Femoropopliteal Artery Disease Research Articles

CRT-200.13 Shockwave Peripheral Intravascular Lithotripsy in Combination With Atherectomy in Treating Severe Calcified Femoropopliteal and Iliac Artery Disease: A Single-Center Experience.

Calcium is a predictor of poor outcome in the treatment of infrainguinal arterial disease. Rotational atherectomy can effectively debulk atherosclerotic calcium but is less likely to significantly modify medial and adventitial calcinosis. We present acute and intermediate outcome data from patients

Association between anatomical distribution of symptomatic peripheral artery disease and cerebrovascular disease.

Peripheral arterial disease is frequently associated with significant atherosclerosis of other vascular beds. The aim of the present study was to investigate a possible association between peripheral arterial disease segment-specific disease burden and cerebrovascular disease. Two-hundred and twenty-six patients with clinically symptomatic peripheral arterial disease from the prospective PureASO registry were followed up after revascularization. The breadth of peripheral arterial disease was quantified at the time patients entered the study. The segment-specific peripheral arterial disease burden was correlated to cerebrovascular disease and imaging findings during a five-year follow-up. At five years, cerebrovascular disease-free survival after lower limb revascularization was 31%. Patients with peripheral arterial disease involving the crural arteries had significantly more ischemic degenerative changes at brain imaging (p = 0.031), whereas patients with aorto-iliac and femoropopliteal segment peripheral arterial disease had more significant (>50% uni- or bilaterally) internal carotid artery stenosis compared to patients with crural peripheral arterial disease (p = 0.006). According to Cox regression analyses, crural arteries burden was associated with a significantly increased risk of mortality (adjusted HR 2.07, CI 95% 1.12-3.28, p = 0.021) and cerebrovascular events (adjusted HR 1.97, CI 95% 1.19-3.26, p = 0.008). Present results suggest that atherosclerosis burden at different lower limb artery segments is associated with defined cerebrovascular disease. This further suggests that risk factors and pathophysiological mechanisms are congruent across particular vascular beds.

Ticagrelor versus clopidogrel in patients undergoing implantation of paclitaxel-eluting stent in the femoropopliteal district: A randomized pilot study using frequency-domain optical coherence tomography

ObjectivesAim of this study was to evaluate different response in platelet reactivity and vessel healing using high-resolution frequency-domain optical coherence tomography (FD-OCT) in patients with femoropopliteal artery disease treated with ZILVER PTX drug eluting stents (DES), and randomly assigned to clopidogrel or ticagrelor for 12 months. BackgroundThe optimal antithrombotic regimen for long-term management of patients with peripheral artery disease (PAD) after revascularization is poorly defined and often extrapolated from trials performed on patients undergoing percutaneous coronary intervention. MethodsIn this single center randomized trial 40 patients with femoropopliteal artery disease treated with ZILVER PTX DES stents, were randomized to Ticagrelor (T) + Aspirin for 3 months, subsequently continuing Ticagrelor alone for another 9 months or Clopidogrel (C) + Aspirin for 3 months, subsequently continuing Clopidogrel alone for 9 months. Platelet reactivity via the P2Y12 pathway was evaluated at baseline and at 3 months follow-up, angiographic and FD-OCT follow-up along the entire stented segment was performed at 12 months. ResultsNo significant difference between T and C group was found concerning net percentage volume obstruction (29.7% ± 17.6% vs. 31.2% ± 10.7%; p = 0.78). FD-OCT at 12 months showed a high percentage of uncovered stent struts in both groups: 24.2% ± 32.8% in the T group vs 15.3% ± 15.8% in the C group (p = 0.4). Mean values of platelet reactivity units (PRU) at 3 month follow-up were 81 ± 72 in the T group and 200 ± 61 in the C group (p < 0.001). ConclusionsSignificantly higher platelet reactivity remains in patients treated with clopidogrel as compared to ticagrelor 3 months after PTA and stent implantation. Ticagrelor does not reduce neointimal proliferation in patients treated with DES in the femoropopliteal district as compared with clopidogrel. A large amount of uncovered stent struts at 12-month follow-up was found in these patients regardless of the antiplatelet treatment assumed.

