Baseline modern medical management in the BEST-CLI trial.

OBJECTIVES: The use of optimal medical therapy (OMT) in patients with chronic limb-threatening ischemia (CLTI) has not been well-studied. The Best Endovascular vs Best Surgical Therapy in Patients with CLTI study (BEST-CLI) is a multicenter, randomized, controlled trial sponsored by the National Institutes of Health comparing revascularization strategies in patients with CLTI. We evaluated the use of guideline-based OMT among patients with CLTI at the time of their enrollment into the trial. METHODS: A multidisciplinary committee defined OMT criteria related to blood pressure and diabetic management, lipid-lowering and antiplatelet medication use, and smoking status for patients enrolled in BEST-CLI. Status reports indicating adherence to OMT were provided to participating sites at regular intervals. Baseline demographic characteristics, comorbid medical conditions, and use of OMT at trial entry were evaluated for all randomized patients. A linear regression model was used to identify the relationship of predictors to the use of OMT. RESULTS: At the time of randomization (n = 1830 total enrolled), 87% of patients in BEST-CLI had hypertension, 69% had diabetes, 73% had hyperlipidemia, and 35% were currently smoking. Adherence to four OMT components (controlled blood pressure, not currently smoking, use of one lipid-lowering medication, and use of an antiplatelet agent) was modest. Only 25% of patients met all four OMT criteria; 38% met three, 24% met two, 11% met only one, and 2% met none. Age ≥80 years, coronary artery disease, diabetes, and Hispanic ethnicity were positively associated, whereas Black race was negatively associated, with the use of OMT. CONCLUSIONS: A significant proportion of patients in BEST-CLI did not meet OMT guideline-based recommendations at time of entry. These data suggest a persistent major gap in the medical management of patients with advanced peripheral atherosclerosis and CLTI. Changes in OMT adherence over the course of the trial and their impact on clinical outcomes and quality of life will be assessed in future analyses.

The addition of evolocumab to maximal tolerated statin therapy improves walking performance in patients with peripheral arterial disease and intermittent claudication (Evol-PAD study).

OBJECTIVE: To test the hypothesis that in patients with peripheral arterial disease (PAD) and claudication, treated with maximal tolerated statin therapy, the addition of a monthly subcutaneous injection of evolocumab for 6 months improves treadmill walking performance. BACKGROUND: Lipid lowering therapy improves walking parameters in patients with PAD and claudication. Evolocumab decreases cardiac and limb adverse events in patients with PAD; however, the effect of evolocumab on walking performance is not known. METHODS: We performed a double-blind, randomized, placebo-controlled study to compare maximal walking time (MWT) and pain free walking time (PFWT) in patients with PAD and claudication treated with monthly subcutaneous injections of evolocumab 420 mg (n = 35) or placebo (n = 35). We also performed measurements of lower limb perfusion, brachial flow mediated dilatation (FMD), carotid intima media thickness (IMT), and serum biomarkers of PAD disease severity. RESULTS: After six-months of treatment with evolocumab MWT increased by 37.7 % (87.5 ± 24 s) compared to 1.4 % (-21.7 ± 22.9 s) in the placebo group, p = 0.01. PFWT increased by 55.3 % (67.3 ± 21.2 s) in the evolocumab group compared to 20.3 % (8.5 ± 20.3 s) in the placebo group, p = 0.051. There was no difference in lower extremity arterial perfusion measurements. FMD increased by 42.0 ± 73.9 % (1.01 ± 0.7 %) in the evolocumab group and decreased by 16.29 ± 20.06 % (0.99 ± 0.68 %) in the placebo group (p < 0.001). IMT decreased by 7.16 ± 4.6 % (0.06 ± 0.04 mm) in the evolocumab group and increased by 6.68 ± 4.9 % (0.05 ± 0.03 mm) in the placebo group, (p < 0.001). CONCLUSIONS: The addition of evolocumab to maximal tolerated statin therapy improves maximal walking time in patients with PAD and claudication, increases FMD, and decreases IMT. CONDENSED ABSTRACT: Peripheral arterial disease (PAD) impairs quality of life by causing lower extremity intermittent claudication, rest pain, or amputation. Evolocumab is a monthly injectable monoclonal antibody medication that reduces cholesterol. In this study, we randomly treated patients with PAD and claudication, and on background statin therapy, with evolocumab or placebo, and found that evolocumab improves walking performance on a treadmill test by increasing maximal walking time. We also found that evolocumab decreases plasma MRP-14 levels, a marker of PAD severity.

Relationship between WIfI stage and quality of life at revascularization in the BEST-CLI trial.

