Assessment of Sirolimus- vs. paCLitaxEl-coated balloon angioPlasty In atherosclerotic femoropopliteal lesiOnS (ASCLEPIOS Study): preliminary results.

BACKGROUND: There appears to be an association between paclitaxel-coated devices and increased 5-year all-cause mortality. METHODS: We are conducting a prospective, randomized, controlled, single-center, noninferiority study. All consecutive patients with femoropopliteal arterial disease who fulfilled the inclusion/exclusion criteria are sequentially and consecutively assigned to either paclitaxel (Ranger, Boston Scientific) or sirolimus (MagicTouch, Concept Medical) coated balloon angioplasty treatment. The primary outcome are procedural success and primary vessel patency at index procedure. The secondary outcomes are 30-day and 12-month freedom from MAEs (amputation, death, TLR/TVR, MI, distal embolization that requires a separate intervention or hospitalization), procedural success (≤30% residual diameter stenosis or occlusion after the procedure), Rutherford category improvement (reduction ≤1 category) and ABI improvement (increase ≥0.10 from baseline). RESULTS: A total of six patients have been enrolled in the present study up to now. The mean age was 72.6 years old and five were male. All patients had angiographic evidence of isolated occlusion in the transition segment of the distal femoral superficial artery in the popliteal artery. The mean length was 109 mm. Three patients were treated by sirolimus-coated (group A) and three by paclitaxel coated balloon angioplasty (group B). The primary patency and procedural success was in two of three and three of three patients, for group A and B, respectively. CONCLUSIONS: Preliminary results show safety and feasibility of the Sirolimus-coated balloon angioplasty. Further investigation and increase of sample size will allow for more sustained conclusions regarding patency and procedural success of this type of balloons for the endovascular treatment of peripheral arterial disease.

Paclitaxel coated balloon versus conventional balloon angioplasty in dysfunctional dialysis arteriovenous fistula: a systematic review and meta-analysis of randomized controlled trials.

PURPOSE: To compare the efficacy and safety between paclitaxel coated balloon (PCB) angioplasty and conventional balloon (CB) angioplasty in the treatment of dysfunctional arteriovenous fistula (AVF). METHODS: We searched four major electronic databases (PubMed, EMBASE, Web of Science and the Cochrane Library) for randomized controlled trials (RCTs) published from inception through November 28, 2021. Outcomes of interest included target lesion primary patency (TLPP), technical success and all-cause mortality. The STATA package version 15.1 was utilized to undertake meta-analyses. RESULTS: Fourteen RCTs totaling 1535 patients were analyzed. The available data showed that there were no significant differences of TLPP rates at 3, 6, 9 and 12 months between the PCB group and the CB group (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.93-1.07, p = 1.000, I2 = 33.5%, Cochrane Q test p = 0.185, fixed-effect model; RR 1.17, 95% CI 0.99-1.39, p = 0.065, I2 = 75.4%, Cochrane Q test p = 0.000, random-effect model; RR 0.81, 95% CI 0.35-1.89, p = 0.625, I2 = 62.8%, Cochrane Q test p = 0.045, random-effect model; RR 1.19, 95% CI 0.97-1.47, p = 0.096, I2 = 40.5%, Cochrane Q test p = 0.071, random-effect model). In addition, two groups had similar technical success rates (RR 1.00, 95% CI 0.97-1.03, p = 1.000, I2 = 0.0%, Cochrane Q test p = 0.596, fixed-effect model) and all-cause mortality rates (RR 1.00, 95% CI 0.54-1.84, p = 1.000, I2 = 0.0%, Cochrane Q test p = 0.599, fixed-effect model). CONCLUSIONS: PCB angioplasty did not appear to convey any obvious advantage over CB angioplasty in the treatment of dysfunctional AVF. However, further multi-center, large-scale and well-designed RCTs are needed to prove outcomes.

Effects of Peripheral Arterial Disease Interventions on Survival: A Propensity-Score Matched Analysis Using VQI Data.