Stents in the femoropopliteal territory: prevalence of fractures and their consequences.

Endovascular treatment for femoropopliteal arterial disease has made revascularization procedures less invasive, but the self-expanding stents used can suffer great wear in arteries with extreme mobility. To evaluate the prevalence of fractures in stents implanted in the femoropopliteal segment, to identify predisposing factors and consequences on arterial patency. between March and June 2019, thirty patients previously operated for femoropopliteal obstruction underwent stent X-rays in anteroposterior and lateral views to detect fractures and Doppler to analyze arterial patency. we observed 12 cases with fractures (33.3%): 1 type I (2.8%), 3 type II (8.3%), 5 type III (13.9%), 3 type IV (8.3%) and no type V. According to the TASC II we had 1 in group B (8.3%), 6 in group C (50%) and 5 in group D (41.6%) p <0.004. The number of stents per limb was 3.1 (± 1.3) in cases of fracture versus 2.3 (± 1.3) in cases without fracture (p = 0.08). The extension was 274.17mm (± 100.94) in cases of fracture and 230.83mm (± 135.44) in cases without fracture (p = 0.29). On Doppler we had: 17 patients (47.2%) without stenosis, 9 patients (25%) with stenosis> 50% and 10 patients (27.8%) with occlusion (p = 0.37). There was no correlation between fracture and arterial obstruction (p = 0.33). stent fractures are a frequent finding in the femoropopliteal area (33.3%), being more prevalent in cases of more advanced disease (C and D). There was no association between the finding of fracture and arterial obstruction.

Excimer laser atherectomy combined with drug-coated balloon angioplasty for the treatment of chronic obstructive femoropopliteal arterial disease.

The aim of the present retrospective study was to evaluate the feasibility, safety and the primary results following application of excimer laser atherectomy (ELA) combined with adjunctive drug-coated balloon angioplasty (DCBA) as the first-line endovascular treatment for patients with chronic obstructive femoropopliteal arterial disease. The baseline characteristics and angiographic variables of all patients who underwent ELA for stable chronic obstructive femoropopliteal arterial disease at Tianjin First Central Hospital (Tianjin, China) between May and December 2017 were collected. Information on clinical characteristics, including the 12-month primary patency rate, technical success rate, procedural success rate, bailout stenting rate, target lesion revascularization and major adverse events, was obtained following review of the patients' medical records. A descriptive analysis was performed on all variables. Kaplan-Meier curves were plotted for the primary patency rate. The present study included 17 consecutive patients (age, 68.9±7.4 years; 94.1% males) who were followed up for 12 months after the intervention. Adjunctive BA was performed in 100% of the cases. The occlusion length was 23.3±8.9 cm (range, 5.6–40.5 cm). The technical success rate was 100% and the procedural success rate was 88.2%. Bailout stenting was required in 5 of the 17 patients (29.4%) and the 12-month primary patency rate was 82.4%. The clinically driven target lesion revascularization rate was 5.9% at 12 months. An embolic protection device was used in 23.5% of the patients. The following adverse events were reported: Distal embolization requiring treatment, 5.9% (1 patient with embolic protection device); and flow-limiting dissection requiring treatment, 5.9%. In the present study, there were no major adverse events (all-cause death, unplanned major amputation or target lesion revascularization) at 30 days after the intervention. Therefore, ELA combined with adjunctive DCBA for the treatment of chronic obstructive femoropopliteal arterial disease appears to be safe, practicable and associated with a high procedural success rate; furthermore, endoluminal-driven atherectomy may effectively reduce the requirement for stent placement in the lower limb arteries and is associated with long-term patency.

