Antimicrobial resistance is not increasing in subsequent cases of ischaemic foot infections, a single-centre cohort from 2012 to 2021.

Patients with chronic limb-threatening ischaemia (CLTI) are at risk of foot infections, which is associated with an increase in amputation rates. The use of antibiotics may lead to a higher incidence of antimicrobial resistance (AMR) in subsequent episodes of ischaemic foot infections (IFI). This retrospective single-centre cohort study included 130 patients with IFI undergoing endovascular revascularisation. Staphylococcus aureus and Pseudomonas aeruginosa were the two most common pathogens, accounting for 20.5% and 10.8% of cases, respectively. The prevalence of antimicrobial resistance (AMR) and multi-drug resistance did not significantly increase between episodes (10.2% vs. 13.4%, p = 0.42). In 59% of subsequent episodes, the identified pathogens were unrelated to the previous episode. However, the partial concordance of identified pathogens significantly increased to 66.7% when S. aureus was identified (p = 0.027). Subsequent episodes of IFI in the same patient are likely to differ in causative pathogens. However, in the case of S. aureus, the risk of reinfection, particularly with S. aureus, is increased. Multi-drug resistance does not appear to change between IFI episodes. Therefore, recommendations for empirical antimicrobial therapy should be based on local pathogen and resistance statistics without the need to broaden the spectrum of antibiotics in subsequent episodes.

Acute and Mid-Term Results of Atherectomy in Femoropopliteal Lesions.

BACKGROUND: The femoropopliteal arteries are commonly affected by atherosclerotic lesions. The use of atherectomy may increase the benefit of definitive therapy, such as drug-coated balloon (DCB) angioplasty. PURPOSE: To analyze the 2-year safety and efficacy of atherectomy in general and stratified by directional atherectomy (DA) and front-cutting atherectomy (FA) for the treatment of atherosclerotic lesions of the femoropopliteal arteries. METHODS: A retrospective analysis was performed including patients who underwent vessel preparation with atherectomy. The primary endpoint was the 2-year incidence of target lesion revascularization (TLR). Secondary endpoints included primary patency, changes in ankle-brachial index (ABI) and Rutherford-Becker class (RBC), and amputation rate up to 2 years. RESULTS: Nine hundred and fifty-five patients (37.8% female; mean age: 69.7±9.6 years) were included in this analysis. Eight hundred and twenty-one patients (86%) were claudicants, 134 patients (14%) had critical limb-threatening ischemia. Six hundred and forty-four lesions (67.4%) were in a native artery and 145 lesions (15.2%) were in-stent restenoses. In 166 patients (17.4%), atherectomy was performed in native and in-stent segments. Eight hundred and thirty-seven patients were treated with DA and 118 patients with FA. Five-hundred and seventy-four procedures (60.1%) were followed by DCB angioplasty, provisional stent rate was 20% overall. One hundred and fifty-four procedure-related adverse events (16.1%) were documented, four complications (0.4%) required surgical intervention. At 2 years, 279 patients (34.3%) required TLR. After DA, TLR rates were 9%, 19.5%, and 32.2% at 6, 12, and 24 months, respectively, and 14.2%, 29.4%, and 49%, at 6, 12, and 24 months after FA. After DA, primary patency rates were 75.9%, 57.4%, and 40.3% at 6, 12, and 24 months, respectively, and 64.9%, 44.8%, and 26%, at 6, 12, and 24 months, respectively, after FA. Mean ABI and mean RBC improved significantly during follow-up (p<0.001), 17 patients required amputation, 13 minor (1.6%) and four major (0.5%). Regression analysis shows that more calcified lesions are more likely to have a TLR. Compared with a vessel diameter of 4 mm or smaller, larger diameters are associated with fewer TLRs. CONCLUSION: In this retrospective analysis, atherectomy of femoropopliteal lesions shows satisfactory mid-term results. CLINICAL TRIAL REGISTRATION: German Clinical Trials Register: DRKS00031245. CLINICAL IMPACT: The results of this analysis could influence the daily practice of the interventionalists. A combination of atherectomy as vessel preparation followed by drug coated balloon angioplasty appears to be promising, but would need to be investigated in randomised trials.

Matched comparison of uncoated and paclitaxel-coated balloon angioplasty for isolated popliteal lesions excluding bail-out stenting.