BACKGROUND: Atherectomy is currently being used extensively for occlusive peripheral artery disease (PAD) interventions without proven benefits. This analysis examines the effects of atherectomy and other endovascular interventions on patient survival. OBJECTIVES: The aim of this study is to compare overall survival for patients undergoing PAD endovascular interventions, such as plain old balloon angioplasty (POBA), stent deployment and atherectomy. METHODS: Propensity score matched cohorts were constructed to conduct pairwise comparisons of overall survival in patients who underwent stenosis and occlusive PAD interventions between May 2011 and February 2020 using Vascular Quality Initiative (VQI) regional registry data. Inverse probability treatment weighting method was used to compare secondary outcomes of in-hospital mortality, length of stay, complications and major amputations. Comparative analysis was performed for POBA vs stenting, POBA vs atherectomy, and stenting vs atherectomy. RESULTS: A total number of 15281 eligible cases were identified. After propensity score matching, 6094, 4032, and 3312 cases were used to compare POBA versus stent deployment, POBA versus atherectomy and stent versus atherectomy, respectively. Stent deployment had significantly better overall survival compared with POBA and atherectomy (P < 0.001). Multivariable Cox proportional hazard models suggested stenting was associated with a reduction in mortality hazard by 30% compared with POBA (HR: 0.7; 95% CI: 0.6-0.82; P < 0.001) and a 40% mortality reduction compared with atherectomy (HR: 0.6; 95% CI: 0.48-0.75; P < 0.001). No significant difference was found between POBA and atherectomy. There was no statistical difference in other secondary outcomes which were comparable among all cohorts. CONCLUSIONS: Stent deployment was significantly superior to POBA and atherectomy in terms of overall survival with comparable complication and amputation rates. The natural history of PAD patients presenting with claudication is associated with an extremely low annual mortality risk. Therefore, further examinations of outcomes, especially in regards to mortality rates, both POBA and atherectomy on the management of PAD patients especially those presenting with claudication is warranted.

Editor's Choice - Paclitaxel Coated Balloon Angioplasty vs. Plain Balloon Angioplasty for Haemodialysis Arteriovenous Access Stenosis: A Systematic Review and a Time to Event Meta-Analysis of Randomised Controlled Trials.

OBJECTIVE: A systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to determine the effectiveness and safety of drug coated balloon (DCB) angioplasty compared with uncoated plain balloon (PB) angioplasty in treating arteriovenous access stenosis. METHODS: MEDLINE, Embase, Scopus, and the Cochrane Central Register of Controlled Trials were searched for RCTs comparing paclitaxel coated DCB and PB angioplasty for arteriovenous access stenosis. The last date of the literature search was 31 December 2020. Risk of bias of the retrieved studies was assessed with the Cochrane Collaboration tool for assessing risk of bias (RoB 2.0). The random effects model was used to estimate the risk of loss of target lesion patency (six and 12 months) and circuit patency (six and 12 months). Procedure related adverse events and mortality rate were also compared. Patency results were pooled using the time to event meta-analytical method and the quality of evidence was assessed according to the GRADE approach. RESULTS: Sixteen eligible trials, including 1 682 lesions, were included in the quantitative analysis for the efficacy and safety of paclitaxel coated DCBs. DCBs were associated with a lower risk of loss of target lesion patency at six months (HR 0.53, 95% CI 0.42 - 0.66) and 12 months (HR 0.60, 95% CI 0.47 - 0.76), and were also associated with improved six and 12 month circuit patency. Overall quality of evidence was moderate to low. Procedural complications were rare, and the risk of death up to 12 months was similar between the two groups (OR 1.03, 95% CI 0.68 - 1.56). CONCLUSION: Paclitaxel coated DCBs reduced the risk of loss of target lesion patency and circuit patency in arteriovenous access stenosis compared with PBs. Considering the heterogeneity of the included trials, there is a need to investigate optimal treatment regimens regarding drug dose and agent of the DCB and the treatment procedure.

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

BACKGROUND: Drug-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. METHODS: This 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). RESULTS: One 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. CONCLUSION: In 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%.

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

OBJECTIVE: Paclitaxel (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. METHODS: We 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. RESULTS: Demographics, 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. CONCLUSIONS: In 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.

Efficacy and one-year outcomes of Luminor® paclitaxel-coated drug-eluting balloon in the treatment of popliteal artery atherosclerosis lesions.

