Femoropopliteal Artery Research Articles

Angioplasty of Flow-Limiting Stenosis Reduces Aortic and Brachial Blood Pressure in Patients With Peripheral Artery Disease.

BackgroundArterial hypertension affects cardiovascular outcome in patients with peripheral artery disease (PAD). We hypothesized that angioplasty of peripheral arterial stenoses decreases aortic (aBP) and brachial blood pressure (bBP).Methods and ResultsIn an index cohort (n=30), we simultaneously measured aBP, bBP, augmentation index (AIx), and aortic pulse wave velocity (PWV) before and after angioplasty of the iliac and femoropopliteal arteries; diagnostic angiography served as a control. In an all‐comer registry cohort (n=381), we prospectively measured bBP in patients scheduled for angioplasty of the iliac, femoral, and crural arteries or diagnostic angiography. Systolic aBP decreased after iliac (Δ−25 mmHg; 95% CI, −30 to −20; P<0.0001) and femoropopliteal angioplasty (Δ−12 mmHg; 95% CI, −17 to −5; P<0.0001) as compared with diagnostic angiography. Diastolic aBP decreased after iliac (Δ−9 mmHg; 95% CI, −13 to −1; P=0.01) but not femoropopliteal angioplasty. In parallel, AIx significantly dropped, whereas PWV remained stable. In the registry cohort, systolic bBP decreased after angioplasty of the iliac (Δ−17 mmHg; 95% CI, −31 to −8; P=0.0005) and femoropopliteal arteries (Δ−10 mmHg; 95% CI, −23 to −1; P=0.04) but not the crural arteries, as compared with diagnostic angiography. Diastolic bBP decreased after iliac (Δ−10 mmHg; 95% CI, −17 to −2; P=0.01) and femoropopliteal angioplasty (Δ−9 mmHg; 95% CI, −15 to −1; P=0.04). Multivariate analysis identified baseline systolic bBP and site of lesion as determinants of systolic bBP drop after endovascular treatment.ConclusionsAngioplasty of flow‐limiting stenoses in patients with peripheral artery disease lowers aortic and brachial blood pressure with more pronounced effects at more proximal lesion sites and elevated baseline systolic blood pressure. These data indicate a role of endovascular treatment to acutely optimize blood pressure in patients with peripheral artery disease.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT02728479.

One-year outcomes of drug-coated balloon treatment for long femoropopliteal lesions: a multicentre cohort and real-world study

BackgroundDrug-coated balloons (DCBs) have shown superiority in the endovascular treatment of short femoropopliteal artery disease. Few studies have focused on outcomes in long lesions. This study aimed to evaluate the safety and effectiveness of Orchid® DCBs in long lesions over 1 year of follow-up.MethodsThis study is a multicentre cohort and real-world study. The patients had lesions longer than or equal to 150 mm of the femoropopliteal artery and were revascularized with DCBs. The primary endpoints were primary patency, freedom from clinically driven target lesion revascularization (TLR) at 12 months and major adverse events (all-cause death and major target limb amputation). The secondary endpoints were the changes in Rutherford classification and the ankle brachial index (ABI).ResultsOne hundred fifteen lesions in 109 patients (mean age 67 ± 11 years, male proportion 71.6%) were included in this study. The mean lesion length was 252.3 ± 55.4 mm, and 78.3% of the lesions were chronic total occlusion (CTO). Primary patency by Kaplan–Meier estimation was 98.1% at 6 months and 82.1% at 12 months. The rate of freedom from TLR by Kaplan–Meier estimation was 88.4% through 12 months. There were no procedure- or device-related deaths through 12 months. The rate of all-cause death was 2.8%. Cox regression analysis suggested that renal failure and critical limb ischaemia (CLI) were statistically significant predictors of the primary patency endpoint.ConclusionIn our real-world study, DCBs were safe and effective when used in long femoropopliteal lesions, and the primary patency rate at 12 months by Kaplan–Meier estimation was 82.1%.

