Infrapopliteal Peripheral Arterial Disease Research Articles

Factors effecting the success of retrograde tibiopedal access and recanalization in infrapopliteal artery occlusions.

Peripheral arterial disease (PAD) is increasingly prevalent, particularly among the aging population. Retrograde tibiopedal access (RTPA) has emerged as a useful endovascular treatment for PAD. However, there is limited research examining factors that influence the efficacy of RTPA. To investigate factors affecting the access, crossing, and recanalization success rates of RTPA for infrapopliteal PAD treatment. A retrospective study was conducted on 720 patients who underwent endovascular treatment for PAD. Of these, 104 patients (mean age: 65.5 ± 16.2; 89 men) with 131 RTPA trials were included in the final evaluation. The disease and its duration, Rutherford score, smoking status, access site, and its occlusion status, access, crossing, and recanalization success were noted. Data were analyzed using Pearson's chi-square and Mann-Whitney U tests and multivariate logistic regression to evaluate the impact of various factors on success rates. The access success rate was 82.6%, the crossing success rate was 95.4%, and the recanalization success rate was 74%. Access success was significantly higher when the dorsal pedal artery (DPA) was the access artery compared with the posterior tibial artery (91.3% vs. 74.2%, P = 0.009). Access success was notably lower in patients with thromboangiitis obliterans compared with patients with diabetes mellitus (DM) and non-DM atherosclerosis (68.6% vs. 90.3% and 80.3%, P = 0.019). Recanalization success was higher when the puncture site was non-occluded (76.7% vs. 53.5%, P = 0.023). The study suggests that RTPA is a generally effective and safe technique for infrapopliteal PAD treatment. The most favorable outcomes are observed in individuals with DM who have a non-occluded DPA at the puncture site. Recanalization success is only affected by the patency of the artery at the puncture site. These findings offer targeted guidance for clinicians and highlight areas requiring further investigation.

Efficacy and Outcomes of Stenting Versus Balloon Angioplasty for Chronic Limb-Threatening Ischemia in Infrapopliteal Peripheral Arterial Disease: A Meta-Analysis of Randomized Controlled Trials.

Peripheral arterial disease (PAD) and its severe complication, chronic limb-threatening ischemia (CLTI) are associated with significant morbidity and mortality worldwide. Conventionally, balloon angioplasty has been regarded as superior to stenting in CLTI associated with infrapopliteal PAD. Stenting is often considered a "rescue" or "bail-out" procedure in managing CLTI. However, stenting using newer generation stents coated with antiproliferative drugs such as paclitaxel has demonstrated noninferior results compared with balloon angioplasty in terms of risk of restenosis. However, the current data comparing stenting to balloon angioplasty for other outcomes is rather inconsistent. Major bibliographic databases were searched systematically to identify randomized controlled trials (RCTs) comparing stenting to balloon angioplasty in CLTI in infrapopliteal PAD patients. Risk ratios (RR) with 95% confidence intervals (CI) were pooled in a random-effects model with statistical significance considered at P < 0.05. 9 RCTs with 1125 patients (634, stenting; 491, balloon angioplasty) were included. Stenting was associated with a statistically significant reduction in the risk of binary restenosis (RR, 0.61; 95% CI, 0.38-0.97; P = 0.04] compared with balloon angioplasty. However, no statistically significant difference in technical success, all-cause mortality, clinically driven target lesion revascularization, major limb amputation, and primary patency was observed between the 2 groups. In infrapopliteal PAD associated with CLTI, stenting is noninferior to balloon angioplasty. Future large multicentric RCTs are warranted, particularly evaluating the newer generation drug-eluting stents, in a diverse patient population with longer follow-up periods to corroborate the results of this meta-analysis.

Abstract 17625: Comparative Analysis of Mortality and Amputation Rates in Patients Undergoing Atherectomy for Infra-Popliteal Peripheral Arterial Disease: Insight From the VQI

