Major Randomized Controlled Trials Research Articles

Controversies in the management of proximal deep vein thrombosis.

Controversies in the management of proximal deep vein thrombosis.

Efficacy and safety of tofacitinib in the treatment of rheumatoid arthritis: results of 10 years of use

The article presents a review of the basic data on the efficacy and safety of the drug tofacitinib, the place of the drug in the treatment of rheumatoid arthritis (RA) patients according to current international and Russian recommendations. Data on the mechanism of action of Janus kinase inhibitors, the spectrum of cytokines inhibited by tofacitinib is presented. The results of major randomised controlled trials demonstrating high clinical efficacy in patients who have not responded to methotrexate (MT) and other synthetic classical anti-rheumatic drugs (SCARDs), genetically engineered biologic drugs, are presented, with equal efficacy of tofacitinib when given as monotherapy or in combination with MT or other SCARDs, with adalimumab. The safety of tofacitinib with long-term treatment (up to 9.5 years) is analysed. The cardiovascular tolerability of tofacitinib is presented separately, considering the proposals discussed at the last EULAR 2022 Congress. The low incidence of serious cardiovascular adverse events, including venous thrombosis and thromboembolism over the long-term follow-up period, and the risk of these adverse events, which was no higher than on the selective Janus kinase inhibitor baricitinib, are presented. Changes in laboratory parameters (haemoglobin, neutrophil count, aminotransferase concentration) during tofacitinib administration are described. Domestic data on the use of tofacitinib in the treatment of RA patients is demonstrated. An association was shown between early clinical response to tofacitinib (5 mg twice daily) and a reduction in RA activity after 3 and 6 months in RA patients. Tofacitinib in real clinical practice showed early development of effect (by week 12) in the group of patients who did not respond to MT and in 60% of cases to genetically engineered biologic drugs, with respect to indicators of inflammatory activity of RA and functional status of patients. Domestic authors have noted the high safety of tofacitinib. A domestic generic version of the original drug tofacitinib has been reported to be registered for the same indications: RA, psoriatic arthritis, plaque psoriasis, ulcerative colitis.

Managing Heart Failure with Preserved Ejection Fraction; A Short Review of Latest Evidences

Heart failure with preserved ejection fraction (HFpEF) is a clinical dilemma and various clinical trials so far have failed to give a concrete evidence of reducing mortality and major adverse cardiac events (MACE) in this condition. A detailed analysis of the existing evidences and a future plan for a concrete trial design with long duration of follow up is needed to address the dilemma of Heart failure with preserved ejection fraction.
 The objective of this short review was to review the latest and major randomized controlled trials and study the primary outcomes. The public database of PubMed, Google Scholar and Cochrane were extensively searched for all randomized controlled trials using keywords of Heart failure with preserved ejection fraction, major adverse cardiac events, Hospitalizations; and studies were included in the review if data were reported for patients with ejection fraction > 40%, did not include congenital heart disease, and demonstrated evidence of diastolic failure on echocardiogram (ECHO), and evaluated hospitalizations, major adverse cardiac events and cardiovascular mortality.
 Despite the major trials reporting improved primary composite endpoints with newer drugs the results have to be interpreted cautiously since the primary outcome were mostly driven by heart failure hospitalizations and not mortality reduction.

Current recommendations for revascularization of non-infarct-related artery in patients presenting with ST-segment elevation myocardial infarction and multivessel disease.

ST-segment elevation myocardial infarction (STEMI) is a leading cause of morbidity and mortality worldwide. Immediate reperfusion therapy of the infarct-related artery (IRA) is the mainstay of treatment, either via primary percutaneous coronary intervention (PPCI) or thrombolytic therapy when PPCI is not feasible. Several studies have reported the incidence of multivessel disease (MVD) to be about 50% of total STEMI cases. This means that after successful PPCI of the IRA, residual lesion(s) of the non-IRA may persist. Unlike the atherosclerotic plaque of stable coronary artery disease, the residual obstructive lesion of the non-IRA contains a significantly higher prevalence of vulnerable plaques. Since these lesions are a strong predictor of acute coronary syndrome, if left untreated they are a possible cause of future adverse cardiovascular events. Percutaneous coronary intervention (PCI) of the obstructive lesion of the non-IRA to achieve complete revascularization (CR) is therefore preferable. Several major randomized controlled trials (RCTs) and meta-analyses demonstrated the clinical benefits of the CR strategy in the setting of STEMI with MVD, not only for enhancing survival but also for reducing unplanned revascularization. The CR strategy is now supported by recently published clinical practice guidelines. Nevertheless, the benefit of revascularization must be weighed against the risks from additional procedures.