Endovascular community response to mortality data in use of paclitaxel devices for peripheral vascular disease

ObjectiveWe examined the endovascular community response to data demonstrating increased mortality in paclitaxel devices for the treatment of peripheral arterial disease in femoropopliteal lesions. MethodsA retrospective observational study using the Vascular Quality Initiative Peripheral Vascular Intervention registry dataset was performed to examine paclitaxel device use for peripheral arterial disease in femoropopliteal arteries treated from 2017 to 2019. A total of 41,707 patients and 52,208 procedures were analyzed during the study period. A post hoc analysis was performed to examine paclitaxel device use during selected periods in 2019. ResultsThe total number of femoropopliteal procedures in 2017, 2018, and 2019 were 17,458, 21,140, and 21,322, respectively. Paclitaxel devices were used for 8852 arteries in 2017, 10,691 in 2018, and 6732 in 2019, which was significantly reduced in 2019 compared with 2017 or 2018 (P < .0001) and 2019 compared with the 2018 and 2017 volumes combined (P < .0001). Post hoc analysis of selected periods in 2019 demonstrated variable use throughout 2019. ConclusionsAfter the report of data with concerns of mortality associated with paclitaxel device use in 2018, a rapid reduction in overall paclitaxel device use was observed in 2019.

Roles of Angioplasty With Drug-Coated Balloon for Chronic Ischemia in Wound Healing

Purpose: Clinical trials have demonstrated sustained benefits of drug-coated balloon (DCB) angioplasty compared with noncoated balloon angioplasty in symptomatic peripheral artery disease (PAD) presenting with femoropopliteal (FP) artery disease. However, there is still controversy whether particulate embolization caused by crystalline paclitaxel, the so-called “downstream effect,” is adversely associated with clinical outcomes after use of FP DCB among chronic limb-threatening ischemia (CLTI) patients. The current RADISH (Roles of Angioplasty with Drug-coated balloon for chronic ISchemia in wound Healing) study investigated wound healing following DCB therapy vs non-DCB therapy for real-world CLTI patients presenting with FP lesions. Materials and Methods: This multicenter, retrospective study analyzed 927 patients with CLTI (mean age, 76±10 years; male, 57.8%; diabetes mellitus, 64.5%; dialysis, 50.7%) presenting with FP lesions and treated endovascularly via DCB (138 patients) vs non-DCB therapy (789 patients) between April 2014 and March 2019. The primary outcome measure was 1-year wound healing, while the secondary outcome measure was 1-year primary patency. Clinically-driven target lesion revascularization (CD-TLR), limb salvage and overall survival were also analyzed by using propensity score matching analysis. Results: The propensity score matching extracted 111 pairs (as many patients in the DCB group and 629 patients in the non-DCB group). The 1-year cumulative incidence of wound healing (95% CI) was 74.4% (62.6% to 82.5%) in the DCB group and 71.9% (60.4% to 80.1%) in the non-DCB group, with no significant intergroup difference (p=0.93). The DCB group had a higher rate of primary patency (p=0.002) and freedom from CD-TLR (p=0.010) than the non-DCB group, whereas there was no significant intergroup difference in limb salvage (p=0.21) or overall survival (p=0.93). Conclusion: The current analysis of data from the RADISH study demonstrated that DCB therapy did not lead to delayed wound healing and reduced restenosis rate in CLTI patients presenting FP lesions. From this results, DCB therapy would be a reasonable treatment option for CLTI patients.

Mortality Rates After Paclitaxel-Coated Device Use in Patients With Occlusive Femoropopliteal Disease: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials

Purpose: A late increased mortality risk has been reported in a summary level meta-analysis of patients with femoropopliteal artery occlusive disease treated with paclitaxel-coated angioplasty balloons and stents. However, at the longer follow up timepoints that analysis was limited by small trial numbers and few participants. The aim of this study was to report an updated summary level risk of all-cause mortality after treatment with paclitaxel-coated devices in that same patient group. Materials and Methods: We performed a systematic review and meta-analysis of randomized controlled trials to investigate the mortality outcomes associated with paclitaxel-coated devices used to treat patients with occlusive disease of femoropopliteal arteries (last search date December 10, 2020). The single primary endpoint was all-cause mortality. Results: We identified 34 randomized controlled trials (7654 patients; 84% intermittent claudication). There were 622 deaths among 4147 (15.0%) subjects in the paclitaxel device group and 475 deaths among 3507 (13.5%) subjects in the noncoated control group [relative risk ratio (RR) 1.07, 95% confidence interval (CI) 0.96 to 1.20, p=0.20, I2=0%). All-cause mortality was similar between groups at 12 months (34 studies, 7654 patients; RR 0.99, 95% CI 0.81 to 1.22, p=0.94, I2=0%), 24 months (20 studies, 3799 patients; RR 1.16, 95% CI 0.87 to 1.55, p=0.31, I2=0%), and 60 months (9 studies, 2288 patients; RR 1.19, 95% CI 0.98 to 1.45, p=0.08, I2=0%). Conclusion: This updated meta-analysis with included additional trials and larger patient numbers shows no evidence of increased risk of all-cause mortality in patients treated with paclitaxel-coated devices, compared with uncoated devices for femoropopliteal disease at all time points to 60 months. There is therefore no justification to limit their use, or alter regulatory body follow-up recommendations in this patient population. Systematic Review Registration: CRD42020216140.