Introduction: Infra-popliteal peripheral arterial disease (IPPAD) poses challenges due to complex vasculature. The BASIL-2 trial demonstrated superiority in endovascular treatment compared with surgical bypass in patients with IPPAD. However, the choice of endovascular modality has not been conclusive. Hypothesis: Combining plain balloon angioplasty (POBA)+atherectomy is associated with improved clinical outcomes compared to POBA. Methods: Patients that underwent POBA vs POBA+Atherectomy for IPPAD from the Vascular Quality Initiative database were identified. Propensity score matching (PSM) was employed to balance the distribution of confounding variables for mortality identified on multivariable logistic regression. Patient characteristics and long-term outcomes between the two treatment groups were compared. Results: A total of 10,494 individuals (74.6%) were treated with POBA, while 3,569 (25.4%) were treated with POBA+atherectomy. PSM ensured minimal differences in baseline characteristics, such as indication for procedure and prior revascularization. The atherectomy group was associated with higher technical success and lower perioperative complications, such as renal complications and hematoma, at the expense of higher rates of distal embolization. During long term follow up, patients who underwent atherectomy had lower rates of major amputation but lower freedom from reintervention. There were no differences in major adverse limb events and mortality. Conclusion: Combining POBA with atherectomy appears to be a safe approach in IPPAD, with lower rates of long-term amputation at the cost of higher risk for future re-intervention.

Comparative Analysis of Mortality and Amputation Rates in Patients Undergoing Atherectomy for Infra-Popliteal Peripheral Arterial Disease: Insight From the VQI.

Infra-popliteal peripheral arterial disease (IPPAD) poses challenges due to high restenosis and occlusion rates. The BASIL-2 trial demonstrated the superiority of endovascular treatment compared with surgical bypass in patients with IPPAD. However, the association between different endovascular modalities and clinical outcomes has not been conclusive. Combining plain old balloon angioplasty (POBA) with atherectomy is associated with improved clinical outcomes compared with POBA alone. Patients who underwent POBA vs POBA+atherectomy for IPPAD from the Vascular Quality Initiative database were identified. To mitigate potential selection bias, we employed propensity score matching (PSM) to balance the distribution of confounding variables for mortality identified on multivariable logistic regression. Subsequently, we compared patient characteristics and long-term outcomes between the 2 treatment groups. Among patients who underwent endovascular intervention for IPPAD, 19 979 individuals (80.8%) were treated with POBA alone, while 4747 (19.2%) were treated with both POBA+atherectomy after PSM. Propensity score matching ensured minimal differences in baseline characteristics, such as indication for lower extremity revascularization (LER) and history of LER. After PSM, patients receiving POBA+atherectomy experienced higher rates of technical success and lower perioperative complications, such as renal complications and hematoma, compared with POBA alone. During long-term follow-up, patients who underwent atherectomy had lower rates of major amputation and major adverse limb events (MALE) but slightly lower freedom from reintervention. Nonetheless, there were no differences in mortality. Combining POBA with atherectomy appears to be a safe approach in patients with IPPAD, with lower rates of long-term amputation and MALE at the cost of a higher risk of reintervention. The use of adjunctive atherectomy is associated with improved long-term outcomes in patients with infra-popliteal disease.

Clinical and Cardiovascular Profile in Patients With Peripheral Artery Disease.

Background Peripheral artery disease (PAD) is a vascular disorder leading to serious complications if not managed promptly. This study is conductedto analyze clinical and cardiovascular risk factors in PAD patients presenting at a tertiary care hospital and management strategies. Methodology This observational study was conducted at the Department of Cardiology, Mohamed Bin Khalifa Specialist Cardiac Centre. One hundred and twenty patients aged more than 35 yearswith PAD were included in the study. Data regarding age, gender, physical exam, cardiovascular risk profile, carotid disease, coronary artery disease,and treatment strategy were recorded on a pre-designed questionnaire by the researcher himself. The data were analyzed using IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp. Results The mean age of patients with PAD was 65.46±10.56 years. About 79.2% were hypertensive, 81.7% had hyperlipidemia, 83.3% had diabetes,29.2% had renal insufficiency, and 38.3% were active smokers, respectively.In age ≥65 years, infra-popliteal PAD was significantly lower as compared to above-knee PAD (23.4% vs. 76.6%, p=0.002). In diabetic patients, the proportion of above-knee PAD was higher than below-knee PAD (60% vs. 40%, p=0.033). Conclusion Older age, diabetes, and carotid disease were significant predictors for peripheral artery disease, and these are significantly associated with above-the-knee peripheral artery disease.

Rotational atherectomy for below the knee lesions in critical limb threatening ischemia: Is it a wild goose chase?