OBJECTIVE: The WIfI (Wound, Ischemia, foot Infection) stage measures the extent of wounds, ischemia, and foot infection in patients with chronic limb threatening ischemia (CLTI) and has been associated with the risk of major amputation. Patients with CLTI have impaired health-related quality of life (HRQoL), which can be multifactorial. We hypothesized that the severity of the limb threat (WIfI stage) would be associated with poor HRQoL among patients with CLTI presenting for revascularization. METHODS: The dataset of the BEST-CLI (best endovascular versus best surgical therapy in patients with CLTI) trial, a prospective, randomized trial comparing open and endovascular revascularization strategies, was queried for HRQoL assessments at patient enrollment. The HRQoL assessments included (1) Vascular Quality of Life; (2) 12-item short form survey (SF-12), containing the utility index score (short-form six-dimension R2 utility index, incorporating physical, emotional, and mental well-being) and mental and physical components; and (3) the EQ-5D. Multivariable regression analysis was used to identify the independent associations with the baseline HRQoL assessments. RESULTS: A total of 1568 patients with complete WIfI data were analyzed, of whom 71.5% were men. The WIfI distribution was 35.5% with stage 4, 29.6% with stage 3, 28.6% with stage 2, and 6.3% with stage 1. Patients presenting with WIfI stage 4, compared with stage 1 to 3, were more often men (74.9% vs 69.6%) and current smokers (25.4% vs. 17.6%), had had end-stage renal disease (13.3% vs 8.5%) and diabetes (83.6% vs 60.2%), were not independently ambulatory (56.8% vs 38.5%), and had had higher median morbidity scores (4 vs 3; P < .05 for all). On multivariable analysis, WIfI stage 4, compared with stage 1 to 3, was associated with lower SF-12 mental component scale scores (estimate, -2.43; 95% confidence interval, -3.73 to -1.13; P < .001) and short-form six-dimension R2 utility index scores (estimate, -0.02; 95% confidence interval, -0.03 to 0.001; P = .04). The WIfI stage was not independently associated with the baseline Vascular Quality of Life, SF-12 physical component scale, or EQ-5D assessments. CONCLUSIONS: WIfI stage was independently associated with poorer quality of life because of mental, rather than physical, health for patients with CLTI. Clinicians should be aware of the burden of mental stress borne by those with the greatest limb impairment.

Surgery or Endovascular Therapy for Chronic Limb-Threatening Ischemia.

BACKGROUND: Patients with chronic limb-threatening ischemia (CLTI) require revascularization to improve limb perfusion and thereby limit the risk of amputation. It is uncertain whether an initial strategy of endovascular therapy or surgical revascularization for CLTI is superior for improving limb outcomes. METHODS: In this international, randomized trial, we enrolled 1830 patients with CLTI and infrainguinal peripheral artery disease in two parallel-cohort trials. Patients who had a single segment of great saphenous vein that could be used for surgery were assigned to cohort 1. Patients who needed an alternative bypass conduit were assigned to cohort 2. The primary outcome was a composite of a major adverse limb event - which was defined as amputation above the ankle or a major limb reintervention (a new bypass graft or graft revision, thrombectomy, or thrombolysis) - or death from any cause. RESULTS: In cohort 1, after a median follow-up of 2.7 years, a primary-outcome event occurred in 302 of 709 patients (42.6%) in the surgical group and in 408 of 711 patients (57.4%) in the endovascular group (hazard ratio, 0.68; 95% confidence interval [CI], 0.59 to 0.79; P<0.001). In cohort 2, a primary-outcome event occurred in 83 of 194 patients (42.8%) in the surgical group and in 95 of 199 patients (47.7%) in the endovascular group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06; P = 0.12) after a median follow-up of 1.6 years. The incidence of adverse events was similar in the two groups in the two cohorts. CONCLUSIONS: Among patients with CLTI who had an adequate great saphenous vein for surgical revascularization (cohort 1), the incidence of a major adverse limb event or death was significantly lower in the surgical group than in the endovascular group. Among the patients who lacked an adequate saphenous vein conduit (cohort 2), the outcomes in the two groups were similar. (Funded by the National Heart, Lung, and Blood Institute; BEST-CLI ClinicalTrials.gov number, NCT02060630.).

Evaluation of percutaneous transcatheter embolization for pulmonary arteriovenous malformations.