Paclitaxel-coated peripheral arterial devices are associated with improved overall survival and limb salvage in patients with chronic limb-threatening ischemia

ObjectivePaclitaxel (PTX)-coated peripheral arterial devices have been shown to decrease femoropopliteal artery restenosis and the need for reintervention compared with non-PTX-coated devices. The data regarding PTX efficacy and safety come from randomized controlled trials that almost exclusively enrolled patients with claudication. The outcomes of PTX treatment in patients who present with chronic limb-threatening ischemia (CLTI) are unknown. This study compares long-term outcomes in patients with CLTI treated with and without PTX. MethodsWe retrospectively reviewed 983 patients with CLTI treated with femoropopliteal artery angioplasty, atherectomy, stent, or combination between 2011 and 2019. Procedures were performed with additional proximal or distal tibial interventions as needed. Kaplan-Meier survival analysis and multivariable Cox-regression analysis compared overall survival (OS), amputation-free survival (AFS), freedom from major amputation (ff-MA), and freedom from target vessel revascularization (ff-TVR) between patients treated with and without PTX. ResultsDemographics, comorbidities, and Rutherford class were similar between 574 PTX (58.5%) and 409 non-PTX (41.6%) patients except that non-PTX patients were more likely to be male (56.2% vs 49.7%), dialysis dependent (19.6% vs 14.3%), and have higher average creatinine (2.3 vs 1.8 mg/dL). Through 4-year follow-up, the PTX group demonstrated a significant increase in OS (56.2% vs 43.9%, P = .013), AFS (52.6% vs 36.1%, P < .0001), ff-MA (87.4% vs 78.7%, P = .0007), and ff-TVR (77.6% vs 70.6%, P = .012). Multivariable Cox-regression analysis demonstrated that PTX treatment was associated with improved OS, AFS, ff-MA, and ff-TVR. ConclusionsIn patients with CLTI, treatment with a PTX-coated device is associated with improved OS, AFS, ff-MA, and ff-TVR through 4-year follow-up. PTX-coated devices may be especially beneficial in patients who present with CLTI.

Directional atherectomy before paclitaxel coated balloon angioplasty in complex femoropopliteal disease: The VIVA REALITY study.

Drug coated balloon (DCB) angioplasty significantly reduces reintervention rates in patients with symptomatic femoropopliteal peripheral artery disease (PAD). However, stand-alone DCB use in long, severely calcified lesions is frequently associated with vessel recoil and/or high-grade dissections necessitating provisional stent implantation. Assess the safety and effectiveness of a vessel preparation strategy with directional atherectomy (DA) prior to DCB angioplasty in patients with symptomatic severely calcified femoropopliteal PAD. REALITY (NCT02850107) prospectively enrolled subjects at 13 multinational centers with 8-36 cm femoropopliteal stenoses or occlusions with bilateral vessel wall calcification treated with DA prior to DCB angioplasty. The primary effectiveness endpoint was 12-month primary patency, and the primary safety endpoint was freedom from major adverse events through 30 days. Independent angiographic and duplex core laboratories assessed outcomes and a Clinical Events Committee adjudicated events. A total of 102 subjects were enrolled; one lesion was treated per subject. The mean lesion length was 17.9 ± 8.1cm, 39.0% were chronic total occlusions (mean lesion length 22.6 ± 8.6cm); 86.2% of lesions exhibited moderate to severe bilateral calcification. Provisional stents were implanted in 8.8% (9/102) of subjects. Twelve-month primary patency rate was 76.7% (66/86) and freedom from CD-TLR rate was 92.6% (87/94). No device or procedure related deaths and one index-limb major amputation were reported. Plaque excision with DA in patients with symptomatic severely calcified femoropopliteal arterial disease prior to DCB angioplasty is a safe and effective treatment strategy with a low provisional stent rate.