Aim: Treatment of infrapopliteal peripheral arterial disease is still challenging. Rotational atherectomy (RA) is a novel option that aims removal of calcium from the lumen and improvement in outcomes. Material and Methods: Data of 27 patients (19 males, 8 females; mean age: 59.8±13.7 years; range, 25 to 79 years) with infrapopliteal occlusions treated by RA between January 2017 and December 2019 was retrospectively collected. The Global Limb Anatomic Staging System (GLASS) and the Rutherford classification (RC) were used for evaluation. The objective performance goals of Conte et al. (major adverse limb event [MALE] and major adverse cardiovascular event [MACE]) were used for assessing outcome performance. Visits were scheduled at 1, 6, 12, 18, and 24 months after treatment. In each visit, symptoms, RC, wound status, smoking status, lifestyle modifications, and medications were questioned, laboratory tests and Doppler ultrasonography were carried out, and the next visit was planned. Results: Device success was 88.89%, whereas procedural success was 100%. Unanticipated amputation rate was 11.1% in the 12-month follow-up. Over half of the patients (66.67%) showed RC improvement with a mean change of 3±1.17. Thirty-day safety endpoints were as follows: MALE, MACE, and amputation rates were 12.5%, 0%, and 8.33%, respectively. One-year efficacy endpoints were as follows: freedom from MALE+perioperative death was 71.42%, amputation-free survival was 76.19%, freedom from reintervention (amputation was 75%, limb salvage was 80%, and survival was 90.47%. Associations between RC (5-6) and calcification, chronic renal insufficiency and amputation, being a nonsmoker and failure to improve RC, and smoking and high infrapopliteal GLASS were found. Smoking cessation came with RC improvement in every case. Nonquitters experienced worsening more often compared to quitters (0% vs. 25%). Conclusion: Rotational atherectomy is feasible and effective in infrapopliteal chronic total occlusions. Closer follow-up is suggested for nonsmokers and patients with chronic renal insufficiency or advanced GLASS stages as they are prone to unfavorable clinical results. Quitting smoking should be underlined with its potential positive clinical effect even after the procedure.

Revascularization Techniques for Infra-popliteal Peripheral Artery Disease in Diabetic Foot: A Literature Review

Foot ulcers are one of the problems that are often encountered in uncontrolled diabetes mellitus. With diabetic peripheral neuropathy, the typical clinical symptoms of PAD (peripheral arterial disease) may be obscured, leading to critical limb ischemia (CLTI). Diabetes may accelerate atherosclerosis that diminishes blood flow in PAD—further, diabetic patients with PAD often enfaces infra-popliteal lesions and require revascularization. However, studies on revascularization techniques in infra-popliteal PAD remain minimal. We reviewed the literature on EBSCO, and PubMed focused on the revascularization techniques in PAD, namely: expanded polytetrafluoroethylene (ePTFE), saphenous vein graft (SVG), atherectomy, surgical revascularization first, revascularization with endovascular bypass, direct and indirect angiosome revascularization, open surgery, direct bypass, indirect bypass, PTA, drug-eluting stent, pedal artery angioplasty, non-drug balloon angioplasty, DCB balloon angioplasty, infra-popliteal angioplasty, and cryoplasty. The methods of cryoplasty, atherectomy, direct bypass, balloon angioplasty, and eluting drug stent showed a better outcome in infra-popliteal CLTI.

Drug-coated balloons in below-the-knee arteries.

Background: The search for an optimal interventional treatment strategy in infrapopliteal peripheral artery disease remains in the focus of interest. Whether drug-coated balloons (DCB) might enhance interventional outcomes after crural interventions is a matter of debate, as studies yielded conflicting results on DCB safety and efficacy. Patients and methods: We analyzed a retrospective cohort of 75 infrapopliteal DCB interventions performed at our institution in 68 patients with peripheral artery disease in Rutherford category 3 to 6. Results: Despite a high rate of long complex lesions and multi-vessel disease, freedom from clinically driven target lesions revascularization (TLR) after 365 days was 68%. After six months, healing or significant improvement of the ischemic ulcer was observed in 78% of cases. Accordingly, freedom from major amputation and death after 365 days was 82%. Freedom from major amputation and death was 76.2% of cases in patients with diabetes mellitus as opposed to 91.5% in patients without diabetes mellitus (p=0.049). Conclusions: With this real-world analysis we would like to contribute to the ongoing discussion on the benefit and safety of DCB treatment in below-the-knee interventions.