BACKGROUND: The purpose of this study was to assess the safety and efficacy of percutaneous transcatheter embolization (TCE) for the treatment of pulmonary arteriovenous malformations (PAVMs). METHODS: Forty-three consecutive patients (n = 17 males; n = 26 females) with 72 untreated PAVMs underwent coil and/or plug embolization between January 2010 and February 2018. The mean patient age was 42 ± 14 years (range 19-71 years). The median size of the feeding artery was 7.9 ± 2.9 mm (range 3.5-14.0 mm). The arterial blood gas level and cardiac function of all patients were analysed. The technical success rate, recanalization rate, and complications were evaluated. Computed tomography angiography (CTA) examinations were scheduled for 12 months after treatment and every 2-4 years thereafter. RESULTS: Twenty-five PAVMs were treated with coils alone, twenty-one were treated with plugs alone, and twenty-six were treated with both coils and plugs. The technical success rate was 100%. There were no complications during operation. However, one patient (2.3%) had pulmonary thrombosis and embolism post-operation. The patients' pre-operative and post-operative PaO2 and SaO2 levels were significantly different (p < 0.01). A comparison of the New York Heart Association (NYHA) grade before and after embolization in all patients showed a significant decrease in the post-operative grade (p < 0.01). The 72 PAVMs were divided into three groups (coils only group [n = 25], plugs only group [n = 21], and coils/plugs combined group [n = 26]). After 12 months of follow-up, there were seven reperfusion PAVMs in the coil group, seven reperfusion PAVMs in the plug group, and 1 reperfusion PAVM in the combined group. There were significant differences between the two groups and the combined group. CONCLUSION: Percutaneous TCE is safe and effective for the treatment of PAVMs. A combination of coils and vascular plugs may be useful for preventing recanalization after the embolization of PAVMs.

Factors Associated With the Use of Bare Metal Stents in Patients With ST Elevation Myocardial Infarction.

BACKGROUND: Drug eluting stents (DES) are used in the majority of patients undergoing percutaneous coronary intervention (PCI). Factors associated with the use of bare metal stents (BMS) for patients undergoing primary PCI for ST elevation myocardial infarction (STEMI) have not been adequately explored. The objective of this study was to evaluate factors associated with BMS use in STEMI patients undergoing primary PCI. METHODS: Patients undergoing primary PCI for STEMI between January 2008 and February 2015 were retrospectively identified. Patients who received both a DES and BMS were included in the DES group and patients receiving balloon angioplasty only were excluded. Baseline demographics, angiographic variables, procedure related variables and in-hospital events were collected. Multivariate analysis was performed to identify factors associated with BMS use. RESULTS: Eight hundred and sixty-five patients underwent primary PCI for STEMI during the study period. Seventy-two patients (8.3%) received balloon angioplasty only and were excluded, yielding 793 patients for the study cohort. Three hundred fifty-two patients (44%) received BMS and 441 patients (56%) received DES. Patients receiving DES had a higher prevalence of diabetes mellitus, prior myocardial infarction, prior PCI, left anterior descending artery culprit location and Medicaid Insurance compared to those receiving BMS. Patients receiving BMS had a higher prevalence of cardiogenic shock and right coronary artery culprit location. Unadjusted in-hospital mortality was significantly higher for patients receiving BMS compared to patients receiving DES, 11.1% vs 3.2%, respectively, p < 0.0001. Multivariate predictors of BMS use were cardiogenic shock (OR 30.3; 95% CI 11.25 to 81.73) and diabetes mellitus (OR 2.99; 95% CI 1.04 to 8.64). CONCLUSION: In a contemporary series of patients undergoing primary PCI for STEMI, BMS were used in 44% of patients and independent factors associated with BMS use were cardiogenic shock and diabetes mellitus.

Predictors of Major Adverse Limb Events after Open Forefoot Amputation in Patients with Chronic Limb-Threatening Ischemia.

BACKGROUND: Management of patients with chronic limb-threatening ischemia (CLTI) and extensive foot necrosis presents a challenge for limb salvage. Our study evaluates preoperative risk factors that contributed to durability and efficacy of limb salvage after open transmetatarsal amputation (TMA) in patients with critical limb-threatening ischemia. METHODS: We abstracted data from patients who underwent open TMA at Los Angeles County-University of Southern California Medical Center and Keck Hospital of University of Southern California from 2009 to 2018. Multivariable logistic regression analysis, adjusting for preoperative risk factors, was used to examine predictors of major adverse limb events (MALE). The aim was to evaluate outcomes following open TMA with MALE as the primary outcome. Our hypotheses were that outcomes would be worse for patients with foot infections and renal failure. RESULTS: Forty-three open TMAs were done in 39 patients during the study period. The cohort had a mean age of 63 ± 11.6 years, 89% had a history of diabetes, 95% hypertension (HTN), 54% had end-stage renal disease (ESRD), and 26% were current smokers. MALE occurred in 39% of the cohort. Sex, race, indication, HTN, smoking status, and history of prior ipsilateral revascularization or minor amputations were not associated with MALE (P > 0.05). Multivariate logistic regression found ESRD to be an independent predictor of MALE (odds ratio 7.43, 95% confidence interval 1.12-49.17, P = 0.038) after adjusting for clinically significant covariates. CONCLUSIONS: Open TMA provides acceptable rates of limb salvage for complex patients with CLTI. ESRD is an independent risk factor for MALE following open TMA in these patients. Vigilant follow-up is essential for this morbid patient population given poorer outcomes after forefoot amputation.

