Post hoc analysis of the SuperB and Zilverpass trials for treatment of long and complex superficial femoral artery lesions.

OBJECTIVE: In two randomized controlled trials, the outcomes of endovascular treatment of complex femoropopliteal arterial lesions were compared with bypass surgery and considered a valid alternative treatment. The aim of this study was to compare both endovascular treatment options with the hypothesis that implantation of heparin-bonded self-expanding covered stents (Viabahn [SECS]) or drug-eluting stents (ZilverPTX [DES]) are related to similar clinical outcomes at 1-year follow-up. METHODS: In a post-hoc analysis, the SuperB trial and Zilverpass databases were merged. Patients in the endovascular treatment arms were included, and data was analyzed in an intention-to-treat (ITT) and a per-protocol (PP) fashion. Data included baseline and lesion characteristics, procedural details, and follow-up data. The primary endpoint of this study was primary patency at 1-year follow-up. The secondary endpoints were secondary patency, target lesion revascularization (TLR), limb loss, and all-cause mortality. RESULTS: A total of 176 patients were included; 63 in the SECS arm and 113 in the DES arm. Through 1-year follow-up, there were no significant differences in primary patency (ITT: 63.4% vs 71.1%: P = .183 and PP: 60.8% vs 71.1%; P = .100). Secondary patency rates were not significantly different in the ITT analysis (86.5% vs 95.1%; P = .054), but in the PP analysis, there was a significant difference in favor of the DES group (SECS, 85.6% vs DES, 95.1%; P = .038). There was no significant difference in freedom from TLR between groups (79.6% vs 77.0%; P = .481). No major amputations were performed in the SECS group, and two were performed in the DES group (1.8%). Survival rate was 98.2% in the SECS group, and 91.3% in the DES group after 1-year follow-up (P = .106). Based on diagnosis (intermittent claudication vs chronic limb-threatening ischemia) no differences between patients with intermittent claudication and chronic limb-threatening ischemia were observed in primary patency, secondary patency and freedom from TLR. CONCLUSIONS: Treatment of complex femoropopliteal arterial disease with the heparin-bonded Viabahn endoprosthesis and the Zilver PTX drug-eluting stent are related to similar primary and secondary patency, and TLR rates at 1 year, except for secondary patency in the PP analysis. This study further supports the endovascular treatment of long complex lesions in the femoropopliteal artery.

The BioMimics 3D Helical Centreline Nitinol Stent in Chronic Limb Threatening Ischaemia and Complex Lesions: Three Year Outcomes of the MIMICS-3D Registry.

OBJECTIVE: There is a need for improved outcomes in the endovascular treatment of patients suffering from chronic limb threatening ischaemia (CLTI), highly calcified lesions, and chronic total occlusions (CTOs). The helical centreline self expanding BioMimics 3D stent might be particularly useful in these high risk subsets, combining flexibility and fracture resistance with radial strength. Herein, the performance of the BioMimics 3D stent was assessed in these high risk subsets. METHODS: MIMICS-3D is a prospective, multicentre, European real world registry. This was a post hoc analysis, comparing patients with CLTI vs. intermittent claudication (IC), lesions with bilateral calcification vs. those without (peripheral arterial calcium scoring system [PACSS] 3,4 vs. PACSS 0 - 2), and CTO vs. no CTO. Propensity score matching was performed to reduce the impact of baseline variables. The 36 month endpoints were clinically driven target lesion revascularisation (CD-TLR), death, major target limb amputation, and stent patency. RESULTS: A total of 507 patients were enrolled. At 36 months, patients with CLTI had lower freedom from major amputation than patients with IC (92.6% vs. 100%, p < .001). In terms of primary patency, patients with CTO had lower patency rates than those without (63.9% vs. 77.8%, p = .003), but the difference reduced after propensity score matching (70.5% vs. 76.8%, p = .43). Primary patency was not impaired for patients with PACSS 3,4 or patients with CLTI. Freedom from CD-TLR was not significantly different among the groups and was 73.8% for CLTI vs. 78.9% for IC (p = .15), 77.6% for PACSS 3,4 vs. 78.7% for PACSS 0 - 2 (p = .55), and 75.6% for CTO vs. 81.0% for no CTO (p = .11). CONCLUSIONS: The outcome of the MIMICS-3D registry suggests that the BioMimics 3D stent is effective in the endovascular treatment of complex femoropopliteal lesions and in CLTI. Future randomised controlled trials should confirm its non-inferiority or superiority compared with existing alternatives.