Prospective Study of Serration Angioplasty in the Infrapopliteal Arteries Using the Serranator Device: PRELUDE BTK Study

Purpose: The purpose was to evaluate the safety and efficacy of the Serranator percutaneous transluminal angioplasty serration balloon catheter in patients with infrapopliteal peripheral artery disease. Materials and Methods: A prospective, multicenter, single-arm feasibility study in 46 patients with claudication or chronic limb-threatening ischemia, Rutherford Clinical Category (RCC) 3 to 5, that required treatment of the infrapopliteal arteries above the tibiotalar joint. The primary efficacy outcome was device success—successful insertion, balloon inflation and deflation, and removal of the device(s) with a final diameter stenosis of <50%. The primary safety endpoint was a composite of major adverse limb events (MALE) and perioperative death (POD) through 30 day postprocedure. Other outcomes were change in RCC and ankle-brachial index, wound healing, and clinically-driven target lesion revascularization (CD-TLR). A subset of 9 patients were further evaluated by optical coherence tomography (OCT) or intravascular ultrasound (IVUS) for the presence of serrations in treated lesions. Patient follow-up occurred at 30 days and 6 months. Results: Forty-six patients received treatment with the Serranator device and 55 lesions were treated. Fifty-three lesions were deemed analyzable by the core lab with data and reported hereafter. Device success was 91.7% and freedom from MALE + POD through 30 days was 95.7%. Pretreatment stenosis of 82% was reduced to 21.8% and only 1 lesion (1.9%) required a bailout stent for a grade D dissection. The average maximum balloon inflation pressure was 6 atmospheres. Serrations were present in all treated lesions (n=10) in 9 patients imaged with OCT/IVUS as reviewed by the core laboratory. The RCC score improved by 1 or more level in 70% of patients at 6 months with 42% having a score of 0. The 6 month freedom from CD-TLR was 97.7%. Conclusion: Serranator treatment of infrapopliteal lesions showed excellent lumen gain with minimal evidence of arterial injury and low 6 month CD-TLR. Imaging by IVUS and OCT showed serrations without significant dissection, supporting the device’s proposed mechanism of action.

Anterior, Posterior, or All-Vessel Infrapopliteal Revascularization in Patients With Moderate-Severe Claudication: Insights From the LIBERTY 360 Study

Background Little data guides revascularization of infrapopliteal peripheral arterial disease (PAD) in patients with claudication. We assessed outcomes after infrapopliteal-only intervention for claudication in the LIBERTY 360 observational study. Methods In this post hoc analysis, LIBERTY 360 patients (N = 128) with claudication and isolated infrapopliteal disease undergoing endovascular revascularization were divided by territory into anterior-vessel, posterior-vessel, or all-vessel groups. Patients were followed for periprocedural, in-hospital, and long-term outcomes. Logistic regression for odds ratios, Cox proportional hazard models, ANOVA, and Kaplan-Meier estimates were utilized to compare outcomes. Results Patients underwent anterior (N = 37), posterior (N = 76), or all-vessel (N = 15) infrapopliteal revascularization. Initial procedural success was 86%, 86%, and 69% for anterior, posterior, and all-vessel groups, respectively. Each group had improvements in Rutherford classification (RC) from baseline to 2 years (mean RC change: -1.3, -1.5, and -1.5, respectively). Compared with all-vessel intervention, both anterior and posterior groups had lower rate of major adverse events (MAE) and target vessel revascularization (TVR) at 3 years (MAE: 12% and 15% in anterior and posterior groups, respectively compared with 51% in the all-vessel group; hazard ratios and 95% CIs 0.22 [0.06-0.74], p = .015; 0.24 [0.09-0.64], p = .004). Other outcomes were similar among the three groups. The anterior group showed more improvement in pain subdomain and total VascuQoL scores compared with posterior and all-vessel groups at 2 years (p = .016, p = .020 and p = .068, p = .009, respectively). Conclusions Both anterior or posterior revascularization have favorable outcomes and may be beneficial for improvement of symptoms in claudicants with isolated infrapopliteal PAD.

Anterior, posterior, or all-vessel infrapopliteal revascularization in patients with moderate-severe claudication: Insights from the LIBERTY 360 study.