Intravascular Lithotripsy for Peripheral Artery Calcification: 30-Day Outcomes From the Randomized Disrupt PAD III Trial.

The study sought to compare short-term outcomes in patients with femoropopliteal artery calcification receiving vessel preparation with intravascular lithotripsy (IVL) or percutaneous transluminal angioplasty (PTA) prior to drug-coated balloon (DCB) for symptomatic peripheral artery disease. Endovascular treatment of calcified peripheral artery lesions is associated with suboptimal vessel expansion and increased complication risk. Although initial results from single-arm studies with IVL have been reported, comparative evidence from randomized trials is lacking for most devices in the presence of heavy calcification. The Disrupt PAD III (Shockwave Medical Peripheral Lithoplasty System Study for PAD) randomized trial enrolled patients with moderate or severe calcification in a femoropopliteal artery who underwent vessel preparation with IVL or PTA prior to DCB or stenting. The primary endpoint was core lab-adjudicated procedural success (residual stenosis≤30% without flow-limiting dissection) prior to DCB or stenting. In patients receiving IVL (n=153) or PTA (n=153), procedural success was greater in the IVL group (65.8% vs. 50.4%; p=0.01) and the percentage of lesions with residual stenosis≤30% (66.4% vs. 51.9%; p=0.02) was greater in the IVL group, while flow-limiting dissections occurred more frequently in the PTA group (1.4% vs. 6.8%; p=0.03). Post-dilatation (5.2% vs. 17.0%; p=0.001) and stent placement (4.6% vs. 18.3%; p<0.001) were also greater in the PTA group. The rates of major adverse events (IVL: 0% vs. PTA: 1.3%; p=0.16) and clinically driven target lesion revascularization (IVL: 0.7% vs. PTA: 0.7%; p=1.0) at 30days were comparable between groups. IVL is an effective vessel preparation strategy that facilitates definitive endovascular treatment in calcified femoropopliteal arteries in patients with peripheral artery disease. (Shockwave Medical Peripheral Lithoplasty System Study for PAD [Disrupt PAD III]; NCT02923193).

Different Lower Extremity Arterial Calcification Patterns in Patients with Chronic Limb-Threatening Ischemia Compared with Asymptomatic Controls.

Objectives: The most severe type of peripheral arterial disease (PAD) is critical limb-threatening ischemia (CLI). In CLI, calcification of the vessel wall plays an important role in symptoms, amputation rate, and mortality. However, calcified arteries are also found in asymptomatic persons (non-PAD patients). We investigated whether the calcification pattern in CLI patients and non- PAD patients are different and could possibly explain the symptoms in CLI patients. Materials and Methods: 130 CLI and 204 non-PAD patients underwent a CT of the lower extremities. This resulted in 118 CLI patients (mean age 72 ± 12, 70.3% male) that were age-matched with 118 non-PAD patients (mean age 71 ± 11, 51.7% male). The characteristics severity, annularity, thickness, and continuity were assessed in the femoral and crural arteries and analyzed by binary multiple logistic regression. Results: Nearly all CLI patients have calcifications and these are equally frequent in the femoropopliteal (98.3%) and crural arteries (97.5%), while the non-PAD patients had in just 67% any calcifications with more calcifications in the femoropopliteal (70.3%) than in the crural arteries (55.9%, p < 0.005). The crural arteries of CLI patients had significantly more complete annular calcifications (OR 2.92, p = 0.001), while in non-PAD patients dot-like calcifications dominated. In CLI patients, the femoropopliteal arteries had more severe, irregular/patchy, and thick calcifications (OR 2.40, 3.27, 1.81, p ≤ 0.05, respectively) while in non-PAD patients, thin continuous calcifications prevailed. Conclusions: Compared with non-PAD patients, arteries of the lower extremities of CLI patients are more frequently and extensively calcified. Annular calcifications were found in the crural arteries of CLI patients while dot-like calcifications were mostly present in non-PAD patients. These different patterns of calcifications in CLI point at different etiology and can have prognostic and eventually therapeutic consequences.

Orchid drug-coated balloon versus standard percutaneous transluminal angioplasty for the treatment of femoropopliteal artery disease: 12-month result of the randomized controlled trial.