PURPOSE: Reporting outcomes with a new generation paclitaxel eluting balloon (Luminor®; iVascular, Vascular, S.L.U., Barcelona, Spain) in the popliteal district. Endovascular treatment of popliteal artery atherosclerotic disease is still debated without definitive evidences. METHODS: From January to June 2019, patients' data presenting popliteal artery atherosclerotic diseases and treated with the Luminor® (iVascular) drug eluting balloon (DEB) were prospectively collected. Critical limb ischemia (CLI) or severe claudication associated with popliteal artery stenosis >50% were the inclusion criteria. Measured outcomes were technical success, early and late results; including mortality, morbidity, symptoms recurrence, amputation, ankle-brachial index (ABI), survival, primary patency, secondary patency, freedom from restenosis. Median follow-up was 22.43 ± 4 (mean:21.58; IQR:20-24) months. RESULTS: Of the 33 included patients, 28 (85%) were diagnosed with CLI, with a mean preoperative run-off score of 5.39 (r:0-10; SD:3) and a chronic popliteal occlusion in 21 (64%). Technical success was achieved in all cases. Perioperative mortality was observed in 1 (3%) patient and perioperative complications in 2 (6%). During the follow-up were reported 2 symptoms recurrence; a significant ABI increase (0.57; IQR:0.41-0.47 vs. 0.69; IQR:0.50-0.67; P < 0.01); 1 (3%) major and 2 (6%) minor amputations. Estimated 24 months survival, primary patency, secondary patency, and freedom from restenosis were 97%, 96.9%, 100%, and 93.8% respectively. CONCLUSIONS: In this prospective study, the use of the Luminor® (iVascular) was safe and effective in addressing atherosclerotic popliteal artery lesions. Larger studies with longer term-outcomes are required to assess the durability of this device in the popliteal artery.

A Comparison of Contemporary Clinical Outcomes Following Femoro-Popliteal Plain Balloon Angioplasty and Bypass Surgery for Chronic Limb Threatening Ischemia.

INTRODUCTION: Despite the BASIL-1 trial concluding that bypass surgery (BS) was superior to plain balloon angioplasty (PBA) in terms of longer-term amputation free (AFS) and overall survival (OS), CLTI patients are increasingly offered an endovascular-first revascularization strategy. This study investigates whether the results of BASIL-1 are still relevant to current practice by comparing femoro-popliteal (FP) BS with PBA in a series of CLTI patients treated in our unit 10 years after BASIL-1 (1999-2004). METHODS: We retrospectively analyzed prospectively gathered hospital data pertaining to 279 patients undergoing primary FP BS or PBA for CLTI in the period 2009 to 2014. We report baseline characteristics, 30-day morbidity and mortality, major adverse cardiovascular events (MACE) and long-term AFS, limb salvage (LS), OS, major adverse limb events (MALE), and freedom from re-intervention (FFR). RESULTS: 234 (84%) and 45 (16%) patients underwent PBA and BS respectively. PBA patients were significantly older (77 vs 71 years, P = 0.001) and more likely to be female (45% vs 28%, P = 0.026). Bollinger and GLASS anatomic scores were significantly more severe in the BS group. Technical success was better for BS (100% vs 87%, P = 0.007). Index hospital stay was shorter for PBA (9.1 vs 15.6 days, P = 0.035) but there was no difference in hospital days or admissions over the next 12 months. AFS (HR 1.00), LS (HR 1.44), OS (HR 0.81), MALE (HR 1.25) and FFR (HR = 1.00) were not significantly different between PBA and BS. CONCLUSION: Important clinical outcomes following FP BS and PBA for CLTI have not changed significantly in our unit in the 10 years following the BASIL-1 trial. BASIL-1 therefore remains relevant to our current practice and should inform our approach to the management of CLTI going forward.

The Rollercoaster of Paclitaxel in the Lower Limbs and Skeletons in the Closet: An Opinion Review.

There have been concerns about the long-term risk of all-cause death with the use of paclitaxel-coated devices in the lower limbs. Results from a 2018 meta-analysis were corroborated by the US Food and Drug Administration and later confirmed by an individual patient data meta-analysis. However, population-based observational studies have produced contradictory results and often claimed a survival benefit with the use of paclitaxel. The recently published Swedish drug-elution trial in peripheral arterial disease did not confirm a significant mortality risk. In this review, the authors discuss the key elements of the identified mortality signal and stress important facts and figures that remain underrecognized and elusive. They also highlight the important types of epidemiological bias that pertain to the ongoing debate on paclitaxel.

Benefits with drug-coated balloon as compared to a conventional revascularization strategy for the treatment of coronary and non-coronary arterial disease: a comprehensive meta-analysis of 45 randomized trials.