Little data guides revascularization of infrapopliteal peripheral arterial disease (PAD) in patients with claudication. We assessed outcomes after infrapopliteal-only intervention for claudication in the LIBERTY 360 observational study. In this post hoc analysis, LIBERTY 360 patients (N=128) with claudication and isolated infrapopliteal disease undergoing endovascular revascularization were divided by territory into anterior-vessel, posterior-vessel, or all-vessel groups. Patients were followed for periprocedural, in-hospital, and long-term outcomes. Logistic regression for odds ratios, Cox proportional hazard models, ANOVA, and Kaplan-Meier estimates were utilized to compare outcomes. Patients underwent anterior (N=37), posterior (N=76), or all-vessel (N=15) infrapopliteal revascularization. Initial procedural success was 86%, 86%, and 69% for anterior, posterior, and all-vessel groups, respectively. Each group had improvements in Rutherford classification (RC) from baseline to 2 years (mean RC change: -1.3, -1.5, and -1.5, respectively). Compared with all-vessel intervention, both anterior and posterior groups had lower rate of major adverse events (MAE) and target vessel revascularization (TVR) at 3 years (MAE: 12% and 15% in anterior and posterior groups, respectively compared with 51% in the all-vessel group; hazard ratios and 95% CIs 0.22 [0.06-0.74], p=.015; 0.24 [0.09-0.64], p=.004). Other outcomes were similar among the three groups. The anterior group showed more improvement in pain subdomain and total VascuQoL scores compared with posterior and all-vessel groups at 2 years (p=.016, p=.020 and p=.068, p=.009, respectively). Both anterior or posterior revascularization have favorable outcomes and may be beneficial for improvement of symptoms in claudicants with isolated infrapopliteal PAD.

Outcomes of endovascular treatment for infrapopliteal peripheral artery disease based on the updated TASC II classification.

We retrospectively analyzed all endovascular procedures of infrapopliteal arterial lesions (n = 383) performed in 270 patients at our institution between December 2008 and January 2018. The overall technical success rate was 97% and yielded 98% for stenoses (n = 214) and 95% for occlusions (n = 169). Trans-Atlantic Inter-Society Consensus (TASC II) classification had no impact on success rates (TASC A + B vs C + D; 96.5% vs 96.9%, p = 0.837). Freedom from clinically driven target lesion revascularization (TLR) after 6 and 12 months was 88.3% and 77.2%. TLR was comparable for TASC A to C lesions and no difference was observed comparing groups of moderately complex TASC A/B lesions and more complex TASC C/D lesions (TASC A + B vs C + D; 78.5% vs 74.2%, p = 0.457). Freedom from TLR was significantly lower in very complex TASC D lesions (TASC A + B + C vs D; 79.7% vs 42.5%, p < 0.001). Multivariate analysis identified TASC D lesions (hazard ratio D/A: 1.5; overall p = 0.002), Fontaine class III and IV (hazard ratio III or IV/IIa or IIb: 2.4; p = 0.041), and occlusive lesions (hazard ratio occlusion/stenosis: 2.4; p = 0.026) as predictors for TLR. In conclusion, endovascular therapy for infrapopliteal artery disease was safe and accompanied with a promising long-term outcome.

Two-year follow-up of bioresorbable vascular scaffolds in severe infra-popliteal arterial disease.

To assess the safety, efficacy, and durability of the Absorb bioresorbable vascular scaffold in predominantly complex, infra-popliteal lesions for the management of chronic limb ischemia at two-year clinical follow-up. Bioresorbable vascular scaffold are biodegradable scaffolds that provide short-term vascular support before undergoing intravascular degradation. A recent trial reported excellent 36-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb bioresorbable vascular scaffold. This single-center, retrospective study evaluated the use of the Absorb bioresorbable vascular scaffold (everolimus impregnated poly-L-lactic scaffold) in patients with infra-popliteal peripheral arterial disease (PAD) with respect to safety (thrombosis and TIMI bleeding), technical success, and freedom from clinically driven target vessel failure at 24 months. 31 patients (51.6% male) with a median age of 67 years with predominantly advanced infra-popliteal disease were treated with 49 bioresorbable vascular scaffold in 41 vessels. The mean stenosis was 94% (80-100), with 49% of lesions being chronic thrombotic occlusions. No scaffold thrombosis or peri-procedural bleeding was observed. Procedural success was achieved in all patients; 93.5% of patients experienced freedom from clinically driven target vessel failure at 24 months, driven by one revascularization and one amputation. Primary patency was 96.7% at 12 months and 87.1% at 24 months. All patients were alive at 12 and 24 months. At 24 months, our study found that patients with predominantly advanced infra-popliteal PAD who were treated with Absorb bioresorbable vascular scaffold reported improved clinical status and a low and durable rate of clinically driven target vessel failure extending out to 24 months.