OBJECTIVE: To evaluate the safety and effectiveness of drug-coated balloon angioplasty (DCB) in isolated popliteal lesions. BACKGROUND: The benefit of using DCB in femoropopliteal arteries including the proximal popliteal artery has been demonstrated, but has not yet been evaluated for isolated popliteal lesions. METHODS: This retrospective, single-center study includes patients requiring treatment with DCB of isolated popliteal lesions. Two cohorts matched (Plain old balloon angioplasty (POBA) versus DCB) by their baseline and lesion characteristics were compared. Lesions receiving bail-out stents were excluded. Primary endpoint was the 1-year target lesion revascularization (TLR) rate. Secondary endpoints included the procedural success and complication rate, primary patency, changes in Rutherford-Becker class (RBC) and ankle-brachial index (ABI). RESULTS: One hundred and seven patients were included in this study. More than one third of the patients had critical limb threatening ischaemia (CLTI) (35 % (POBA) versus 40.4 % (DCB), p = 0.354. The technical success rate of the procedure was 85.1 % (n = 40/47) in the DCB group and 83.3 % (n = 60) in the POBA group (p = 0.510). There were three complications in the POBA group (5.0 %) but none in the DCB group (p = 0.172). After 12 months, in the entire cohort 14 patients (13.1 %) had to undergo a TLR. The TLR-free survival was 81.7 % in the POBA and 93.6 % in the DCB group (p = 0.060). Primary patency rates after POBA and DCB were 65.1 % and 87.5 % at 6 months (p = 0.024), respectively. At 12 months, the patency rates were 71.7 % and 85.1 % (p = 0.076), respectively. For both treatment arms, there was a significant improvement in ABI and RBC compared to baseline. Four patients from the DCB group and two from the POBA group received a minor amputation (p = 0.232). One patient in the DCB group died within 12 months. CONCLUSION: After one year the use of DCB is by trend more effective for the treatment of isolated popliteal stenosis compared to POBA. A larger scale prospective study is mandatory.

Evaluation of Femoropopliteal In-Stent Restenosis Characteristics Stratified by Stent Design.

PURPOSE: To evaluate the potential differences in characteristics of femoropopliteal in-stent restenosis (ISR) stratified by stent design with a focus on the swirling flow-inducing BioMimics 3D helical centerline stent. METHODS: Patients with ISR of the superficial femoral and popliteal arteries undergoing reintervention were included in this study. The primary endpoint was the angiographic localization and extent of restenosis or reocclusion with the following five different stent systems: SMART Control stent, Supera peripheral stent, GORE® VIABAHN® endoprosthesis, BioMimics 3D stent, and Zilver® PTX® stent. RESULTS: 414 ISR lesions were analyzed, affecting 236 Supera stents, 67 BioMimics 3D stents, 48 Zilver® PTX® stents, 38 SMART Control stents, and 25 VIABAHN® endoprostheses. The mean stent diameter and length were 5.7 ± 0.77 mm and 121.4 ± 94.8 mm, respectively. ISR included 310 (74.9%) lesions with 1 stent, 89 (21.5%) lesions with 2 stents, 14 (3.4%) lesions with 3 stents, and 1 lesion (0.2%) with 4 stents. Most lesions presented as reocclusions (67.4%) rather than focal (13.3%) or diffuse restenoses (19.3%). No significant differences in ISR lesion morphology were found. By trend, BioMimics 3D stent lesion extension was more focal (16.4% versus 12.7%, p = 0.258), with the highest proportion of lesions in which only the proximal stent third was affected (9.0% versus 5.8%, p = 0.230), as compared to the average of the other four devices. The occlusion rate was the second lowest for the BioMimics 3D stent (64.2 vs. 68.0%, p = 0.316). Risk factors for restenosis or occlusion were active smoking, pre-interventional occlusion, and popliteal intervention. CONCLUSION: Our results suggest that the helical centerline stent design of the BioMimics 3D stent, which results in a swirling flow with increased wall shear stress, may offer protective properties over straight stent designs, including DES and endoprosthesis, regarding localization and extension of restenosis. Prospective, randomized studies are warranted.

Evaluation of the MYNX CONTROL™ Arterial Closure System for Achieving Primary Hemostasis after Arterial Femoral Access Following Peripheral Arterial Interventions, Compared to the FemoSealTM Closure System.

Background: In addition to manual compression, various vascular closure devices (VCD) are available to seal the puncture site following arterial vascular procedures. Purpose: To evaluate the efficacy and safety of the extravascular MYNX CONTROL closure system for achieving primary hemostasis after femoral arterial access following peripheral arterial procedures, compared to the intravascular FemoSeal Aclosure system. Patients and Methods: A retrospective analysis of consecutive patients who underwent endovascular intervention between April and November 2022 was performed. The primary endpoint was the incidence of significant puncture site complication defined as a complication resulting in medical treatment. Secondary endpoints included peri-interventional incidence of hematoma, peri-interventional changes in hemoglobin, incidence of emergency diagnostics and predictors for closure system failure. Results: Five hundred and forty-eight patients were included in this analysis. False aneurysm occurred in 18/273 cases (6.6%) following the use of the MYNX closure system, compared to 6/275 cases after using the FemoSeal closure system (2.2%, p = 0.006). The incidence of post-interventional hematoma was not significantly different (28 (10.3%) in the MYNX group versus 32 (11.6%) in the FemoSeal group, p = 0.358). Peri-interventional hemoglobin drop did not differ between groups (p = 0.449). Emergency diagnostics were not significantly performed more often in the MYNX group (14 (5.1%) versus 8 (2.9%), p = 0.134). A post-interventional duplex sonography showed stenosis at the puncture site in one patient after use of the MYNX system. For the entire cohort, oral anticoagulation was the only predictor for the failure of the closure device (p = 0.036). Conclusions: Device failure was more common after using the extravascular MYNX CONTROL system than after using the intravascular FemoSeal system. However, the need for surgical or interventional therapy due to device failure was low.

Arterial leg ulcers-Bacterial patterns, antimicrobial resistance and clinical characteristics, a retrospective single-centre cohort, 2012-2021.

OBJECTIVE: Severe wound infections in patients with peripheral artery disease (PAD) are common, potentially life- and limb-threatening, and difficult to treat. Evidence on patients with infected leg ulcers in PAD is scarce. This study aims to provide insight into the microbiological patterns and antimicrobial resistance (AMR) of specific pathogens in patients with arterial leg ulcers. METHODS AND DESIGN: In this retrospective, consecutive, single-centre study 16,553 patients underwent an endovascular revascularization procedure between 2012 and 2021. Of these, 1,142 patients had PAD Rutherford category 5 or 6 with infected leg ulcers. Logistic regression was used to identify risk factors for Staphylococcus aureus-associated infections. RESULTS: A total of 3,431 bacterial isolates were detected, of which 2,335 (68.1%) bacterial isolates were gram-positive and 1,096 (31.9%) were gram-negative species. The most prevalent bacteria were S. aureus (18.6%), Enterococcus faecalis (9.1%) and S. epidermidis (7.8%). Pseudomonas aeruginosa (5.6%), Proteus mirabilis (3.7%) and Escherichia coli (3.4%). The resistance of S. aureus isolates to clindamycin was 11.0%. Resistance to oxacillin was rare (1.5%). P. aeruginosa is frequently resistant to ciprofloxacin (14.4%) whilst intrinsically resistant to trimethoprim/sulfamethoxazole. P. mirabilis and E. coli were frequently resistant to both ciprofloxacin (7.3; 20.7%) and trimethoprim/sulfamethoxazole (24.6; 22.6%), respectively. Resistance to amoxicillin/clavulanic acid was high among E. coli isolates (36.8%). Multi-drug resistance (MDR) was rare among S. aureus and P. aeruginosa isolates. In contrast, the proportion of MDR was high in E. coli isolates. End-stage renal disease was independently positively associated with S. aureus identification (p = .042). CONCLUSION: S. aureus was the most common pathogen in arterial leg ulcers with end-stage renal disease being an independent risk factor. Clindamycin resistance was common, making empirical therapy likely to fail. Isolated E. coli species had a high proportion of MDR.

Chocolate Touch Versus Lutonix Drug-Coated Balloon for Femoropopliteal Lesions in Diabetes: The Chocolate Touch Study.