To assess the efficacy and safety of the Orchid drug-coated balloon (coated with paclitaxel) for the treatment of femoropopliteal artery disease versus percutaneous transluminal angioplasty in Chinese population. This is a prospective, single center, single-blinded, randomized controlled trial that randomized (1:1) 60 patients (38 men; mean age 68.7 ± 8.8) to drug-coated balloon group (n = 30) or percutaneous transluminal angioplasty group (n = 30). The primary efficacy endpoint was primary patency of the target lesion and clinically driven target lesion revascularization (CD-TLR) at 12 months. The primary safety end point was freedom from perioperative death at 30 days and freedom from limb-related death and major amputation at 12 months. Baseline characteristics were similar between the two groups. Drug-coated balloon group resulted in higher primary patency (82.8% vs. 48.3%, p = 0.005) and lower CD-TLR rates (3.5% vs. 27.6%; p = 0.001) versus percutaneous transluminal angioplasty group at 12 months. The ABI was significantly higher in drug-coated balloon group than percutaneous transluminal angioplasty group (0.86 ± 0.13 vs. 0.72 ± 0.18, p = 0.025). There were no perioperative death at 30 days, no limb-related death and no major amputation at 12 months in either group. The randomized controlled trial showed superior treatment effect with drug-coated balloon versus percutaneous transluminal angioplasty, with remarkably higher patency and lower CD-TLR rates. The result is consistent with other study and demonstrates the safety and efficacy of the Orchid drug-coated balloon for the treatment of femoropopliteal artery disease.

Association of Postangioplasty Femoropopliteal Dissections With Outcomes After Drug-Coated Balloon Angioplasty in the Femoropopliteal Arteries

Purpose: Balloon angioplasty for the treatment of femoropopliteal lesions is often complicated by postangioplasty dissections. While dissections are known to affect patency and reintervention after balloon angioplasty, the association between dissections and major adverse limb event (MALE) after drug-coated balloon (DCB) angioplasty remains uncertain. Thus, the postangioplasty dissection and bailout stenting patterns were investigated. Materials and Methods: This was a single-center retrospective study enrolling patients with de novo femoropopliteal lesions treated with DCB with/without stenting. Postangioplasty target vessel dissection was graded based to the coronary artery classification grades A-F, with grade C-F considered “severe.” Cox regression analysis was performed to examine the association of dissection severity with outcomes during 2-year follow up, among nonstented cases. Results: In 85.3% of the cases (N=203/238) a postangioplasty dissection was observed. The average dissection length was 55.57 mm (SD 36.71 mm), with 1 dissection present in 91.8% (N=180/196) and 2 or more dissections present in 8.2% (N=16/196). Dissection severity was grade A (19.8%), B (20.6%), C (23.1%), D (10.9%), E (10.1%), and F (0.8%). Bailout stenting was required in 40.4% of the patients, being more prevalent among grade C and grade E cases. Among 142 nonstented cases, dissections were present in 85.2%. A total of 75 (52.8%) of these dissections were grade A and B, while 46 (32.4%) were grade C to F. Among nonstented cases, grade C (hazard ratio [HR] 5.83; 95% CI 1.25 to 27.31; p=0.025) and grade D (HR 6.32; 95% CI 1.39 to 28.86; p=0.017) vs grade A dissections were associated with a higher risk for 2-year MALE. Multivariate analysis adjusting for several lesion characteristics demonstrated a statistically significant higher risk for 2-year MALE among the severe dissection group (HR 2.94; 95% CI 1.27 to 6.79; p = 0.012). Interestingly, the risks of limb loss (HR 1.30; 95% CI 0.22 to 7.79; p=0.774) and repeat revascularization (HR 0.95; 95% CI 0.40 to 2.26; p=0.905) during follow-up were similar between the 2 groups. Conclusion: This study indicated that nonstented moderate and severe postangioplasty dissections after DCB angioplasty were associated with higher risk for MALE. Future studies are needed to validate our results and determine other dissection characteristics (eg, total dissection length, lumen area, total number of dissections) that may affect the efficacy of DCB.

Radiation dose and diagnostic reference levels for four interventional radiology procedures: results of the prospective European multicenter survey EUCLID.