Bayes Factor Meta-Analysis of the Mortality Claim for Peripheral Paclitaxel-Eluting Devices

ObjectivesThe aim of the present study was to quantify the probability of increased mortality with paclitaxel compared with control in a dataset of 28 randomized controlled trials. BackgroundAnalysis of data from 28 randomized controlled trials using conventional null-hypothesis statistical testing has produced the unexpected finding of a 68% increase in mortality at 2 years and a 93% increase at 3 to 5 years after using paclitaxel-eluting balloons and stents to treat femoropopliteal arterial disease, but no biologic explanation for increased mortality has been identified. MethodsA Bayesian sequential model was developed to quantify the probability of increased mortality 1, 2, and 3 to 5 years after treatment, and p values were replaced with meta-analytic Bayes factors (BFs), which provide decisive evidence at values >100 and very strong evidence at values of 32 to 100. ResultsThe evidence for increased mortality at 1 year (BF = 0.02), 2 years (BF = 8.5), and 3 to 5 years (BF = 14.6) was less than conclusive. All-cause mortality at 1 year was similar between the paclitaxel and control arms at 1 year (odds ratio: 0.92; 95% Bayesian credible interval: 0.53 to 1.53) and 2 years (odds ratio: 1.23; 95% Bayesian credible interval: 0.84 to 1.71) but was increased at 3 to 5 years (odds ratio: 1.43; 95% Bayesian credible interval: 1.01 to 1.90). ConclusionsThis study finds some support for increased mortality after using paclitaxel-eluting devices in femoropopliteal arterial disease, but the evidence is not unequivocal and may not sway skeptical investigators concerned about causation, unreported studies, or the post hoc analysis of trials underpowered for mortality.

Association of Plasma Marker of Oxidized Lipid with Histologic Plaque Instability in Patients with Peripheral Artery Disease

The association between oxidized low-density lipoprotein (OxLDL) and plaque instability in coronary and carotid artery disease is well established. However, the association between OxLDL and the histologic changes of plaque in peripheral artery disease has not been clearly elucidated. This study aims to investigate the association between plasma OxLDL and histologic plaque instability in patients with peripheral artery disease. Prospectively obtained plaques from 48 patients who underwent endovascular atherectomy (n=20), surgical endarterectomy (n=9), or bypass surgery (n=19) for treatment of atherosclerotic femoropopliteal artery disease were evaluated for histologic fibrosis, sclerosis, calcification, necrosis, cholesterol cleft, and foamy macrophages using hematoxylin and eosin, oil red O, and immunohistochemical staining. Unstable plaques were defined as plaques that were positive for foamy macrophages and with lipid content of more than 10% of the total plaque area. Plasma OxLDL levels were measured using an enzyme-linked immunosorbent assay (Mercodia AB, Uppsala, Sweden). Of the 48 patients, 26 (54%) had unstable plaques. The unstable plaque group was younger, had fewer angiographic total occlusions, less calcification, and more CD68-positive and LOX-1-positive cells than the stable plaque group. Plasma OxLDL levels were significantly higher in the unstable plaque group than in the stable plaque group (57.4±13.9 vs. 47.2±13.6 U/L, P=0.014). Multivariate analysis revealed that plasma OxLDL level, smoking, angiographic nontotal occlusion, and statin nonuse were independent predictors of unstable plaque. Among patients with peripheral artery disease, the histologic instability of femoropopliteal plaque was independently associated with high plasma OxLDL, smoking, nontotal occlusion, and statin nonuse. Further large-scale studies are necessary to evaluate the role of noninvasive OxLDL measurement for predicting plaque instability and future adverse vascular event.

Comparison of Drug-Coated Balloon Treatment of Femoropopliteal Artery Disease

Comparison of Drug-Coated Balloon Treatment of Femoropopliteal Artery Disease

Midterm Outcomes of Drug-Coated Balloon Angioplasty in Femoropopliteal Lesions in a Daily Practice Cohort

