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.

Navigating complexity with low-crossing profile dual-layer micromesh carotid stent: implications for contemporary carotid artery stenting outcomes (ROADSAVER study insights).

BACKGROUND: The safety and efficacy of carotid artery stenting (CAS) can be affected by certain technical and anatomical factors. However, it is not known whether the use of a dual-layer micromesh stent (DLMS) with a low-crossing profile could reduce the risks associated with complex vascular anatomies during CAS. METHODS: This study involved 1965 asymptomatic or symptomatic carotid artery stenosis patients who received the Roadsaver DLMS during CAS, as part of a prospective, multicenter observational ROADSAVER study, conducted from January 2018 to February 2021. The primary outcome was the 30-day rate of major adverse events (MAE; i.e. any death or stroke) after CAS. Procedural details and outcomes were compared between patients with complex anatomical features and those without. RESULTS: One or more complex anatomical characteristics were identified in 1639 (83.4%) patents. Patients with complex anatomies were older and had a higher prevalence of arterial hypertension, cardiovascular disease, and prior stroke. Between patients with or without complex anatomical features, no significant differences were found either in procedural techniques, or in 30-day MAE (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.76 (0.35, 1.66); p=0.4905) and any stroke (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.89 (0.37, 2.17); p=0.8032) incidence. Furthermore, neither the presence of specific types of anatomic complexity nor their number (per patient) markedly influenced the 30-day MAE and any stroke incidence. CONCLUSIONS: In this real-world cohort of patients undergoing CAS with the Roadsaver DLMS, no significant difference in the occurrence of 30-day MAE and any stroke was observed between patients with or without high-risk anatomical features.

Endovascular thrombectomy for acute ischaemic stroke with established large infarct (TENSION): 12-month outcomes of a multicentre, open-label, randomised trial.

BACKGROUND: Long-term data showing the benefits of endovascular thrombectomy for stroke with large infarct are scarce. The TENSION trial showed the safety and efficacy of endovascular thrombectomy in patients with ischaemic stroke and large infarct at 90 days. We aimed to investigate the safety and efficacy at 12 months of endovascular thrombectomy in patients who were enrolled in the TENSION trial. METHODS: TENSION was an open-label, blinded endpoint, randomised trial done at 40 hospitals across Europe and one hospital in Canada. We included patients (aged ≥18 years) with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and who had a large infarct, as indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 on standard-of-care stroke imaging. We randomly assigned patients (1:1) to receive either endovascular thrombectomy with medical treatment or medical treatment only up to 12 h from stroke onset. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days. Here, we report the prespecified 12-month follow-up analyses for functional outcome (using the simplified modified Rankin Scale questionnaire), quality of life (using the Patient-Reported Outcomes Measurement Information System 10-item [PROMIS-10] and EQ-5D questionnaires), post-stroke anxiety and depression (using the Patient Health Questionnaire-4 [PHQ-4]), and overall survival. Outcomes (except survival) were assessed in the intention-to-treat population; the survival analysis was based on treatment received. This trial is registered with ClinicalTrials.gov, NCT03094715, and is completed. FINDINGS: We enrolled patients between July 17, 2018, and Feb 21, 2023, when the trial was stopped early for efficacy. 253 patients were randomly assigned, 125 (49%) to endovascular thrombectomy and 128 (51%) to medical treatment only. Median follow-up was 8·36 months (IQR 0·02-12·00). Endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better functional outcome at 12 months (adjusted common odds ratio 2·39 [95% CI 1·47-3·90]). Endovascular thrombectomy was also associated with a better quality of life compared with medical treatment only, as reflected by median scores on the EQ-5D questionnaire index (0·7 [IQR 0·4-0·9] vs 0·4 [0·2-0·7]), median scores for health status on the EQ-5D questionnaire visual analogue scale (50 [IQR 35-70] vs 30 [5-60]), and median global physical health scores on the PROMIS-10 questionnaire (T-score 39·8 [IQR 37·4-50·8] vs 37·4 [32·4-44·9]); although there was not enough evidence to suggest a difference between groups in global mental health scores on PROMIS-10 (41·1 [IQR 36·3-48·3] vs 38·8 [31·3-44·7]) or the numbers of patients reporting anxiety (13 [22%] of 58 vs 15 [42%] of 36) and depression (18 [31%] vs 18 [50%]) on PHQ-4. Overall survival was slightly better in the endovascular thrombectomy group compared with medical treatment only (adjusted hazard ratio 0·70 [95% CI 0·50-0·99]). INTERPRETATION: In patients with acute ischaemic stroke from large vessel occlusion with established large infarct, compared with medical treatment only, endovascular thrombectomy was associated at 12 months after stroke with better functional outcome, quality of life, and overall survival. These findings suggest that the benefits of endovascular thrombectomy in patients with an ischaemic stroke and a large infarct are sustained in the long term and support the use of endovascular thrombectomy in these patients. FUNDING: European Union Horizon 2020 Research and Innovation Programme.