BACKGROUND: Drug-coated balloons (DCB) have shown promising results for the percutaneous treatment of de novo and restenotic lesions, involving both the coronary and femoropopliteal district. However, clinical outcomes data associated with the use of this devices are still unclear, with potential warnings on increased mortality being raised from initial studies. We aimed at performing an updated and comprehensive meta-analysis comparing DCB with conventional percutaneous revascularization strategies for the treatment of coronary (CAD) or peripheral artery disease (PAD). METHODS: Literature and main scientific session abstracts were searched for studies comparing DCB vs a standard percutaneous revascularization strategy, with or without stenting, for the treatment of CAD and PAD. The primary efficacy endpoint was mortality. Secondary endpoints were recurrent acute ischemic events (myocardial infarction or amputation) or target lesion revascularization (TLR). RESULTS: We included 45 randomized trials, (CAD: 27 studies, PAD: 18 studies) with an overall population of 7718 patients, (56.4%) randomized to a DCB strategy. At a mean follow-up of19.3 ± 15.2 months, death occurred in 5.8% of the patients, with no significant difference between DCB or conventionally treated patients (5.9% vs 5.7%, OR[95%CI] = 0.89[0.71,1.11], p = 0.31; phet = 0.43). We observed a non-significant reduction in recurrent acute ischemic events, whereas the use of DCB significantly reduced the rate of TLR, with larger benefits observed in patients with PAD and respect to balloon-only angioplasty, while being lower in comparison with stent implantation. No significant interaction was observed with de novo lesions or in-stent restenosis. CONCLUSIONS: Based on the current meta-analysis, the use of drug-coated balloons for the percutaneous treatment of CAD and PAD is associated to a comparable risk of mortality and recurrent acute ischemic events as compared to a conventional revascularization strategy, although offering larger benefits in terms of TLR, especially when compared with balloon-only angioplasty and in femoropopliteal disease.

The Real-World CONSEQUENT ALL COMERS Study: Predictors for Target Lesion Revascularization and Mortality in an Unselected Patient Population.

We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Secondary end points included vessel patency, target vessel revascularization, and all-cause mortality. A total of 879 lesions in 784 consecutive patients (71.3 ± 10.4 years old, 57.7% male) were analyzed; 53.3% had claudication, whereas the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12.0 ± 9.3 cm and 31.8% were Transatlantic Inter-Society Consensus II C/D lesions. The overall technical success rate of the 1269 drug-coated balloon (DCB)'s used was 99.6% (1.60 ± 0.79 DCB's/patient). At 12 months, the TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). The most important predictors for TLR were female gender, in-stent restenosis at baseline and lesion length.

Simultaneous treatment of common carotid lesions increases the risk of stroke and death after carotid artery stenting.

BACKGROUND: Tandem carotid artery lesions that involve simultaneous internal carotid artery (ICA) and common carotid artery (CCA) stenoses present a complex clinical problem. Some studies have shown that the addition of a retrograde proximal intervention to treat a CCA lesion during a carotid endarterectomy (CEA) increases the risk of stroke and death. However, the stroke and death risks associated with a totally endovascular approach to tandem lesions is unknown and is the subject of this study. METHODS: Vascular Study Group of New England data for the years 2005 to 2020 were queried for carotid artery stenting (CAS) procedures. Emergent and bilateral procedures, procedures for indications other than atherosclerosis, patients with prior ipsilateral CAS, ICA lesions with stenosis of less than 50%, and transcarotid procedures were excluded. The cohort was divided into tandem and isolated lesion groups. The primary outcome was the composite of stroke and death. Predictors of stroke or death were determined with multivariable logistic regression. RESULTS: There were 2016 carotid arteries stented in 1950 patients-1881 (96%) with isolated lesions and 135 (4%) with tandem lesions. The mean patient age was 69.6 ± 9.0 years. Tandem lesions were more likely to be present in women (50.4% vs 33.0%; P < .001) and in patients with a prior carotid endarterectomy (45.9% vs 35.4%; P = .014). Other covariates were similar between the groups. Symptomatic lesions accounted for 42.3% of cases (isolated, 42.2% vs tandem, 43.0%; P = .86). Arteries in the tandem group more often required multiple stents to treat the ICA lesion (9.6% vs 5.2%; P = .027). ICA neuroprotection had similar outcomes in both groups (tandem: success 94.1%, failure 3.7%; isolated: success 96.3%, failure 1.8%; P = .29). The tandem group experienced a higher 30-day mortality (2.2% vs 0.6%; P = .039), more perioperative neurologic events (stroke or transient ischemic attack) (8.1% vs 2.0%; P < .001), and a higher incidence of stroke or death (5.9% vs 1.9%; P = .002). Predictors of the primary outcome in the multivariable model included treatment of tandem lesions (odds ratio [OR], 3.10; 95% confidence interval [CI], 1.39-6.89; P = .006), symptomatic lesions (OR, 2.24; 95% CI, 1.21-4.17; P = .010), chronic obstructive pulmonary disease (OR, 2.14; 95% CI, 1.17-3.92; P = .014), general anesthesia (OR, 3.34; 95% CI, 1.35-8.26; P = .009), and advancing age (OR, 1.05 per year; 95% CI, 1.01-1.09; P = .006). CONCLUSIONS: The addition of endovascular treatment of tandem CCA lesions with CAS is associated with a three-fold increase in perioperative stroke and death and should be avoided if possible.

