TransAtlantic Inter-Society Consensus Research Articles

Drug-Coated Balloon for the Treatment of Long-Segment Femoropopliteal Artery Disease: Pooled Analysis from the BIOLUX P-III SPAIN and BIOLUX P-III All-Comers Registry Long Lesion Subgroup

PurposeTo investigate the clinical performance and safety of the Passeo-18 Lux drug-coated balloon (DCB) in complex femoropopliteal Trans-Atlantic Inter-Society Consensus (TASC) C and D lesions in an all-comers patient population. Material and MethodsData from BIOLUX P-III SPAIN, a prospective, national, multicenter, postmarket all-comers registry conducted from 2017 to 2019, and a matching long lesion subgroup from the BIOLUX P-III All-Comers global registry conducted from 2014 to 2018 were pooled for analysis. The primary safety end point was freedom from major adverse events (MAEs) at 6 months, and the primary performance end point was freedom from clinically driven target lesion revascularization (fCD-TLR) at 12 months, both adjudicated by an independent clinical events committee. ResultsA total of 159 patients, of whom 32.7% had critical limb ischemia, were included in the Passeo-18 Lux long lesion cohort. The mean lesion length was 248.5 mm ± 71.6, and the majority were occluded (54.1%), calcified (87.4%), and of type TASC C (49.1%) or TASC D (50.9%). Freedom from MAEs was 90.6% (95% CI, 84.6–94.3) at 6 months and 83.9% (95% CI, 76.7–89.0) at 12 months. fCD-TLR was 84.4% (95% CI, 77.3–89.5) at 12 months. Freedom from target limb major amputation was 98.6% (95% CI, 94.6–99.7), and all-cause mortality was 5.3% (95% CI, 2.7–10.4) at 12 months. There were no device- or procedure-related deaths or amputations up to the 12-month follow-up. ConclusionPasseo-18 Lux DCB is safe and effective for the treatment of long femoropopliteal lesions in a real-word setting.

Device Effectiveness for Femoropopliteal Artery Disease Treatment: An Analysis of K-VIS ELLA Registry

BackgroundAlthough drug-coated balloons (DCBs) and drug-eluting stents (DES) are frequently used for the treatment of femoropopliteal artery (FPA) disease, their mid- or long-term clinical efficacy in real-world practice is still limited. ObjectivesFrom the K-VIS ELLA (Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases) multicenter registry cohort, clinical outcomes of drug-eluting devices for FPA lesions in comparison with bare-metal stents (BMS) were evaluated. MethodsLimbs that underwent percutaneous transluminal angioplasty for FPA lesions with plain old balloon angioplasty (POBA, n = 826), BMS (n = 943), DCBs (n = 778), or DES (n = 227) between 2012 and 2020 were included. The primary outcome was target lesion revascularization (TLR) at 2 years. Inverse probability of treatment weighting was used to account for confounding. ResultsAfter inverse probability of treatment weighting, baseline characteristics were well-balanced among groups. Compared with the 2-year cumulative incidence of TLR with BMS (26.5%), the incidence of TLR was significantly lower in limbs treated with DCBs (15.9%; HR: 0.44; 95% CI: 0.30-0.64; P < 0.001) or DES (15.9%; HR: 0.51; 95% CI: 0.29-0.87; P = 0.014). No significant differences were observed in the risk of TLR between DCBs vs DES (HR: 0.87; 95% CI: 0.51-1.49; P = 0.613) and POBA vs BMS (HR: 0.94; 95% CI: 0.73-1.21; P = 0.626). All-cause mortality was comparable in the 4 groups. Treatment with DCBs showed a more pronounced favorable outcome in limbs with Trans-Atlantic Inter-Society Consensus II type C/D lesions or long lesions (≥150 mm) compared with POBA, BMS, or DES (Pinteraction< 0.05). ConclusionsIn real-world practice, DCBs and DES demonstrated comparably superior midterm outcomes over POBA or BMS in the treatment of FPA lesions.

Endovascular Revascularization and Outcomes of Critical Limb-Threatening Ischemia in Trinidad and Tobago: The EVENT Pilot Study-Challenges in a Limited-Resource, Caribbean Setting.

This retrospective study investigated major adverse limb events (MALE) and mortality outcomes in critical limb-threatening ischemia (CLTI) patients with tissue loss after an endovascular revascularization-first (EVR-1st) strategy. MALE and mortality were assessed in 157 consecutive patients with CLTI and tissue loss from June 2019 to June 2022 at the Eric Williams Medical Sciences Complex, Trinidad and Tobago. 157 patients underwent the EVR-1st strategy, of whom 20 were pivoted to immediate surgical revascularization (SR). Of the remaining 137 patients, successful EVR was achieved in 112, giving a procedural success of 82% and an all-comer overall success of 71%. The mortality and MALE rates were 2.7% and 8.9% at 2 years, respectively. Males and patients with previous major amputations were at significantly higher risk for MALE (p values of 0.016 and 0.018, respectively). There was a statistically significant difference in successful EVR for both Rutherford-Baker (RB) 5 (minor) and RB 6 (major) classifications: 63 (56%) vs. 5 (20%) and 49 (44%) vs. 20 (80%), both with a p value of 0.01. There were no differences in successful EVR amongst Wound, Ischemia, Foot Infection (WIfI) clinical stages. There were no differences in successful EVR amongst the Trans-Atlantic Inter-Society Consensus (TASC II) classifications. This study may prove clinically informative and applicable for an EVR-1st management strategy for high-risk patients with CLTI in a limited-resource, Caribbean setting. NCT05547022 (retrospectively registered).