Thyroglossal Duct Cyst Mimicking a Hygroma Colli - An Unusual Presentation.

A thyroglossal duct cyst (TGDC) is the result of incomplete degeneration of the thyroglossal duct during gestation. It is the most common type of congenital cyst of the neck, and is usually seen in children. The tumor mostly appears at the midline of the neck and generally causes no symptoms, but the mass typically moves when the patient swallows. We present the unusual case of a 50-year-old man with a large cervical mass lateralized on the right side of the neck. There was no association between swallowing and movement of the mass. Clinical examination and computed tomography (CT) suggested a lymphangioma or cystic hygroma. Surgical resection showed a large cyst of 71 x 40 x 52 mm with no attachment to the hyoid bone and no invasion in blood vessels or other surrounding tissue. Histopathological investigation led to a diagnosis of TGDC.

Combining the Passeo-18 Lux Drug-Coated Balloon and the Pulsar-18 Bare Metal Stent: 12- and 24-Month Outcomes of the BIOLUX 4EVER Investigator-Initiated Trial.

PURPOSE: To report the outcomes after treating stenotic or occluded femoropopliteal lesions with a drug-coated balloon (DCB) followed by the implantation of a thin-strut self-expanding bare metal stent in the BIOLUX 4EVER trial (ClinicalTrials.gov identifier NCT02211664). MATERIALS AND METHODS: The prospective, multicenter, physician-initiated BIOLUX 4-EVER trial was conducted at 5 centers in Belgium and enrolled 120 patients (mean age 70.9±10.5 years; 79 men) with symptomatic stenotic or occluded de novo femoropopliteal lesions. A fifth of the patients had diabetes mellitus and nearly half had previous peripheral artery interventions. The lesions were a mean 83.3±49.5 mm long with a mean reference vessel diameter of 5.26±0.59 mm. Lesions were treated with a Passeo-18 Lux DCB followed by the implantation of a Pulsar-18 bare metal stent. Follow-up visits were conducted at 1, 6, 12, and 24 months postprocedure; the main outcome was primary patency at 12 months. RESULTS: Technical success was obtained in all patients. Primary patency was observed in 89.9% of patients (95% CI 84.0% to 95.8%) at 12 months and in 83.5% at 24 months (95% CI 89.9% to 97.3%), and freedom from target lesion revascularization was 93.6% (95% CI 89.9% to 97.3%) and 86.1% (95% CI 79.9% to 92.3%), respectively. Ten patients died throughout the course of the trial (90.7% survival at 24 months), all of noncardiovascular causes. The ankle-brachial index improved from 0.68±0.09 at baseline to 0.93±0.11 and 0.93±0.12 at 12- and 24-month follow-up visits (p<0.001). An improvement of at least 1 Rutherford category was observed in 91 of 94 patients (96.8%) at 12 months and 78 of 83 patients (93.4%) at 24 months (p<0.001). CONCLUSION: The combination of a Passeo-18 Lux DCB followed by a Pulsar-18 stent implantation produced safe and effective outcomes in the treatment of femoropopliteal lesions at up to 24 months. Adding paclitaxel to the bare nitinol stent platform by predilating with a Passeo-18 Lux DCB seems to increase efficacy at 1 and 2 years compared with the use of bare metal stents only, which were investigated in the precursor 4-EVER study.

ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions.

Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. Results: The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). Conclusion: With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.

Multivariable Analysis of Patients With Severe Persistent Postprocedural Hypotension After Carotid Artery Stenting.

Purpose: To assess the incidence and predictors of severe, persistent postprocedural hypotension (PPH) after carotid artery stenting (CAS). Materials and Methods: A total of 146 patients (mean age 72.8 years; 104 men) who underwent 160 CAS procedures using a standardized protocol at 3 vascular centers were retrospectively analyzed. The primary endpoint was postprocedural hypotension, defined as a reduction in systolic blood pressure (SBP) >40 mm Hg from baseline or an SBP of <90 mm Hg sustained for >1 hour after CAS. Potential prognostic factors for postprocedural hypotension were identified and subjected to logistic regression analyses; outcomes are presented as the odds ratios (ORs) with 95% confidence intervals (CIs). Results: PPH developed in 36 (24.7%) patients after 37 (23.1%) CAS procedures. These patients had significantly longer intensive care unit and hospital stays than those who did not develop hypotension (p<0.001). PPH was associated with severe lesion calcification (OR 6.28, 95% CI 1.81 to 21.98, p=0.004) and contrast volume (OR 1.02, 95% CI 1.01 to 1.02, p<0.001). A 4-fold increase in the risk of PPH (OR 4.22, 95% CI 1.38 to 13.33, p=0.012) was found between the embolic protection device most associated with PPH (Angioguard) and the device least associated with PPH (Emboshield NAV6). A similar trend was also observed for the Precise vs Xact stents (OR 6, 95% CI 2.08 to 17.6, p=0.001). Bootstrapped multivariable modeling identified the Precise stent and contrast volume as significant predictors of persistent postprocedural hypotension. Further investigation of the contrast volume revealed associations with sex, severe calcification, arch type, previous coronary artery bypass surgery, and primary stenting, suggesting that the contrast volume reflects the complexity of the procedure. Conclusion: The complexity of the procedure and type of stent may play a role in the development of postprocedural hypotension after CAS.

Endovascular Treatment of No-Stent Zones Quo Vadis?

Endovascular treatment of peripheral artery disease has recently become more important due to its minimally invasive nature. Elderly patients as well as fragile patients, like diabetics and those with end-stage renal disease, can benefit from this low-morbidity/-mortality treatment. Very successful results have been achieved with percutaneous balloon angioplasty and stenting in the superficial femoral and iliac arteries. In some areas, however, such as the common femoral artery and the popliteal artery, vascular physicians remain somewhat reluctant to use endovascular strategies. Common femoral endarterectomy, the most often used technique for treatment of common femoral artery lesions, has shown very good long-term results, but is associated with relatively high complication rates, such as superficial and deep wound problems and lymph leakage. This article describes less-invasive endovascular alternatives, such as atherectomy, drug-coated balloons and stenting, and their results. The popliteal artery is also difficult to treat in an endovascular manner due to biomechanical forces during bending and stretching of the knee or leg. Thus, we also describe currently available minimally invasive treatment options for the popliteal artery.

One-Year Outcomes of the Paclitaxel-Eluting, Self-Expanding Stentys Stent System in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia.