Long-term safety and efficacy of angioplasty of femoropopliteal artery disease with drug-coated balloons from the AcoArt I trial.

OBJECTIVE: We evaluated the long-term safety and efficacy of treatment using drug-coated balloons (DCBs) in Chinese patients with severe femoropopliteal artery (FPA) disease (FPAD). METHODS: In this prospective, multicenter, randomized controlled trial, 200 Chinese patients with FPAD were prospectively randomized to undergo percutaneous transluminal angioplasty with a DCB or an uncoated balloon (UCB). The clinical endpoints were all-cause mortality, clinically driven target lesion revascularization, and major amputation of the treated leg within 5 years after treatment. RESULTS: During the 5-year follow-up period, freedom from all-cause mortality was 82.7% in the DCB group compared with 73.2% in the UCB group (log-rank P = .262). Freedom from clinically driven target lesion revascularization was 77.5% in the DCB group vs 59.1% in the UCB group (log-rank P < .001). No device- or procedure-related deaths occurred in either group. Cox regression analysis revealed that coronary heart disease and provisional FPA lesion stenting were associated with an increased mortality risk and the nominal paclitaxel dose was not associated with mortality during the 5-year follow-up period. CONCLUSIONS: We found no significant differences in 5-year mortality between patients with FPAD treated with DCBs vs UCBs. The clinical benefit of DCBs vs UCBs in terms of clinically driven target lesion revascularization persisted for the 5-year period.

A Multicenter Global Registry of Paclitaxel Drug-Coated Balloon in Dysfunctional Arteriovenous Fistulae and Grafts: 6-Month Results.

PURPOSE: To assess the safety and clinical benefit of the Lutonix drug-coated balloon (DCB) catheter for the treatment of dysfunctional arteriovenous fistulae (AVF) and grafts (AVG) in a heterogenous real-world population. MATERIALS AND METHODS: This multicenter, prospective study enrolled 320 subjects from 12 countries in 25 sites across Europe and Asia. A total of 392 lesions were treated with the Lutonix 035 DCB catheter. Lesions were de novo and restenotic, located in every part of the circuit from the cannulation zone to central venous outflow. In-stent restenotic lesions also were treated. The primary safety endpoint was freedom from serious adverse events involving the access circuit through 30 days. The primary effectiveness endpoint was target lesion primary patency (TLPP) through 6 months. Secondary endpoints included access circuit primary patency (ACPP) at 6 months and the investigation of factors that would independently influence the primary endpoints. RESULTS: The primary safety endpoint was 95.5%, while TLPP was 73.9% at 6 months, per Kaplan-Meier survival analysis. ACPP was 71% at 6 months. TLPP for stenosis of AVFs was 78.1%. Subgroup analysis showed significantly improved TLPP when DCB was dilated for ≥120 seconds (P = .007). TLPP was significantly better when predilation occurred compared with cases where only DCB angioplasty was performed (77% vs 48.6%, P = .0005). CONCLUSIONS: The Lutonix AV Global Registry confirms that the Lutonix DCB is a safe and effective treatment option in real-world patients with dysfunctional AVF or AVG. Procedural details had a significant role in TLPP. No significant difference in TLPP was observed among different treatment areas.

Atherectomy plus drug-coated balloon versus drug-coated balloon only for treatment of femoropopliteal artery lesions: A systematic review and meta-analysis.

OBJECTIVES: To compare the safety and efficiency of atherectomy plus drug-coated balloon with drug-coated balloon only for the treatment of femoropopliteal artery lesions. METHODS: This systematic review and meta-analysis was performed and reported following the requirement of the PRISMA. EMBASE, MEDLINE, and Cochrane library were queried from January 2000 to June 2020 to identify eligible literature. The modified Downs and Black checklist was used to assess the quality of included studies. Outcome measures included bail-out stenting, distal embolization, perforation, hematoma, primary patency at 12 months, target lesion revascularization at 12 months, leg amputation at 12 months, and mortality at 12 months. We used DerSimonian and Laird random-effects model to pool the dichotomous data on risk ratio (RR) with 95% confidence intervals (CIs) from each study to obtain an overall estimate for major outcomes. Subgroup analysis and sensitivity analyses were conducted. RESULTS: Six studies (two randomized controlled trials and four retrospective cohort studies) with 470 patients were included. Atherectomy plus drug-coated balloon group was associated with lower rates of bail-out stenting (RR: 0.49, 95%CI: 0.34-0.71, P < 0.001). There was no significant difference between two groups in terms of distal embolization (RR: 2.06, 95%CI: 0.51-8.38, P = 0.31), perforation (RR: 2.04, 95%CI: 0.43-9.71, P = 0.37), hematoma (RR: 1.75, 95%CI: 0.43-7.09, P = 0.43), primary patency at 12 months (1.09, 95%CI: 0.98-1.21, P = 0.12), target lesion revascularization at 12 months (RR: 0.68, 95%CI: 0.41-1.14, P = 0.15), leg amputations at 12 months (RR: 0.54, 95%CI: 0.13-2.23, P = 0.39), mortality at 12 months (RR: 2.18, 95%CI: 0.71-6.64, P = 0.17). Sensitivity analysis had no effect on our findings. CONCLUSIONS: The combination of atherectomy and drug-coated balloon was safe and effective in the treatment of femoropopliteal artery lesions, with lower incidence of bail-out stenting compared with drug-coated balloon only.