Most previous drug-coated balloon (DCB) angioplasty studies used strict inclusion and exclusion criteria and therefore might not be representative for daily practice. This study was performed to evaluate the midterm outcomes of DCB angioplasty in femoropopliteal artery disease and to identify risk factors for restenosis. All patients treated with DCB angioplasty between January 2015 and September 2016 were included. Provisional stents were placed if indicated. Data were retrospectively collected from digital patient records. No exclusion criteria were applied. The primary end point was primary patency. Secondary end points were primary assisted patency, secondary patency, clinically driven target lesion revascularization (CD-TLR) and major adverse events. All end points were calculated with the Kaplan-Meier analysis. The univariable and multivariable Cox regression analyses were performed to identify risk factors for restenosis. A total of 109 patients (113 legs) were included (45% male; mean age, 72±10). The rate of critical limb ischemia was 52% and total occlusions were treated in 38%. The mean follow-up was 24±13months. Primary patency rates were 87%, 79%, and 61% at 1, 2, and 3years, respectively. Primary assisted patency rates were 95%; 89%, and 79%; secondary patency rates were 99%, 97%, and 91%; and CD-TLR rates were 6.9%, 14.3%, and 20.6% at 1, 2, and 3years, respectively. Overall mortality and major target limb amputation rates were 18% and 5% at 3years. Multivariable analysis demonstrated that only Trans-Atlantic Inter-Society Consensus (TASC) D lesions were associated with restenosis (P=0.008). DCB angioplasty is an effective and safe treatment option for femoropopliteal lesions in daily practice with excellent 1- and 2-year results. The 3-year results were slightly less favorable, which may be caused by the ongoing vascular disease or a late "catch-up" phenomenon. Only TASC D lesions were associated with loss of primary patency after adjustment for confounders.

Benefit and risk from paclitaxel-coated balloon angioplasty for the treatment of femoropopliteal artery disease: A systematic review and meta-analysis of randomised controlled trials

BackgroundPaclitaxel-coated balloons (DCB) are suitable to reduce the risk of restenosis after angioplasty of atherosclerotic femoropopliteal lesions. However, numerous types of DCBs are distinguished by drug density and coating. Conflicting evidence exists about the risk of mortality. This study sought to evaluate benefit and risk of DCB angioplasty compared to plain old balloon angioplasty (POBA). MethodsRandomised trials published between January 1, 2005 and February 3, 2019 were identified by searching MEDLINE, CENTRAL, and Clinical.trials.gov. Studies on DCB versus POBA for the treatment of femoropopliteal artery disease were included, and those focused on in-stent restenosis or critical limb ischemia were excluded. Random-effects meta-analysis was conducted to assess the main outcomes of freedom from target lesion revascularisation (FfTLR) and all-cause mortality. FindingsOf 552 identified records, 14 studies including 2504 patients were eligible. DCB significantly increased the risk of FfTLR with substantial heterogeneity (12-month: risk ratio [RR] 1·24 [95% CI 1·14–2·27], I2 = 66%; 24-month RR 1·39 [95% CI 1·39–1·52], I2 = 21%). The risk of 24-month all-cause mortality was increased after DCB (random-effects model: RR 1·53 [95% CI 0·94–2·50], p = 0·09; fixed-effect model: RR 1·74 [95% CI 1·08–2·81], p = 0·02). InterpretationEfficacy of DCB differs substantially across studies. Effect size depends on the type of DCB, treatment strategy, and lesion complexity. The risk of 2-year all-cause mortality at 2 years was increased, but without evidence of causation.

Evaluation of versatility of drug-coated balloons in prevention of restenosis after angioplasty of superficial femoral artery occlusive lesions: a 2-year surveillance study

Purpose To assess superiority of paclitaxel drug-coated balloons (DCB) in prevention of neointimal hyperplasia and restenosis after treatment of symptomatic superficial femoral artery (SFA) occlusive lesions. Background Endovascular treatment (ET) has become the first choice for SFA atherosclerotic lesions. Despite enhanced immediate technical success, neointimal hyperplasia and restenosis remain the Achilles heel of ET. Patients and methods This prospective randomized controlled two-arm blind interventional study was conducted on 134 patients with symptomatic SFA atherosclerotic lesions. Patients were randomly allocated by using simple random allocation method, where 134 cards were used for allotment of cases into two groups (67 patients were assigned to group A, in which patients were subjected to treatment with paclitaxel DCB and other 67 were assigned to group B, where patients were subjected to treatment with plain old balloon angioplasty). Follow-up was for 2 years. Results Primary patency and limb salvage after 1 and 6 months were statistically insignificant in both groups (P=0.21 and 0.19 and 0.049 and 0.051, respectively), but after 12 and 24 months, primary patency and limb salvage were statistically highly significant in group A (P=0.0018 and 0.0011 and 0.0019 and 0.0023, respectively). Conclusion ET with DCB has equal risks but higher antirestenotic efficacy than plain old balloon angioplasty in femoropopliteal artery disease. The use of DCB increases patency and limb salvage. Stenting still has a rising role in bail-out in the treatment of SFA occlusive disease and is associated with better acute angiographic results.

Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years.

A recent summary-level meta-analysis comprising randomized, controlled trials (RCTs) of femoropopliteal paclitaxel-coated balloon and stent intervention identified excess late mortality in the paclitaxel-treated patients. We evaluated the safety of the Stellarex drug-coated balloon (DCB) for femoropopliteal artery disease with an independently performed meta-analysis of patient-level data from all patients in the Stellarex femoropopliteal clinical program. To compare mortality after DCB or uncoated percutaneous transluminal angioplasty (PTA), we aggregated data from 2 RCTs comprising 419 patients treated with DCB and 170 patients treated with PTA. In an additional analysis, data were aggregated from 6 poolable Stellarex DCB studies (2 RCTs, 3 single-arm studies, and 1 registry). All serious adverse events including deaths were adjudicated by a blinded, third-party, independent Clinical Events Committee. Kaplan-Meier estimates in the RCTs were compared with restricted mean survival time. Predictors of death were assessed with hazard ratios (HRs) and Cox proportional hazards modeling. Baseline characteristics were similar in the patients treated with DCB and PTA in the pooled RCT analysis, with the exception that the DCB cohort was younger (67.4±9.7 versus 69.4±9.4 years, P=0.02), smoked more frequently (86.6% versus 78.8%, P=0.02), and were less often treated for recurrent lesions (8.8% versus 14.7%, P=0.04). In the RCTs, patients treated with DCB had all-cause mortality rates that were not different from those of patients treated with PTA (Kaplan-Meier estimates 1.8±0.7% versus 1.3±0.9%, 6.5±1.2% versus 5.9±1.9%, and 9.3±1.5% versus 9.9±2.4% at 1, 2, and 3 years, respectively, P=0.86). All-cause mortality rates were similar in a 1906-patient pooled nonrandomized DCB data set (Kaplan-Meier estimates of 2.1%, 4.9%, and 7.0% at 1, 2, and 3 years, respectively). Clinical Events Committee-adjudicated causes of death were balanced between the DCB and PTA cohorts. Multivariable Cox modeling identified age (HR, 1.06; 95% CI, 1.04-1.08; P<0.001), diabetes mellitus (HR, 1.42; 95% CI, 1.01-2.00; P=0.04), congestive heart failure (HR, 1.88; 95% CI, 1.12-3.16; P=0.02), and renal insufficiency (HR, 2.00; 95% CI, 1.33-3.01; P<0.001) as predictors of mortality. Paclitaxel exposure was unrelated to mortality (HR, 1.04; 95% CI, 0.98-1.10; P=0.23). The mortality rates for patients treated with the DCB and uncoated PTA were indistinguishable over 3-year follow-up. Additional patient-level, adequately powered meta-analyses with larger RCT data sets will be needed to confirm the generalizability of these findings. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT02110524, NCT01858363, NCT01858428, NCT03421561, NCT01912937, NCT01927068, and NCT02769273.

Safety of Paclitaxel-Coated Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease

ObjectivesThe aim of this study was to assess safety outcomes of femoropopliteal drug-coated balloon (DCB) angioplasty using patient-level data from the Lutonix clinical program. BackgroundA recent systematic review and meta-analysis of heterogenous trials and summary-level data identified increased long-term mortality in patients treated with paclitaxel-coated balloons and stents. MethodsWe evaluated DCB angioplasty (n = 1,093) and uncoated balloon angioplasty (percutaneous transluminal angioplasty [PTA]) (n = 250) outcomes in LEVANT 1 (The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis), LEVANT 2 (Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries), and the LEVANT Japan Clinical Trial. Hazard ratios (HRs) were calculated with Cox proportional hazards modeling. ResultsThere were no significant differences in mortality rates between DCB angioplasty and PTA. The 5-year HR was 1.01 (95% confidence interval [CI]: 0.68 to 1.52) in the aggregated LEVANT trials. The 2-year HR after DCB angioplasty was 0.99 (95% CI: 0.25 to 3.95) in LEVANT 1, 1.40 (95% CI: 0.62 to 3.14) in LEVANT 2, and 0.32 (95% CI: 0.05 to 1.92) in the LEVANT Japan Clinical Trial. The 5-year HR was 1.60 (95% CI: 0.94 to 2.72) in LEVANT 2. Adverse events and causes of death were balanced, without clustering between DCB angioplasty and PTA. Patients who underwent paclitaxel or nonpaclitaxel reinterventions had higher survival rates than those who did not undergo reinterventions. Baseline covariates predicting mortality included, among others, age (HR: 1.03 per year; p < 0.0001), prior treatment of target lesion (HR: 1.67; p = 0.022), arrhythmia (HR: 1.65; p = 0.031), and diabetes (HR: 1.18; p = 0.047), without differences between the 2 arms. No dose-response relationship was identified when adjusted for key predictors of mortality. ConclusionsAnalyses of patient-level data identified no mortality differences between DCB angioplasty and PTA. Furthermore, the lack of dose-response relationships or clustering of causes of death argues against a causal relationship between paclitaxel and mortality. (LEVANT 1, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis [LEVANT 1], NCT00930813; Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries [LEVANT 2], NCT01412541; LEVANT 2 Continued Access Registry, NCT01628159; LEVANT Japan Clinical Trial, NCT01816412)

Jetstream Atherectomy System for Treatment of Femoropopliteal Artery Disease: A Single Center Experience and Mid-term Outcomes

The aim of this study is to assess our experience and mid-term outcomes using Jetstream atherectomy system for treatment of femoropopliteal artery disease (FPAD). Data of 30 patients with FPAD treated at our center between 2013 and 2016 were analyzed. Two subgroups of patients were identified: Group A included patients (n=18) with de novo lesions; Group B (n=12) included those with in-stent restenosis. The primary study end points assessed were technical success, perioperative mortality, and major adverse event (MAE) rate at 30 days (distal embolization, major amputation, and target lesion revascularization). Other outcomes measured were survival, primary, and secondary patency, and freedom from amputation at 1 and 3 years of follow-up, respectively. Technical success was 100% for both groups. The MAE rate was 8.7%. No distal filter was adopted during intervention. Angioplasty was associated with 93.3% of cases (93.3% vs. 100%; P=0.15), drug-eluting balloon (DEB) in 12 cases (22.2% vs. 66.6%; P=0.008), drug-eluting stent and bare metal implantation in 1 (5.6% vs. 0%; P=1) and 4 cases (11.1% vs. 16.7%; P=1), respectively. The cumulative primary and secondary patency rates were 75.1% and 95.5% at 1year, and 70.4% and 84.8% at 3 years of follow-up, respectively. The survival and freedom from amputation were 96.4% and 85.8% at 1 and 3 years of follow-up, respectively. The freedom from target lesion revascularization was 91.7% and 83.4% at 1 and 3 years from intervention. The use of the Jetstream appears to be safe and feasible with no distal embolization and low rate perioperative complications. Moreover, encouraging outcomes were observed when atherectomy was associated to DEB angioplasty.

Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts

ObjectiveRandomized controlled trials have shown that drug-coated balloons (DCBs) provide superior results compared with percutaneous transluminal angioplasty (PTA) for the treatment of femoropopliteal artery disease. However, these trials have generally included short lesions, few occlusions, and small sample sizes. The present study was an individual-level pooled analysis of duplex ultrasonography (DUS) core laboratory-adjudicated and clinical events committee-adjudicated IN.PACT Admiral DCB subjects across two randomized controlled trials and two single-arm prospective studies to characterize the safety and effectiveness of DCB compared with PTA. MethodsThe subjects were treated with DCB (n = 926) or PTA (n = 143). The end points through 12 months included DUS core laboratory-adjudicated primary patency and clinically driven target lesion revascularization (CD-TLR) using Kaplan-Meier estimates and primary safety using proportions. A propensity-matched analysis of DCB (n = 466) to PTA (n = 136) was conducted to address confounders. ResultsAt 12 months, DCB compared with PTA had significantly greater primary patency (88.8% vs 53.9%; P < .001), freedom from CD-TLR (94.3% vs 80.2%; P < .001), and better primary safety composite end point (94.1% vs 78.0%; P < .001). After propensity-matched analysis, DCB remained superior to PTA at 12 months for primary patency (90.5% vs 53.8%; P < .001), freedom from CD-TLR (96.9% vs 80.7%; P < .001), and the primary safety composite end point (96.3% vs 78.4%; P < .001). Across multiple prespecified subgroup analyses, including provisional stenting, DCB remained persistently superior to PTA. ConclusionsIn the largest, DUS core laboratory-adjudicated, multiethnic, pooled DCB series to date, the IN.PACT Admiral DCB demonstrated significantly greater primary patency, freedom from CD-TLR, and better composite safety at 12 months compared with PTA.

