BackgroundData regarding clinical outcomes after optical coherence tomography (OCT)–guided percutaneous coronary intervention (PCI) as compared with angiography-guided PCI are limited.MethodsIn this prospective, randomized, single-blind trial, we randomly assigned patients with medication-treated diabetes or complex coronary-artery lesions to undergo OCT-guided PCI or angiography-guided PCI. A final blinded OCT procedure was performed in patients in the angiography group. The two primary efficacy end points were the minimum stent area after PCI as assessed with OCT and target-vessel failure at 2 years, defined as a composite of death from cardiac causes, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization. Safety was also assessed.ResultsThe trial was conducted at 80 sites in 18 countries. A total of 2487 patients underwent randomization: 1233 patients were assigned to undergo OCT-guided PCI, and 1254 to undergo angiography-guided PCI. The minimum stent area after PCI was 5.72±2.04 mm2 in the OCT group and 5.36±1.87 mm2 in the angiography group (mean difference, 0.36 mm2; 95% confidence interval [CI], 0.21 to 0.51; P<0.001). Target-vessel failure within 2 years occurred in 88 patients in the OCT group and in 99 patients in the angiography group (Kaplan–Meier estimates, 7.4% and 8.2%, respectively; hazard ratio, 0.90; 95% CI, 0.67 to 1.19; P=0.45). OCT-related adverse events occurred in 1 patient in the OCT group and in 2 patients in the angiography group. Stent thrombosis within 2 years occurred in 6 patients (0.5%) in the OCT group and in 17 patients (1.4%) in the angiography group.ConclusionsAmong patients undergoing PCI, OCT guidance resulted in a larger minimum stent area than angiography guidance, but there was no apparent between-group difference in the percentage of patients with target-vessel failure at 2 years. (Funded by Abbott; ILUMIEN IV: OPTIMAL PCI ClinicalTrials.gov number, NCT03507777.)

BackgroundMay-Thurner syndrome (MTS) is defined as compression of the left iliac vein between the right iliac artery and the lumbar vertebral body in the presence of signs and symptoms of unilateral left chronic venous insufficiency. However, imaging findings of compression are not manifest in symptoms of the syndrome in all subjects.ObjectivesTo evaluate findings of compression in an asymptomatic population.MethodsComputed tomography angiographies or venous phase computed tomographies were analyzed. Demographic data and reason for the exam were recorded. Vein diameter was measured at the site of greatest compression and distal of the compression and the ratio between the two diameters was calculated.ResultsFrom January to July of 2016, 590 computed tomography scans were analyzed (357 women and 233 men). Left iliac compression was found in 14.74% of patients. Patients with a left iliac diameter below the 5mm threshold had a mean diameter at the site of greatest iliac vein compression of 4.4 mm (range: 2.67 mm-4.97 mm). The ratio between the two measurements was < 0.5 in 30% of patients.ConclusionsOur study suggests that iliac vein compression is common among random patients who have had computed tomography for any other reason. This indicates that compression found on tomography images is not the only finding to consider when treating a patient.

There is still limited data on the very long term clinical outcomes after ABSORB BRS in daily practice. We sought to evaluate the 3 year-performance of the Absorb bioresorbable vascular scaffolds for the treatment of low/moderate complexity patients enrolled in the ABSORB EXTEND trial. ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and reference vessel diameter of 2.0-3.8 mm (as assessed by on-line QCA). To determine the independent predictors of MACE, a multivariable logistic regression model was built using a stepwise (forward/backward) procedure. Average population age was 61 years and 26.5% had diabetes. Most patients had single target lesion (92.4%). Adequate scaffold deployment (PSP) was achieved in 14.2% of the cases. At three years, the composite endpoints of MACE and ischemia-driven target vessel failure were 9.2% and 10.6%, respectively. The cumulative rate of ARC definite/probable thrombosis was 2.2%, with 1.2% of the cases occurring after the 1st year. Independent predictors of MACE were hypertension and the need for "bail out" stent. At three-year follow-up, the use of ABSORB in low/moderate complex PCI was associated with low and acceptable rates of major adverse clinical events, despite the infrequent use of the recommended contemporary scaffold deployment technique. However, scaffold thrombosis rate was higher than reported with current generation of metallic DES. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).