Therapeutic Window of Clopidogrel and Ticagrelor in Patients With Critical Limb-Threatening Ischemia.

BACKGROUND: Critical limb-threatening ischemia (CLTI) is associated with an increased risk of major adverse limb events and mortality. High on-treatment platelet reactivity (HPR) is associated with an increased risk of ischemic events, while low on-treatment platelet reactivity (LPR) is associated with an increased risk of bleeding. This study investigates the frequency with which patients with CLTI on clopidogrel or ticagrelor achieve a "therapeutic window" (TW) of platelet inhibition. METHODS: Data from the "Switch To Ticagrelor in Critical Limb Ischemia Anti-Platelet Study" were assessed retrospectively to determine the incidence of TW of on-treatment platelet reactivity in 50 consecutive patients with CLTI (mean age: 65.2 ± 10.5 years, 54% male). The data included 4 measurements of patients' platelet reactivity using the VerifyNow P2Y12 Assay: baseline and steady state platelet reactivity on clopidogrel 75 mg daily and on ticagrelor 90 mg twice daily. RESULTS: At baseline, 46% of patients on clopidogrel were within TW of on-treatment platelet reactivity compared to 10% of patients on ticagrelor (P < .0001). At steady state, 42% of patients on clopidogrel were within the TW compared to 10% of patients on ticagrelor (P < .0001). Patients on ticagrelor exhibited higher rates of LPR compared to those on clopidogrel at baseline as well as at steady state (baseline 88% vs 18%, steady state 88% vs 28%; P < .0001). CONCLUSION: Although ticagrelor has been proposed as an alternative for patients with HPR on clopidogrel, the current study observes an excess of platelet inhibition with ticagrelor in most patients with CLTI at a dose of 90 mg twice daily.

"The Renal Foot" - Angiographic Pattern of Patients with Chronic Limb Threatening Ischemia and End-Stage Renal Disease.

BACKGROUND: Patients with chronic limb threatening ischemia (CLTI) and end-stage renal disease (ESRD) have greater risk of limb loss compared to those with CLTI alone. We investigated angiographic patterns in patients with CLTI and evaluated for differences based on ESRD status. METHODS: We reviewed lower extremity angiograms of 152 CLTI patients at a single academic medical center from 2011 to 2017 and analyzed them based on the Graziani and Bollinger classification systems. We used these classification systems to evaluate for angiographic patterns and arterial disease severity categorized by the presence or absence of ESRD. RESULTS: The analysis included 152 CLTI patients (161 angiograms). Patients' mean age was 63.4 ±â€¯11.3 years and 20 (12.4%) patients had ESRD. In our study population, infrapopliteal arterial disease was more severe than femoropopliteal disease. Disease of the arteries providing direct flow to the plantar arch was more severe in ESRD patients compared to non-ESRD patients, evident by higher Graziani Class VII disease (20% vs. 4.9%, p = .03). ESRD patients also had higher rates of concurrent significant stenosis of the posterior tibial and lateral plantar arteries (70% vs. 23%, p < .0001). CONCLUSION: In people with CLTI, infrapopliteal arteries are more severely affected than proximal femoropopliteal arteries. ESRD patients exhibit a pattern of arterial disease, we termed the "renal foot," that frequently involves arteries providing direct flow to the plantar arch.

How to Create a Hot Foot Line to Prevent Diabetes-Related Amputations: Instant Triage for Emergency Department and Inpatient Consultations.

Emergency department visits for lower extremity complications of diabetes are extremely common throughout the world. Surprisingly, recent data suggest that such visits generate an 81.2% hospital admission rate with an annual bill of at least $1.2 billion in the United States alone. The likelihood of amputation and other subsequent adverse outcomes is strongly associated with three factors: 1) wound severity (degree of tissue loss), 2) ischemia, and 3) foot infection. Using these factors, this article outlines the basic principles needed to create an evidence-based, rapid foot assessment for diabetic foot ulcers presenting to the emergency department, and suggests the establishment of a "hot foot line" for an organized, expeditious response from limb salvage team members. We present a nearly immediate assessment and referral system for patients with atraumatic tissue loss below the knee that has the potential to vastly expedite lower extremity triage in the emergency room setting through greater collaboration and organization.

