondary patency rates were more reasonable at 65.7% and 71.8%, and more importantly, limb salvages rates were 81.9% and 83.1% at 36 months.

It was confirmed that PTA was an effective and safe therapy for short iliac arterial stenosis. But the long-term patency rates of PTA in complicated iliac arterial lesions such as long occlusion were relative low. The 3-year primary patency rates in PTA group were lower than 60% [18, 19]; whereas primary patency rates in stenting group were up to 90% [20‐22]. Bosch and Hunink [23] reported the technical success rate of interventional therapy for iliac occlusive disease in stent group was higher than that in PTA group, but the difference was not statistically significant. In our study, 1-year and 3-year primary patency rate for iliac arterial lesions in diabetes group or non-diabetes group were 87.5%, 75.1% and 86.5%, 71.1%, respectively.

Bakken et al. [24] reported the clinical results of interventional therapy for femoral lesions with diabetes was better than that without diabetes. In our study, 1, 3 years primary patency rate for femoral lesions in with or without diabetes group were similar (73.2%, 58.6% and 80.9%, 52.8%). Role of femoral arterial stents in the management of PAOD was still controversial. In one meta-analysis [25] which included 452 patients who underwent femoropopliteal PTA and 482 patients who underwent femoropopliteal stenting, the 1-year primary patency rates following PTA ranged from 45% to 84.2% and at 2 years it varied from 25% to 77.2%, the 1-year primary patency rates in the stent implantation group varing from 63% to 90%, and 2-year primary patency ranging from 46% to 87%. In 73 patients with average 8 cm long femoral arterial stenosis or occlusion, restenosis rates in the stent and PTA groups were 2.9% versus 18.9%, 18.2% versus 50.0%, and 34.4% versus 61.1% at 3, 6, and 12 months by sonography [26]. Perrio et al. [27] reported 1 year femoral artery primary patency rates were 57% in stent group and 53% in PTA group. Kougias et al. [28] reported at 1 year femoral artery primary patency for the subintimal balloon angioplasty and subintimal placement of covered stent groups was 28% versus 75%, whereas secondary patency was 37% versus 84%. But in other study undergoing subintimal angioplasty in the femoral and popliteal arteries, one-year primary and secondary patency for stent vs. no-stent group was 50% versus 45% and 70% versus 78% [29]. In a contrast study between selective stenting and systematic stenting of femoral artery, Becquemin et al. [30] reported at 1-year follow-up restenosis of the treated site was noted in 32.3% patients in selective stent group and 34.7% patients in systematic stent group. After 4 years, limb-salvage rates in selective stent group and in systematic stent group were 57%, 44%, respectively. Systematic stenting in femoral artery did not improve long term patency.

The treatment of infra-popliteal arterial occlusive disease was still a clinical puzzle for vascular surgeons and interventional radiologists. The first reason was that infra-popliteal arterial occlusive disease usually comorbided with diabetic arteriosclerosis which have more calcification and more hard plaque. The second reason was that the outflow tract of infra-popliteal artery has higher resistance. In a meta analysis, Romiti et al. [31] reported the immediate technique success rate of PTA in infra-popliteal arterial occlusive disease was 89%. After 12 and 36 months primary patency rates, secondary patency rates, and limb salvage rates were 77.4% and 48.6%, 83.3% and 62.9%, 93.4% and 82.4%, respectively. Lejay et al. [32] reported at 1 year the infra-popliteal arteries primary patency rates and limb salvage rates for PTA were 60% and 85%, respectively. In a contrast study between PTA and atherectomy of infra-popliteal arterial occlusive disease, Semaan et al. [33] reported primary patency of the popliteal artery at 12 months were 75% and 73%, respectively, but the difference was not statistically significant. In our study, 6, 12 months primary patency rate for tibial arterial lesions with or without diabetes were 75%, 53.8% and 73.7%, 55.3%. The result was lower than the result in literature. 26 patients (26/35) in the study comorbided with proximal arterial occlusive lesions may be the origin.

This was a single-center, consecutive patient trial. ABIs were obtained before intervention to evaluate hemodynamic impairment and at one week after intervention to measure improvement. ABI value responded objectively to the status of blood supply in lower extremity, but the mickle factors influenced its magnitude. In the condition of profuse collateral circulation in lower extremity, ABI value could exactly respond to the extent of vascular flow in treated position. The sample number of this study is relative deficient, and subgroups divided by distinct lesions position had not enough information for contrasting with literature. As the follow-up period was relative short, this study could not illuminate the long term patency of interventional therapy for PAOD.