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Smaller Superficial Femoral Artery is associated with Worse Outcomes after Percutaneous Transluminal Angioplasty for De Novo Atherosclerotic Disease

Chang, Heepeel; Veith, Frank J; Rockman, Caron B; Cayne, Neal S; Babaev, Anvar; Jacobowitz, Glenn R; Ramkhelawon, Bhama; Patel, Virendra I; Garg, Karan
BACKGROUND:With the exponential increase in the use of endovascular techniques in the treatment of peripheral artery disease, our understanding of factors that affect intervention failures continues to grow. We sought to assess the outcomes of percutaneous transluminal angioplasty for isolated de novo superficial femoral artery (SFA) disease based on balloon diameter. METHODS:The Vascular Quality Initiative database was queried for patients undergoing percutaneous balloon angioplasty for isolated de novo atherosclerotic SFA disease. Based on the diameter of the angioplasty balloon as a surrogate measure of arterial diameter, patients were stratified into two groups: group 1, balloon diameter < 5 mm (354 patients) and group 2, balloon diameter ≥ 5 mm (1,550 patients). The primary patency and major adverse limb event (MALE) were estimated by the Kaplan-Meier method and compared with the log-rank test, based on vessel diameter. multivariable Cox regression analysis was used to determine factors associated with the primary patency. RESULTS:From January 2010 through December 2018, a total of 1,904 patients met criteria for analysis, with a mean follow-up of 13.3 ± 4.5 months. The mean balloon diameters were 3.92 ± 0.26 mm and 5.47 ± 0.55 mm in group 1 and 2, respectively (P<.001). The mean length of treatment and distribution of TASC lesions were not statistically different between the groups. Primary patency at 18 months was significantly lower in group 1, compared with group 2 (55% vs 67%; log-rank P<.001). The MALE rate was higher in group 1 than group 2 (33% vs 26%; log-rank P<.001). Among patients with claudication, there was no significant difference in the primary patency (61% vs 68%; log-rank P=.073) and MALE (27% vs 22%; log-rank P=.176) at 18 months between groups 1 and 2, respectively. However, in patients with CLTI, group 1 had significantly lower 18-month primary patency (47% vs 64%; log-rank P<.014) and higher MALE rates (41% vs 35%; log-rank P=.012) than group 2. Cox proportional hazard analysis confirmed that balloon diameter < 5 mm was independently associated with increased risks of primary patency loss (HR 1.35; 95% CI, 1.04-1.72; P=.021) and MALE (HR 1.29; 95% CI, 1-1.67; P=.048) at 18-months. CONCLUSIONS:In patients undergoing isolated SFA balloon angioplasty for CLTI, smaller SFA (< 5mm) was associated with worse primary patency and MALE. Using balloon size as a surrogate, our findings suggest that patients with a smaller SFA diameter appear to be at increased risk for treatment failure and warrant closer surveillance. Furthermore, these patients may also be considered for alternative approaches, including open revascularization.
PMID: 33838233
ISSN: 1615-5947
CID: 4845472

Two-Year Efficacy and Safety Results from the IMPERIAL Randomized Study of the Eluvia Polymer-Coated Drug-Eluting Stent and the Zilver PTX Polymer-free Drug-Coated Stent