ObjectiveThe current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible. MethodsUnder the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative—and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards—the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI. ResultsThe current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI. ConclusionsUltimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.

To evaluate evidence that statins reduce cardiovascular risk in patients living with HIV. Moderate to high-dose atorvastatin and rosuvastatin appear to reduce noncalcified coronary plaque volume and slow progression of carotid intima-media thickness in patients with treated HIV infection. Expected lipoprotein changes with statins on the background of modern antiretroviral therapy are similar to the general population. In addition to lipids, the statin benefit may be mediated in part by improvements in vascular inflammation and levels of T-cell and monocyte activation. One concern is the potential for rosuvastatin to cause insulin resistance. Decisions to prescribe statins must be done in the context of global risk assessment, but traditional risk calculators such as the Framingham Risk Score or the American College of Cardiology/American Heart Association pooled-risk equations underestimate risk in this population. Furthermore, many patients with subclinical disease would not be recommended for statins according to the most recent American College of Cardiology/American Heart Association guidelines. Statins are likely to improve cardiovascular outcomes for patients with HIV, but results of the first outcome study are not expected until 2020. In the meantime, clinicians should individualize statin prescriptions, and should consider using more potent statins (rosuvastatin, atorvastatin, and pitavastatin) when possible.

BackgroundIn patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes.MethodsIn this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt–chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year.ResultsTarget-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95% confidence interval, −0.5 to 3.9; P=0.007 for noninferiority and P=0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P=0.29), target-vessel myocardial infarction (6.0% and 4.6%, respectively; P=0.18), or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively; P=0.50). Device thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in 0.7% of patients in the Xience group (P=0.13).ConclusionsIn this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt–chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. (Funded by Abbott Vascular; ABSORB III ClinicalTrials.gov number, NCT01751906.)

To determine the relationships between Krüppel-like factors (KLF) 2 and 4, immune-activation, and subclinical vascular disease in HIV-infected patients on antiretroviral therapy (ART). Double-blind, randomized, placebo-controlled trial. We studied 74 HIV-infected adults on ART enrolled in a randomized clinical trial of statin therapy. KLF2 and KLF4 gene expression was measured by quantitative PCR from peripheral blood mononuclear cells (PBMCs) at baseline and after 24 weeks of 10 mg daily rosuvastatin or placebo. At the same time points, T-cell and monocyte activation were assessed by flow cytometry and vascular health was assessed by cardiac computed tomography and carotid ultrasound. KLF4 expression was negatively correlated with duration of ART (r = -0.351, P = 0.004) and positively correlated with measures of immune activation: proinflammatory monocytes [CD14CD16 (r = 0.343, P = 0.003)], patrolling monocytes [CD14CD16 (r = 0.276, P = 0.017)], and activated CD8 T-lymphocytes [CD8DRCD38 (r = 0.264, P = 0.023)]. KLF2 expression was negatively correlated with subclinical atherosclerosis: mean-mean common carotid artery intima-media thickness (r = -0.231, P = 0.048), mean-max carotid artery intima-media thickness (r = -0.271, P = 0.020), and coronary artery calcium score (r = -0.254, P = 0.029). There were no statistically significant changes in KLF2/4 expression in PBMCs after 24 weeks of rosuvastatin. Expression of KLF4 in PBMCs positively correlates with cellular markers of immune activation, whereas KLF2 expression negatively correlates with markers of subclinical atherosclerosis in this HIV-infected population on ART. Additional studies are needed to determine if targeted interventions might alter KLF2/4 expression to reduce inflammation and vascular risk in humans.

BACKGROUND: The lower limb edema observed in normal people at the end of their working days can vary in intensity and frequency depending on the predominant working positions required to perform different jobs.OBJECTIVES: To compare lower limb volumes of volunteers allocated to three study groups, depending on the predominant positions in which they work.METHODS: Volumetric assessments were conducted of both lower limbs of 51 people free from vascular disease, allocated to three groups of 17 individuals each by predominant working position: sitting, static standing or alternating between the two. Volumes were measured at the start and at the end of the working day and the differences in volumes were calculated for each group. Means and frequencies were compared using appropriate inferential statistics and correlation coefficients were calculated.RESULTS: The groups were homogenous in terms of sex distribution, age, skin color and BMI. The volumetric data from measurements taken before starting work revealed significant differences between all three groups. Volunteers who predominantly worked sitting down had largest volumes, followed by those who remained standing for long periods and then those who varied between these positions. The frequency of lower limb volume increase &gt; 100 mL was significantly higher in the group of people who worked sitting down and maintained this position for long periods.CONCLUSIONS: Postural edema is more common among people who work sitting down for long periods, among whom it appears that there is a cumulative effect from the position, since they exhibit larger lower limb volumes at the start of the day.

BACKGROUND: Varicose veins of the lower limbs have a high prevalence worldwide. New treatment techniques have been developed with the objectives of improving patients' quality of life and reducing recovery times. OBJECTIVE: To evaluate patients with incompetent saphenous veins treated using conventional saphenectomy or radiofrequency ablation (RF), in terms of postoperative status. METHODS: From May 2012 to April 2013 146 varicose veins patients with saphenous insufficiency, 90 of whom were treated with conventional surgery (G1) and 56 with RF ablation (G2), were evaluated prospectively. RESULTS: In G1, 88.61% of patients complained of postoperative pain and needed to take analgesics, compared with 28.85% in G2 (p&lt;0.05). Mean pain rating on an analog scale from 0 to 10 was 3.91±2.13 points for G1 and 1.76±3.01 points for G2 (p&lt;0.05). Recovery periods ranged from 26.63±13.3 days to 18.26±19.37 days, for G1 and G2 respectively. Mean time taken to become totally asymptomatic was 66.78±60.9 days for G1 and 38.38±46.8 days for G2 (p&lt;0.05). CONCLUSIONS: The RF treatment method caused less postoperative pain and resulted in earlier recovery, when compared to conventional saphenectomy.

The aim of this study was to assess clinical complications of limbs undergone harvesting of the great saphenous vein for venous coronary artery bypass graft surgery using bridge technique. Fourty-four patients who had undergone CABG using the great saphenous vein harvested by the bridge technique over more than 3 months ago were randomly selected. The exclusion criteria were the harvesting of both saphenous veins, prior saphenectomy of the contralateral limb, edema caused by a systemic etiology, such as heart, renal, thyroid or hepatic diseases and venous insufficiency of the lower limbs as characterized by swollen varicose veins both with and without trophic changes. The age, gender, diabetes, time of surgery and occurrence of complications, such as edema, paresthesia, infection, lymphorrhea, erysipelas and deep venous thrombosis, were assessed. The assessment was clinic and diagnosis of the diabetes was performed by the preoperative exams. The chi-square, Fisher and Student's t tests were used for statistical analysis with an alpha error of 5%. The time between surgery and assessment ranged between 3 and 187 months with a mean of 47.3+/-42.5 months. Infections of the saphenous harvest site were detected in 25% of the cases, edema in 52.3%, paresthesia in 29.5%, erysipelas in 9.1%, lymphorrhea in 4.5% and deep venous thrombosis in 2.3%. There was no association between diabetes and complications. The saphenous vein harvesting using bridge technique for coronary artery bypass grafting does not eliminate clinical complications, such as paresthesia, infection and edema of the saphenous vein harvesting site.