In-Hospital Outcomes of Rotational Atherectomy in High-Risk Patients With Severely Calcified Left Main Coronary Artery Disease: A Single-Center Experience.

BACKGROUND: Severe coronary artery calcification is a challenge for percutaneous coronary intervention (PCI), particularly in left main coronary artery disease (LM-CAD). Rotational atherectomy (RA) is a useful tool for modification of calcified plaque prior to PCI. We report our experience with RA for severely calcified LM-CAD. METHODS: From January 2008 to January 2017, all patients who underwent RA-assisted LM-PCI were evaluated. The study population included both protected and unprotected LM-CAD patients. Clinical characteristics and in-hospital outcomes were collected retrospectively. In-hospital outcomes included post-PCI myocardial infarction, stroke, death, emergency coronary artery bypass graft surgery, and urgent repeat PCI. Angiographic success was defined by residual stenosis <20% and presence of TIMI 3 flow. RESULTS: Fifty-five consecutive patients who underwent RA-assisted PCI of LM-CAD were identified (mean age, 73.0 ± 10 years; 64% male). Mean left ventricular ejection fraction was 37.5 ± 15.7%. Fifty-one patients (93%) had multivessel disease and 39 patients (71%) underwent RA-assisted LM-PCI with use of a mechanical support device. The median largest burr size used was 1.5 mm. The mean number of LM stents implanted was 0.95 ± 0.3. The mean LM stent diameter and length were 3.7 ± 0.3 mm and 15.8 ± 7.5 mm, respectively. Intravascular ultrasound was used to assess vessel size and stent apposition in 20 patients (36.0%). Angiographic success was obtained in all patients (100%). CONCLUSION: Despite technical challenges, RA of the LM coronary artery can be performed safely and is associated with a high rate of angiographic success.

Anticoagulation Patterns in Patients with Atrial Fibrillation Following Percutaneous Coronary Intervention in an Academic Center.

A common dilemma facing physicians treating patients with atrial fibrillation (AF) who have undergone percutaneous coronary intervention (PCI) is the management of oral anticoagulation (OAC) therapy, because there is also an indication for dual antiplatelet therapy in these patients. The purpose of this study was therefore to evaluate anticoagulation patterns in this patient population in an attempt to identify patterns of risk factors that may influence OAC prescribing habits. This retrospective study entailed a review of a total of 4,648 patients from two academic hospitals who underwent PCI between 2008 and 2016. We ultimately included 211 patients who had AF and an indication for OAC. Chart review revealed patients' risk factors, CHA2DS2-VASc and HAS-BLED scores, and antithrombotic regimens. Only 105 (49.8%) patients who met the indications for OAC were actually placed on OAC post-PCI. There was no significant relationship between discharge on OAC and HAS-BLED score (t = 0.14; p = 0.44) or CHA2DS2-VASc score (t = 0.76; p = 0.22). Patients younger than 65 years of age were prescribed more triple therapy (56% versus 33%; p < 0.01) or any OAC (69% versus 41%; p < 0.01) on discharge in comparison with patients 65 years of age or older. The older patient group had a significantly higher average CHA2DS2-VASc score (4.4 versus 3.2; p < 0.01) and a higher average HAS-BLED score (2.8 versus 2.4; p < 0.01). Ultimately, this study indicated that less than half of AF patients with an indication for OAC were placed on OAC post-PCI. There was no association between discharge on OAC and CHA2DS2-VASc score, HAS-BLED score, or any other individual risk factor, with the exception of age.

Use of the STEMI Team for Treatment of Patients With Pulmonary Embolism: A Pilot Study.