Outcomes of Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) Procedure for the Treatment of Extensive Aortoiliac Occlusive Disease Using the BeGraft Balloon-Expandable Covered Stent: A Multicenter Observational Study.

The covered endovascular reconstruction of the aortic bifurcation (CERAB) technique offers an alternative for Trans-Atlantic Inter-Society Consensus (TASC) C/D lesions involving the aortic bifurcation. The study aims to evaluate the outcomes of the CERAB technique for extensive aortoiliac occlusive disease (AIOD) using the BeGraft balloon-expandable covered stent (BECS). This is a physician-initiated, multicenter, retrospective, observational study. Between June 2017 and June 2021, all consecutive patients who underwent the CERAB procedure using the BeGraft stent (Bentley InnoMed, Hechingen, Germany) in 3 clinics were enrolled. Patients' demographics, lesion characteristics, and procedural results were collected and retrospectively analyzed. Follow-up was done at 1, 6, and 12 months and then annually with clinical examination, ankle-brachial index (ABI), and duplex ultrasound. The primary endpoint was the patency at 12 months. Secondary endpoints included procedural-related complications, secondary patency, freedom from target lesion revascularization (TLR), and clinical improvement. In all, 120 patients (64 men) with a median age of 65 years (range: 34-84 years) were analyzed. Most patients had extensive AIOD classified as TASC II C (n=32; 26.7%) or TASC II D (n=81; 67.5%). The median duration of the procedure was 120 minutes (interquartile range [IQR]: 80-180 minutes). All 454 BeGraft stents (137 aortic and 317 peripheral) were successfully delivered and deployed. The overall procedural complication rate was 14 (11.7%). The median hospital length of stay was 5 days (IQR: 3-6 days). All patients improved clinically, and the ABI increased significantly (p<0.05). The median follow-up was 19 months (range: 6-56 months). The primary patency rate, secondary patency rate, and freedom from TLR at 12 months were 94.5%, 97.3%, and 93.5%, respectively. The CERAB procedure with BeGraft BECSs has a high technical success rate, favorable patency outcomes, and low morbidity, even in relatively ill patients with extensive AIOD. Prospective randomized studies on the CERAB technique are definitely recommended. This study evaluates the outcomes of BeGraft stents used during the covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure. To date, several balloon-expandable covered stents have been used for this technique with satisfactory results. This study showed the safety and excellent patency of the CERAB technique in extensive AIOD using BeGraft balloon-expandable covered stents.

One Year Outcomes of Zilver PTX Versus Eluvia for Femoropopliteal Disease in Real-World Practice: REALDES Study.

This multicenter, prospective, observational study aimed to compare Zilver PTX and Eluvia stents in real-world settings for treating femoropopliteal lesions as the differences in the 1-year outcomes of these stents have not been elucidated. Overall, 200 limbs with native femoropopliteal artery disease were treated with Zilver PTX (96 limbs) or Eluvia (104 limbs) at 8 Japanese hospitals between February 2019 and September 2020. The primary outcome measure of this study was primary patency at 12 months, defined as a peak systolic velocity ratio of ≤2.4, without clinically-driven target lesion revascularization (TLR) or stenosis ≤50% based on angiographic findings. The baseline clinical and lesion characteristics of Zilver PTX and Eluvia groups were roughly comparable (of all limbs analyzed, approximately 30% presented with critical limb-threatening ischemia, approximately 60% presented with Trans-Atlantic Inter-Society Consensus II C-D, and approximately half had total occlusion), except for the longer lesion lengths in the Zilver PTX group (185.7±92.0 mm vs 160.0±98.5 mm, p=0.030). The Kaplan-Meier estimates of primary patency at 12 months were 84.9% and 88.1% for Zilver PTX and Eluvia, respectively (log-rank p=0.417). Freedom from clinically-driven TLR rates were 88.8% and 90.9% for Zilver PTX and Eluvia, respectively (log-rank p=0.812). The results of the Zilver PTX and Eluvia stents were not different regarding primary patency and freedom from clinically-driven TLR at 12 months after treating patients with femoropopliteal peripheral artery disease in real-world settings. This is the first study to reveal that the Zilver PTX and Eluvia have similar results in real-world practice when the proper vessel preparation is performed. However, the type of restenosis in the Eluvia stent may differ from that in the Zilver PTX stent. Therefore, the results of this study may influence the selection of DES for femoropopliteal lesions in routine clinical practice.