Safety and Efficacy of Paclitaxel-Eluting Balloon Angioplasty for Dysfunctional Hemodialysis Access: A randomized trial Comparing with Angioplasty Alone.

PURPOSE: To assess whether angioplasty of hemodialysis access (HA) stenosis with a drug-coated balloon (DCB) would prevent restenosis in comparison with plain-balloon percutaneous transluminal angioplasty (PTA). MATERIALS AND METHODS: This prospective randomized clinical trial enrolled 120 patients with dysfunctional arteriovenous fistulae (n = 109) and grafts (n = 11), due to a ≥50% stenosis between March 2014 and April 2018. All patients underwent high-pressure balloon angioplasty and were then randomized to either DCB (n = 60) or PTA (n = 60). Patients were followed-up for 1 year, and angiography was performed 6 months after angioplasty. The primary endpoint was the late lumen loss (LLL) at 6 months. Secondary endpoints included other angiographic parameters at 6 months and HA failures, adverse event, and mortality at 12 months. Continuous variables were compared with a Student t-test, and Kaplan-Meier curves were used for freedom from HA failure and for mortality. RESULTS: LLL in the DCB and in the PTA group were 0.64 mm ± 1.20 and 1.13 mm ± 1.51, respectively (P = .082, adjusted P = .0498). DCB was associated with lower percentage stenosis (54.2% ± 19.3 vs 61.7% ± 18.2; P = .047) and binary restenosis ≥50% (56.5% vs 81.1%; P = .009) than PTA. The number of HA failures after 12 months was lower for DCB than for PTA (45% vs 66.7%; P = .017). Mortality at 12 months was 10% and 8.3% in the DCB and PTA groups, respectively (P = .75). CONCLUSIONS: Despite LLL improvement that failed to reach statistical significance, this study demonstrated decreased incidence and severity of restenosis with DCB compared with PTA to treat dysfunctional HA.

Efficacy of Rotational Atherectomy Followed by Drug-coated Balloon Angioplasty for the Treatment of Femoropopliteal Lesions-Comparison with Sole Drug-coated Balloon Revascularization: Two-year Outcomes.