Angioplasty or bare metal stent versus drug-eluting endovascular treatment in femoropopliteal artery disease: a systematic review and meta-analysis

Endovascular treatment represents nowadays the preferred therapeutic approach for disabling femoro-popliteal arterial occlusive disease in fit patients. In the latest years, in order to improve short- and long-term outcomes, drug eluting devices have been developed. Drug coated balloons (DCB) and drug eluting stents (DES) are today employed in clinical practice, and several studies has been completed to assess their performance in different clinical scenarios. Objective of the present review and meta-analysis is to compare clinical results of different endovascular treatment modalities in the published literature in the last 10 years. A systematic review and meta-analysis following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement on the literature regarding direct comparisons between DCB, DES, bare metal stents (BMS) and Plain Old Balloon Angioplasty (POBA) has been conducted. Primary outcomes were considered Primary Patency and Target Lesion Revascularization (TLR) at 12 months. Analysis of late survival in different treatment groups was outside the scope of the present study and was therefore not included as main end point. Meta analysis results confirm that DCB outperforms POBA in both primary patency (estimate OR=3.17, 95% CI: 2.10-4.76) and TLR (POBA estimate OR=3.59, 95% CI= 2.31-5.56). No clear evidences emerged comparing DES and BMS; however, DES were shown to fare better than BMS in terms of TLR when analyzing lesions <15 cm (OR 0.36, 95% CI: 0.35-0.36). Comparison of DCB and DES revealed higher rates of TLR for DES (OR 1.26 95% CI: 1.07-1.49), however no significant differences have been found regarding primary patency analyzing such long lesions (range 14-19.4 cm) as those included in the studies. While confirming that DCB outperforms POBA in terms of primary patency and TLR at 12 months, only TLR benefits are noted for DES vs. BMS and DCB vs. DES in limited clinical settings. Further RCTs are needed to strongly assess the compared performance of drug eluting devices in relation to lesion length and controlling possible confounders.

Directional Atherectomy with Antirestenotic Therapy for Femoropopliteal Artery Disease: A Systematic Review and Meta-Analysis.

Systematic literature searches using Embase, PubMed, and Cochrane Library for directional atherectomy with antirestenotic therapy (DAART) in femoropopliteal artery disease (FPAD) from January 2003 to February 2018 were conducted to evaluate clinical safety and effectiveness. A meta-analysis was conducted using Stata software for the event rate of technical success, bailout stent placement, primary patency, and target lesion revascularization (TLR) at 12 months. Five studies with 189 patients who received DAART were included in the meta-analysis. Pooled rates of technical success and bailout stent placement were 90.4% (95% confidence interval [CI] 86.3%-94.6%) and 4.8% (95% CI 0.7%-8.9%), respectively. Primary patency and TLR at 12 months were 85.3% (95% CI 79.6%-91.1%) and 5.5% (95% CI 1.9%-9.1%), respectively. Meta-analysis of 3 comparative studies demonstrated that DAART was not superior in performance in clinical endpoints, including technical success, bailout stent placement, primary patency, and TLR at 12 months (relative risk [RR] 1.111, 95% CI 0.896-1.377, P= .337; RR 0.400, 95% CI 0.120-1.332, P= .135; RR 1.136, 95% CI 0.841-1.535, P= .405; and RR 0.722, 95% CI 0.291-1.789, P= .482). The data did not suggest that DAART was an improvement over paclitaxel-coated balloon angioplasty for FPAD. The theoretical advantages of DAART still require further confirmation.