The Impact of Patient Sex on Outcomes after Endovascular Treatment of Aortoiliac Occlusive Disease

The aim of this study was to explore the effect of patient sex on short and long-term outcomes after endovascular treatment for aortoiliac occlusive disease (AIOD). A multi-center retrospective analysis was performed on all patients who underwent iliac artery stenting for aorto-iliac occlusive disease across the three participating sites from October 1, 2018 to September 21, 2021. Preoperative clinical, operative, and post-operative data were collected on a dedicated database. Demographics and outcomes were compared between male and female patients and the probability of freedom from amputation and freedom from target lesion reintervention were estimated with the Kaplan-Meier method. Of 574 patients, 346 (60%) were male and 228 (40%) were female. Mean follow-up was 12 months. Female patients were significantly older (69.2 ± 10.2 years vs. 67.8 ± 8.9 years, p=0.025) and more likely to have Trans-Atlantic Inter-Society Consensus (TASC II) D disease (p=0.003). The female cohort had significantly less coronary artery disease (40% vs. 50%, p=0.013), coronary stenting (14% vs. 21%, p=0.039), and coronary artery bypass grafting (13% vs. 25%, p < 0.001) than the male cohort, as well as less statin use (69% vs 80%, p=0.004). There were no differences in stent type, concomitant open surgery, intraoperative events or hospital length of stay. For 30-day post-operative complications, female patients had a significantly higher rate of thrombotic acute limb ischemia (2% vs. 0%, p=0.01), while male patients had a higher rate of amputation (4% vs. 9%, p=0.048). On mid-term outcomes, there was no difference in freedom from amputation or target lesion re-intervention between male and female patients (p=0.14, p=0.32 respectively). Female patients had lower incidence of cardiovascular risk factors but presented with higher TASC II classification and had higher rates of 30-day thrombotic acute limb ischemia. Male patients were more likely to require amputation within 30 days. Despite no differences in the mid-term, these short-term findings suggest that patient sex may be a relevant consideration in post-operative management and surveillance after endovascular treatment of AIOD.

Long-Term Outcome of Bypass Surgery versus Endovascular Revascularization in Long Femoropopliteal Lesions.

Long-term follow-up data comparing surgical and endovascular revascularization of femoropopliteal lesions is rarely reported. This study presents 4-year results of revascularization for long femoropopliteal lesions (Trans-Atlantic Inter-Society Consensus Types C and D) with vein bypass (VBP), polytetrafluorethylene bypass (PTFE), and endovascular intervention with a nitinol stent (NS). Data from a randomized-controlled trial on VBP and NS was compared with a retrospective patient cohort using PTFE with the same inclusion and exclusion criteria. Primary, primary assisted, and secondary patency, as well as changes in Rutherford categories and limb salvage rates, are reported. Between 2016 and 2020, 332 femoropopliteal lesions underwent revascularization. The lesion lengths and basic patient characteristics were similar between the groups. 49% of the patients presented with chronic limb threatening ischemia at the time of revascularization. During the four-year follow-up, primary patency was comparable for all three groups. Primary assisted and secondary patency were significantly higher after VBP, while PTFE and NS had similar results. Clinical improvement was also significantly superior after VBP. After four years of follow-up, patency rates as well as the clinical outcome clearly favor VBP. If no vein is available, NS is as effective as PTFE bypass with regard to patency and clinical outcome.

Treatment of Long Femoropopliteal Occlusive Lesions With Self-expanding Interwoven Nitinol Stent: 24 Month Outcomes of the STELLA-SUPERA-SIBERIA Register Trial.

The efficacy and safety of the Supera stent in superficial femoral artery (SFA) have been reported mostly in shorter lesions with relatively low proportion of occlusions. There are little data on the effectiveness of the Supera stent in long lesions. The aim of this study was to assess the clinical safety and efficiency of the Supera stent in the treatment of long femoropopliteal occlusive lesions (Trans-Atlantic Inter-Society Consensus [TASC] C/D) in patients with symptomatic peripheral artery disease. The STELLA-SUPERA-SIBERIA is a prospective, single-center, single-arm study. Patients with symptomatic (Rutherford stages 3-6) de novo and TASC C/D occlusive lesions of the femoropopliteal segment were treated with Supera stent. The primary endpoint was the 12 month rate of primary sustained clinical improvement (upward shift on the Rutherford classification to a one level without the need for repeated target lesion revascularization (TLR) in surviving patients without the need for unplanned amputation). Secondary endpoints were the 24 month of primary sustained clinical improvement, MALE, limb salvage, the primary patency, the secondary patency, 24 month MACE. Follow-up included clinical examination, duplex scan, and biplane x-ray up to 24 months. Between April 2019 and January 2020, 52 symptomatic patients with 55 long femoropopliteal occlusive lesions (52.7% TASC D lesions and 47.3% TASC C lesions) were treated. The mean target lesion length was 205±72 mm. All patients had total occlusions. The mean lesion length of the implanted Supera stents was 198±82 mm. At 12 and 24 months, the primary sustained clinical improvement rate was 80.2% and 63.6%, respectively. The Rutherford category assessment was significantly improved at 24 months compared with baseline (p=0.02). The primary patency rate at 12 and 24 months was 78.1% and 60.0%, respectively. At 12 and 24 months, freedom from TLR was 83.5% and 81.8%, respectively. There were no stent fractures at 24 months. Supera Stent implantation for TASC C/D femoropopliteal lesions revascularization appears to be a safe and efficient implant given the complexity of the treated lesions. Head-to-head studies are mandatory to establish Supera Stent as an alternative tool to open surgery for long femoropopliteal lesions. Our study indicated, that using self-expanding interwoven nitinol stent for TASC C/D femoropopliteal lesions revascularization appears to be a safe and efficient implant given the complexity of the treated lesions. Although bypass grafting is recommended for prolonged femoropopliteal lesions, open surgery is more traumatic and is associated with greater risks than endovascular procedures. Our findings suggest that the use of interwoven nitinol stents can overcome the disadvantages of traditional stents in such cases, which may help to improve patients' outcomes and reduce the risk of adverse events.