Limb Preservation Using Edetate Disodium-based Chelation in Patients with Diabetes and Critical Limb Ischemia: An Open-label Pilot Study.

BackgroundIn 2015, there were 30.3 million patients with diabetes in the US, including 25.2% of people ages 65 or older and 108,000 hospitalizations for non-traumatic amputations. Severe diabetic limb disease includes critical limb ischemia (CLI ) due to an infrapopliteal disease with foot pain and ischemic ulcerations including gangrene. Environmentally acquired toxic metals, such as lead and cadmium, have been associated with cardiovascular disease. Thus, we designed the present unblinded pilot study to determine whether there was a signal of benefit for edetate disodium-based infusions in patients with critical limb ischemia.MethodsThis was an open-label pilot study in 10 patients with diabetes and critical limb ischemia. Each patient received up to 50 edetate disodium-based infusions and was assessed for safety, clinical efficacy, metal excretion, and quality of life. The primary endpoint was to assess the effect of edetate disodium-based therapy plus vitamins in patients with diabetes and infra-popliteal peripheral artery disease presenting with severe CLI and determine if there were improvements in vascular flow parameters.ResultsWe enrolled 10 (60% male) predominantly Caucasian (90%) subjects. The mean age was 75.3 (8.0) years. Smoking was reported by 30%. There were 70% with coronary artery disease (30% had prior coronary artery bypass grafting) and 50% had a prior lower-extremity amputation, three having previous minor amputations and two major amputations. There were no major adverse cardiovascular events during the infusion phase through the one-year follow-up. Patients completing 40 infusions demonstrated complete wound healing and improvement in the quality of life.ConclusionPatients with diabetes and CLI treated with a regimen of edetate disodium-based infusions demonstrated a potential signal of benefit and preliminary evidence of safety. The Trial to Assess Chelation Therapy in Critical Limb Ischemia (TACT3a), a randomized double-blind, placebo-controlled clinical trial now in progress, will further test these findings.

Contemporary outcomes of infrapopliteal atherectomy with angioplasty versus balloon angioplasty alone for critical limb ischemia

ObjectiveLimited data exist comparing atherectomy (At) with balloon angioplasty for infrapopliteal peripheral arterial disease. The objective of this study was to compare the outcomes of infrapopliteal At with angioplasty vs angioplasty alone in patients with critical limb ischemia. MethodsThis is a retrospective, single-center, longitudinal study comparing patients undergoing either infrapopliteal At with angioplasty or angioplasty alone for critical limb ischemia, between January 2014 and October 2017. The primary outcome was primary patency rates. Secondary outcomes were reintervention rates, assisted primary patency, secondary patency, major adverse cardiac events, major adverse limb events, amputation-free survival, overall survival, and wound healing rates. Data were analyzed in multivariate generalized linear models with log rank tests to determine survival in Kaplan-Meier curves. ResultsThere were 342 infrapopliteal interventions, 183 percutaneous balloon angioplasty (PTA; 54%), and 159 atherectomies (At) with PTA (46%) performed on 290 patients, with a mean age of 67 ± 12 years; 61% of the patients were male. The PTA and At/PTA groups had similar demographics, tissue loss (79% vs 84%; P = .26), ischemic rest pain (21% vs 16%; P = .51), mean follow-up (19 ± 9 vs 20 ± 9 months; P = .32), mean number of vessels treated (1.7 ± 0.8 vs 1.9 ± 0.8; P = .08) and the mean lesion length treated (6.55 ± 5.00 cm vs 6.02 ± 4.00 cm; P = .08), respectively. Similar 3-month (96 ± 1% vs 94 ± 1%), 6-month (85 ± 2% vs 86 ± 3%), 12-month (68 ± 3% vs 69 ± 4%), and 18-month (57 ± 4% vs 62 ± 4%) primary patency rates were seen in the two groups (P = .87). At/PTA patients had significantly higher reintervention rates as compared with the PTA patients (28% vs 16%; P = .02). Similar assisted primary patency rates (67 ± 4% vs 69 ± 4%; P = .78) and secondary patency rates (61 ± 4% vs 66 ± 4%; P = .98) were seen in the PTA and At/PTA groups at 18 months. The 30-days major adverse cardiac event rates (3% vs 2%; P = .13) and 30-day major adverse limb event rates (5% vs 4%; P = .2) were similar in both groups. Wound healing rates (72 ± 3% vs 75 ± 2%; P = .12), 1-year amputation-free survival (68 ± 4.1% vs 70 ± 2%; P = .5), and 1-year overall survival (76 ± 4% vs 78 ± 4%; P = .39) rates did not differ in the PTA and At/PTA groups. THE At/PTA group had higher local complication rates (7 [4%] vs 1 [0.5%]; P = .03) ConclusionsAt with angioplasty provides similar patency rates compared with angioplasty alone for infrapopliteal peripheral arterial disease, but associated with higher reintervention and local complication rates. Further appropriately designed studies are required to determine the exact role of At in this subset of patients.