To assess information reflecting radiation dose and define diagnostic reference levels (DRL) on a European basis for four interventional radiology (IR) procedures considering clinical indication, anatomical region, and procedure. A prospective European study was performed to provide data on the IR procedures percutaneous recanalization of iliac arteries, percutaneous recanalization of femoropopliteal arteries, transarterial chemoembolization of hepatocellular carcinoma, and percutaneous transhepatic biliary drainage. Hospitals were asked to complete a questionnaire giving information on procedure, equipment, and protocol. Patient size and weight, experience of the operator graded in number of procedures performed, and complexity level of each procedure were reported. Sixteen hospitals from 13 countries could be surveyed. The percentiles of the kerma-area product, fluoroscopy time, cumulative air kerma at the interventional reference point, and number of images were determined. The impact of equipment, year of installation, and complexity level of the procedure on dose were analyzed. DRLs based on clinical indication were defined. Dose values varied considerably within hospitals, between them, and within each subgroup of complexity level. The use of state-of-the-art equipment reduced dose significantly by 52%. Although dose also varied within each subgroup of complexity level, for transarterial chemoembolization of hepatocellular carcinoma and percutaneous transhepatic biliary drainage, dose significantly correlated with complexity. This was the first study reporting exposure practice and defining DRLs based on clinical indication for four IR procedures on a European basis. These DRLs can serve as a baseline for comparison with local practice, the study as a guideline for future surveys. • The use of state-of-the-art angiographic equipment reduces dose significantly. • A significant correlation between radiation dose and complexity level is found. • Dose values vary considerably, both within and between individual hospitals, and within each complexity level of interventional radiology procedure.

Long-term impact of high-sensitivity C-reactive protein in patients with intermittent claudication due to peripheral artery disease following endovascular treatment.

Little is known about the prognostic impact of high-sensitivity C-reactive protein (hs-CRP) levels on causes of death during long-term follow-up. We, therefore, investigated the associations between hs-CRP and clinical outcomes in the patients with intermittent claudication. Three hundred thirty-five consecutive patients (mean age, 72 ± 8years, 82% men) undergoing first intervention for de novo iliac and/or femoropopliteal artery lesions from 2009 to 2020 were studied. Patients were divided into 2 groups based on the optimal cutoff value of hs-CRP (> or ≤ 0.15mg/dL). The median follow-up duration was 3.6years (interquartile range, 1.0-6.2years). Although the cumulative incidence rate of major adverse cardiovascular limb events was not significantly different between the higher and lower hs-CRP groups (29.0 and 22.1%, respectively; log-rank test, p = 0.410), that of all-cause death was significantly higher in the higher hs-CRP group than in the lower hs-CRP group (18.7 vs. 5.8%, log-rank test, p = 0.007), even in cardiovascular-related death and malignancy-related death (log-rank test, p = 0.030 and 0.046, respectively). Higher hs-CRP levels at the time of intervention were significantly associated with higher frequency of all-cause death, even after adjusting for other risk factors (hazard ratio 2.79; 95% confidence interval 1.66-7.17, p = 0.024). In addition, malignancy-related death was most frequent as high as 60% (21/35 deaths), and elevated hs-CRP levels and the Brinkman index were strongly independent predictors of malignancy-related death. In conclusion, elevated hs-CRP levels were significantly associated with cardiovascular-related and malignancy-related deaths in patients with intermittent claudication. Furthermore, the result that cancer mortality exceeds cardiovascular mortality is different from previous reports, so the present findings warrant further investigation.

Clinical Impact of Stent Graft Thrombosis in Femoropopliteal Arterial Lesions.

This study sought to elucidate the clinical impact and prognosis of stent graft (SG) thrombosis. The VIABAHN SG offers a favorable outcome in long peripheral artery occlusive disease (PAOD) lesions in the femoropopliteal artery. One concern after SG deployment is the incidence of stent thrombosis and consequent acute limb ischemia (ALI). In this retrospective multicenter study, we collected the clinical data of PAOD patients treated with VIABAHN SG who subsequently experienced SG thrombosis. The clinical symptoms of SG thrombosis, patency after reintervention, and predictors of loss of patency after reintervention were examined. VIABAHN SGs were used for 1,215 patients; SG thrombosis occurred in 159 (13%) patients at a median of 6.4 months (interquartile range: 2.8 to 13.5 months) after SG implantation; 21 (13%) patients presented with ALI. A total of 131 (82%) patients underwent reintervention for SG thrombosis, whereas 2 (1%) underwent primary major amputation and the remaining 26 (16%) were treated conservatively. The patency rate 1 year after reintervention, freedom from major adverse limb events, and limb salvage after reintervention were 54.9%, 73.6%, and 92.5%, respectively. Critical limb-threatening ischemia at SG implantation and ALI presentation at SG thrombosis were positively associated with an increased risk of rethrombosis, whereas distal stent diameter was negatively associated with the risk of rethrombosis. SG thrombosis is associated with a considerable risk of ALI, but the risk of primary major amputation was not high. Clinical outcomes after reinterventions for thrombosed SGs were suboptimal.