Aorto-iliac and infrainguinal artery occlusive disease: different revascularization options according to the critical limb threatening ischemia category.

Critical limb threatening-ischemia (CLTI) can be due to an extensive involvement of both the aorto-iliac (AI) and the infra-inguinal (II) districts and the efficacy of and extensive AI+II vs. only AI revascularization is still matter of debate. The aim of the present study was to evaluate the outcome in CLTI patients with concomitant AI and II peripheral artery disease (PAD) after revascularization limited to the AI or extended also to the II segment. Patients with CLTI and concomitant AI (TransAtlantic InterSociety Consensus: C-D) and II PAD (Global-Anatomic-Staging-System: II-III) from 2016 to 2021 were retrospectively evaluated. Patients were compared according to type of revascularization: limited to AI vs. AI+II. Common femoral and profunda artery endarterectomy (C/P-TEA) was considered in both groups. Perioperative mortality, limb salvage, foot healing (within 6 months after surgery), necessity of adjunctive revascularization and survival were analyzed and the follow-up performed with clinical and duplex assessment every six months. The primary endpoint was to evaluate the composite event of limb salvage, wound healing and necessity of adjunctive revascularization during follow-up in AI vs. AI+II groups, through Kaplan Meier and Cox regression analysis. Over a total of 1105 peripheral revascularizations for CLTI, 96 (8.7%) patients met the inclusion criteria for the study. AI revascularization was performed in 38 (40%) and AI+II in 58 (60%). AI and AI+II groups were similar for preoperative risk factors and extension of PAD with the exception of American Society of Anesthesiology (ASA) Classification (ASA IV: 50% vs. 25%, P=0.02, respectively). The AI group was treated with angioplasty/stenting in all cases and with C/P-TEA in 20 (52%) cases. In the AI+II group, the AI district was treated by angioplasty/stenting in 55 (95%) and by aorto-bifemoral bypass in 3 (5%) and C/P-TEA in 20 (34%). The II revascularization was performed by femoro-popliteal/tibial bypass in 27 (47%); and endovascular revascularization in 31 (53%) patients. Minor amputation rate was similar between AI and AI+II revascularization (39% vs. 48%, P=1.0); length of stay, blood transfusion units, were significantly higher in AI+II group: 7±4 days vs. 12±5 days, P=0.04 and 2±2 vs. 4±2, P=0.02. The 30-day mortality was 7% with no differences according to the type of treatment. At a mean follow-up of 28±10 months, the overall limb salvage was 87±4% with similar results in AI vs. AI+II revascularization (95±5% vs. 86±6%; P=0.56). AI had a higher necessity of adjunctive revascularization and lower wound healing compared to AI+II (18±9% vs. 0%, P=0.02; 72% vs. 100%, P=0.001, respectively). AI+II was associated with a better primary endpoint compared to AI (87±5% vs. 53±9%, P=0.01), and it was confirmed in Rutherford 5 and 6 patients (100% vs. 54±14%, P=0.01; 78±9 vs. 50±13%, P=0.04), and no differences in Rutherford 4 (100% vs. 100%). Cox regression analysis confirmed AI+II as an independent protector for the primary outcome (hazard ratio: 0.23, 95% confidence interval 0.08-0.71). CLTI with extensive PAD disease can be treated with limited AI revascularization in Rutherford 4 patients however in case of category 5 or 6 an extensive revascularization (AI+II) should be considered.

ZILVERPASS Study: ZILVER PTX Stent vs. Bypass Surgery in Femoropopliteal Lesions, 3 year results and economic analysis.

To report the 3-year safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to surgical bypass and to conduct a health economic analysis up to 3-year follow-up of the two treatment modalities. This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs. surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.40%) or the bypass treatment group (107, 48.60%). One of the secondary outcomes was primary patency at 3-year, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. An economic analysis was conducted to analyze the cost differences between ZILVER PTX and bypass, which shows the perspective of the public authority/organization that pays for healthcare in the two countries (payor), Germany and USA. The 3-year primary patency rate was 53.30% (95% CI 61.40% to 45.20%) for the ZILVER PTX group vs. 58.20% (95% CI 67.10% to 49.30%) for the bypass arm (P=0.9721). Freedom from TLR at 3-year was 62.80% (95% CI 72.60% to 53%) for the ZILVER PTX group vs. 65.30% (95% CI 75.40% to 55.20%) for the bypass group (P=0.635). There was also no significant difference (P=0.358) in survival rate at 3-year between the ZILVER PTX group 78.50%, (95% CI to 87.70% to 69.30%) and the bypass group 87.40% (95% CI 97.6% to 77.2%). None of the deaths was categorized as related to the procedure or device. The economic analysis, taking into account procedural-, hospitalization- and reintervention costs, showed a clear cost-benefit for Zilver PTX in both investigated countries up to 3-year follow-up: Germany (Bypass €9446 per patient versus ZILVER PTX €5755) and USA (Bypass $26,373 per patient versus ZILVER PTX $19,186). The non-inferior safety and effectiveness results of the ZILVER PTX stent were associated with lower costs for the payer and confirmed that ZILVER PTX stent treatment can be considered as a valid alternative for bypass surgery in long and complex femoropopliteal lesions.