Paclitaxel density and clinical efficacy of drug-coated balloon angioplasty for femoropopliteal artery disease: meta-analysis and adjusted indirect comparison of 20 randomised trials.

Paclitaxel density and clinical efficacy of drug-coated balloon angioplasty for femoropopliteal artery disease: meta-analysis and adjusted indirect comparison of 20 randomised trials.

Low-Dose Paclitaxel-Coated Balloon Angioplasty versus Uncoated Percutaneous Transluminal Balloon Angioplasty for Femoropopliteal Peripheral Artery Disease: 6-Month Results in a Tertiary Care Hospital of Central India

Abstract Introduction Superficial femoral and popliteal arteries are the most common locations of peripheral vascular disease (PVD). Endovascular interventional therapy including drug-coated balloon (DEB) angioplasty or percutaneous transluminal angioplasty (PTA) and stenting are important options for treatment of PVD. Aims and Objectives The main objective is to compare the efficacy of DEB over PTA with optional stenting in management of obstructive femoropopliteal lesions in terms of 6-month patency rate. Materials and Methods The clinical experimental study was carried out in a tertiary care center over duration of 2 years. All symptomatic patients having lower limb PVD in femoropopliteal segment were included. Total 37 patients were included in this study in which 16 underwent plain balloon angioplasty (with 3 patients undergoing bare metal stenting [BMS]) and 21 additional underwent DEB angioplasty. Patients with previously intervened lesions, primary lesion failure, major ischemic tissue loss, poor aortoiliac or common femoral inflow, or end-stage kidney disorders were excluded. Result At 1-month follow-up, patency rates in DEB and conventional PTA ± BMS were 85.71% and 87.5%, respectively. On 6-month follow-up, patency rates were found to be 71.4% versus 37.5%, respectively (p = 0.039; significant). In case of occluded lesions, on 6-month follow-up, patency rate in DEB group was higher than that in plain balloon group (66.7% vs. 25%). In both the cohorts, success rate, i.e., patency rates were more in short and intermediate length lesions than long segment lesions. DEB was found to be superior to plain angioplasty with optional stenting in terms of 6-month patency rate.

Benefit and Risk from Paclitaxel-Coated Balloon Angioplasty for the Treatment of Femoropopliteal Artery Disease: A Systematic Review and Meta-Analysis of Randomised Controlled Trials

Background: Paclitaxel-coated balloons (DCB) are suitable to reduce the risk of restenosis after angioplasty of atherosclerotic femoropopliteal lesions. However, numerous types of DCBs are distinguished by drug density and coating. Conflicting evidence exists about the risk of all-cause death. Methods: Randomised trials published between Jan 1, 2005 and Feb 3, 2019 were identified by searching MEDLINE, CENTRAL, and Clinical.trials.gov. Studies on DCB versus plain old balloon angioplasty (POBA) for the treatment of femoropopliteal artery disease were included, and those focused on in-stent restenosis or critical limb ischemia were excluded. Random-effects meta-analysis was conducted to assess the main outcomes of freedom from target lesion revascularisation (FfTLR) and all-cause mortality. Findings: Of 552 identified records, 14 studies including 2504 patients were eligible. DCB significantly increased the probability of FfTLR with substantial heterogeneity (12-month: risk ratio [RR] 1·24 [95% CI 1·14- 2·27], I2 = 66%; 24-month RR 1·39 [95% CI 1·39-1·52], I2 = 21%). The risk of all-cause mortality was similar between groups at 12 months (RR 0·87 [95% CI 0·48-1·59]), and non-significantly increased after DCB angioplasty at 24 months (RR 1·53 [95% CI 0·94-2·50]). Interpretation: Efficacy of DCB for femoropopliteal angioplasty differs substantial across studies. Effect size depends on the type of DCB, treatment strategy, and lesion complexity. The risk of all-cause death at two years tended to be increased after DCB without evidence of causation. Trial Registration Number: This study is registered with ClinicalTrials.gov (NCT02927574). Funding Statement: The authors stated: There was no funding source for this study. Declaration of Interests: All authors declare no competing interests. Ethics Approval Statement: This systematic review and meta-analysis was conducted according to the Preferred Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines.