Why selective screening for asymptomatic carotid stenosis is currently appropriate: a special report.

INTRODUCTION: Two of the main reasons recent guidelines do not recommend routine population-wide screening programs for asymptomatic carotid artery stenosis (AsxCS) is that screening could lead to an increase of carotid revascularization procedures and that such mass screening programs may not be cost-effective. Nevertheless, selective screening for AsxCS could have several benefits. This article presents the rationale for such a program. AREAS COVERED: The benefits of selective screening for AsxCS include early recognition of AsxCS allowing timely initiation of preventive measures to reduce future myocardial infarction (MI), stroke, cardiac death and cardiovascular (CV) event rates. EXPERT OPINION: Mass screening programs for AsxCS are neither clinically effective nor cost-effective. Nevertheless, targeted screening of populations at high risk for AsxCS provides an opportunity to identify these individuals earlier rather than later and to initiate a number of lifestyle measures, risk factor modifications, and intensive medical therapy in order to prevent future strokes and CV events. For patients at 'higher risk of stroke' on best medical treatment, a prophylactic carotid intervention may be considered.

Relevance of BEST-CLI trial endpoints in a tertiary care limb preservation program.

OBJECTIVE: Major adverse limb event-free survival (MALE-FS) differed significantly by initial revascularization approach in the BEST-CLI randomized trial. The BEST-CLI trial represented a highly selected subgroup of patients seen in clinical practice; thus, we examined the endpoint of MALE-FS in an all-comers tertiary care practice setting. METHODS: This is a single-center retrospective study of consecutive, unique patients who underwent technically successful infrainguinal revascularization for chronic limb-threatening ischemia (2011-2021). MALE was major amputation (transtibial or above) or major reintervention (new bypass, open bypass revision, thrombectomy, or thrombolysis). RESULTS: Among 469 subjects, the mean age was 70 years, and 34% were female. Characteristics included diabetes (68%), end-stage renal disease (ESRD) (16%), Wound, Ischemia, and foot Infection (WIfI) stage 4 (44%), Global Limb Anatomic Staging System (GLASS) stage 3 (62%), and high pedal artery calcium score (pMAC) (22%). Index revascularization was autogenous vein bypass (AVB) (30%), non-autogenous bypass (NAB) (13%), or endovascular (ENDO) (57%). The composite endpoint of MALE or death occurred in 237 patients (51%) at a median time of 189 days from index revascularization. In an adjusted Cox model, factors independently associated with MALE or death included younger age, ESRD, WIfI stage 4, higher GLASS stage, and moderate-severe pMAC, whereas AVB was associated with improved MALE-FS. Freedom from MALE-FS, MALE, and major amputation at 30 days were 90%, 92%, and 95%; and at 1 year were 63%, 70%, and 83%, respectively. MALE occurred in 144 patients (31%) and was associated with ESRD, WIfI stage, GLASS stage, pMAC score, and index revascularization approach. AVB had superior durability, with adjusted 2-year freedom from MALE of 72%, compared with 66% for ENDO and 51% for NAB. Within the AVB group, spliced vein conduit had higher MALE compared with single-segment vein (hazard ratio, 1.8; 95% confidence interval, 0.9-3.7; P = .008 after inverse propensity weighting), but there was no statistically significant difference in major amputation. Of the 144 patients with any MALE, the first MALE was major reintervention in 47% and major amputation in 53%. Major amputation as first MALE was associated with non-AVB index approach. Indications for major reintervention were symptomatic stenosis/occlusion (54%), lack of clinical improvement (28%), asymptomatic graft stenosis (16%), and iatrogenic events (3%). Conversion to bypass occurred after 6% of ENDO cases, two-thirds of which involved distal bypass targets at the ankle or foot. CONCLUSIONS: In this consecutive, all-comers cohort, disease complexity was associated with procedural selection and MALE-FS. AVB independently provided the greatest MALE-FS and freedom from MALE and major amputation. Compared with the BEST-CLI randomized trial, MALE after ENDO in this series was more frequently major amputation, with relatively few conversions to open bypass.

Outcomes following carotid revascularization for stroke stratified by Modified Rankin Scale and time of intervention.

OBJECTIVES: The relationship between baseline Modified Rankin Scale (mRS) in patients with prior stroke and optimal timing of carotid revascularization is unclear. Therefore, we evaluated the timing of transfemoral carotid artery stenting (tfCAS), transcarotid artery revascularization (TCAR), and carotid endarterectomy (CEA) after prior stroke, stratified by preoperative mRS. METHODS: We identified patients with recent stroke who underwent tfCAS, TCAR, or CEA between 2012 and 2021. Patients were stratified by preoperative mRS (0-1, 2, 3-4, or 5) and days from symptom onset to intervention (time to intervention; ≤2 days, 3-14 days, 15-90 days, and 91-180 days). First, we performed univariate analyses comparing in-hospital outcomes between separate mRS or time-to-intervention cohorts for all carotid intervention methods. Afterward, multivariable logistic regression was used to adjust for demographics and comorbidities across groups, and outcomes between the various intervention methods were compared. Primary outcome was the in-hospital stroke/death rate. RESULTS: We identified 4260 patients who underwent tfCAS, 3130 patients who underwent TCAR, and 20,012 patients who underwent CEA. Patients were most likely to have minimal disability (mRS, 0-1 [61%]) and least likely to have severe disability (mRS, 5 [1.5%]). Patients most often underwent revascularization in 3 to 14 days (45%). Across all intervention methods, increasing preoperative mRS was associated with higher procedural in-hospital stroke/death (all P < .03), whereas increasing time to intervention was associated with lower stroke/death rates (all P < .01). After adjustment for demographics and comorbidities, undergoing tfCAS was associated with higher stroke/death compared with undergoing CEA (adjusted odds ratio, 1.6; 95% confidence interval, 1.3-1.9; P < .01) or undergoing TCAR (adjusted odds ratio, 1.3; 95% confidence interval, 1.0-1.8; P = .03). CONCLUSIONS: In patients with preoperative stroke, optimal timing for carotid revascularization varies with stroke severity. Increasing preoperative mRS was associated with higher procedural in-hospital stroke/death rates, whereas increasing time to-intervention was associated with lower stroke/death rates. Overall, patients undergoing CEA were associated with lower in-hospital stroke/deaths. To determine benefit for delayed intervention, these results should be weighed against the risk of recurrent stroke during the interval before intervention.

Recent advances and controversial issues in the optimal management of asymptomatic carotid stenosis.

OBJECTIVE: The optimal management of patients with asymptomatic carotid stenosis (AsxCS) is enduringly controversial. We updated our 2021 Expert Review and Position Statement, focusing on recent advances in the diagnosis and management of patients with AsxCS. METHODS: A systematic review of the literature was performed up to August 1, 2023, using PubMed/PubMed Central, EMBASE and Scopus. The following keywords were used in various combinations: "asymptomatic carotid stenosis," "carotid endarterectomy" (CEA), "carotid artery stenting" (CAS), and "transcarotid artery revascularization" (TCAR). Areas covered included (i) improvements in best medical treatment (BMT) for patients with AsxCS and declining stroke risk, (ii) technological advances in surgical/endovascular skills/techniques and outcomes, (iii) risk factors, clinical/imaging characteristics and risk prediction models for the identification of high-risk AsxCS patient subgroups, and (iv) the association between cognitive dysfunction and AsxCS. RESULTS: BMT is essential for all patients with AsxCS, regardless of whether they will eventually be offered CEA, CAS, or TCAR. Specific patient subgroups at high risk for stroke despite BMT should be considered for a carotid revascularization procedure. These patients include those with severe (≥80%) AsxCS, transcranial Doppler-detected microemboli, plaque echolucency on Duplex ultrasound examination, silent infarcts on brain computed tomography or magnetic resonance angiography scans, decreased cerebrovascular reserve, increased size of juxtaluminal hypoechoic area, AsxCS progression, carotid plaque ulceration, and intraplaque hemorrhage. Treatment of patients with AsxCS should be individualized, taking into consideration individual patient preferences and needs, clinical and imaging characteristics, and cultural, ethnic, and social factors. Solid evidence supporting or refuting an association between AsxCS and cognitive dysfunction is lacking. CONCLUSIONS: The optimal management of patients with AsxCS should include BMT for all individuals and a prophylactic carotid revascularization procedure (CEA, CAS, or TCAR) for some asymptomatic patient subgroups, additionally taking into consideration individual patient needs and preference, clinical and imaging characteristics, social and cultural factors, and the available stroke risk prediction models. Future studies should investigate the association between AsxCS with cognitive function and the role of carotid revascularization procedures in the progression or reversal of cognitive dysfunction.

Female and male patients have similar outcomes after transcarotid artery revascularization in prospective trials.

OBJECTIVE: Sex disparities in outcomes after carotid revascularization have long been a concern, with several studies demonstrating increased postoperative death and stroke for female patients after either carotid endarterectomy or transfemoral stenting. Adverse events after transfemoral stenting are higher in female patients, particularly in symptomatic cases. Our objective was to investigate outcomes after transcarotid artery revascularization (TCAR) stratified by patient sex hypothesizing that the results would be similar between males and females. METHODS: We analyzed prospectively collected data from the Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)1 (pivotal), ROADSTER2 (US Food and Drug Administration indicated postmarket), and ROADSTER Extended Access TCAR trials. All patients had verified carotid stenosis meeting criteria for intervention (≥80% for asymptomatic patients and ≥50% in patient with symptomatic disease), and were included based on anatomical or clinical high-risk criteria for carotid stenting. Neurological assessments (National Institutes of Health Stroke Scale, Modified Rankin Scale) were obtained before and within 24 hours from procedure end by an independent neurologist or National Institutes of Health Stroke Scale-certified nurse. Patients were stratified by sex (male vs female). Baseline demographics were compared using χ2 and Fisher's exact tests where appropriate; primary outcomes were combination stroke/death (S/D) and S/D/myocardial infarction (S/D/M) at 30 days, and secondary outcomes were the individual components of S/D/M. Univariate logistic regression was conducted. RESULTS: We included 910 patients for analysis (306 female [33.6%], 604 male [66.4%]). Female patients were more often <65 years old (20.6% vs 15%) or ≥80 years old (22.6% vs 20.2%) compared with males, and were more often of Black/African American ethnicity (7.5% vs 4.3%). There were no differences by sex in term of comorbidities, current or prior smoking status, prior stroke, symptomatic status, or prevalence of anatomical and/or clinical high-risk criteria. General anesthetic use, stent brands used, and procedure times did not differ by sex, although flow reversal times were longer in female patients (10.9 minutes male vs 12.4 minutes female; P = .01), as was more contrast used in procedures for female patients (43 mL male vs 48.9 mL female; P = .049). The 30-day S/D and S/D/M rates were similar between male and female patients (S/D, 2.7% male vs 1.6% female [P = .34]; S/D/M, 3.6% male vs 2.6% female [P = .41]), which did not differ when stratified by symptom status. Secondary outcomes did not differ by sex, including stroke rates at 30 days (2.2% male vs 1.6% female; P = .80), nor were differences seen with stratification by symptom status. Univariate analysis demonstrated that history of a prior ipsilateral stroke was associated with increased odds of S/D (odds ratio [OR], 4.19; P = .001) and S/D/M (OR, 2.78; P = .01), as was symptomatic presentation with increased odds for S/D (OR, 2.78; P = .02). CONCLUSIONS: Prospective TCAR trial data demonstrate exceptionally low rates of S/D/MI, which do not differ by patient sex.

Serration Angioplasty Is Associated With Less Recoil in Infrapopliteal Arteries Compared With Plain Balloon Angioplasty.

PURPOSE: Recoil following balloon angioplasty of tibial arteries is a known mechanism of lumen loss and widely considered to be a contributing factor in early failure or later restenosis. The Serranator balloon has been designed to provide a controlled lumen gain while minimizing vessel injury. The objective of this study was to assess the ability to define and measure postangioplasty recoil in infrapopliteal arteries and to compare recoil after serration angioplasty and plain balloon angioplasty (POBA). METHODS: This multi-center, sequential comparative study included patients with de novo or restenotic lesions of infrapopliteal arteries up to 22 cm in length. Patients were enrolled sequentially and underwent alternating POBA or serration angioplasty with Serranator. The study captured angiographic imaging at pre, immediately post, and 15-minute after angioplasty. Vessel recoil, final diameter stenosis, and dissection were compared using core laboratory analysis. RESULTS: This study enrolled 36 patients who underwent treatment of 39 infrapopliteal lesions. There was no significant difference between Serranator (n=20) and POBA (n=19) with respect to baseline demographics and lesion characteristics. Arterial recoil (>10%) occurred in 25% of Serranator-treated lesions versus 64% in POBA-treated lesions (p=0.02. Clinically relevant recoil (>30%) was present after serration angioplasty in 10% of patients and after POBA in 53% (p=0.01). There was no significant difference in technical success (100% for both), dissection rate between Serranator (5%) and POBA (5.2%). CONCLUSIONS: Arterial recoil occurs after infrapopliteal angioplasty. Serration angioplasty produces substantially less arterial recoil compared with POBA. Additional studies are needed to assess whether reduced arterial recoil translates into superior long-term clinical outcomes. CLINICAL IMPACT: Prior studies have demonstrated over 90% recoil in patients after balloon angioplasty (POBA) of the infrapopliteal vessels, which significantly impacts the durability and impact of endovascular interventions in this clinical space. This study compared recoil after infrapopliteal angioplasty with serration angioplasty and POBA. Serration angioplasty produces substantially less arterial recoil compared with POBA. Additional studies are needed to assess whether reduced arterial recoil translates into superior long-term clinical outcomes.

Mortality in randomised controlled trials using paclitaxel-coated devices for femoropopliteal interventional procedures: an updated patient-level meta-analysis.

BACKGROUND: Numerous randomised clinical trials and real-world studies have supported the safety of paclitaxel-coated devices for the treatment of femoropopliteal occlusive disease. However, a 2018 summary-level meta-analysis suggested an increased mortality risk for paclitaxel-coated devices compared with uncoated control devices. This study presents an updated analysis of deaths using the most complete and current data available from pivotal trials of paclitaxel-coated versus control devices. METHODS: Ten trials comparing paclitaxel-coated versus control devices were included in a patient-level pooled analysis. Cox regression models were used to evaluate the effect of paclitaxel exposure on risk of death in both intention-to-treat (ITT; primary analysis) and three as-treated analysis sets accounting for treatment group crossover at the index procedure and over time. The effect of paclitaxel dose and baseline covariates were also evaluated. FINDINGS: A total of 2666 participants were included with a median follow-up of 4·9 years. No significant increase in deaths was observed for patients treated with paclitaxel-coated devices. This was true in the ITT analysis (hazard ratio [HR] 1·14, 95% CI 0·93-1·40), the as-treated analysis (HR 1·13, 95% CI 0·92-1·39), and in two crossover analyses: 1·07 (0·87-1·31) when late crossovers were censored and 1·04 (0·84-1·28) when crossovers were analysed from the date of paclitaxel exposure. There was no significant effect of paclitaxel dose on mortality risk. INTERPRETATION: This meta-analysis found no association between paclitaxel-coated device exposure and risk of death, providing reassurance to patients, physicians, and regulators on the safety of paclitaxel-coated devices. FUNDING: Becton Dickinson, Boston Scientific, Cook, Medtronic, Philips, Surmodics, and TriReme Medical.

How I do it: optimizing angioplasty using the Tack endovascular system in the management of chronic limb threatening ischemia.

Dissection occurring after percutaneous transluminal angioplasty (PTA) is associated with decreased vessel patency and an increased incidence of target lesion revascularization. Management of post-PTA dissection with the Tack Endovascular System (Philips, N.V., Amsterdam, Netherlands) has created an effective and durable treatment strategy for infrainguinal dissections. In this report, we discuss the indications and optimal methods for using Tack devices in post-PTA dissections.

Delphi Consensus on Reporting Standards in Clinical Studies for Endovascular Treatment of Acute Iliofemoral Venous Thrombosis and Chronic Iliofemoral Venous Obstruction.

Acute iliofemoral deep vein thrombosis and chronic iliofemoral venous obstruction cause substantial patient harm and are increasingly managed with endovascular venous interventions, including percutaneous mechanical thrombectomy and stent placement. However, studies of these treatment elements have not been designed and reported with sufficient rigor to support confident conclusions about their clinical utility. In this project, the Trustworthy consensus-based statement approach was utilized to develop, via a structured process, consensus-based statements to guide future investigators of venous interventions. Thirty statements were drafted to encompass major topics relevant to venous study description and design, safety outcome assessment, efficacy outcome assessment, and topics specific to evaluating percutaneous venous thrombectomy and stent placement. Using modified Delphi techniques for consensus achievement, a panel of physician experts in vascular disease voted on the statements and succeeded in reaching the predefined threshold of >80% consensus (agreement or strong agreement) on all 30 statements. It is hoped that the guidance from these statements will improve standardization, objectivity, and patient-centered relevance in the reporting of clinical outcomes of endovascular interventions for acute iliofemoral deep venous thrombosis and chronic iliofemoral venous obstruction in clinical studies and thereby enhance venous patient care.

High-Risk Characteristics for Clinical Failure after Isolated Femoropopliteal Peripheral Vascular Interventions.

BACKGROUND: Recent studies suggesting increased late mortality with paclitaxel-coated devices (PCDs) in femoropopliteal peripheral vascular interventions (PVIs) prompted the US Food and Drug Administration to recommend limiting the use of PCDs to "patients at particularly high risk for restenosis". This study's aim is to characterize patients at high risk for restenosis and develop a risk score to guide clinicians in selecting patients for treatment with PCDs. METHODS: Patients who underwent isolated femoropopliteal PVI for claudication or rest pain from 2016-2019 in the Vascular Quality Initiative were included. Patients who received intervention with a PCD, hybrid procedures, died within 1 year, or had missing follow-up data were excluded. The primary end point was clinical failure at 1 year defined as > 50% restenosis, loss of patency, reintervention, or major amputation. Data were split randomly into 2/3 for development and 1/3 for validation. A parsimonious multivariable hierarchical logistic regression for clinical failure was developed and a risk score was created using beta-coefficients. The risk score was applied to the validation dataset and tested for goodness-of-fit and discrimination. RESULTS: Among 4,856 treated patients, 718 (14.8%) experienced clinical failure within 1 year. Clinical failure was associated with age ≤ 50 years, female sex (48.1% vs. 39.5%), insulin-dependent diabetes (29.9% vs. 23.1%), creatinine > 2.0 mg/dL (9.9% vs. 5.7%), prior ipsilateral lower extremity revascularization (48.5% vs. 38.5%), prior ipsilateral minor amputation (5.3% vs. 1.7%), rest pain versus claudication (30.8% vs. 18.7%), occlusion length ≥ 20 cm (18.8% vs. 15.0%), and Trans-Atlantic Inter-Society Consensus II Classification C or D (40.4% vs. 28.0%), all P ≤ 0.01. Risk score development was performed using a multivariable regression. The model demonstrated good fit and discrimination (C-statistic 0.71 in development and 0.72 in validation dataset). Predicted clinical failure was 8.9% for standard-risk (45.9% of interventions), 15.5% for high-risk (44.2% of interventions), and 33.8% for very high-risk patients (9.8% of interventions). CONCLUSIONS: A novel risk score was created with good discrimination for identifying patients at high risk for clinical failure at 1 year after femoropopliteal PVI for claudication and rest pain. Patients at high risk and very high risk for clinical failure may benefit from alternative strategies including PCDs.

Presenting limb severity is associated with long-term outcomes after infrainguinal revascularization for chronic limb-threatening ischemia.

OBJECTIVE: The SVS Wound, Ischemia, foot Infection (WIfI) limb staging system was established to estimate risk of major amputation in chronic limb-threatening ischemia (CLTI) and better stratify outcomes comparisons. There is little data on treatment outcomes beyond 1 year based on presenting WIfI stage. METHODS: This is a single-institution retrospective study of 413 patients who underwent infrainguinal revascularization for CLTI (2011-2021) with data available for WIfI staging. Patient characteristics and outcomes were gathered from the electronic medical record. Data were analyzed based on presenting WIfI stage and initial treatment received at our center. RESULTS: Presenting WIfI stages were 1 to 2 (23%), 3 (27%), and 4 (50%). Index revascularization approach was endoluminal (59%), autogenous vein bypass (29%), or non-autogenous bypass (13%). Operative mortality within 30 days was 2.9% and was not associated with WIfI stage or revascularization approach. Median limb follow-up time was 502 days (interquartile range [IQR], 112-1256 days), and median survival follow-up time was 932 days (IQR, 343-1770 days). Major amputation or death occurred in 19% and 46% of patients at median times of 119 days (IQR, 28-314 days) and 739 days (IQR, 204-1475 days), respectively. WIfI stage was independently associated with major amputation (P = .001), as was initial revascularization approach (P = .01). In a Cox proportional hazards model, factors independently associated with major amputation were male sex (hazard ratio [HR], 1.4; 95% confidence interval [CI], 1.04-2.0; P = .03), diabetes (HR, 1.8; 95% CI, 1.3-2.5; P = .001), WIfI stage 4 (HR, 2.3; 95% CI, 1.5-3.5; P < .001), and non-autogenous bypass (HR, 2.9; 95% CI, 2.1-4.2; P < .001). In a Cox proportional hazards model for mortality, independently associated factors were age (HR, 1.04; 95% CI, 1.02-1.05; P < .001), end-stage renal disease (HR, 2.8; 95% CI, 1.9-4.0; P < .001), congestive heart failure (HR, 1.9; 95% CI, 1.4-2.5; P < .001), chronic obstructive pulmonary disease (HR, 1.5; 95% CI, 1.1-2.1; P = .02), and WIfI stage 4 (HR, 1.6; 95% CI, 1.04-2.2; P = .03). Among those presenting with WIfI stage 4 limbs, Kaplan-Meier estimated rates of freedom from major amputation or death at 2 years were 71% ± 3.7% and 68% ± 3.5%, respectively. In an inverse propensity weighted Cox proportional hazards model, non-white race (HR, 1.5; 95% CI, 1.01-2.2; P = .047), diabetes (HR, 2.0; 95% CI, 1.2-3.3; P = .008), Global Anatomic Staging System infrapopliteal grade (HR, 1.2; 95% CI, 1.05-1.3; P = .005), non-autogenous bypass (HR, 3.2; 95% CI, 1.9-5.3; P < .001), and endoluminal revascularization (HR, 2.6; 95% CI, 1.6-4.3; P < .001) were independently associated with major amputation in the WIfI stage 4 subgroup. CONCLUSIONS: Presenting WIfI stage is strongly associated with long-term risks of major amputation and death following infrainguinal revascularization for CLTI and should be used to stratify outcomes comparisons. Effective revascularization is critical in WIfI stage 4 disease, and autogenous vein bypass provides durable long-term limb preservation.

Efficacy and safety of single versus dual antiplatelet therapy in carotid artery stenting.

OBJECTIVE: Current guidelines recommend dual antiplatelet (AP) therapy (DAPT) before carotid artery stenting (CAS); however, the true clinical effect of single AP therapy vs DAPT is unknown. We examined the efficacy and safety of preoperative single AP therapy vs DAPT in patients who had undergone transfemoral CAS (tfCAS) or transcarotid artery revascularization (TCAR). METHODS: We identified all patients who had undergone tfCAS or TCAR in the Vascular Quality Initiative database from 2016 to 2021. We stratified the patients by procedure and identified those who had received the following preoperative AP regimens: DAPT (acetylsalicylic acid [ASA] + P2Y12 inhibitor [P2Yi]), no AP therapy, ASA only, ASA + AP loading dose, P2Yi only, and P2Yi + AP loading dose. The AP loading dose was given within 4 hours of CAS. We generated propensity scores for each treatment regimen and assessed in-hospital outcomes using inverse probability weighted log binomial regression, with DAPT as the reference and adjusting for intraoperative protamine use. The primary efficacy outcome was a composite end point of stroke and death, and the primary safety outcome was access-related bleeding. RESULTS: Of the 18,570 tfCAS patients, 70% had received DAPT, 5.6% no AP therapy, 10% ASA only, 8.0% ASA + AP loading dose, 4.6% P2Yi only, and 2.9% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 2.2%, 6.8%, 4.1%, 5.1%, 2.4%, and 2.3%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (relative risk [RR], 2.3; 95% confidence interval [CI], 1.7-3.2), ASA only (RR, 1.6; 95% CI, 1.2-2.1), and ASA + AP loading dose (RR, 2.0; 95% CI, 1.5-2.7) but was similar with P2Yi only (RR, 0.99; 95% CI, 0.58-1.7) and P2Yi + AP loading dose (RR, 1.1; 95% CI, 0.49-2.5). Of the 25,459 TCAR patients, 81% had received DAPT, 2.0% no AP therapy, 5.5% ASA only, 3.5% ASA + AP loading dose, 4.9% P2Yi only, and 2.4% P2Yi + AP loading dose. The corresponding unadjusted rates of stroke/death were 1.5%, 3.3%, 3.3%, 2.9%, 1.2%, and 1.1%. After adjustment, compared with DAPT, the incidence of stroke/death was higher with no AP therapy (RR, 2.0; 95% CI, 1.2-3.3) and ASA only (RR, 2.2; 95% CI, 1.5-3.1), with a trend toward a higher incidence with ASA + AP loading dose (RR, 1.6; 95% CI, 0.99-2.6), and was similar with P2Yi only (RR, 0.98; 95% CI, 0.54-1.8) and P2Yi + AP loading dose (RR, 0.66; 95% CI, 0.27-1.6). No differences were found in the incidence of access-related bleeding between the treatment groups after tfCAS or TCAR. CONCLUSIONS: Compared with DAPT, no AP therapy or ASA monotherapy was associated with higher rates of stroke/death after CAS and should be discouraged as unsafe practice. Meanwhile, P2Yi monotherapy was associated with similar rates of stroke/death. No differences were found in the incidence of bleeding complications, and adding an AP loading dose to ASA or P2Yi monotherapy within 4 hours of the procedure did not affect the outcomes. Overall, these findings support the current guidelines recommending DAPT before CAS but also suggest that P2Yi monotherapy might confer thromboembolic benefits similar to those with DAPT. However, an immediate preoperative AP loading dose might not provide additional thromboembolic benefits.

Cognitive Impairment is Common in a Veterans Affairs Population with Peripheral Arterial Disease.

BACKGROUND: Despite the shared pathogenesis of peripheral arterial disease (PAD) and vascular dementia, there are little data on cognitive impairment in PAD patients. We hypothesized that cognitive impairment will be common and previously unrecognized. METHODS: Cognitive impairment screening was prospectively performed for veterans presenting to a single Veterans Affairs outpatient vascular surgery clinic from 2020-2021 for PAD consultation or disease surveillance. Overall, 125 Veterans were screened. Cognitive impairment was defined as a score of <26 on the Montreal Cognitive Assessment (MoCA) survey. A multivariable logistic regression assessed for independent risk factors for cognitive impairment. RESULTS: Overall, 77 (61%) had cognitive impairment, 92% was previously unrecognized. Cognitive impairment was associated with increased age (74.4 vs. 71.8 years, P = 0.03), Black versus White race (94% vs. 54%, P < 0.01), hypertension (66% vs. 31%, P = 0.01), prior stroke/TIA (79% vs. 58%, P = 0.03), diabetes treated with insulin (79% vs. 58%, P = 0.05), and post-traumatic stress disorder (PTSD) (80% vs. 57%, P = 0.04). On multivariable analysis, risk factors for newly diagnosed cognitive impairment included age ≥70 years, diabetes treated with insulin, PTSD, and Black race. CONCLUSIONS: Many veterans with PAD have evidence of cognitive impairment and is overwhelmingly underdiagnosed. This study suggests cognitive impairment is an unrecognized issue in a VA population with PAD, requiring more study to determine cognitive impairment's impact on surgical outcomes, and how it can be mitigated and incorporated into clinical care.

Physiologic risk factors increase risk of myocardial infarction with transcarotid artery revascularization in prospective trials.

OBJECTIVE: Patients can be considered at high risk for carotid endarterectomy (CEA) because of either anatomic or physiologic factors and will often undergo transcarotid artery revascularization (TCAR). Patients with physiologic criteria will be considered to have a higher overall surgical risk because of more significant comorbidities. Our aim was to study the incidence of stroke, myocardial infarction (MI), death, and combined end points for patients who had undergone TCAR stratified by the risk factors (anatomic vs physiologic). METHODS: An analysis of prospectively collected data from the ROADSTER (pivotal; safety and efficacy study for reverse flow used during carotid artery stenting procedure), ROADSTER 2 (Food and Drug Administration indicated postmarket trial; postapproval study of transcarotid artery revascularization in patients with significant carotid artery disease), and ROADSTER extended access TCAR trials was performed. All 851 patients were considered to be at high risk for CEA and were included and stratified using high-risk anatomic criteria (ie, contralateral occlusion, tandem stenosis, high cervical artery stenosis, restenosis after previous endarterectomy, bilateral carotid stenting, hostile neck anatomy with previous neck irradiation, neck dissection, cervical spine immobility) or high-risk physiologic criteria (ie, age >75 years, multivessel coronary artery disease, history of angina, congestive heart failure New York Heart Association class III/IV, left ventricular ejection fraction <30%, recent MI, severe chronic obstructive pulmonary disease, permanent contralateral cranial nerve injury, chronic renal insufficiency). For trial inclusion, asymptomatic patients were required to have had ≥80% carotid stenosis and symptomatic patients to have had ≥50% stenosis. The primary outcome measures were stroke, death, and MI at 30 days. The data were statistically analyzed using the χ2 test, as appropriate. RESULTS: A total of 851 high surgical risk patients were categorized into two groups: those with anatomic-only risk factors (n = 372) or at least one physiologic risk factor present (n = 479). Of the 851 patients, 74.5% of those in the anatomic subset were asymptomatic, and 76.6% in the physiologic subset were asymptomatic. General anesthesia was used similarly in both groups (67.7% anatomic vs 68.1% physiologic). MI had occurred in eight patients in the physiologic group (1.7%), all of whom had been asymptomatic and in none of the anatomic patients (P = .01). The combined stroke, death, and MI rate was 2.1% in the anatomic cohort and 4.2% in the physiologic cohort (P = .10). Stratification of each group into asymptomatic and symptomatic patients did not yield any further differences. CONCLUSIONS: The patients who had undergone TCAR in the present prospective, neurologically adjudicated trial because of high-risk physiologic factors had had a higher rate of MI compared with the patients who had qualified for TCAR using anatomic criteria only. These patients had experienced comparable rates of combined stroke, death, and MI rates. The anatomic patients represented a healthier and younger subset of patients, with notably low overall event rates.

In-hospital outcomes after carotid endarterectomy for stroke stratified by modified Rankin scale score and time of intervention.