BACKGROUND: Patients with massive and submassive pulmonary embolism (PE) require rapid identification, triage, and consideration for reperfusion therapy. Use of an existing ST-segment elevation myocardial infarction (STEMI) team and activation protocol may be an effective means to care for these patients. OBJECTIVE: The objective of this analysis was to evaluate a pilot study using the STEMI team and a dedicated PE protocol for treatment of patients with massive and submassive PE. METHODS: From June 2014 to April 2016, a total of 40 patients with massive and submassive PE were evaluated. Baseline demographics, mode of hospital entry (transfer-in, in-hospital, and emergency department [ED] arrival), treatment time intervals (door to computed tomography PE protocol [CTPE], CTPE to invasive pulmonary angiogram, door to treatment time), procedures performed, and in-hospital clinical events were collected. RESULTS: Mean age was 56 ± 14 years, 17 (42%) were male, and 12 (30%) had a prior history of deep venous thrombosis or PE. Twenty-three patients (57%) had massive PE and 17 patients (43%) had submassive PE. Mode of hospital entry was transfer-in (38%), in-hospital (20%), and ED arrival (42%). Four patients (10%) presented with cardiac arrest, 8 patients (20%) required intubation, and 5 patients (12%) required extracorporeal membrane oxygenation. Ten patients (25%) received anticoagulation therapy or placement of inferior vena cava filter, 3 patients (7.5%) received diagnostic pulmonary angiography alone, and 27 patients (67.5%) received endovascular treatment. For patients arriving via the ED, door to CTPE was 4.9 ± 3.6 hours, CTPE to diagnostic pulmonary angiography was 7.8 ± 8.5 hours, and door to treatment time was 10.2 ± 9.0 hours. Endovascular devices utilized included combinations of rheolytic and other thrombectomy devices as well as catheter-directed fibrinolysis. Length of hospital stay was 15 ± 15 days and in-hospital survival rate was 90%. CONCLUSIONS: Use of an existing STEMI team and activation protocol is a feasible method to care for patients with massive and submassive PE. This pilot study demonstrated rapid treatment times with low in-hospital mortality.

Comparison of devices used in carotid artery stenting: A vascular quality initiative analysis of commonly used carotid stents and embolic protection devices.

BACKGROUND: Data regarding efficacy of various stent and embolic protection device (EPD) combinations to prevent stroke during carotid artery stenting (CAS) is limited. We compared post-procedure inpatient neurologic outcomes across various carotid stent-EPD platforms recorded in the Vascular Quality Initiative (VQI) registry. METHODS: We analyzed 13,786 consecutive CAS procedures in the VQI registry performed between January 1, 2005 and December 31, 2015. The most commonly used stent-EPD combinations (n = 5407) were included in the analysis. Post-procedure inpatient neurologic outcomes included (1) ipsilateral stroke/transient ischemic attack (TIA) and (2) any stroke/TIA. Multivariate generalized estimating equation regression analysis was performed, adjusting for age, sex, tobacco use, coronary artery disease, congestive heart failure, prior stroke/TIA, hypertension, history of carotid revascularization, and presence of a second ipsilateral stenosis >70%, to determine whether risk of outcomes differed according to device. RESULTS: Of 13,786 CAS procedures, Xact-Emboshield (n = 2,438, 17.6%), Precise-Angioguard (n = 1,480, 10.7%), Acculink-Accunet (n = 829, 6.01%), and Acculink-Emboshield (n = 660, 4.8%) were the most commonly used combinations, accounting for a total of 5,407 procedures. Inpatient event rates for ipsilateral stroke/TIA and any stroke/TIA were 1.9 and 2.7% in the Accunet-Acculink, 3.0 and 3.2% in Acculink-Emboshield, 3.2 and 4.1% in Precise-Angioguard and 2.2 and 3.0% in Xact-Emboshield. There was no evidence of difference in risk of ipsilateral stroke/TIA or any stroke/TIA across device combinations (P = 0.15 and P = 0.16, respectively). CONCLUSION: CAS with current carotid stent-EPD combinations is associated with low rates of inpatient stroke/TIA. There is no statistically significant difference in rates of inpatient stroke/TIA across device combinations.

Switch to Ticagrelor in critical limb ischemia antiplatelet study (STT-CLIPS).

OBJECTIVE: To investigate platelet reactivity in patients with critical limb ischemia (CLI) after switching from clopidogrel to ticagrelor. BACKGROUND: High on-treatment platelet reactivity (HPR) is highly prevalent in patients with CLI treated with clopidogrel. The effect of ticagrelor in patients with CLI is not known, however. METHODS: We performed P2Y12 platelet receptor inhibition studies (VASP and VerifyNow) in 50 patients with CLI. Tests were performed before and 6±1h after daily 75mg clopidogrel dose. Patients were then switched to ticagrelor 90mg twice daily for two weeks and platelet assays repeated. Patients were divided based on VerifyNow P2Y12 reaction units (PRU). Group 1: HPR defined as PRU ≥208 and Group 2: Appropriate platelet inhibition (API), PRU <208. RESULTS: After two weeks of uninterrupted antiplatelet therapy, mean PRU results were 173 PRU and 71 PRU at baseline (p<0.0001) and 140 PRU and 63 PRU after 6h (p<0.0001) for clopidogrel and ticagrelor, respectively. Before daily clopidogrel dose, 36% of patients (n=18) demonstrated HPR and after 6h, 30% (n=15). One patient (2%) had HPR on ticagrelor. Ninety-four percent of patients with HPR on clopidogrel demonstrated appropriate platelet inhibition after switching to ticagrelor and all patients with API on clopidogrel remained with API after switching to ticagrelor. Six hours after daily dosing, VASP-PRI >50% was found in 42% of clopidogrel and 2% of ticagrelor treated patients. CONCLUSIONS: Among patients with CLI, ticagrelor achieved greater platelet inhibition than clopidogrel during maintenance treatment and at 6h after daily dosing. High on-treatment platelet reactivity to clopidogrel in patients with CLI can be overcome by switching to ticagrelor.

Prevalence of high on-treatment (aspirin and clopidogrel) platelet reactivity in patients with critical limb ischemia.

OBJECTIVES: The goal of this study is to establish the prevalence of high on-treatment platelet reactivity to aspirin (HPRA) and clopidogrel (HPRC) in patients with critical limb ischemia (CLI). BACKGROUND: CLI is associated with an increased risk of death and cardiovascular events. Unlike other patient populations with atherosclerotic cardiovascular disease, previous studies failed to demonstrate a benefit of antiplatelet therapy in patients with CLI. METHODS: From June 2014 to November 2016, we performed platelet reactivity studies for P2Y12 and thromboxane A2 (TXA2) inhibition in 100 CLI patients receiving daily treatment with aspirin and clopidogrel. P2Y12 inhibition was measured by two assays: vasodilator-stimulated phosphoprotein (VASP) and VerifyNow P2Y12 assays. HPRC was defined as VerifyNow P2Y12 reactive units (PRU) >208 and VASP-platelet reactivity index (VASP-PRI) >50%. TXA2 inhibition was measured with the VerifyNow aspirin test and HPRA was defined as aspirin reaction units (ARU) >550. RESULTS: Mean age was 67±11 years, 50% were male, 80% had diabetes mellitus, and 26% had chronic renal insufficiency. Thirty-three percent of patients had a PRU >208 and 46% a VASP-PRI >50%. HPRC was present in 26% of patients based on the criteria of both a PRU >208 and VASP-PRI >50%. HPRA was present in 25% of patients. The overall prevalence of HPR to ASA or clopidogrel was 35% and HPR to both drugs was present in 8% of patients. Clinical characteristics were similar between groups. CONCLUSIONS: HPR to aspirin or clopidogrel is highly prevalent in patients with CLI. Nearly one in ten patients with CLI is a hyporesponder to both aspirin and clopidogrel.

Computerized tomography angiography by direct intra-aortic low volume contrast injection in patients being evaluated for EVAR.

Background Computerized tomography angiography is an important tool for endovascular repair of abdominal aortic aneurysm planning. This study aimed to evaluate the utility of computerized tomography angiography using direct intra-aortic injection of low volume of iodinated contrast in patients being considered for endovascular repair of abdominal aortic aneurysm. Design A 5F high-flow angiographic catheter was positioned in the mid-thoracic aorta through femoral percutaneous access. Computerized tomography angiography was performed with image acquisition starting simultaneously with power injection of 10 mL of iopamidol 76% diluted with normal saline to 50 mL, at 6 mL/s through the angiographic catheter. Aortic enhancement was assessed with a circular region-of-interest within the aorta. Values ≥150 HU were considered adequate. Results Nine patients with abdominal aortic aneurysm and chronic renal dysfunction underwent computerized tomography angiography with intra-arterial contrast injection for endovascular repair of abdominal aortic aneurysm planning. Mean age 78.8 ± 5.0 years, mean baseline creatinine 1.8 ± 0.4 mg/dL and mean glomerular filtration rate 36.8 ± 4.2 mL/min. Adequate computerized tomography angiography aortic enhancement was obtained in all cases (mean intra-aortic density: 300.4 ± 72.8 HU). The total contrast volume used for the computerized tomography angiography and the endovascular repair of abdominal aortic aneurysm combined was 30.0 ± 21.4 mL. Seventy-five percent of the patients received ≤30 mL of contrast. No significant renal function deterioration occurred (creatinine clearance pre- and post-procedure 36.8 ± 4.2 mL/min versus 38.6 ± 6.1 mL/min, p = 0.32). Successful endovascular repair of abdominal aortic aneurysm was achieved in eight patients. One patient underwent open treatment based on computerized tomography angiography information. No endoleak or aneurysm growth occurred (median follow-up: 121 days (range 36-1242)). Conclusion Direct intra-aortic injection of low volume of iodinated contrast provides adequate and reproducible pattern of aortic enhancement on computerized tomography angiography. The computerized tomography angiography so acquired can be used for endovascular repair of abdominal aortic aneurysm limiting the total volume of iodinated contrast required.