Müller-Hülsbeck, Stefan; Benko, Andrew; Soga, Yoshimitsu; Fujihara, Masahiko; Iida, Osamu; Babaev, Anvar; O'Connor, David; Zeller, Thomas; Dulas, Daniel D; Diaz-Cartelle, Juan; Gray, William A
PURPOSE/OBJECTIVE:To report additional endpoints, including 2-year primary patency, patient outcomes, and safety results, as well as the initial assessment of hypoechogenic halo from the IMPERIAL Randomized Controlled Trial (RCT). MATERIALS AND METHODS/METHODS:IMPERIAL RCT is a prospective, randomized (2:1), multicenter study of patients with symptomatic femoropopliteal artery lesions (length 30-140 mm, Rutherford category 2-4) treated with the Eluvia paclitaxel-eluting nitinol stent or the Zilver PTX paclitaxel-coated stent. Two-year follow-up included patency, safety, and mortality assessments and core laboratory-reviewed B-mode ultrasound imaging to screen for hypoechogenic halo in the stented segment, and assess blood flow. RESULTS:At 24 months, all-cause mortality was 7.1% (21/295) for Eluvia and 8.3% (12/145) for Zilver PTX (P = 0.6649). The clinically driven target lesion revascularization rate was significantly less for patients treated with Eluvia vs Zilver PTX (12.7% vs 20.1%; P = 0.0495). The Kaplan-Meier estimate of primary patency at 24 months was 83.0% for Eluvia and 77.1% for Zilver PTX (log rank P = 0.1008). Transverse ultrasound imaging was implemented during the 24-month follow-up window and was evaluable for 27.5% (128/465) of patients. Hypoechogenic halo prevalence rates did not differ significantly between Eluvia and Zilver PTX study arms (33.7% [29/86] vs 21.4% [9/42]; P = 0.153). In no case was flow documented within the halo; no adverse events were associated with these ultrasound findings. CONCLUSION/CONCLUSIONS:Two-year follow-up suggests a sustained advantage for Eluvia for avoiding target lesion revascularization. Initial hypoechogenic halo assessment showed no difference in prevalence between the study arms, no flow within the halo, and no associated adverse events. CLINICAL TRIAL REGISTRATION/BACKGROUND:clinicaltrials.gov identifier NCT02574481. Date of registration: October 14, 2015. LEVEL OF EVIDENCE/METHODS:Level 1; randomized controlled trial.
PMID: 33225377
ISSN: 1432-086x
CID: 4680262

Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent

Golzar, Jaafer; Soga, Yoshimitsu; Babaev, Anvar; Iida, Osamu; Kawasaki, Daizo; Bachinsky, William; Park, James; Prem, Jeffery T; Vermassen, Frank; Diaz-Cartelle, Juan; Müller-Hülsbeck, Stefan; Gray, William A
Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy (ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent.
PMID: 31989856
ISSN: 1545-1550
CID: 4294042

Bivalirudin versus heparin in patients undergoing percutaneous peripheral interventions: A systematic review and meta-analysis

Olmedo, Wilman; Villablanca, Pedro A; Sanina, Cristina; Walker, Jonathan; Weinreich, Michael; Brevik, Jeannine; Avendano, Ricardo; Bravo, Claudio A; Romero, Jorge; Ramakrishna, Harish; Babaev, Anvar; Attubato, Michael; Hernandez-Suarez, D F; Cox-Alomar, P; Pyo, Robert; Krishnan, Prakash; Wiley, Jose
BACKGROUND:Bivalirudin may be an effective alternative anticoagulant to heparin for use in percutaneous peripheral interventions. We aimed to compare the safety and efficacy of bivalirudin versus heparin as the procedural anticoagulant agent in patients undergoing percutaneous peripheral intervention. METHODS:For this meta-analysis and systematic review, we conducted a search in PubMed, Medline, Embase, and Cochrane for all the clinical studies in which bivalirudin was compared to heparin as the procedural anticoagulant in percutaneous peripheral interventions. Outcomes studied included all-cause mortality, all-bleeding, major and minor bleeding, and access site complications. RESULTS:Eleven studies were included in the analysis, totaling 20,137 patients. There was a significant difference favoring bivalirudin over heparin for all-cause mortality (risk ratio 0.58, 95% CI 0.39-0.87), all-bleeding (risk ratio 0.62, 95% CI 0.50-0.78), major bleeding (risk ratio 0.61, 95% CI 0.39-0.96), minor bleeding (risk ratio 0.66, 95% CI 0.47-0.92), and access site complications (risk ratio 0.66, 95% CI 0.51-0.84). There was no significant difference in peri-procedural need for blood transfusions (risk ratio 0.79, 95% CI 0.57-1.08), myocardial infarction (risk ratio 0.87, 95% CI 0.59-1.28), stroke (risk ratio 0.77, 95% CI 0.59-1.01), intracranial bleeding (risk ratio 0.77, 95% CI 0.29-2.02), or amputations (OR 0.75, 95% CI 0.53-1.05). CONCLUSION/CONCLUSIONS:Our meta-analysis suggests that bivalirudin use for percutaneous peripheral interventions is associated with lower all-cause mortality, bleeding, and access site complications as compared to heparin. Further large randomized trials are needed to confirm the current results.
PMID: 30501582
ISSN: 1708-539x
CID: 3520432

A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial

Gray, William A; Keirse, Koen; Soga, Yoshimitsu; Benko, Andrew; Babaev, Anvar; Yokoi, Yoshiaki; Schroeder, Henrik; Prem, Jeffery T; Holden, Andrew; Popma, Jeffrey; Jaff, Michael R; Diaz-Cartelle, Juan; Müller-Hülsbeck, Stefan
BACKGROUND:The clinical effect of a drug-eluting stent in the femoropopliteal segment has not been investigated in a randomised trial with a contemporary comparator. The IMPERIAL study sought to compare the safety and efficacy of the polymer-coated, paclitaxel-eluting Eluvia stent with the polymer-free, paclitaxel-coated Zilver PTX stent for treatment of femoropopliteal artery segment lesions. METHODS:In this randomised, single-blind, non-inferiority study, patients with symptomatic lower-limb ischaemia manifesting as claudication (Rutherford category 2, 3, or 4) with atherosclerotic lesions in the native superficial femoral artery or proximal popliteal artery were enrolled at 65 centres in Austria, Belgium, Canada, Germany, Japan, New Zealand, and the USA. Patients were randomly assigned (2:1) with a site-specific, web-based randomisation schedule to receive treatment with Eluvia or Zilver PTX. All patients, site personnel, and investigators were masked to treatment assignment until all patients had completed 12 months of follow-up. The primary efficacy endpoint was primary patency (defined as a peak systolic velocity ratio ≤2·4, without clinically driven target lesion revascularisation or bypass of the target lesion) and the primary safety endpoint was major adverse events (ie, all causes of death through 1 month, major amputation of target limb through 12 months, and target lesion revascularisation through 12 months). We set a non-inferiority margin of -10% at 12 months. Primary non-inferiority analyses were done when the minimum sample size required for adequate statistical power had completed 12 months of follow-up. The primary safety non-inferiority analysis included all patients who had completed 12 months of follow-up or had a major adverse event through 12 months. This trial is registered with ClinicalTrials.gov, number NCT02574481. FINDINGS/RESULTS:Between Dec 2, 2015, and Feb 15, 2017, 465 patients were randomly assigned to Eluvia (n=309) or to Zilver PTX (n=156). Non-inferiority was shown for both efficacy and safety endpoints at 12 months: primary patency was 86·8% (231/266) in the Eluvia group and 81·5% (106/130) in the Zilver PTX group (difference 5·3% [one-sided lower bound of 95% CI -0·66]; p<0·0001). 259 (94·9%) of 273 patients in the Eluvia group and 121 (91·0%) of 133 patients in the Zilver PTX group had not had a major adverse event at 12 months (difference 3·9% [one-sided lower bound of 95% CI -0·46]; p<0.0001). No deaths were reported in either group. One patient in the Eluvia group had a major amputation and 13 patients in each group required target lesion revascularisation. INTERPRETATION/CONCLUSIONS:The Eluvia stent was non-inferior to the Zilver PTX stent in terms of primary patency and major adverse events at 12 months after treatment of patients for femoropopliteal peripheral artery disease. FUNDING/BACKGROUND:Boston Scientific.
PMID: 30262332
ISSN: 1474-547x
CID: 3314492

A single-center retrospective analysis of patency rates of intraluminal versus subintimal endovascular revascularization of long femoropopliteal occlusions

Babaev, Anvar; Hari, Pawan; Gokhale, Rohit; Zavlunova, Susanna
OBJECTIVE:The evaluation of patency rates of intraluminal versus subintimal endovascular revascularization of long femoropopliteal (FP) lesions. BACKGROUND:Chronic total occlusions (CTO) of the FP artery in peripheral interventions are crossed either with a support catheter-guidewire based technique or subintimal dissection and re-entry device assisted approach. Both techniques have a high procedural success rate, but their long term patency is not well studied. There is also lack of comparative data addressing the patency of long non-CTO vs. CTO occlusions. METHODS:We performed a single center retrospective analysis, studying the patency rates in 215 patients (254 limbs) with TASC C and D FP lesions treated with stents. There were 3 patient groups: without CTO (non-CTO); CTO crossed using support catheter and guide-wire (CTO-SW) and CTO crossed with a re-entry device (CTO-RE). RESULTS:There were 155 limbs in CTO-SW group; 50 in CTO-RE group and 49 in non-CTO. Lesion length (mean±SD) was 251.81±7.48mm in CTO-SW group; 280±13.18mm in CTO-RE group and 248.77±13.31 in non-CTO group (p=non-significant). In-stent restenosis (ISR) at a mean follow-up of 19.26±16.14months did not differ between groups occurring in 23 (47%) limbs in non-CTO; 66 (42%) in CTO-SW; and 24 (48%) in CTO-RE. Smoking and stent fracture were predictors of ISR by multivariate analysis. CONCLUSION/CONCLUSIONS:In patients with long FP lesions, ISR rates were similar between patients with and without CTO. In the CTO group mid-term vessel patency was not affected by the crossing technique utilized.
PMID: 28347605
ISSN: 1878-0938
CID: 3081292

Relationship between neutrophil-lymphocyte ratio and severity of lower extremity peripheral artery disease

Teperman, Jacob; Carruthers, David; Guo, Yu; Barnett, Mallory P; Harris, Adam A; Sedlis, Steven P; Pillinger, Michael; Babaev, Anvar; Staniloae, Cezar; Attubato, Michael; Shah, Binita
BACKGROUND: The aim of this study was to determine the association between neutrophil-lymphocyte ratio (NLR) and severity of lower extremity peripheral artery disease (PAD). METHODS: A retrospective chart review identified 928 patients referred for peripheral angiography. NLR was assessed from routine pre-procedural hemograms with automated differentials and available in 733 patients. Outcomes of interest were extent of disease on peripheral angiography and target vessel revascularization. Median follow-up was 10.4months. Odds ratio (OR) [95% confidence intervals] was assessed using a logistic regression model. RESULTS: There was a significant association between elevated NLR and presence of severe multi-level PAD versus isolated suprapopliteal or isolated infrapopliteal disease (OR 1.11 [1.03-1.19], p=0.007). This association remained significant even after adjustment for age (OR 1.09 [1.01-1.17], p=0.02); age, sex, race, and body mass index (OR 1.08 [1.00-1.16], p=0.046); and age, sex, race, body mass index, hypertension, diabetes mellitus, coronary artery disease, and creatinine (OR 1.07 [1.00-1.15], p=0.049). After additional adjustment for clinical presentation, there was a trend towards association between NLR and severe multi-level PAD (OR 1.07 [1.00-1.15], p=0.056), likely limited by sample size. In patients who underwent endovascular intervention (n=523), there was no significant difference in rate of target vessel revascularization across tertiles of NLR (1st tertile 14.8%, 2nd tertile 14.1%, 3rd tertile 20.1%; p=0.32). CONCLUSION: In a contemporary cohort of patients undergoing peripheral angiography with possible endovascular intervention, elevated NLR was independently associated with severe multi-level PAD. Larger studies evaluating the association between this inexpensive biomarker and clinical outcomes are warranted.
PMID: 27865186
ISSN: 1874-1754
CID: 2311112

Minimal Medial Injury After Orbital Atherectomy: An Intravascular Ultrasound Analysis

Krishnan, Prakash; Martinsen, Brad J; Tarricone, Arthur; Babaev, Anvar; Maehara, Akiko
PMCID:5302080
PMID: 27864454
ISSN: 1545-1550
CID: 2311102

Treatment of Angio-Seal-Related Femoral Artery Occlusion Using Directional Atherectomy-Primary Results and Midterm Follow-Up

Babaev, Anvar; Gokhale, Rohit; Zavlunova, Susanna; Attubato, Michael
OBJECTIVE: We describe a novel approach for the endovascular treatment of femoral artery occlusion as a result of Angio-Seal closure device deployment. BACKGROUND: Angio-Seal is the most commonly used vascular closure device following percutaneous coronary and peripheral catheterizations worldwide. A rare complication of Angio-Seal deployment is an occlusion of the femoral artery leading to limb ischemia requiring revascularization. Given its unique ability to cut both atherosclerotic plaque and the Angio-Seal anchor with a collagen plug at operator-directed planes, TurboHawk/HawkOne atherectomy device can be a fast and effective approach to treat Angio-Seal-associated femoral artery occlusions. METHODS: We studied 13 consecutive patients who developed Angio-Seal-associated femoral artery occlusions that occurred from 3 hours to several weeks after catheterization. These patients were successfully treated with TurboHawk/HawkOne directional atherectomy followed by balloon angioplasty with no complications. During a mean follow-up period of 20.4 +/- 17.3 months, 12 patients remained claudication free with no evidence of obstructive arterial disease of the treated segment on imaging studies. One patient developed restenosis that was treated with repeat atherectomy and balloon angioplasty following which he was asymptomatic at follow-up. CONCLUSION: The use of directional atherectomy followed by balloon angioplasty is a quick, safe, and effective endovascular approach to treating Angio-Seal-associated femoral artery occlusions. It is associated with an excellent success rate, no complications, and good midterm outcomes.
PMID: 27852881
ISSN: 1938-9116
CID: 2431172

Relationship between neutrophil-lymphocyte ratio and severity of lower extremity peripheral artery disease in patients undergoing peripheral angiography [Meeting Abstract]

Teperman, J; Barnett, M P; Carruthers, D; Pillinger, M; Sedlis, S P; Babaev, A; Attubato, M; Staniloae, C S; Shah, B
Background: Unlike for coronary artery disease, the association between neutrophil-lymphocyte ratio (NLR) and peripheral artery disease (PAD) has not been well established. The aim of this study was to determine the association between neutrophil-lymphocyte ratio and the severity of lower extremity peripheral artery disease. Methods: A retrospective chart review analysis identified 928 patients referred for peripheral angiography at a tertiary care center between December 2012 and June 2015. NLR was assessed from routine pre-procedural hemograms with automated differentials and available in 733 (79%) patients. Outcomes of interest included extent of disease on peripheral angiography and target vessel revascularization. Median follow-up was 10.4 months. Odds ratio (OR) [95% confidence intervals] was assessed using a logistic regression model. Results: There was a significant association between elevated NLR and the presence of severe multi-level PAD versus isolated suprapopliteal or isolated infrapopliteal disease (OR 1.42 [1.18-1.70], p=<0.001). This association between NLR and severe multi-level PAD remained significant even after adjustment for age (OR 1.31 [1.09-1.58], p=0.004); age, sex, race, and body mass index (OR 1.27 [1.05-1.5], p=0.015); and age, sex, race, body mass index, hypertension, diabetes, coronary artery disease, and creatinine (OR 1.25 [1.03-1.53], p=0.024). In patients who underwent endovascular intervention (n=523), there was no significant difference in the rate of target vessel revascularization on follow-up across tertiles of NLR (1st tertile 14.8%, 2nd tertile 14.1%, 3rd tertile 20.1%; p= 0.32). Conclusion: In a contemporary cohort of patients undergoing peripheral angiography with possible endovascular intervention, elevated NLR was independently associated with severe multi-level PAD
EMBASE:72281982
ISSN: 1522-726x
CID: 2151582