Comparison of Clinical Outcomes of Endovascular Therapy and Hybrid Surgery in the Treatment of Trans-Atlantic Inter-Society Consensus II D Aortoiliac Occlusive Disease.

To study and compare the clinical outcomes of endovascular therapy with those of hybrid surgery in the treatment of Trans-Atlantic Inter-Society Consensus II (TASC II) D aortoiliac occlusive disease (AIOD). Patients with TASC II D-type AIOD who underwent their first surgical treatment at our hospital between March 2018 and March 2021 were enrolled and followed up to evaluate the improvement in symptoms, complications, and primary patency. The Kaplan-Meier method was used to compare the differences in primary patency between the treatment groups. In total, 132 of 139 enrolled patients (94.96%) achieved technical success following treatment. The perioperative mortality rate was 1.44% (2/139), and postoperative complications occurred in two patients. Among the patients who successfully underwent surgery, 120 underwent endovascular treatment (110 patients with stenting and 10 patients with thrombolysis before stenting), 10 underwent hybrid surgery, and 2 underwent open surgery. The follow-up data were compared between the endovascular and hybrid groups. At the end of the follow-up period, the patency rates in the hybrid and endovascular groups were 100% and 89.17% (107/120), respectively. The endovascular group achieved primary patency rates of 94.12%, 92.44%, and 89.08% at 6, 12, and 24 months postoperatively, respectively, whereas the primary patency rate remained at 100% in the hybrid group, with no significant variation between the endovascular and hybrid groups (P = 0.289). The endovascular group was further divided into a stent subgroup (110 patients) and a thrombolysis/stent subgroup (10 patients), and no prominent variation was noted in the primary patency between the two subgroups (P = 0.276). Although open surgery is the gold standard treatment for TASC II D-type AIOD, endovascular and hybrid treatments are feasible and effective. Both methods showed good technical success and early to midterm primary patency rates.

Comparison between Kissing Stents and Direct Surgical Bypass for Aortoiliac Occlusive Disease.

The optimal management strategy for aortoiliac occlusive disease (AIOD) remains debatable. This study compared early and late outcomes between direct surgical bypass and kissing stents for AIOD treatment. We retrospectively reviewed data, including age, sex, risk factors, comorbidities, symptoms, TransAtlantic Inter-Society Consensus (TASC) II classification, operation time, perioperative complications, in-hospital mortality, and length of hospital stay, from a cohort of 46 patients treated for AIOD (24 with kissing stents and 22 with direct surgical bypass) at Pusan National University Hostpital from January 2007 to December 2016. The primary, assisted primary, and secondary patency rates in both groups were compared. The hospital stay (direct surgical bypass vs. kissing stents: 16.36±5.19 days vs. 9.08±10.88 days, p=0.007) and operation time (direct surgical bypass vs. kissing stents: 316.09±141.78 minutes vs. 99.54±37.95 minutes, p<0.001) were significantly shorter for kissing stents. Kaplan-Meier analysis revealed that the primary, assisted primary, and secondary patency rates in the direct surgical bypass group were 95.5%, 95.5%, and 95.5%, respectively, at 1 year; 86.4%, 86.4%, and 95.5% at 3 years; and 77.3%, 77.3%, and 95.5% at 5 years. The primary, assisted primary, and secondary patency rates in the kissing stent group were 100.0%, 100.0%, and 100.0%, respectively, at 1 year; 95.8%, 95.8%, and 100.0% at 3 years; and 95.8%, 95.8%, and 100.0% at 5 years. Except for special cases wherein endovascular revascularization is difficult, kissing stents are more advantageous for TASC II C and D lesions.

High-Risk Characteristics for Clinical Failure after Isolated Femoropopliteal Peripheral Vascular Interventions