OBJECTIVE: Although the benefits of carotid endarterectomy (CEA) for treating symptomatic carotid stenosis are well known, the optimal timing of intervention after acute stroke and whether the optimal timing will vary with preoperative stroke severity has remained unclear. Therefore, we assessed the effect of stroke severity and timing of the intervention on the postoperative outcomes for patients who had undergone CEA for stroke. METHODS: We identified all patients in the Vascular Quality Initiative who had undergone CEA from 2012 to 2020 for prior stroke. The patients were stratified using the preoperative modified Rankin scale score (mRS score, 0-5) and time to CEA after stroke onset (≤2 days, 3-14 days, 15-90 days, 91-180 days). After univariate comparisons, the patients were stratified into the following mRS cohorts for further analysis: 0 to 1, 2, 3 to 4, and 5. The primary outcome was in-hospital stroke/death. RESULTS: We identified 15,601 patients, of whom 30% had had an mRS score of 0, 34% an mRS score of 1, 17% an mRS score of 2, 11% an mRS score of 3, 8% an mRS score of 4, and 1% an mRS score of 5. Overall, 9.3% of the patients had undergone CEA within ≤2 days, 46% within 3 to 14 days, 36% in 15 to 90 days, and 8.4% within 90 to 180 days. A decreasing mRS score and an increasing time to CEA were associated with lower rates of perioperative stroke/death (Ptrend < .01). After risk adjustment, with CEA at 3 to 14 days as the comparator group, the mRS score 0 to 1 group had had a higher incidence of stroke/death after CEA within ≤2 days (3.6% vs 2.0%; odds ratio [OR], 1.8; 95% confidence interval [CI], 1.2-2.7). The mRS score 2 group had had a similar incidence of stroke/death after CEA within ≤2 days (4.4% vs 3.9%; OR, 1.2; 95% CI, 0.6-2.3) but a lower incidence after CEA at 15 to 90 days (2.1% vs 3.9%; OR 0.5; 95% CI, 0.3-0.96). The mRS score 3 to 4 group had had a higher incidence of stroke/death after CEA within ≤2 days (8.0% vs 3.8%; OR, 2.4; 95% CI, 1.5-3.9) but a similar incidence of stroke/death after CEA at 15 to 90 days (3.0% vs 3.8%; OR, 0.8; 95% CI, 0.5-1.3). For the mRS score 5 group, the stroke/death rates were ≥6.5% across all the time to CEA groups. However, the low sample size limited meaningful comparisons. CONCLUSIONS: Patients with minimal disability after stroke (mRS score, 0-1) seemed to benefit from CEA within 3 to 14 days. However, those with severe disability (mRS score 5) have a very high risk from CEA at any time point given the poor outcomes. In contrast to the current guidelines, patients with mild disability (mRS score 2) could benefit from delaying CEA to 15 to 90 days, and those with moderate disability (mRS score 3-4) might benefit from CEA within 3 to 90 days given the acceptable in-hospital outcomes. These data should be considered within the context of the clinical situation in the weeks after index event to determine the net benefit of delayed CEA.

Comparison of Drug-Coated Balloons vs Bare-Metal Stents in Patients With Femoropopliteal Arterial Disease.

BACKGROUND: Endovascular treatment of femoropopliteal artery disease has shifted toward drug-coated balloons (DCB). However, limited data are available regarding the safety and efficacy of DCB vs bare-metal stents (BMS). OBJECTIVES: The purpose of this study was to compare DCB vs BMS outcomes in a propensity-adjusted, pooled analysis of 4 prospective, multicenter trials. METHODS: Patient-level data were pooled from 4 prospective, multicenter studies: the IN.PACT SFA I/II and IN.PACT SFA Japan randomized controlled DCB trials and the Complete SE and DURABILITY II single-arm BMS studies. Outcomes were compared using inverse probability of treatment weighting (IPTW). Clinical endpoints were 12-month primary patency, freedom from 36-month clinically driven target lesion revascularization, and cumulative 36-month major adverse events (MAE). RESULTS: The primary analysis included 771 patients (288 DCB, 483 BMS). IPTW-adjusted demographic, baseline lesion, and procedural characteristics were matched between groups. The adjusted mean lesion length was 8.1 ± 4.7 cm DCB and 7.9 ± 4.5 cm BMS. The IPTW-adjusted Kaplan-Meier estimates of 12-month primary patency (90.4% DCB, 80.9% BMS, P = 0.007), freedom from 36-month clinically driven target lesion revascularization (85.6% DCB, 73.7% BMS, P = 0.001), and cumulative incidence of 36-month MAE (25.3% DCB, 38.8% BMS, P < 0.001) favored DCB. There were no statistically significant differences observed in all-cause mortality, target limb major amputation, or thrombosis through 36 months. CONCLUSIONS: In a patient-level, IPTW-adjusted pooled analysis of prospective, multicenter pivotal studies, DCB demonstrated significantly higher patency, lower revascularization and MAE rates, and no statistically significant differences in mortality, amputation, or thrombosis vs BMS. This analysis supports DCB use vs BMS in moderately complex femoropopliteal lesions amenable to both treatments.