Long-term outcomes of patients with diabetes mellitus undergoing percutaneous intervention for popliteal and infrapopliteal peripheral arterial disease.

To evaluate the association of diabetes mellitus (DM) with clinical and angiographic characteristics and outcomes of patients with popliteal and infrapopliteal peripheral arterial disease (PAD) undergoing peripheral vascular intervention (PVI). Clinical features and outcomes in patients with DM and popliteal or infrapopliteal PAD undergoing PVI are not well described. Using the data from the laser in popliteal and infrapopliteal stenosis study, we retrospectively examined the association of diabetes with clinical and angiographic characteristics and risk adjusted short- and intermediate term outcomes (all cause death, major adverse events (MAE) [composite of death, ipsilateral major amputation, or repeat revascularization]) in patients with popliteal and infrapopliteal PAD undergoing PVI for critical limb ischemia treated either with laser-assisted balloon angioplasty or balloon angioplasty alone. Of 714 patients, 418 had DM (58.5%). Patients with DM were younger with higher prevalence of history of coronary artery disease, heart failure, end-stage renal disease, and prior contralateral limb amputation compared to those without DM. At 5 years, mean event free survival for all cause mortality (39.9 vs. 45.5 months; P = 0.001), MAE (29.3 vs. 36.8 months; P < 0.001), ipsilateral major amputation (55.3 vs. 57.4 months; P = 0.001), and repeat revascularization (42.0 vs. 45.8 months; P = 0.03) were significantly lower in DM patients. On multivariate analysis, DM was associated with significantly higher all cause mortality (HR = 1.83, 95% CI 1.33-2.52), MAE (HR = 1.73, 95% CI 1.35-2.23), and ipsilateral major amputation (HR = 5.52, 95% CI 1.82-16.71). Among patients with popliteal and infrapopliteal PAD undergoing PVI, DM was associated with higher mortality, major amputations and MAE that was independent of baseline comorbidities. Our data suggested the need for future studies evaluating existing and/or novel therapies to improve the poor long-term outcomes in diabetic patients with popliteal and infrapopliteal PAD.

Techniques for Infrapopliteal Arterial Bifurcation Stenting

Endovascular treatment of infrapopliteal peripheral arterial disease (PAD) is an established and effective treatment strategy for patients with symptomatic PAD. Increasingly, complex infrapopliteal lesions are treated with an endovascular first approach, especially in the setting of critical limb ischemia (CLI) for limb salvage, avoiding major amputations which impact on mobility and quality of life. However, many complex infrapopliteal lesions involving the bifurcation of the tibial arteries remain challenging to treat because of recoil or acute dissection after angioplasty and may require stenting using specialized techniques. We illustrated techniques for infrapopliteal arterial bifurcation stenting using case-based examples. The techniques covered include the single-stent, culottes, kissing, crush, and T-stenting techniques, and each is considered based on individual strengths and limitations. Infrapopliteal bifurcation stenting allows complex bifurcation lesions to be treated effectively when flow-limiting complications are encountered after angioplasty.

Outcomes of infrapopliteal angioplasty for limb salvage based on the updated TASC II classification.