BACKGROUND: We aimed to evaluate the results of the combined use of rotational atherectomy (RA) followed by drug-coated balloon (DCB) treatment against DCB angioplasty alone in patients who had significantly calcified and symptomatic femoropopliteal peripheral arterial disease. METHODS: Patients presented to the clinic with symptoms of chronic limb ischemia of femoropopliteal segment such as moderate or severe claudication and rest pain, who received endovascular therapy between January 2016 and January 2018 in our hospital comprised the study cohort and investigated, retrospectively. Patients with minor or major tissue loss were excluded from the study. We evaluated the effect of RA system followed by DCB with DCB alone in 121 patients and a total of 226 significantly calcified and symptomatic femoropopliteal lesions. Fifty-eight patients and 112 (49.5%) lesions were treated with RA + DCB, whereas 63 patients and 114 (50.5%) lesions were treated with DCB only. The mean age was 61.2 ± 9.7 years. Primary patency is evaluated with duplex ultrasound/angiography at 6, 12, and 24 months and with angiography on 12 and 24 months. Patients were followed up for 24 months to assign clinically driven target lesion revascularization (TLR). Overall survival rates were 96.5% (56/58) in RA + DCB group and 93.6% (59/63) in DCB alone group both at one-year and two-year follow-up. Amputation-free survival rates of RA + DCB and DCB-only groups are 96.5% (56/58) to 87.3% (55/63) at one year, and 94.8% (55/58) to 82.5% (52/63) at two years, respectively. RESULTS: Baseline characteristics of groups were similar. The lesions were longer in the RA + DCB group than the DCB alone group (14.4 ± 5.2 cm vs. 10.2 ± 3.1 cm; P = 0.05). The technical success rate in the RA + DCB group was superior to that of DCB-only group (95.4% vs. 84.8%, P = 0.006). The 12-month and 24-month patency rates with angiography in the RA-DCB group were similar to those in the DCB-only group (85.7% vs. 74.6% and 73.2% vs. 62.7%, respectively). The rates of bailout stenting were significantly lower among patients treated with RA + DCB (n = 3; 5.1% vs. n = 13; 20.6%, P < 0.001). The rates of flow-limiting dissections and vessel recoils after procedures were significantly in RA + DCB group (n = 2; 3.4% vs. n = 8; 12.6%, P < 0.001) than DCB only (n = 1; 1.7% vs. n = 4; 6.3%, P < 0.002). The freedom from TLR rate was significantly increased in the RA + DCB group at 12 months (95.2% vs. 76.3%, P = 0.002) and 24 months (93.4% vs. 63.7%, P = 0.002). The mean ankle brachial index at discharge in the RA-DCB group improved by 0.35 ± 0.24, and in the DCB-only group, it was 0.30 ± 0.23 (P = 0.683). CONCLUSIONS: Combined use of RA and DCB treatment is an effective, safe, and durable method for the treatment of the complex femoropopliteal lesions. Combination of RA and DCB angioplasty reveals increased technical success, fewer flow-limiting dissections, significantly reduced TLR, and bailout stenting rates compared with sole DCB angioplasty.

Comparison of drug-coated balloon angioplasty versus uncoated balloon angioplasty in treatment of total occlusions with severe femoropopliteal lesions: An additional analysis from the AcoArt I study.

OBJECTIVES: Femoropopliteal chronic total occlusions are challenging to treat, and evidence of the effectiveness of drug-coated balloon angioplasty for long femoropopliteal chronic total occlusion lesions is limited. We compared the midterm outcomes of drug-coated balloon angioplasty versus plain old balloon angioplasty (POBA) for femoropopliteal chronic total occlusions. METHODS: In total, 95 patients from the AcoArt I trial (ClinicalTrials.gov identifier NCT01850056) with ≥5-cm femoropopliteal chronic total occlusion lesions were enrolled in this post-hoc subset analysis (drug-coated balloon, n = 50; POBA, n = 45). The primary endpoints were primary patency and clinically driven target lesion revascularization (CD-TLR) at 24 months. The secondary endpoints were late lumen loss at six months and binary restenosis, major adverse events (composite of death and target limb amputation), change in the Rutherford class, and the ankle-brachial index at 24 months. RESULTS: Demographic, clinical, and lesion characteristics were matched (mean lesion length, 20 cm). The six-month late-lumen loss rate was lower in the drug-coated balloon than POBA group (0.18 ± 0.81 vs. 1.34 ± 0.94 mm, respectively; P < 0.001). The 24-month primary patency rate was significantly higher in the drug-coated balloon than POBA group (53.85% vs. 17.50%, respectively; P < 0.001). The CD-TLR rate in the drug-coated balloon and POBA groups was 12.77 and 45.24%, respectively (P = 0.002). The 24-month overall mortality rate in the drug-coated balloon and POBA groups was 12.77% and 6.98%, respectively (P = 0.360), with no device- or procedure-related deaths. One major amputation had occurred in each group by the 24-month follow-up. CONCLUSION: The paclitaxel drug-coated balloon shows better primary patency and freedom from target lesion revascularization than POBA at 24month after treatment of femoropopliteal chronic total occlusions (≥5 cm) lesion.

Propensity-Matched Comparison of Endovascular versus Open Reconstruction for TASC-II C/D AortoIliac Occlusive Disease. A Ten-Year Single-Center Experience with Self-Expanding Covered Stents.