Polymer-based drug-eluting stent treatment extends the time to reintervention for patients with symptomatic femoropopliteal artery disease: clinical evidence and potential economic value.

Aim: Use long-term follow-up data from the IMPERIAL study to determine whether drug-eluting polymer-based nitinol stent treatment can delay the time to repeat intervention for femoropopliteal artery disease and how such a delay may result in cost savings in a value-based episode of care. Patients & methods: The IMPERIAL randomized controlled trial was an international study of a paclitaxel-eluting polymer-coated stent (Eluvia, Boston Scientific, MA, USA) versus a polymer-free paclitaxel-coated stent (Zilver PTX, Cook Corporation, IN, USA) for treating lesions of the femoropopliteal arterial segment. Study patients (n = 465) had symptomatic lower limb ischemia. Safety and efficacy assessments were performed through 5 years. Mean time to first reintervention was calculated in post-hoc analysis for patients who underwent a clinically driven target lesion revascularization (CD-TLR) through 3 or 5 years following the index procedure. To simulate potential cost savings associated with differential CD-TLR burden over time, a cost-avoidance analysis using input parameters from IMPERIAL and US 100% Medicare standard analytical files was developed. Results: Among patients with a first CD-TLR through 3 years of follow-up, mean time to reintervention was 5.5 months longer (difference 166 days, 95% CI: 51, 282 days; p = 0.0058) for patients treated with Eluvia (n = 56) than for those treated with Zilver PTX (n = 30). Through the 5-year study follow-up period, CD-TLR rates were 29.3% (68/232) for Eluvia and 34.2% (39/114) for Zilver PTX (p = 0.3540) and mean time to first reintervention exceeded 2 years for patients treated with Eluvia at 737 days versus 645 days for the Zilver PTX group (difference 92 days, 95% CI: -85, 269 days; p = 0.3099). Simulated savings considering reinterventions occurring over 1 and 5 years following initial use of Eluvia over Zilver PTX were US $1,395,635 and US $1,531,795, respectively, when IMPERIAL CD-TLR rates were extrapolated to 1000 patients. Conclusion: IMPERIAL data suggest initial treatment with Eluvia extends the time patients spend without undergoing reintervention. This extension may be associated with cost savings in relevant time frames.

CIRSE Standards of Practice on Carotid Artery Stenting.

BACKGROUND: Carotid artery stenting has been used effectively to treat internal carotid artery stenosis since 1989 (Mathias et al. in World J Surg. 25(3):328-34, 2001), with refined and expanded techniques and tools presently delivering outstanding results in percutaneous endoluminal treatment of carotid artery stenosis. PURPOSE: This CIRSE Standards of Practice document is directed at interventional radiologists and details the guidelines for carotid artery stenting, as well as the different implementation techniques. In addition to updating all previously published material on the different clinical indications, it will provide all technical details reflective of European practice for carotid artery stenting. CIRSE Standards of Practice documents do not aim to implement a standard of clinical patient care, but rather to provide a realistic strategy and best practices for the execution of this procedure. METHODS: The writing group, which was established by the CIRSE Standards of Practice Committee, consisted of five clinicians with internationally recognised expertise in carotid artery stenting procedures. The writing group reviewed existing literature on carotid artery stenting procedures, performing a pragmatic evidence search using PubMed to select relevant publications in the English language from 2006 to 2022. RESULTS: Carotid artery stenting has an established role in the management of internal carotid artery stenosis; this Standards of Practice document provides up-to-date recommendations for its safe performance.

Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial.

BACKGROUND: Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice. METHODS: In a prospective multicentre, open-label, randomised trial, patients with acute ischaemic stroke due to large vessel occlusion in the anterior circulation and a large established infarct indicated by an Alberta Stroke Program Early Computed Tomographic Score (ASPECTS) of 3-5 were randomly assigned using a central, web-based system (using a 1:1 ratio) to receive either endovascular thrombectomy with medical treatment or medical treatment (ie, standard of care) alone up to 12 h from stroke onset. The study was conducted in 40 hospitals in Europe and one site in Canada. The primary outcome was functional outcome across the entire range of the modified Rankin Scale at 90 days, assessed by investigators masked to treatment assignment. The primary analysis was done in the intention-to-treat population. Safety endpoints included mortality and rates of symptomatic intracranial haemorrhage and were analysed in the safety population, which included all patients based on the treatment they received. This trial is registered with ClinicalTrials.gov, NCT03094715. FINDINGS: From July 17, 2018, to Feb 21, 2023, 253 patients were randomly assigned, with 125 patients assigned to endovascular thrombectomy and 128 to medical treatment alone. The trial was stopped early for efficacy after the first pre-planned interim analysis. At 90 days, endovascular thrombectomy was associated with a shift in the distribution of scores on the modified Rankin Scale towards better outcome (adjusted common OR 2·58 [95% CI 1·60-4·15]; p=0·0001) and with lower mortality (hazard ratio 0·67 [95% CI 0·46-0·98]; p=0·038). Symptomatic intracranial haemorrhage occurred in seven (6%) patients with thrombectomy and in six (5%) with medical treatment alone. INTERPRETATION: Endovascular thrombectomy was associated with improved functional outcome and lower mortality in patients with acute ischaemic stroke from large vessel occlusion with established large infarct in a setting using non-contrast CT as the predominant imaging modality for patient selection. FUNDING: EU Horizon 2020.

The Current Use of Drug-Eluting Balloons and Stents in Peripheral Arterial Disease: An Online Survey by the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).

PURPOSE: To assess the current use of drug-eluting devices for peripheral arterial disease (PAD) among interventional radiologists following the controversy caused by the 2018 meta-analysis suggesting an increased mortality risk for paclitaxel-eluting devices. METHODS: An anonymous survey was sent to 7035 CIRSE members via email; only complete responses were included and statistically analysed. RESULTS: Three hundred and seven members (4.4%) completed the survey. Among these, 95.8% indicated that they personally perform peripheral vascular procedures. Thirty-eight percentage of respondents did not see any change of practice since 2018, while 47% reported that the use of drug-eluting devices decreased; for 13%, the use stopped altogether, while it increased in 3% of responses. 45.6% of respondents also felt the impact of the controversy in terms of pricing, availability or directives from hospital administration. A large majority of respondents (83.7%) who perform peripheral vascular procedures consider the use of these devices as safe, 12.9% were undecided and 3.4% did not consider them as safe. Among the respondents who do not perform endovascular procedures, 77% considered these devices as safe and 23% were undecided. CONCLUSION: Although the 2018 meta-analysis had a disruptive impact on the use of drug-eluting devices in PAD, with the increasing body of evidence available, a majority of respondents continue to believe in the safety of these devices for use in femoropopliteal disease.

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

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

Leadership in Interventional Radiology - Fostering a Culture of Excellence.

This invited article reviews the current status of Interventional Radiology (IR), in terms of its status as a speciality, and outlines the conditions needed for IR to function optimally within healthcare settings. Guidance is offered in terms of developing an IR department, ensuring high-quality practice, dealing with administrative and political challenges, dealing with industry and creating a legacy.

Cost-effectiveness of a paclitaxel-eluting stent (Eluvia) compared to Zilver PTX for endovascular femoropopliteal intervention.

OBJECTIVES: Antiproliferative therapies based on paclitaxel have been developed to extend the durability of endovascular interventions for lower-extremity atherosclerotic peripheral artery disease, resulting in improved primary vessel patency and fewer target lesion revascularizations. This study evaluated the cost-effectiveness of the sustained-release, paclitaxel-eluting Eluvia stent (Boston Scientific, Marlborough, MA) versus the paclitaxel-coated Zilver PTX stent (Cook Medical, Bloomington, IN) for endovascular intervention in the superficial femoral or proximal popliteal artery. DESIGN: A microsimulation model was constructed from a United States Medicare perspective with a 24-month time horizon. Patients entering the model were assigned to initial endovascular intervention with either Eluvia or Zilver PTX. Each month patients were exposed to the risks of primary vessel patency loss, target lesion revascularization, amputation, and death. Clinical input parameters were taken from a randomized trial (IMPERIAL) comparing the two interventions at 24-months follow-up. Cost parameters were obtained from analyses of Medicare administrative and claims data. Cost-effectiveness analysis entailed sampling a complete set of clinical and cost parameters from their respective distributions, and then running cohorts of 10,000 patients through each intervention arm of the model. One-way and probabilistic sensitivity analyses were performed. RESULTS: In the base case microsimulation, at 24 months, the modeled target lesion revascularization was 11.6% for Eluvia and 19.0% for Zilver PTX, and the mean total direct costs were $20,010 and $21,356, respectively (Eluvia average savings=$1,346). In probabilistic sensitivity analyses, Eluvia was cost-effective in 87.8% of all simulations at a willingness-to-pay threshold of $10,000 per target lesion revascularization prevented. Eluvia was more effective and less costly (dominant) than Zilver PTX in 73.6% of simulations. CONCLUSIONS: In this comparison of a paclitaxel-eluting to a paclitaxel-coated stent for endovascular femoropopliteal intervention, Eluvia was more effective and less costly (dominant) than Zilver PTX from a US Medicare perspective. These findings should be considered when formulating reimbursement policy and clinical practice guidelines.

Paclitaxel is a drug used in the treatment of peripheral artery disease (PAD) to help maintain primary vessel patency and reduce the need for revascularization procedures. This study evaluated the cost-effectiveness of the paclitaxel-eluting Eluvia stent (Boston Scientific, Marlborough, MA) versus the paclitaxel-coated Zilver PTX stent (Cook Medical, Bloomington, IN) in Medicare patients with PAD. Cost-effectiveness is defined as the degree to which a particular treatment option is effective relative to its costs. Therefore, this study compared both the effectiveness, in terms of target lesion revascularization rates, and the costs of Eluvia versus Zilver PTX over 24 months.A microsimulation model was developed from a United States Medicare perspective with a 24-month time horizon. Simulated patients entered the model and were assigned to receive either Eluvia or Zilver PTX. Monthly, patients were exposed to the risks of primary vessel patency loss, target lesion revascularization (TLR), amputation, and death. These risks were taken from a randomized controlled trial that compared Eluvia and Zilver PTX over 24 months. Patients also accrued costs over time. The costs used in the model were obtained from Medicare administrative and claims data analyses.In health economics, a treatment is considered to be the dominant treatment option if it is both more effective and less costly than the alternative treatment. In this case, Eluvia was found to be dominant over Zilver PTX because it was associated with lower TLR rates and lower costs. These findings should be considered when formulating reimbursement policy and clinical practice guidelines.

"Real-World Study of a Dual-Layer Micromesh Stent in Elective Treatment of Symptomatic and Asymptomatic Carotid Artery Stenosis (ROADSAVER)".

PURPOSE: Endovascular carotid artery stenosis treatment is associated with a higher peri- and early post-procedural stroke risk relative to surgery. Dual-layer micromesh carotid stents were specifically designed for improved plaque coverage to reduce the cerebral embolization risk and related ischemic events. ROADSAVER study aims to further confirm the safety and efficacy of the Roadsaver™ dual-layer micromesh stent for the treatment of elective patients with carotid artery stenosis. MATERIALS AND METHODS: ROADSAVER is a prospective, multi-center, observational study. Between January 2018 and February 2021, a total of 1967 patients featuring asymptomatic or symptomatic, non-occlusive and non-thrombotic carotid stenosis eligible for an elective stenting procedure were enrolled across 13 European countries (52 centers). Follow-up visits are scheduled at 30 days and at 12 months. The primary outcome measure is the major adverse event rate, i.e., cumulative incidence of any death or stroke up to 30 days post-procedure. All deaths, strokes and carotid revascularizations are adjudicated by an independent Clinical Events Committee. Sub-analyses are prespecified and focused on baseline patient characteristics (e.g., age, neurologic status), procedural features (e.g., access route, embolic protection use), advanced imaging, and treatment efficacy up to 12 months. CONCLUSION: The present study evaluates the Roadsaver™ dual-layer micromesh carotid stent in the real-world clinical practice aiming to provide valuable insights into the contemporary European treatment trends and outcomes of elective carotid artery stenting. The large study population and predefined sub-analyses should help identify the best practices and patient subsets to benefit most from the treatment. TRIAL REGISTRATION: Clinicaltrial.gov identifier: NCT03504228.

24-Month Efficacy and Safety Results from Japanese Patients in the IMPERIAL Randomized Study of the Eluvia Drug-Eluting Stent and the Zilver PTX Drug-Coated Stent.

PURPOSE: The purpose of the study is to report 24-month efficacy and safety results for the Japanese patient cohort in a prospective randomized controlled trial (RCT) of drug-eluting stent (DES) use for peripheral artery disease. MATERIALS AND METHODS: Patients in the global IMPERIAL RCT had femoropopliteal lesions treated with either the Eluvia DES (Boston Scientific, Marlborough, MA, USA) or the Zilver PTX drug-coated stent (Cook Medical, Bloomington, IN, USA). At 24 months, assessments included duplex ultrasound imaging for core laboratory vessel patency measurement, target lesion revascularization (TLR) rates, and clinical outcome measures. RESULTS: The Japanese cohort included 84 patients (56 treated with Eluvia and 28 with Zilver PTX). The clinically driven TLR rates were 5.6% (3/54) and 18.5% (5/27) for patients treated with Eluvia and Zilver PTX, respectively (difference -13.0%, 95%CI -28.8, 2.9%; p = 0.11). The Kaplan-Meier estimates for freedom from clinically driven TLR at 24 months were 94.3% for patients who received Eluvia and 80.4% for those who received Zilver PTX (log rank p = 0.05), and for primary patency they were 88.5% and 80.4%, respectively (log rank p = 0.28). Mortality rates were 5.6% (3/54) and 11.1% (3/27); p = 0.39. Rutherford classification improved by at least one category without TLR for 91.8% (45/49) and 68.2% (15/22) of patients (p = 0.03). Walking impairment score improvements were sustained over time. CONCLUSION: The results at 24 months support the efficacy and safety of DES in Japanese patients, with sustained clinical improvements and numerically fewer reinterventions for those treated with Eluvia. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT02574481. https://clinicaltrials.gov/ct2/show/NCT02574481 LEVEL OF EVIDENCE: EBM Level III; cohort analysis of randomized trial.

Early prediction of final infarct volume with material decomposition images of dual-energy CT after mechanical thrombectomy.

PURPOSE: Evaluation of water material density images (wMDIm) of dual-energy CT (DECT) for earlier prediction of final infarct volume (fiV) in follow-up single-energy CT (SECT) and correlation with clinical outcome. METHODS: Fifty patients (69 years, ± 12.1, 40-90, 50% female) with middle cerebral artery (MCA) occlusions were included. Early infarct volumes were analyzed in monoenergetic images (MonoIm) and wMDIm at 60 keV and compared with the fiV in SECT 4.9 days (± 4) after thrombectomy. Association between infarct volume and functional outcome was tested by linear regression analysis. RESULTS: wMDIm shows a prior visible infarct demarcation (60.7 ml, ± 74.9 ml) compared with the MonoIm (37.57 ml, ± 76.7 ml). Linear regression analysis, Bland-Altman plots and Pearson correlation coefficients show a close correlation of infarct volume in wMDIm to the fiV in SECT (r = 0.86; 95% CI 0.76-0.92), compared with MonoIm and SECT (r = 0.81; 95% CI 0.69-0.89). The agreement with SECT is substantially higher in patients with infarct volumes < 70 ml (n = 33; 66%). Coefficients were smaller with r = 0.59 (95% CI 0.31; 0.78) for MonoIm and SECT compared with r = 0.77 (95% CI 0.57; 0.88) for wMDIm and SECT. At admission, the mean NIHSS score and mRS were 17.02 (± 4.7) and 4.9 (± 0.2). mRS ≤ 2 was achieved in 56% at 90 days with a mean mRS of 2.5 (± 0.8) at discharge. CONCLUSION: Material decomposition allows earlier visibility of the final infarct volume. This promises an earlier evaluation of the dimension and severity of infarction and may lead to faster initiation of secondary stroke prophylaxis.

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.

PURPOSE: 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: 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: 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: clinicaltrials.gov identifier NCT02574481. Date of registration: October 14, 2015. LEVEL OF EVIDENCE: Level 1; randomized controlled trial.