Simultaneous femoro-popliteal artery bypass and foot free flap for lower limb salvage: a 13-year follow-up.

Critical limb ischemia (CLI) associated with lower extremity complex wounds is challenging for vascular and plastic surgeons. Despite a high risk of perioperative morbidity, complex reconstructive surgery in these patients is an alternative to primary major limb amputation. We present a patient with CLI and a complex foot wound treated with simultaneous femoro-popliteal arterial bypass and free flap for lower limb salvage. The 13-year follow-up showed good functional results.

Abstract No. 10 Percutaneous creation of an extraluminal arterial bypass graft using a commercially available self-expanding stent graft: comparison to surgical arterial bypass graft in a swine model

Peripheral arterial disease (PAD) of the lower extremities is a prevalent disease that can result in claudication, rest pain, ulceration, gangrene, and loss of limb. Not all patients are candidates for surgical bypass grafting. In severe cases, endovascular recanalization of total occlusions of the femoropopliteal arteries may not be possible, and even when successful, severe arterial calcifications can significantly limit patency rates. The objective of this study was to compare the short-term patency of a percutaneous endovascular technique for arterial bypass versus the standard of care, a surgically created bypass using PTFE, in a swine model.

Comparison of drug-coating balloon and bare-metal stent for complex femoropopliteal artery lesions: 2-year outcome of a multicenter experience

Objectives The aim of this study was to evaluate the 24-month outcome of drug-coating balloon (DCB) versus bare-metal stent (BMS) for the treatment of disabling claudication and critical limb ischemia in patients with complex femoropopliteal lesions regarding technical success, primary patency, secondary patency, target lesion revascularization, and limb salvage rate. Background Complex femoropopliteal lesions are difficult to treat, and the effective protocols for intervention remain to be developed. Patients and methods This was a multicenter, prospective, randomized controlled two-arm blind interventional study. A total of 80 patients (92 limbs) complaining of disabling claudication or critical limb ischemia owing to complex femoropopliteal occlusive lesions were randomly assigned into two groups according to the intervention approach used from May 2016 to August 2020. Group A included 42 patients (47 limbs) who have been assigned for treatment with paclitaxel DCBs and group B included 38 patients (45 limbs) assigned for treatment with BMSs. The follow-up period was for 24 months, with regular visits at 3, 6, 9, 12, 15, 18, and 24 months or when new concerns emerged. All data were analyzed by using Statistical Package of Social Science for Windows, version 22.0 and MedCalc Windows. Results The 1-year primary patency rates in the DCB and BMS groups were 87.2 and 75.6% (P=0.15), respectively, and the corresponding 2-year rates were 76.6 and 57.8, respectively (P=0.05). However, the 1-year secondary patency rates in the DCB and BMS groups were 95.7 and 91.1% (P=0.43), respectively, and the corresponding 2-year rates were 91.4 and 75.5%, respectively (P=0.05). There is a statistically significant difference regarding the primary and secondary patency rates at 24 months between both the groups (P=0.05). The 2-year major limb amputation rate was 6.3% in DCB group versus 11.1% in BMS group (P=0.48), which was statistically insignificant. The postprocedural ankle–brachial index shows highly significant difference between both the groups at 24 months (P<0.001). Conclusion The 2-year outcomes showed superior efficacy, higher safety, and greater clinical benefits of DCBs than BMSs for the treatment of complex femoropopliteal lesions. A statistically significant lower rate of restenosis and occlusions and statistically significant higher 2-year primary and secondary patency rates were observed in the DCB group than in the BMS group. However, more studies with a larger sample and long-term follow-up are required.

TCTAP A-042 Microcrystalline Paclitaxel Coated Balloon for Revascularization of Femoro-popliteal Artery Disease: Three-year Outcomes of the Randomized BIOPAC Trial

TCTAP A-042 Microcrystalline Paclitaxel Coated Balloon for Revascularization of Femoro-popliteal Artery Disease: Three-year Outcomes of the Randomized BIOPAC Trial

The Safety of Paclitaxel-Coated Devices for Patients with Peripheral Artery Disease.