BACKGROUND: To compare endovascular therapy (EVT) using kissing self-expanding covered stents, with open repair (OR) with aortobifemoral bypass (ABF), for reconstruction of the aortic bifurcation in Trans-Atlantic Inter-Society Consensus II (TASC-II) C/D aortoiliac occlusive disease (AIOD). METHODS: A single-center retrospective analysis of patients treated by EVT or ABF for TASC-II C/D AIOD (2009-2018) was carried out. The perioperative risk was quantified by the Society for Vascular Surgery (SVS) and American Society of Anesthesiologists (ASA) scores. Outcomes of interest were early (30 days) mortality and complication rates, length of hospitalization, and midterm patency that were compared between EVT and OR after propensity score matching. Follow-up results were analyzed with Kaplan-Meier curves. Cox proportional hazards were used to identify predictors of patency. RESULTS: Sixty-three EVT and 55 OR patients were treated; the EVT group had higher perioperative risk (ASA score, P = 0.012. SVS score, P = 0.012) and less advanced disease (TASC D lesions, 52.3% vs. 72.7%; P = 0.036. Iliac occlusion, 46.8% vs. 87.2%; P = 0.024). After propensity score matching, 148 limbs were selected (74 EVT and 74 OR), resulting in well-balanced groups regarding risk (ASA score, P = 0.514. SVS score, P = 0.373) and anatomical complexity (TASC D lesions, 60.4% vs. 63.0%; P = 0.516. Iliac occlusion, 47.3% vs. 59.5%; P = 0.187). Mortality was 0%. The EVT group showed significantly shorter hospital (4.5 ± 7.6 days vs. 9.9 ± 6.8 days; P < 0.001) and intensive care unit stay (0 ± 0.1 days vs. 1.7 ± 1.5 days; P = 0.046) and less surgical complications (4% vs. 14.8%; P = 0.046). Five-year primary patency was similar between EVT and OR (84.1% vs. 88.3%; P = 0.454); multivariate analysis showed that Rutherford category was the only predictor of primary patency (HR 4.1, P = 0.023). CONCLUSIONS: The endovascular kissing self-expanding covered stent technique for TASC-II C/D AIOD presented a primary patency equal to ABF at 5 years, with the advantage of less surgical complications and shorter hospitalization. Therefore, it may be considered as a valid option for complex atherosclerotic lesions involving the aortic bifurcation.

A systematic review and meta-analysis of combined carotid endarterectomy with ipsilateral proximal intervention (hybrid approach) for tandem carotid artery lesions.

OBJECTIVE: The safety and effectiveness of using the hybrid approach to treat tandem carotid lesions is controversial, and the clinical significance of the technical variants on the perioperative outcomes has not been evaluated. The present meta-analysis was performed to evaluate the technique, safety, effectiveness, and long-term outcomes of the hybrid approach. METHODS: The PubMed, Embase, and Cochrane Library databases were searched to identify studies from January 1, 1996 to January 11, 2020. The baseline patient characteristics, comorbidities, procedural details, and perioperative and long-term outcomes were collected and analyzed. A pooled overall survival curve was drawn. Univariate analysis was performed to compare the perioperative stroke risk between subgroups. RESULTS: Overall, 275 patients (mean age, 66.94 years) from 15 studies were included. All the patients had presented with tandem stenosis of ≥50%, and 67.2% were symptomatic. The overall technical success rate was 99.8% (95% confidence interval [CI], 98.0%-100.0%). The pooled perioperative complications rates were as follows: death, 1.5% (95% CI, 0.0%-2.9%); stroke, 2.6% (95% CI, 0.7%-4.4%); combined stroke/death, 3.3% (95% CI, 1.2%-5.4%); and myocardial infarction, 3.2% (95% CI, 0.7%-9.1%). The overall primary patency rates were 99.2% (95% CI, 96.0%-100.0%) and 88.2% (95% CI, 78.8%-95.4%) at 1 and 2 years, respectively. Reintervention was performed in 6.6% of the patients (95% CI, 3.0%-11.2%). The pooled overall survival rates were 89.9% (95% CI, 83.7%-96.7%), 83.7% (95% CI, 75.9%-92.2%), and 75.9% (95% CI, 66.5%-86.7%) at 1, 3, and 5 years, respectively. Operations in which carotid endarterectomy was performed first carried a significantly greater risk of perioperative stroke compared with those in which proximal intervention had been performed first (5.7% vs 0.0%; P = .01). No difference was found in perioperative stroke risk between the subgroups of baseline symptomatic status (asymptomatic, 5.1%; symptomatic, 1.9%; P = .32), preoperative antiplatelet therapy (dual, 3.6%; single, 5.8%; P = .79), and carotid clamping during intervention (clamping, 2.8%; unclamping, 6.3%; P = .40). CONCLUSIONS: For patients with a presumed high risk of neurologic events because of carotid tandem lesions, the hybrid approach could be considered a reasonable option with high technical success and acceptable perioperative and long-term results. Performing carotid artery stenting before carotid endarterectomy and administering perioperative dual antiplatelet therapy should be considered to promote technical success and better outcomes. Prospective and randomized controlled studies are needed to confirm the results and provide recommendations on patient selection for the hybrid approach.