PURPOSE: To investigate the efficacy of the paclitaxel-coated, self-expanding, nitinol Stentys Stent System in tibioperoneal lesions ≤50 mm long. METHODS: The prospective, single-arm, multicenter PES-BTK-70 trial ( ClinicalTrials.gov identifier NCT01630070) evaluated the safety and efficacy of the coronary Stentys Stent System in the treatment of a stenotic or occlusive lesion ≤50 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). Between January 2012 and May 2013, 70 patients (mean age 74.6±9.4 years; 45 men) with CLI [Rutherford category 4 (37, 52.9%) or 5 (33, 47.1%)] received a Stentys drug-eluting stent for the treatment of infrapopliteal stenosis (60, 85.7%) or occlusion (10, 14.3%). The mean lesion length was 17.2 mm (4.0-58.5). The primary outcome measures were primary patency at 6 months (duplex ultrasound) and 12 months (angiography). Secondary outcomes included limb salvage and freedom from target lesion revascularization (TLR). Kaplan-Meier estimates of the outcomes are given with the 95% confidence intervals (CI). RESULTS: Technical and procedure success (<30% residual stenosis without major complications) was achieved in 68 (97.1%) of 70 cases. Primary patency was 87.6% (95% CI 83.5% to 91.7%) at 6 months and 72.6% (95% CI 66.9% to 78.3%) at 1 year. Freedom from TLR was 79.1% at 1 year (95% CI 73.9% to 84.3) and limb salvage was 98.5% (95% CI 97.0 to 100.0). No stent fractures were found by core laboratory review of all follow-up imaging data available up to 12 months. CONCLUSION: In this study, the self-expanding, nitinol, paclitaxel-eluting, coronary Stentys stent was found to be safe and effective in the below-the-knee region, with results similar to the most recent limus-eluting stent trials.

AbsorbaSeal™ Vascular Closure Device: A Novel Device for Hemostasis Following Interventional Peripheral Vascular Procedures.

INTRODUCTION: Vascular closure devices (VCDs) are designed to achieve rapid hemostasis during percutaneous coronary and peripheral vascular procedures. Studies demonstrate that VCDs improve time to hemostasis (TTH) and time to ambulation (TTA) in comparison to standard manual compression. The available products, however, typically have 13-17 steps in their application, often require hemostatic collagen or other agents as part of the process, and can result in significant scarring at the puncture site that can impact future access. The aim of this study was to investigate the performance of a three-step, novel VCD for access site TTH, short-term and long-term histology, and a first-in-man clinical study. MATERIALS AND METHODS: This study evaluated AbsorbaSeal™ (CyndRx, LLC, Brentwood, Tennessee), a simple, three-step, VCD with bio-absorbable components. Following an institutional review board (IRB) approval, a 6-F sheath was placed directly into the porcine aorta, AbsorbaSeal™ was used to seal the puncture site, and a measure of total time of deployment (TTD) and TTH was performed, as well as histologic evaluation at 30, 60, and 180 days. A complement activation test was performed to determine the potential for activation of the complement system as a mediator of inflammation. The test was performed by directly incubating the VCDs AbsorbaSeal™ and Angio-Seal™ (Terumo Interventional Systems, Tokyo, Japan) in human serum. Serum samples were removed after 30, 60, and 90 minutes and tested for the presence and amount of complement protein SC5b-9. In the first in-man trial, the device was deployed in anticoagulated patients undergoing interventional vascular procedures. The TTH, estimated blood loss, patient pain scores, and procedural and follow-up complications were recorded. RESULTS: In the acute and chronic porcine studies, TTD averaged 25 seconds (17-29 seconds). Vascular control was immediate, yielding a TTH of effectively zero seconds. Histologic evaluation demonstrated complete endothelial coverage of the device by 30 days without evidence of bleeding, clotting, or inflammation. At 60 days, the significant mass of the device had dissolved and normal appearing collagen surrounded the devices with essentially no inflammatory response. By six months, all but one microscopic segment of one of the devices had been absorbed with normal appearing vascular endothelium, and no, or minimal, scarring appreciated. The complement test demonstrated that the AbsorbaSeal™ had similar, or lower, complement concentrations than the negative controls and significantly less than Angio-Seal™. This supported the histologic findings of minimal to no inflammation. The VCD was deployed in 20 patients undergoing interventional vascular procedures. The mean TTH was 2.3 ± 1.5 minutes. Estimated blood loss was 11.7 mL ± 3.5 mL, and no significant hematoma was noted. Post-procedure pain scores were low, with a mean of 1.4 ± 0.8 on a 0-10 pain rating scale. There were no perioperative complications and no adverse events at follow-up. CONCLUSIONS: The AbsorbaSeal™ is safe and simple to use for vascular closure after interventional vascular procedures with favorable outcomes including a short TTH, minimal procedural blood loss, low postoperative pain scores, and no perioperative complications or adverse effects. Histologic evaluation reveals rapid device absorption and little scar formation both short- and long-term. A direct study of complement activation supports that AbsorbaSeal™ evokes a minimal inflammatory response that is significantly less than Angioseal.

Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial.

PURPOSE: To evaluate the short- and midterm outcomes of the Viabahn endoprosthesis with Propaten Bioactive Surface vs. standard balloon angioplasty for treatment of in-stent restenosis in the superficial femoral artery. METHODS: Between June 2010 and February 2012, 83 patients with superficial femoral artery in-stent and Rutherford category 2 to 5 ischemia were enrolled at 7 sites participating in this prospective randomized controlled study (RELINE; ClinicalTrials.gov; identifier NCT01108861). The patients were randomized to treatment with either the heparin-bonded Viabahn endoprosthesis (n = 39: 29 men; mean age 67.7 ± 9.8 years) or a standard angioplasty balloon (n = 44: 32 men; mean age 69.0 ± 9.7 years). The primary effectiveness outcome was primary patency at 12 months, defined as no restenosis/occlusion within the target lesion based on duplex ultrasound and no target lesion revascularization. The primary safety endpoint was the incidence of serious device-related adverse events within 30 days of the procedure. RESULTS: All patients randomized to receive dilation or the Viabahn stent-graft were treated according to their assignment. The technical success was 100% for the Viabahn group and 81.8% for the angioplasty group (p = 0.002) owing to 9 patients requiring a bailout procedure after unsuccessful angioplasty. The 12-month primary patency rates were 74.8% for the Viabahn group and 28.0% for the angioplasty group (p < 0.001). Excluding the 9 angioplasty patients who received bailout stenting, the primary patency for optimal balloon angioplasty was 37.0% (p < 0.001). Three patients experienced device-related adverse events within 30 days: occlusion of the target lesion (Viabahn group), peripheral embolization (angioplasty group), and reocclusion of the target lesion (angioplasty group). CONCLUSION: In this study, the treatment of femoropopliteal in-stent restenosis with a Viabahn endoprosthesis showed significantly better results than treatment with a standard balloon at 1 year.

24-Month Data from the BRAVISSIMO: A Large-Scale Prospective Registry on Iliac Stenting for TASC A & B and TASC C & D Lesions.

BACKGROUND: To evaluate the 24-month outcome of stenting in Trans-Atlantic Inter-Society Consensus (TASC) A & B and TASC C & D iliac lesions in a controlled setting. METHODS: The BRAVISSIMO study is a prospective, nonrandomized, multicenter, multinational, monitored registry including 325 patients with aortoiliac lesions. The end point is the primary patency at 24 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio >2.0). A separate analysis for TASC A & B versus TASC C & D population is performed. RESULTS: Between July 2009 and September 2010, 190 patients with TASC A or B and 135 patients with TASC C or D aortoiliac lesions were included. The demographic data were comparable for TASC A & B cohort and TASC C & D cohort. Technical success was 100%. Significantly more balloon-expandable stents were deployed in TASC A & B lesions, and considerably more self-expanding stents were placed in TASC C & D (P = 0.01). The 24-month primary patency rate after 24 months for the total population was 87.9% (88.0% for TASC A, 88.5% for TASC B, 91.9% for TASC C, and 84.8% for TASC D). No statistically significant difference was shown when comparing these groups. The 24-month primary patency rates were 92.1% for patients treated with the self-expanding stent, 85.2% for patients treated with the balloon-expandable stent, and 75.3% for patients treated with a combination of both stents (P = 0.06). Univariate and multivariable regression analyses using Cox proportional hazards model identified only kissing stent configuration (P = 0.0012) and obesity (P = 0.0109) as independent predictors of restenosis (primary patency failure). Interestingly, as all TASC groups enjoyed high levels of patency, neither TASC category nor lesion length was predictive of restenosis. CONCLUSION: The 24-month data from this large, prospective, multicenter study confirm that endovascular therapy may be considered the preferred first-line treatment option of iliac lesions, irrespectively of TASC lesion category.

Comparative analysis of carotid artery stenting practice and outcomes across operator specialties: insights from a prespecified subanalysis of a large real-world patient cohort (ROADSAVER Study).

BACKGROUND: In contemporary clinical practice, carotid artery stenting (CAS) is increasingly becoming a multispecialty field, joining operators of various training backgrounds, which bring forth their unique expertise, patient management philosophies, and procedural preferences. The best practices and approaches, however, are still debated. Therefore, real-world insights on different operator preferences and related outcomes are of utmost value, yet still rather scarce in the available literature. METHODS: Using the data collected in the ROADSAVER observational, European multicenter CAS study, a prespecified comparative analysis evaluating the impact of the operator's specialization was performed. We used major adverse event (MAE) rate at 30-day follow-up, defined as the cumulative incidence of any death or stroke, and its components as outcome measures. RESULTS: A total of 1965 procedures were analyzed; almost half 878 (44.7%) were performed by radiologists (interventional/neuro), 717 (36.5%) by cardiologists or angiologists, and 370 (18.8%) by surgeons (vascular/neuro). Patients treated by surgeons were the oldest (72.9±8.5), while radiologists treated most symptomatic patients (58.1%) and more often used radial access (37.2%). The 30-day MAE incidence achieved by cardiologists/angiologists was 2.0%, radiologists 2.5%, and surgeons 1.9%; the observed differences in rates were statistically not-significant (P=0.7027), even when adjusted for baseline patient/lesion and procedural disparities across groups. The corresponding incidence rates for death from any cause were 1.0%, 0.8%, and 0.3%, P=0.4880, and for any stroke: 1.4%, 2.3%, and 1.9%, P=0.4477, respectively. CONCLUSIONS: Despite the disparities in patient selection and procedural preferences, the outcomes achieved by different specialties in real-world, contemporary CAS practice remain similar when using modern devices and techniques.

Intraoperative Extravascular Ultrasound in the Identification of Flow-Limiting Dissections after Balloon Angioplasty in the Femoropopliteal Segment.

Background: The BIO REACT study is designed to investigate the incremental value of Extravascular UltraSound (EVUS) added to conventional angiography, compared to conventional angiography only for the identification of Flow-Limiting Dissections (FLD) and to evaluate the safety and efficacy of the REsponse Adapted Combination Therapy (REACT) for the treatment of femoropopliteal lesions. Methods: The primary endpoints were the specificity and sensitivity of EVUS added to angiography for the detection of FLD. Secondary endpoints were primary patency of the REACT therapy within 12 months, fCD-TLR, freedom from MAE, major target limb amputations (mTLA) and survival rates within 24 months. Results: A total of 150 patients were included. EVUS added to angiography had an overall sensitivity of 29% and specificity of 93% for the detection of FLD. There was no PSVR cut-off offering a clinically acceptable trade-off between meaningful sensitivity and specificity values for the detection of FLD. At 12 months, treatment with the REACT resulted in primary patency and fCD-TLR of 81.6% and 94.3%, respectively. In addition, freedom from MAE was 94.3% at 12 months. At 24 months, the survival rate was 94.0%. No mTLA was reported up to the 24-month follow-up. Conclusions: The addition of DUS to angiography showed limited value for detecting FLD in femoropopliteal artery disease.

4-French-compatible endovascular material is safe and effective in the treatment of femoropopliteal occlusive disease: results of the 4-EVER trial.

PURPOSE: To report the 1-year results of a prospective multicenter trial to evaluate the safety and efficacy of treating symptomatic femoropopliteal occlusive disease using 4-F-compatible materials and no closure device. METHODS: The non-randomized 4-EVER trial (4-F endovascular treatment approach to infrainguinal disease) was conducted at 5 European hospitals (ClinicalTrials.gov identifier NCT01413139). The protocol mandated the use of only 4-F sheaths, self-expanding nitinol stents (Astron Pulsar or Pulsar-18 stent), and balloons from a single manufacturer. Between June 2010 and June 2011, 120 symptomatic patients (82 men; mean age 71±9.7 years, range 47-90), primarily claudicants, treated for 120 femoropopliteal lesions (>90% TASC A/B) were enrolled. The mean lesion length was 71.0±45.9 mm. Follow-up evaluations were scheduled on day 1 and at 1, 6, 12, and 24 months. A duplex ultrasound was performed on all follow-up visits to determine vessel patency (primary outcome measure at 1 year), and biplanar radiography was performed at 12 and 24 months to assess stent fracture. RESULTS: Stents were successfully implanted in all patients: an Astron Pulsar stent in 70 (58.3%) lesions and a Pulsar-18 stent in 46 (38.3%); 4 (3.3%) patients had both stents implanted for flow-limiting dissection after predilation. No closure devices were used; the mean manual compression time was 8.1 minutes (2-15). Four (3.3%) patients developed significant hematoma at the puncture site, but none required surgical repair. The overall 12-month primary patency rate was 81.4%: 85.2% for the Astron Pulsar and 73.4% for the Pulsar-18 (p=0.236). Freedom from target lesion revascularization at 12 months for the entire cohort was 89.3%. CONCLUSION: Compared to published historical data for superficial femoral artery type A/B lesion stenting using 6-F devices, the 4-F devices applied in this trial showed similar patency at 12 months, fewer access site complications, and shorter manual compression times, supporting the supposition that 4-F endovascular treatment is safe and effective.

BioMimics 3D Stent in Femoropopliteal Lesions: 3-Year Outcomes with Propensity Matching for Drug-Coated Balloons.

BACKGROUND: Through its helical centreline geometry, the BioMimics 3D vascular stent system is designed for the mobile femoropopliteal region, aiming to improve long-term patency and the risk of stent fractures. METHODS: MIMICS 3D is a prospective, European, multi-centre, observational registry to evaluate the BioMimics 3D stent in a real-world population through 3 years. A propensity-matched comparison was performed to investigate the effect of the additional use of drug-coated balloons (DCB). RESULTS: The MIMICS 3D registry enrolled 507 patients (518 lesion, length 125.9 ± 91.0 mm). At 3 years, the overall survival was 85.2%, freedom from major amputation 98.5%, freedom from clinically driven target lesion revascularisation 78.0%, and primary patency 70.2%. The propensity-matched cohort included 195 patients in each cohort. At 3-year follow-up, there was no statistically significant difference in clinical outcomes, such as overall survival (87.9% in the DCB vs. 85.1% in the no DCB group), freedom from major amputation (99.4% vs. 97.2%), clinically driven TLR (76.4% vs. 80.3%), and primary patency (68.5% vs. 74.4%). CONCLUSION: The MIMICS 3D registry showed good 3-year outcomes of the BioMimics 3D stent in femoropopliteal lesions, demonstrating the safety and performance of this device under real-world conditions, whether used alone or in combination with a DCB.

Head-to-Head Comparison of 2 Paclitaxel-Coated Balloons for Femoropopliteal Lesions.

BACKGROUND: There is a scarcity of published head-to-head comparisons between different paclitaxel-coated angioplasty balloons. More prospective safety data to support the health care economic reimbursement processes are needed. OBJECTIVES: The aim of this study was to report the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) (Biotronik AG) for the treatment of symptomatic peripheral artery disease caused by stenosis, restenosis, or occlusion of the femoral and/or popliteal arteries. METHODS: A total of 302 patients were randomized 1:1 and assigned to the Passeo-18 Lux DCB (study device) group or the IN.PACT Admiral DCB (control device, Medtronic Vascular) group for testing of noninferiority. The primary efficacy endpoint was freedom from clinically driven target lesion revascularization at 12 months. The primary safety endpoint was a composite of freedom from device-/procedure-related death through 30 days postindex procedure, major target limb amputation, and clinically driven target vessel revascularization at 12 months. RESULTS: At 12 months, 130 of 134 patients in the IN.PACT Admiral group had freedom from clinically driven target lesion revascularization (97.0%) compared with 137 of 141 patients in the Passeo-18 Lux group (97.2%). The primary safety endpoint showed 96.3% in the control group vs 95.7% in the study device group. The null hypothesis of inferiority on both efficacy and safety was rejected. The Kaplan-Meier estimate of primary patency at 1 year was 88.7% in the control arm vs 91.5% in the study device arm. CONCLUSIONS: The Passeo-18 Lux and the IN.PACT Admiral DCBs demonstrate comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions.

Radial access for peripheral vascular intervention: the S.M.A.R.T. RADIANZ Vascular Stent System.

INTRODUCTION: Radial access is the standard of care for nearly all cardiac catheterization procedures. It improves patient satisfaction, reduces the length of stay, and is associated with fewer complications. However, few devices and tools are available for the treatment of peripheral arterial disease via a transradial approach (TRA). The S.M.A.R.T. RADIANZ Vascular Stent System is among the RADIANZ suite of products, which is aimed at expanding the portfolio of devices to treat peripheral arterial disease. AREAS COVERED: In this Expert review, the following areas will be covered: (1) Current Landscape of peripheral vascular intervention (PVI) using TRA (2) Detailed description of the S.M.A.R.T. RADIANZ Vascular Stent System. (3) Ongoing clinical trials to evaluate safety of this approach. (4) Future directions and current regulatory status. EXPERT OPINION: TRA for PVI is a promising approach. It holds the possibility of substantially improving the care of patients with peripheral arterial disease (PAD). Numerous challenges must be overcome to realize the full potential of a radial-to-peripheral (RTP) approach. The length of devices and the small sheath size are the main constraints of this approach. The results of the ongoing RADIANCY trial will demonstrate the safety, in selected patients, of the RADIANZ suite of products.

ZILVERPASS Study: ZILVER PTX Stent versus Prosthetic Above-the-Knee Bypass Surgery in Femoropopliteal Lesions, 5-year Results.

PURPOSE: To report the 60-month safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to prosthetic above-the-knee bypass for the treatment of symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions. MATERIALS AND METHODS: Patients were enrolled between October 2013 and July 2017. One of the secondary outcomes was primary patency at 60 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio < 2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass at 60 months. Survival rates after 5 years were also analyzed. RESULTS: 220 patients (mean age 68.6 ± 10.5 years; 159 men) were included and randomized to ZILVER PTX (n = 113, 51.40%) or BYPASS group (n = 107, 48.60%). The 60-month primary patency rate was 49.3% for the ZILVER PTX group versus 40.7% for the bypass group (p = 0.6915). Freedom from TLR was 63.8% for the ZILVER PTX group versus 52.8% for the bypass group (p = 0.2637). At 5 years, no significant difference in survival rate could be seen between the ZILVER PTX and the bypass group (69.1% vs. 71% respectively, p = 0.5503). CONCLUSION: Even at 5 years, non-inferior safety and effectiveness results of the ZILVER PTX could be seen. These findings confirmed that the use of ZILVER PTX stents can be considered as a valid alternative for bypass surgery when treating long and complex femoropopliteal lesions.