Peripheral artery disease (PAD) is a common, debilitating disease that impacts 8.5 million Americans and carries a poor prognosis. The most common manifestation of lower extremity PAD is claudication-a condition which significantly reduces quality of life and functional status. Paclitaxel-coated balloons and stents (PCBs and PESs) represented a breakthrough in the ability to treat medication-refractory patients relative to bare metal stents (BMSs) and percutaneous transluminal angioplasty (PTA) because they improve primary patency rates, reduce target lesion revascularization (TLR), and minimize late-lumen loss for femoropopliteal lesions. As a result, paclitaxel-coated devices (PCDs) were swiftly established as the standard of care for revascularization of femoropopliteal artery disease. A recent meta-analysis of summary-level data demonstrated a late mortality signal for patients treated with paclitaxel-coated devices relative to uncoated devices. This has had a major impact on the vascular community and for the treatment of patients with PAD. Herein, we provide a detailed review of the available data on the late mortality signal associated with paclitaxel. In December of 2018, Katsanos et al. J Am Heart Assoc 7: e011245, 2018) published data from randomized-controlled trials (RCTs) that demonstrated an increase in mortality at 2 and 5 years in patients treated with PCDs involving the femoropopliteal arterial segment relative to patients treated with uncoated devices. As a result of this analysis, randomized trials were stopped and the FDA sent a letter to healthcare providers recommending restriction of use of these devices to patients at the highest risk of restenosis. As additional data emerged supporting the safety of these devices, the FDA organized an advisory committee meeting to review the available data and to determine a pathway forward. The FDA concluded that there were insufficient data to make a final decision regarding the safety of PCDs. They allowed these devices to remain on the market, but with revised safety labeling and updated their letter to healthcare providers to continue to restrict use to patients at highest risk of reintervention. The FDA also called for additional long-term data, including from RCTs and real-world data. To date, an updated patient-level meta-analysis of clinical trial data, RCTs with longer-term follow-up, and large observational studies have been conducted. While meta-analyses conducted using overlapping clinical trial data have found a persistent increase in mortality for those treated with PCDs, individual industry-sponsored RCTs and large observational studies have consistently failed to detect a corresponding mortality increase. To date, no mechanism linking paclitaxel to mortality has been observed. We are currently at an impasse for drawing definitive conclusions regarding the long-term safety of paclitaxel-coated devices. As we await enrollment in ongoing clinical trials, we must proceed with making reasonable decisions for our patients' care from the available data, as these devices have important clinical implications for our patients. A critical lesson that can be learned from this controversy is that, for future device trials, committing to long-term follow-up is crucial.

Outcomes of the paclitaxel-eluting Eluvia stent for long femoropopliteal lesions in Asian patients with predominantly chronic limb-threatening ischemia.

The fluoropolymer-coated, paclitaxel-eluting Eluvia stent has shown promising results for the endovascular treatment of femoropopliteal artery lesions in patients with claudication. The aim of the current study was to evaluate efficacy and safety outcomes of the Eluvia stent for the treatment of long femoropopliteal lesions in Asian patients. This is a single-center, retrospective study. The primary endpoint was primary patency at 1 year. Secondary outcomes were 30-days complication rate, technical success, 1-year freedom from clinically driven target lesion revascularization (CD-TLR), limb salvage, survival, amputation-free survival (AFS), wound healing, and clinical improvement. A total of 64 patients with 67 femoropopliteal lesions were included; 78% suffered from diabetes and 84% had chronic limb-threatening ischemia (CLTI). Of those with ischemic wounds, 79% did not have run-off to the foot. Mean lesion length was 193 ± 128 mm and 52% were severely calcified. Primary patency at 1 year was 84% in the overall cohort and 91% in patients with complete lesion coverage with the Eluvia stent. Technical success was achieved in 100% of the cases and 30-day complications occurred in six patients. Twelve-month freedom from CD-TLR, limb salvage, survival, and AFS were 92%, 93%, 85%, and 80%, respectively. In 80% of patients, complete wound healing was experienced and 84% had clinical improvement after 1 year. The Eluvia stent showed promising 12-month patency and clinical results for femoropopliteal treatment in this CLTI-dominant patient population with severely calcified, long lesions. Patient numbers were, however, small; larger trials are required to validate these findings. Aneurysmal change seen in some cases also needs further investigation.