Recent studies suggesting increased late mortality with paclitaxel-coated devices (PCD) in femoropopliteal peripheral vascular interventions (PVI) prompted the U.S. Food and Drug Administration to recommend limiting the use of PCDs to "patients at particularly high-risk for restenosis". This study's aim is to characterize patients at high-risk for restenosis, and develop a risk score to guide clinicians in selecting patients for treatment with PCDs. Patients who underwent isolated femoropopliteal PVI for claudication or rest pain from 2016-2019 in the Vascular Quality Initiative were included. Patients who received intervention with a PCD, hybrid procedures, died within one year, or had missing follow up data were excluded. The primary endpoint was clinical failure at one year defined as > 50% restenosis, loss of patency, reintervention, or major amputation. Data was split randomly into 2/3 for development and 1/3 for validation. A parsimonious multivariable hierarchical logistic regression for clinical failure was developed and a risk score was created using beta-coefficients. The risk score was applied to the validation dataset and tested for goodness of fit and discrimination. Among 4,856 treated patients, 718 (14.8%) experienced clinical failure within one year. Clinical failure was associated with age ≤ 50, female sex (48.1% vs 39.5%), insulin-dependent diabetes (29.9% vs 23.1%), creatinine >2.0 mg/dL (9.9% vs 5.7%), prior ipsilateral lower extremity revascularization (48.5% vs 38.5%), prior ipsilateral minor amputation (5.3% vs 1.7%), rest pain vs claudication (30.8% vs 18.7%), occlusion length ≥ 20 cm (18.8% vs 15.0%), and Trans-Atlantic Inter-Society Consensus (TASC) II Classification C or D (40.4% vs 28.0%), all P ≤ 0.01. Risk score development was performed using a multivariable regression. The model demonstrated good fit and discrimination (C-statistic 0.71 in development and 0.72 in validation dataset). Predicted clinical failure was 8.9% for standard-risk (45.9% of interventions), 15.5% for high-risk (44.2% of interventions), and 33.8% for very high-risk patients (9.8% of interventions). A novel risk score was created with good discrimination for identifying patients at high-risk for clinical failure at one year after femoropopliteal PVI for claudication and rest pain. Patients at high-risk and very high-risk for clinical failure may benefit from alternative strategies including PCDs.

Novel Therapeutic Concepts for Complex Femoropopliteal Lesions Using the Jetstream Atherectomy System

Introduction: The presence of severe arterial calcification is associated with less favorable outcomes in terms of procedural and clinical success as well as higher rates of major adverse limb events. Recent studies incorporating rotational atherectomy for effective preparation of severely calcified lesions demonstrate beneficial procedural outcomes by obtaining maximal luminal gain and improved long-term outcomes. Methods: This prospective single-center, observational study includes patients with severely calcified femoropopliteal lesions with chronic limb ischemia Rutherford 1–5 between January 2017 and July 2019, who underwent atherectomy using the Jetstream Atherectomy system, followed by drug-coated balloon angioplasty. Lesion calcification was categorized by the Peripheral Arterial Calcium Scoring System (PACSS), whereas lesion complexity was classified by the Transatlantic Inter-Society Consensus (TASC). Safety and efficacy aspects in terms of vessel injury, thromboembolism, and clinical success were systematically analyzed up to 12 months of follow-up (FU). Results: In 162 consecutive patients, 210 non-stented and 22 stented lesions were treated. Twelve (7.4%) patients received bail-out stenting. Mean lesion length was 24.2±4.8 cm; 51% were chronic total occlusions (mean occlusion length 18.2±5.1 cm). TASC C lesions were present in 38 patients (23.5%) and TASC D lesions in 124 patients (76.5%). The mean PACCS score was 3.3±0.9. Device success was achieved in 88%; procedural success was noted in 99% of the lesions. Embolic protection device was used in 11.7%. Perforation or dissection occurred in none of the cases. Asymptomatic peripheral embolization was noted in 10 patients (6.2%). Clinical FU at 12 months was available in 157 of 162 patients (96.9%). At 12 month FU, (1) mean Rutherford classification at baseline of 3.7±0.6 significantly dropped to 1.0±0.9 (p<0.05), (2) baseline mean anke-brachial index (ABI) of 0.4±0.1 significantly increased to 0.8±0.2 (p<0.05), (3) 92.6% were free from target lesion revascularization (TLR), (4) 95.1% were free from target vessel revascularization (TVR), and (5) binary restenosis measured by duplex occurred in 22 patients (13.6%). Multivariate analyses showed lesion length as predictive of stent placement (p=0.02), whereas both lesion length (p=0.006) and PACCS score (p=0.02) are predictive of clinical success. Conclusion: Rotational atherectomy in combination with drug-coated balloon (DCB) can be safely performed in long, calcified (non-) occlusive lesions with a relatively low rate of bail-out stenting and favorable clinical mid-term results. Clinical Impact: In this prospective, single arm study we demonstrated that combination treatment using rotational atherectomy and DCB is safe and effective in complex and calcified TASC C/D femoropopliteal lesions in patients with claudication or CLTI in a real-world clinical setting. Despite mean lesion length of >20cm and a relatively high rate of chronic total occlusions, the rate of bail-out stenting was surprisingly low (7.4%), whereas the rates of freedom from TLR and TVR were surprisingly high. Thus, our study may encourage vascular specialists to choose an endovascular -first approach even in such complex and calcified femoropopliteal lesions and occlusions in daily clinical practice.

Midterm Outcomes of Kissing Covered Self-Expanding Stents for Reconstruction of Complex Aortoiliac Occlusive Disease

We sought to investigate the midterm results of kissing self-expanding covered stents (SECSs) for the reconstruction of aortic bifurcation in complex aortoiliac occlusive disease. Data of consecutive patients who had undergone endovascular treatment for aortoiliac occlusive disease were screened. Only patients with TransAtlantic Inter-Society Consensus (TASC) class C and D lesions treated by bilateral iliac kissing stents (KSs) were included. Midterm primary patency, risk factors, and limb salvage rates were analyzed. Follow-up results were analyzed using the Kaplan-Meier curves. Cox proportional hazards models were used to identify the predictors of primary patency. A total of 48 patients (95.8% men; mean age, 65.3±10.2years) were treated with kissing SECSs. Of them, 17 patients had TASC-II class C lesions and 31 had class D lesions. There were 38 total occlusive lesions, with a mean occlusive lesion length of 108.2±57.3mm. The overall mean lesion length was 140.3±60.5mm, and the mean length of implanted stents in the aortoiliac arteries was 141.9±59.9mm. The mean diameter of the deployed SECSs was 7.8±0.5mm. The mean follow-up time was 36.5±15.8months, and the follow-up rate was 95.8%. At 36months, the overall primary patency, assisted primary patency, secondary patency, and limb salvage rates were 92.2%, 95.7%, 97.8%, and 100%, respectively. Univariate Cox regression analysis revealed that stent diameter ≤7mm (hazard ratio [HR]: 9.53; 95% confidence interval [CI] 1.56-57.94, P=0.014) and severe calcification (HR: 12.66; 95% CI 2.04-78.45, P=0.006) were significantly associated with restenosis. Multivariate analysis showed severe calcification to be the only significant determinant of restenosis (HR: 12.66; 95% CI 2.04-78.45, P=0.006). Kissing SECSs provide good midterm results for the treatment of aortoiliac occlusive disease. A stent diameter >7mm is a potent protective factor against restenosis. Because severe calcification appears to be the only significant determinant of restenosis, patients with severe calcification require close follow-up.

Five-Year Outcomes of the Bioresorbable Peripheral Remedy Stent in the Treatment of Iliac Artery Disease

PurposeTo evaluate the 5-year performance of a bioresorbable vascular scaffold, the Remedy stent, for the treatment of iliac artery atherosclerotic disease. Materials and MethodsThis prospective, multicenter, single-arm clinical study evaluated 97 patients (97 lesions) with symptomatic TransAtlantic Inter-Society Consensus II A/B iliac artery lesions for 5 years after stent placement. The primary efficacy end point was 12-month primary patency compared with the prespecified standard derived from historical data with metallic stents, and the primary safety end point was the occurrence of major adverse clinical events within 5 years. All angiographic and computed tomography angiographic findings were evaluated by an independent core laboratory for quantitative vessel analysis. ResultsThe 12-month primary patency rate was 88.6% (95% CI, 80.1%–94.4%), which was lower than the prespecified standard. No significant difference was noted between the diameter stenosis at 9 and 12 months. There were no device- or procedure-related deaths, major amputation, or distal embolization during the follow-up period. The ankle-brachial index maintained significant improvement through the 5-year period compared with that at baseline. The Kaplan–Meier estimates of freedom from target lesion revascularization (TLR), major adverse cardiovascular events, and major adverse cardiovascular and limb events were 95.8%, 91.7%, and 87.5% at 12 months and 85.4%, 72.1%, and 62.5% at 5 years, respectively. ConclusionsThe 5-year follow-up outcomes, including freedom from TLR, of the Remedy stent in iliac artery lesions were satisfactory, with a good safety profile. Nevertheless, the 12-month primary patency did not meet the expected standard compared with that of contemporary metallic stents.

Endovascular treatment of aorto-iliac occlusive disease with TASC II C and D lesions: 10 year’s experience of clinical technique

ObjectivesThe purpose of this study was to evaluate the therapeutic efficacy and safety of endovascular treatment aorto-iliac occlusive disease (AIOD) with TransAtlantic Inter-Society Consensus II (TASC II) C and D lesions. In addition, 10 years of experience with interventional procedures and treatment options in our center were also worthy of further discussion.MethodsBetween January 2011 and December 2020, a total of 26 consecutive AIOD patients with TASC-II C and D lesions treated endovascular approach were enrolled in this study. Patients' demographic and clinical data were collected, and the safety and efficacy of endovascular therapy were evaluated. In addition, operation procedures were also described.ResultsThe mean age of patients was 62.2 ± 7 years (49–57 years), and the mean body mass index of patients was 24.2 ± 2.6 kg/m2. Fifteen patients (57.7%) were Rutherford 4, 5 each (19.2%) were Rutherford 3 and 5, and 1 (3.8%) was Rutherford 2. No other serious complications occurred except death in 3 patients. Most of the patients (73.1%) had a history of smoking, and hypertension and hyperlipidemia were common comorbidities. Endovascular therapy was successfully performed in 25 patients, and the technical success rate was 96.2%. The patient's ankle-brachial index improved significantly postoperatively compared with preoperatively (preoperative 0.33 ± 0.14 vs 1.0 ± 0.09, P < 0.001). The primary patency rates were 100%, 95.7%, and 91.3% at 1, 3, and 5 years, while the secondary patency rates were 100%. No treatment-related deaths or serious complications occurred.ConclusionsEndovascular treatment of AIOD patients with TASC-II C and D lesions might be safe and have a high rate of middle-term and long-term primary patency.

Prospective, Multicenter Study of Rotational Atherectomy with Antirestenotic Therapy for Infrainguinal Arterial Disease

Thrombi are common in steno-occlusive lesions of infrainguinal atherosclerotic diseases. Despite the easy passage of guidewires through these lesions, conventional ballooning or stenting cannot effectively treat them, and patients are at risk of distal embolization. This study aimed to investigate the clinical outcomes of using a rotational aspiration atherectomy system to treat infrainguinal atherosclerotic disease. Patients underwent revascularization of target lesions using the Jetstream™ Atherectomy System. The primary endpoint was the freedom from clinically driven target lesion revascularization (CD-TLR) 12-month after the procedure. Outcomes were evaluated according to the clinical severity, lesion type, use of drug-coated balloons (DCBs), and lesion length, characteristics, and sites. Survival analysis for CD-TLR over time was plotted. All statistical analyses were performed using SPSS version 22 (IBM; Armonk, NY, USA). P-values <0.05 were considered statistically significant. In total, 150 patients (91.2% male; mean age, 69.8years; 66.2% with diabetes) with de novo or restenotic infrainguinal lesions were enrolled. The mean lesion length was 17.2cm, 75.0% were occlusive, and 38.2% had severe calcification. The lesion types were sclerotic (64.7%), thrombosclerotic (20.6%), thrombotic (8.8%), and in-stent (5.9%). Adjunctive DCB was used in 86.8% of patients. The 12-month primary patency rate (PPR) and CD-TLR rates were 81.6% and 90.1%, respectively. The 12-month CD-TLR rate was significantly better in the sclerotic and thrombosclerotic groups than in the thrombotic group (100% and 100% vs. 66.7%; P=0.001). The 12-month PPR was significant better in TransAtlantic Inter-Society Consensus (TASC) A and B groups than TASC C and D groups (P=0.02). The 12-month PPR is significantly better after using a DCB or stent placement than after using a simple balloon (P=0.01). There were no major adverse events, including procedure-related death, myocardial infarction, or major amputation. The results of this study demonstrated the safety and effectiveness of the Jetstream atherectomy device for complex infrainguinal lesions. This system functions optimally with TASC A/B lesions and sclerotic or thrombosclerotic lesions.

The Complexity of Peripheral Arterial Disease and Coronary Artery Disease in Diabetic Patients: An Observational Study.

Atherosclerosis is a systemic disease that causes luminal narrowing. Patients with peripheral arterial disease (PAD) also exhibit an increased risk of death from cardiovascular complications. This risk is the same for symptomatic or asymptomatic patients. Over a 5-year period, patients with PAD have a 20% chance of suffering from a stroke or myocardial infarction. Additionally, their mortality rate is 30%. This study aimed to assess the relationship between coronary artery disease (CAD) complexity using SYNTAX score and PAD complexity using Trans-Atlantic Inter-Society Consensus II (TASC II) score. The study was designed as single-center cross-sectional observational and included 50 diabetic patients referred for elective coronary angiography and peripheral angiography was done. Most of the patients were males (80%) and smokers (80%) with mean age of 62 years. The mean SYNTAX score was 19.88. There was a significant negative correlation between SYNTAX score and ankle brachial index (ABI) (r = -0.48, P = 0.001) and a significant positive correlation with glycated hemoglobin (HbA1c) level (R2 = 26, P = 0.004). Complex PAD was found in nearly half of the patients with 48% having TASC II C or D classes. Those with TASC II classes C and D had higher SYNTAX scores (P = 0.046). Diabetic patients with more complex CAD had more complex PAD. In diabetic patients with CAD, those with worse glycemic control had higher SYNTAX scores and the higher the SYNTAX score, the lower the ABI.

An Observational Study on Clinical Profile and Management of Transatlantic Intersociety Consensus II C and D Aortoiliac and Femoropopliteal Occlusive Diseases: Role of Hybrid Procedures in Hybrid Operation Theater

Objective: Peripheral arterial disease is a powerful predictor of the loss of limb and even loss of life. Endovascular treatment (ET) and hybrid procedures are gradually replacing open procedures. The purpose of this study is to evaluate the management outcome of transatlantic intersociety consensus (TASC) C and D aortoiliac (AI) and femoropopliteal (FP) disease by various methods. Materials and Methods: Prospective observational study was done at Army Hospital (Research and Referral) Delhi Cantt from June 2015 to January 2017. Patients with TASC C and D AI and FP lesions were included. Patients were treated with either open, endovascular or hybrid technique and followed at 1, 3, and 6 months. Results: A total of 110 (36 AI and 74 FP) patients were included. 96.3% were smokers. Seventeen were TASC C and 93 were TASC D lesions. Fourteen out of 17 TASC C lesions could be managed by endovascular, two by hybrid and only one required open reconstruction. Whereas 58 out of 93 TASC D lesions needed to be opened, 15 were endovascular, and the rest 20 cases were managed by hybrid procedures. One had an iliac artery rupture managed with bypass graft. We have seven mortalities two within 30 days and five from 30 days to 1-year primary and secondary patency for ET was 72.4% and 80%, for open surgery was 76.2% and 93% and for hybrid procedure was 60% and 77.7%. Conclusions: Hybrid therapy simplifies and allows the one-step treatment with complex peripheral multifocal steno-obstructive vascular disease with high technical success rate and excellent long-term patency in few patients.