We aimed to evaluate limb salvage, defined as freedom from major amputation, and to identify predictors of major amputation in patients with infrapopliteal peripheral arterial disease (PAD) based on the updated 2015 TASC II anatomic classification treated by percutaneous transluminal angioplasty (PTA). This was a retrospective study of infrapopliteal PTA procedures performed for PAD over a 4-year period. Patient demographics, medical comorbidities, risk factors, angiographic imaging, technical details, and clinical follow-up were analyzed to determine limb salvage rates, technical success, and all-cause mortality. Predictors of major amputation following PTA were identified. A total of 112 patients were treated by infrapopliteal PTA. Most lesions consisted of TASC C (44%) and D (34%) categories, were over 10 cm in length, and were occlusive and heavily calcified (89%). Overall technical success was 75%, with limb salvage rates of 77% at 1 year and 65% at 3 years following PTA. Smoking, previous stroke or cardiovascular events, and anticoagulation use were associated with an increased risk of major amputation following PTA. PTA of complex infrapopliteal PAD is associated with good intermediate term limb salvage rates.

Abstract 509: Comparison of Drug Elluting Stent and Per Cutenaeous Transluminal Angioplasty in Patients With Infra-Popliteal Peripheral Arterial Disease

Introduction: Drug-eluting Stent(DESs) have demonstrated improved patency and freedom from target lesion revascularization compared with Bare-Metal stents or Percutaneous Transluminal Angioplasty(PTA); however, the effect on clinical outcome parameters, such as limb salvage and wound healing, remains unidentified. We present a direct comparison of clinical outcomes in patients who underwent DES vs PTA. Methods: We collected data of patients who underwent infra-popliteal arterial interventions at our institution. Clinical end points analyzed were all cause mortality, target vessel revascularization, primary vessel patency, and target limb major and minor amputations. Differences between two groups were analyzed by chi square for categorical variables and t test for continuous variables. Statistical significance was considered for P values less than .05 in a 2-sided test. Results: Total of 83 cases, n=42 in DES group and n=41 in PTA group were analyzed. Mean age was 71.6 years (range 49-95). Out of the total 83 patients in the study 45 had a history of diabetes (54%) and 51 (61%) were current /past smokers. Average follow up period of 14 months for both the groups. Primary vessel patency was defined as absence of ≥50% restenosis on follow up. During the follow up period vessel patency in DES group [69% (n=29/42)] was significantly higher as compared to 36% (15/41) in PTA group (P=0.04, odds ratio 3.867, 95% Confidence interval: 1.5 - 9.6). Target vessel revascularization in DES group was 24% (10/42) as compared to 32% (13/28) in PTA group (P=0.47, odds ratio 0.67, 95% confidence interval: 0.26 - 1.77). Target limb amputation was 10% (4/42) in DES group as compared to 24% (10/41) in PTA group (P = 0.085), odds ratio 0.33, 95% confidence interval: 0.09 - 1.14). All cause mortality in both the groups were at 10%, 4/42 in DES group and 4/41 in PTA group (P=1, odds ratio 0.97, 95% confidence interval: 0.23 - 4.19). Conclusion: To conclude primary vessel patency was superior in DES group as compared to PTA group. Target limb amputation rates were higher in PTA group but not statistically significant. Target vessel revascularization and all cause mortality were similar in both the groups. Thus primary treatment with DES should be considered in patients with infra-popliteal PAD.

Evaluation of popliteal artery branching patterns and a new subclassification of the 'usual' branching pattern.

To determine the frequency of popliteal artery branching variations in a wide study cohort and to investigate the relationship between these variations and infrapopliteal peripheral arterial disease (PAD). A subclassification was proposed for the most encountered type I-A, utilizing tibio-fibular trunk (TFT) length. A total number of 1184 lower extremity digital subtraction angiography (DSA) studies of 669 patients were evaluated. Following exclusion, 863 lower extremity DSA studies (431 right, 432 left) of 545 patients were enrolled. Popliteal artery branching type, patency of anterior tibial artery (ATA), fibular artery (FA) and posterior tibial artery (PTA) in each extremity and TFT length for type I-A extremities were recorded. Percentages of branching patterns, mean length and cut-off value of TFT and incidence of PAD in different types of branching were calculated. Type I-A was the most common type of branching (81.3%). Frequency of branching pattern variation was 18.7%, the most common variation category was category III (12.2%) and the most common variation type was type III-A (5.6%). ATA and PTA had higher percentages of PAD in extremities with variant branching types. Cut-off value of 3cm for TFT length was proposed in order to subclassify type I-A. Our study cohort presents a higher incidence of popliteal artery branching variations. Some branching variations might have effect on the involvement pattern of the infrapopliteal arteries by PAD. We propose a subclassification for type I-A; type I-A-S (TFT < 3cm) and type I-A-L (TFT ≥ 3cm) which might have impact on interventional procedures.