BACKGROUND: The randomized Chocolate Touch Study demonstrated that in patients undergoing treatment of femoropopliteal artery lesions, the Chocolate Touch drug-coated balloon (DCB) was safe and had superior efficacy at 12 months compared with the Lutonix DCB. We report the prespecified diabetes subanalysis comparing outcomes among patients with and without diabetes mellitus (DM). METHODS: Patients with claudication or ischemic rest pain (Rutherford class 2-4) were randomized to Chocolate Touch or Lutonix DCB. The primary efficacy endpoint was DCB success defined as primary patency at 12 months (peak systolic velocity ratio <2.4 by duplex ultrasound without clinically driven target lesion revascularization in the absence of bailout stenting). The primary safety endpoint was freedom from major adverse events at 12 months, a composite of target limb-related death, major amputation, or reintervention. RESULTS: A total of 313 patients (38% DM [n=119]) were randomized to either Chocolate Touch (n=66/152) or Lutonix DCB (n=53/161). Among patients with DM, DCB success was 77.2% and 60.5% (p=0.08), and in non-DM patients, DCB success was 80% and 71.3% (p=0.2114) for the Chocolate Touch and Lutonix DCB, respectively. The primary safety endpoint was similar for both cohorts regardless of DM status (interaction test, p=0.96). CONCLUSIONS: This randomized trial demonstrated similar safety and efficacy for the treatment of femoropopliteal disease with the Chocolate Touch DCB compared with using the Lutonix DCB regardless of DM status at 12 months. CLINICAL IMPACT: This substudy of the Chocolate Touch Study demonstrated similar safety and efficacy for treatment of femoropopliteal disease of the Chocolate Touch DCB compared with the Lutonix DCB regardless of diabetes (DM) status at 12 months. Endovascular therapy has become the therapy of choice for the treatment of most symptomatic femoropopliteal lesions regardless of DM status. These results give clinicians another option when treating femoropopliteal disease in this high-risk patient population.

[Endovascular Therapy for Peripheral Artery Disease - Therapeutic Options for Treatment of Severe Calcification]. / Endovaskuläre Therapie der pAVK ­ Therapieoptionen bei starker Verkalkung.

Calcified lesions are a major limitation of endovascular therapy of peripheral artery disease. Recently published studies evaluating the impact of lithotripsy (Disrupt III) and directional atherectomy (REALITY) as vessel preparation devices for calcified femoro-popliteal lesions prior to the final treatment with drug-coated balloons (DCB). Disrupt III, a randomized controlled trial comparing lithotripsy and regular balloon angioplasty for vessel preparation prior to DCB, and REALITY, a single-arm study of directional atherectomy prior to DCB angioplasty resulted in low provisional stent and dissection rates. Moreover, lithotripsy did result in a better 2-year patency rate as compared to predilatation with a regular balloon. Importantly, both vessel preparation strategies resulted in a low rate of post-procedural residual stenosis of >30%, the major predictor for loss of patency following DCB angioplasty in long-term.Lithotripsy is an emerging therapy concept for vessel preparation of calcified pelvic arteries prior to trans-femoral aortic valve implantation.In summary, vessel preparation of calcified arterial lesions by improving vessel compliance or reducing the plaque load represent promising technical methods reducing provisional stent rates and improving longer-term outcomes.

Clinical investigation of the GORE drug-coated PTA balloon catheter for CE mark approval.

OBJECTIVES: Paclitaxel-coated balloon angioplasty has been established as the first-line therapy for femoropopliteal artery disease. The primary objectives of the study were to evaluate the performance and the safety of the GORE-DCB Catheter in the treatment of atherosclerotic femoropopliteal lesions in patients with peripheral artery disease for CE-Mark approval. METHODS: Prospective, single-arm, multicenter study with 24 months follow-up. The GORE-DCB Catheter consists of a drug-coated nylon (inner layer)/ePTFE (outer layer) composite balloon. The ePTFE layer is coated with paclitaxel (concentration: 3.5 µg/mm2) and the excipient stearic acid/tromethamine (tris). The primary endpoints were 6-month late lumen loss (LLL) and 30-day of freedom from Major Adverse Events (MAE). RESULTS: Fifty-two subjects were enrolled, 69% men, median age 69 (49-83) years. Acute device success was 100%, the 30-day MAE rate was zero. Study primary endpoint of LLL (-0.17 mm) showed significant superiority compared to the performance goal of uncoated PTA balloon catheters from literature. At 1 and 2 years, primary patency rates were 81.8% and 68.7%, respectively, and freedom from clinically driven target lesion revascularization rates was 87.9% and 83.4%, respectively. CONCLUSION: The study demonstrates that the treatment of lesions in femoropopliteal arteries with the GORE-DCB Catheter is safe and effective.

Combined treatment of dysfunctional dialysis access with cutting balloon and paclitaxel-coated balloon in real world.

Background: Dysfunction in arteriovenous (AV) access is a common reason for subsequent intervention. To evaluate the results of endovascular treatment of AV access lesions using cutting balloon (CB) and drug-coated balloon (DCB) angioplasty compared to standard treatment using plain-old balloon angioplasty (POBA). Patients and methods: Patients who retrospectively were selected from a prospectively maintained database. Primary endpoint was primary patency rate at the target lesion up to 12 months after index procedure. Secondary endpoints were the acute treatment success, the "bail out" stent rate, primary patency at 6 months, freedom from target lesion revascularization (TLR), AV access replacement and surgical revision during a follow-up period up to 12 months, and all-cause mortality rate stratified to patients treated with and without DCB. Results: One hundred and eighty-four patients met the inclusion criteria. POBA as stand alone or combined with DCB angioplasty was performed in 71 patients (38.6%), CB in 54 patients (29.3%), and in 59 patients (32.1%), both CB and DCB were used. Primary patency rate at 12 months was 31.6% for the POBA/DCB-group, 52.3% for the CB-group, and 64.8% for the CB/DCB-group, respectively. In total, 80 patients (51.6%) had a TLR including endovascular or surgical revision, or a shunt replacement. All-cause mortality at 12 months was 7.2% in the DCB group and 9.1% in the group of patients treated without a DCB (p=0.747). Conclusions: The use of CB seems to be crucial for a better outcome. The combination of CB and DCB achieves the best patency results at mid-term.

Impact of COVID-19 Pandemic on Clinical Care of Peripheral Arterial Disease Patients: A Single-Center Experience.

OBJECTIVE: To better manage the burden of the COVID-19 pandemic on hospitals, numerous scheduled procedures have been postponed nationwide. DESIGN AND METHODS: Retrospective analysis of patient characteristics and outcomes of patients hospitalized with peripheral arterial disease (PAD) in the period prior to the COVID-19 pandemic (2018 and 2019) and during the pandemic (2020 and 2021). This study assesses the in-hospital outcomes. Main endpoints are Rutherford stages at admission for intervention, incidence of amputation, of total occlusion, and duration of intervention. The data were analyzed descriptively. RESULTS: The total number of interventions due to PAD had decreased in 2020, but not significantly during the pandemic period (n = 5351) compared to the period prior to COVID-19 pandemic (n = 5351) (p = 0.589). The proportion of interventions treated for critical limb-threatening ischaemia (CLTI) increased from 2018/2019 (n = 2112) to 2020/2021 (n = 2426) (p < 0.001). However, the proportion of patients with wounds requiring amputation was not higher during the pandemic (n = 191) than before (n = 176) (minor amputations p = 0.2302, major amputations p = 0.9803). The proportion of total occlusions did not differ significantly between the pre-COVID-19 (n = 3082) and the COVID-19 pandemic periods (n = 2996) (p = 0.8207). Multilevel interventions did not increase significantly from 2018/2019 (n = 1930) to 2020/2021 (n = 2071). Between 2018/2019 and 2020/2021, the procedure duration and fluoroscopy duration increased significantly. However, parameters such as contrast agent volume and radiation dose did not differ significantly. The average length of stay was 4.6 days. CONCLUSION: The COVID-19 pandemic had an impact on the in-patient care of PAD patients in terms of disease stage severity and complexity. However, the amputation rate was not affected.

Effect of Paclitaxel Drug-Coated Balloon Angioplasty of Infrapopliteal Lesions on Mortality.

BACKGROUND: Meta-analyses of randomized controlled trials have suggested an increased long-term mortality risk following femoropopliteal and infrapopliteal angioplasty using paclitaxel-coated devices. This study was conducted to evaluate long-term mortality after paclitaxel drug-coated balloon (DCB) and plain old balloon angioplasty (POBA) of infrapopliteal lesions in real-world practice. METHODS: A retrospective mortality analysis of patients with at least 3 years of follow-up who underwent balloon-based endovascular therapy of infrapopliteal lesions was performed. RESULTS: Overall, 2,424 patients with infrapopliteal lesions were treated within the study period. Five hundred seventy-six patients fulfilled the study criteria. Of those, 269 patients were treated with uncoated devices without crossover to a paclitaxel-coated device during follow-up and 307 patients with DCB angioplasty. Mean (SD) follow-up was 46.48 (32.77) months. The mortality rate was 66.9% after POBA and 46.9% after DCB (P < .001). In the matched-pair cohort, 164 patients died after uncoated treatment (66.7%), and 119 in the DCB group died (48.4%; P < .001). There was no correlation between DCB length and mortality rate (P = .357). For the entire cohort, multivariate logistic regression analysis showed type of treatment (uncoated device vs DCB; P = .002), age (P < .001), stroke (P = .005), renal insufficiency (P = .014), and critical limb ischemia (P = .001) to be independent predictors of all-cause mortality. There was no significant difference in mortality among the paclitaxel exposure groups. CONCLUSION: In this real-world retrospective analysis, the long-term mortality rate was lower after DCB angioplasty than after POBA of infrapopliteal lesions.

Low-Dose vs High-Dose Paclitaxel-Coated Balloons for Femoropopliteal Lesions: 2-Year Results From the COMPARE Trial.

BACKGROUND: So far only 1-year data have been reported for direct comparisons of paclitaxel-coated balloons (PCBs) using different coating technologies. OBJECTIVES: The aim of this study was to report the 24-month results on the efficacy and safety of low-dose vs high-dose PCBs with nominal paclitaxel densities of 2.0 and 3.5 µg/mm2 and different coating technologies for femoropopliteal interventions from the COMPARE (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease) trial. Procedural characteristics of clinically driven (CD) target lesion revascularization (TLR) were analyzed. METHODS: Within a prospective, multicenter, clinical trial, 414 patients with symptomatic femoropopliteal lesions (Rutherford categories 2-4, maximum lesion length 30 cm) were randomly assigned in a 1:1 ratio to endovascular treatment with either a low-dose (Ranger) or a high-dose (IN.PACT) PCB after stratification for lesion length. Two-year follow-up included assessment of primary patency (defined as absence of CD TLR or binary restenosis with a peak systolic velocity ratio >2.4 by duplex ultrasound), safety, and functional and clinical outcomes. RESULTS: At 2 years, the Kaplan-Meier estimates of primary patency were 70.6% and 71.4% for the low-dose and high-dose PCBs (log-rank P = 0.96), respectively. One major amputation occurred in the high-dose group, and rates of all-cause mortality (3.6% vs 2.2%; P = 0.55) and CD TLR (17.3% vs 13.0%; P = 0.31) were similar between the groups. Among a total of 57 CD TLRs, 44.6% were performed for reocclusion and 28.1% for in-stent restenosis. Functional and clinical benefits over baseline were sustained in both groups. CONCLUSIONS: The 2-year results of the COMPARE trial demonstrate a sustained treatment benefit of both low-dose and high-dose PCBs for femoropopliteal interventions including a wide range of lesion lengths. (Compare I Pilot Study for the Treatment of Subjects With Symptomatic Femoropopliteal Artery Disease; NCT02701543).

Long-Term Effectiveness and Safety of Femoropopliteal Drug-Coated Balloon Angioplasty : 5-Year Results of the Randomized Controlled EffPac Trial.

PURPOSE: This study aimed to assess 5-year effectiveness and safety of femoropopliteal angioplasty with the Luminor® 35 drug-coated balloon (DCB). MATERIALS AND METHODS: The EffPac trial was a prospective, multicenter, randomized controlled trial that enrolled 171 patients of Rutherford category 2 to 4 with medium length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor® 35 DCB angioplasty or plain old balloon angioplasty (POBA). Assessment at 5 years included primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), clinical improvement, and target limb amputation. Long-term vital status was ascertained in 97.1% of the participants. RESULTS: Kaplan-Meier curves at 5 years demonstrate a primary patency of 61.4% after DCB angioplasty and 53.5% after POBA (log-rank p = 0.040) with a decreasing difference throughout the observation period. Freedom from TLR was 82.1% and 73.7%, respectively (log-rank p = 0.050). Incidence of primary clinical improvement was similar between groups (61% DCB vs. 64% POBA, p = 0.94). Major target limb amputation was necessary in one POBA-group participant. Freedom from all-cause death at 5 years was 88.5% after DCB and 86.0% after POBA (log-rank p = 0.34). CONCLUSIONS: Primary patency after femoropopliteal DCB angioplasty remained superior to POBA throughout 5 years, however, with decreasing difference. Clinical improvement, freedom from TLR, and all-cause mortality were similar between groups over the long term. (Effectiveness of Paclitaxel-Coated Luminor® Balloon Catheter Versus Uncoated Balloon Catheter in the Superficial Femoral Artery [EffPac]; NCT02540018).

Mortality Following Treatment With and Without Paclitaxel-Coated Devices in Dialysis Patients.

OBJECTIVES: To evaluate the mortality after treatment with a paclitaxel (PTX)-coated device and with uncoated devices of iliac, femoropopliteal, and below-the-knee lesions in dialysis patients. METHODS: Retrospective mortality analysis of dialysis patients with peripheral artery disease who underwent treatment of iliac, femoropopliteal, and/or infrapopliteal lesions with PTX-coated or uncoated devices. RESULTS: Between 2010 and 2018, 1125 dialysis patients were treated with iliac and/or femoropopliteal and/or infrapopliteal lesions. In all, 359 patients were selected for this retrospective analysis. Of those, 122 patients were treated with uncoated devices without crossover to a PTX-coated device during follow-up and 237 patients were treated with a PTX-coated device. Mean follow-up time was 27.38±24.76 months (range=0-103). For the entire cohort, the overall mortality was 95.1% after uncoated treatment and 75.9% after PTX treatment (p<0.001). After propensity score matching (n=119), overall mortality was 95.0% after uncoated treatment and 78.2% after PTX treatment (p<0.001). For the entire cohort, multivariate logistic regression analysis revealed age (p=0.002) and critical limb ischemia (p<0.001) as independent predictors for mortality. PTX treatment was a protective factor for mortality (p<0.001). CONCLUSION: Mortality in dialysis patients is in general high and higher after use of uncoated devices compared with PTX-coated devices. Mortality predictors were risk factors and disease severity but not PTX treatment. CLINICAL IMPACT: After the publication of Katsanos's metaanalyses, the uncertainty regarding PTX device safety in peripheral interventions in patients mainly without end-stage renal insufficiency was initially considerable. The present study for the first time investigates the potential long-term mortality risk of dialysis patients following PTX device treatment of PAD. In contrast to a recent meta-analysis, this real-world study could show a better survival after PTX treatment in comparison to uncoated devices.

Sirolimus-Coated Balloon Angioplasty of Infra-popliteal Lesions for the Treatment of Chronic Limb-Threatening Ischemia: Study Protocol for the Randomized Controlled LIMES Study.

PURPOSE: Evidence on efficacy and long-term safety of paclitaxel-coated devices is still conflicting. Therefore, this study aims to assess whether sirolimus-coated balloon angioplasty is safe and effective for the treatment of infra-popliteal occlusions in patients with chronic limb-threatening ischemia (CLTI). STUDY DESIGN: The randomized controlled, single-blinded, multicentre, investigator-initiated study aims to enrol 230 participants with CLTI and infra-popliteal occlusions at up to 25 centres. Patients will be randomized in a 1:1 ratio to either sirolimus-coated balloon angioplasty or to plain old balloon angioplasty (POBA). Bailout stenting in case of flow-limiting dissection or ≥ 50% residual diameter stenosis is permitted. OUTCOME MEASURES: Primary outcome is the Kaplan-Meier estimate of primary patency at 6 months, defined as the absence of target lesion occlusion with restoration of in-line flow to the ankle. Key secondary outcome is non-inferiority in the proportionate occurrence of major adverse limb events and perioperative all-cause death at 30 days. Overall, participants will be followed for 36 months to assess further secondary efficacy and safety outcomes. ASSUMED GAIN OF KNOWLEDGE: If sirolimus-coated balloon angioplasty turns out to be superior to uncoated-balloon angioplasty regarding patency of infra-popliteal lesions without safety signals, it could become a welcome treatment option for patients with CLTI. Trial Registration ClinicalTrial.gov Identifier: NCT04772300, German Clinical Trials Register: DRKS00024629. Level of Evidence Level 2a, randomized controlled trial.

Evaluation of Stent Angioplasty in the Treatment of Arteriosclerotic Lesions of the Common Femoral Artery.

In many vascular segments, endovascular therapy is the treatment of choice for arteriosclerotic lesions. For the treatment of common femoral artery (CFA) lesions, surgical reconstruction is still considered the gold standard. The purpose of this study is to evaluate the safety and efficacy of stent angioplasty for the treatment of common femoral artery (CFA) lesions in a real-world population during a two-year follow up. This retrospective, single-center study includes 250 patients requiring treatment with stent angioplasty of CFA lesions. The primary end point was the target lesion revascularization (TLR) rate. Secondary end points were the overall procedural complication rate, the rate of ipsilateral CFA punctures during follow-up, changes in the Rutherford−Becker class (RBC) and ankle−brachial index (ABI), primary patency rates, amputation rate, time to and the type of TLR. A total of 236 interventions (94.4%) were successfully defined as a residual stenosis < 30%. Periinterventionally, there were 23 complications (9.1%), 3 of which had to be treated surgically. Median follow up was 21 months (average 19.2 ± 7.8). In total, 41 patients (16.4%) needed a TLR. The primary patency rate was 90.8%, 81.2% and 72% at 6, 12 and 24 months, respectively. ABI and RBC were significantly better at all time points compared to baseline. During follow up, seven amputations (three minor and four major) had to be performed. More than half of the patients (56.0%) were punctured at the stented CFA during the follow up. Multivariate logistic regression analysis showed continued nicotine use and coronary heart disease as predictors for TLR. Stent angioplasty for the treatment of CFA lesions is safe and effective. Further studies are needed to compare this endovascular option with surgical therapy.

Randomized Trial of Chocolate Touch Compared With Lutonix Drug-Coated Balloon in Femoropopliteal Lesions (Chocolate Touch Study).

BACKGROUND: First-generation drug-coated balloons (DCBs) have significantly reduced the rate of restenosis compared with balloon angioplasty alone; however, high rates of bailout stenting and dissections persist. The Chocolate Touch DCB is a nitinol constrained balloon designed to reduce acute vessel trauma and inhibit neointima formation and restenosis. METHODS: Patients with claudication or ischemic rest pain (Rutherford class 2-4) and superficial femoral or popliteal disease (≥70% stenosis) were randomized 1:1 to Chocolate Touch or Lutonix DCB at 34 sites in the United States, Europe, and New Zealand. The primary efficacy end point was DCB success, defined as primary patency at 12 months (peak systolic velocity ratio <2.4 by duplex ultrasound without clinically driven target lesion revascularization in the absence of clinically driven bailout stenting). The primary safety end point was freedom from major adverse events at 12 months, a composite of target limb-related death, major amputation, or reintervention. Both primary end points were tested for noninferiority, and if met, sequential superiority testing for efficacy followed by safety was prespecified. An independent clinical events committee, and angiographic and duplex ultrasound core laboratories blinded to treatment allocation reviewed all end points. RESULTS: A total of 313 patients were randomized to Chocolate Touch (n=152) versus Lutonix DCB (n=161). Follow-up at 1 year was available in 94% of patients. The mean age was 69.4±9.5 years, the average lesion length was 78.1±46.9 mm, and 46.2% had moderate-to-severe calcification. The primary efficacy rates of DCB success at 12 months was 78.8% (108/137) with Chocolate Touch and 67.7% (88/130) with Lutonix DCB (difference, 11.1% [95% CI, 0.6-21.7]), meeting noninferiority (Pnoninferiority<0.0001) and sequential superiority (Psuperiority=0.04). The primary safety event rate was 88.9% (128/144) with Chocolate Touch and 84.6% (126/149) with Lutonix DCB (Pnoninferiority<0.001; Psuperiority=0.27). CONCLUSIONS: In this prospective, multicenter, randomized trial, the second-generation Chocolate Touch DCB met both noninferiority end points for efficacy and safety and was more effective than Lutonix DCB at 12 months for the treatment of femoropopliteal disease. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02924857.

Device profile of the FLEX Vessel Prep System for the treatment of peripheral arterial disease: overview of its safety and efficacy.

INTRODUCTION: The standard endovascular treatment for obstructed peripheral arterial disease (PAD) lesions and stenosed arteriovenous (AV) fistulae is percutaneous transluminal angioplasty (PTA). Despite consistent effectiveness in restoring blood flow, PTA does introduce risk of uncontrolled dissections that require stenting. The FLEX Vessel Prep™ System (FLEX VP) is a novel, dynamic, self-sizing, nonballoon device designed to modify obstructive stenoses and plaque, improve vessel compliance and facilitate delivery of drug therapies by creating longitudinal, controlled-depth, circumferential microincisions along the entire length of a lesion. AREAS COVERED: In this profile, the mechanism of action of the FLEX VP system is described and differentiated. Acute procedural complications and long-term clinical outcomes following FLEX VP+PTA are presented. Specifically, the unmet clinical need for safe and effective vessel preparation in long, complex, mixed morphology PAD lesions is highlighted. EXPERT OPINION: The FLEX VP system is an innovative approach to create predictable and consistent longitudinal microincisions in long lesions that improve acute luminal gain and vessel compliance by releasing circumferential tension in the lesion. This nonballoon-based device for plaque modification is safe, effective, easy-to-use, and minimizes PTA-associated dissections, therefore reducing stenting, supporting the 'leave nothing behind' incentive of physicians, and improving long-term clinical outcomes with less vessel trauma.