Same-day discharge after coronary stenting and femoral artery device closure: A randomized study in stable and low-risk acute coronary syndrome patients.

OBJECTIVE: To compare same-day (SD) vs. delayed hospital discharge (DD) after single and multivessel coronary stenting facilitated by femoral closure device in patients with stable angina and low-risk acute coronary syndrome (ACS). METHODS: University of Southern California patients were screened and coronary stenting was performed in 2480 patients. Four hundred ninety-three patients met screening criteria and consented. Four hours after percutaneous coronary intervention, 100 were randomized to SD (n=50) or DD (n=50). Patients were followed for one year; outcomes-, patient satisfaction-, and cost analyses were performed. RESULTS: Groups were well distributed, with similar baseline demographic and angiographic characteristics. Mean age was 58.1±8.8years and 86% were male. Non-ST-elevation myocardial infarction and unstable angina were the clinical presentations in 30% and 44% of the SD and DD groups, respectively (p=0.2). Multivessel stenting was performed in 36% and 30% of SD and DD groups, respectively (p=0.14). At one year, two patients from each group (4%) required unplanned revascularization and one patient in the SD group had a gastrointestinal bleed that required a blood transfusion. Six SD and four DD patients required repeat hospitalization (p=0.74). There were no femoral artery vascular complications in either group. Patient satisfaction scores were equivalent. SD discharge was associated with $1200 savings per patient. CONCLUSIONS: SD discharge after uncomplicated single and multivessel coronary stenting of patients with stable, low-risk ACS, via the femoral approach facilitated by a closure device, is associated with similar clinical outcomes, patient satisfaction, and cost savings compared to overnight (DD) hospital stay.

Platelet inhibition with ticagrelor versus clopidogrel in Hispanic patients with stable coronary artery disease with or without diabetes mellitus.

BACKGROUND/PURPOSE: Diabetes mellitus (DM) disproportionately affects Hispanic patients. DM patients have enhanced platelet reactivity and reduced sensitivity to clopidogrel. Ticagrelor demonstrated a more rapid onset and greater magnitude of platelet inhibition than clopidogrel in Hispanic patients with stable coronary artery disease (CAD). This subgroup analysis examined the onset and level of platelet inhibition of ticagrelor and clopidogrel in Hispanic patients with DM. METHODS/MATERIALS: This was a subgroup analysis of a randomized, open-label, crossover study in which 40 Hispanic patients with stable CAD received ticagrelor 180 mg loading dose (LD)/90 mg twice-daily maintenance dose (MD) then clopidogrel 600 mg LD/75 mg once-daily MD, or vice versa. The primary end point was on-treatment platelet reactivity at 2 hours post-LD using the VerifyNow™ P2Y12 test. RESULTS: 21 patients had DM and 19 were non-diabetic. At 2 hours post-LD, mean platelet reactivity in the diabetic group was 34.5 PRU with ticagrelor versus 219.3 PRU with clopidogrel (P<0.001), and in the non-diabetic group was 33.7 PRU with ticagrelor versus 181.0 PRU with clopidogrel (P<0.001). In both diabetic and non-diabetic subgroups, mean platelet reactivity declined to a significantly greater extent with ticagrelor than clopidogrel at all time points evaluated (0.5, 2, and 8 hours post LD and after 7-9 days of MD). Patients were significantly more likely to have high on-treatment platelet reactivity (≥208 PRU) during treatment with clopidogrel compared with ticagrelor, regardless of diabetic status. CONCLUSIONS: Among Hispanic patients with stable CAD, ticagrelor achieves a faster onset and greater magnitude of platelet inhibition compared with clopidogrel, irrespective of diabetic status.

Critical limb ischemia.

Critical limb ischemia (CLI), the most advanced form of peripheral artery disease (PAD), carries grave implications with regard to morbidity and mortality. Within 1 year of CLI diagnosis, 40% to 50% of diabetics will experience an amputation, and 20% to 25% will die. Management is optimally directed at increasing blood flow to the affected extremity to relieve rest pain, heal ischemic ulcerations, avoid limb loss, and prevent cardiovascular events. This management is achieved by guideline-directed medical therapy and risk factor modification, whereas the mainstay of therapy remains revascularization by endovascular or surgical means for patients who are deemed potential candidates.