Treatment of Nonalcoholic Steatohepatitis by Obeticholic Acid: Current Status.

Roy PP, Mahtab MA, Rahim MA, et al. Treatment of Nonalcoholic Steatohepatitis by Obeticholic Acid: Current Status. Euroasian J Hepato-Gastroenterol 2022;12(Suppl 1):S46-S50.

Blood pressure control according to type 2 diabetes status

The control of arterial hypertension is mandatory in people with and without type 2 diabetes. The Article by the Blood Pressure Lowering Treatment Trialists' Collaboration (BPLTTC), published in The Lancet Diabetes & Endocrinology.1 One-stage individual participant-level data meta-analysis of 51 major randomised controlled trials with information on type 2 diabetes status at baseline was performed. The included trials compared different antihypertensive drugs versus placebo or other classes of drugs, as well as intensive versus standard blood pressure-lowering strategies.

Blood pressure-lowering treatment for prevention of major cardiovascular diseases in people with and without type 2 diabetes: an individual participant-level data meta-analysis

Controversy exists as to whether the threshold for blood pressure-lowering treatment should differ between people with and without type 2 diabetes. We aimed to investigate the effects of blood pressure-lowering treatment on the risk of major cardiovascular events by type 2 diabetes status, as well as by baseline levels of systolic blood pressure. We conducted a one-stage individual participant-level data meta-analysis of major randomised controlled trials using the Blood Pressure Lowering Treatment Trialists' Collaboration dataset. Trials with information on type 2 diabetes status at baseline were eligible if they compared blood pressure-lowering medications versus placebo or other classes of blood pressure-lowering medications, or an intensive versus a standard blood pressure-lowering strategy, and reported at least 1000 persons-years of follow-up in each group. Trials exclusively on participants with heart failure or with short-term therapies and acute myocardial infarction or other acute settings were excluded. We expressed treatment effect per 5 mm Hg reduction in systolic blood pressure on the risk of developing a major cardiovascular event as the primary outcome, defined as the first occurrence of fatal or non-fatal stroke or cerebrovascular disease, fatal or non-fatal ischaemic heart disease, or heart failure causing death or requiring hospitalisation. Cox proportional hazard models, stratified by trial, were used to estimate hazard ratios (HRs) separately by type 2 diabetes status at baseline, with further stratification by baseline categories of systolic blood pressure (in 10 mm Hg increments from <120 mm Hg to ≥170 mm Hg). To estimate absolute risk reductions, we used a Poisson regression model over the follow-up duration. The effect of each of the five major blood pressure-lowering drug classes, including angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, β blockers, calcium channel blockers, and thiazide diuretics, was estimated using a network meta-analysis framework. This study is registered with PROSPERO, CRD42018099283. We included data from 51 randomised clinical trials published between 1981 and 2014 involving 358 533 participants (58% men), among whom 103 325 (29%) had known type 2 diabetes at baseline. The baseline mean systolic/diastolic blood pressure of those with and without type 2 diabetes was 149/84 mm Hg (SD 19/11) and 153/88 mm Hg (SD 21/12), respectively. Over 4·2 years median follow-up (IQR 3·0-5·0), a 5 mm Hg reduction in systolic blood pressure decreased the risk of major cardiovascular events in both groups, but with a weaker relative treatment effect in participants with type 2 diabetes (HR 0·94 [95% CI 0·91-0·98]) compared with those without type 2 diabetes (0·89 [0·87-0·92]; pinteraction=0·0013). However, absolute risk reductions did not differ substantially between people with and without type 2 diabetes because of the higher absolute cardiovascular risk among participants with type 2 diabetes. We found no reliable evidence for heterogeneity of treatment effects by baseline systolic blood pressure in either group. In keeping with the primary findings, analysis using stratified network meta-analysis showed no evidence that relative treatment effects differed substantially between participants with type 2 diabetes and those without for any of the drug classes investigated. Although the relative beneficial effects of blood pressure reduction on major cardiovascular events were weaker in participants with type 2 diabetes than in those without, absolute effects were similar. The difference in relative risk reduction was not related to the baseline blood pressure or allocation to different drug classes. Therefore, the adoption of differential blood pressure thresholds, intensities of blood pressure lowering, or drug classes used in people with and without type 2 diabetes is not warranted. British Heart Foundation, UK National Institute for Health Research, and Oxford Martin School.

Balanced Salt Solutions for Critically Ill Patients: Nonplused and Back to Basics.

The purpose of this article is to summarize the results of major randomized controlled trials (RCTs) comparing clinical outcomes of critically ill patients treated with normal saline (NS) or balanced salt solutions (BSSs), address discordant results of these studies, and provide direction for future investigations. PubMed (2011 to January 2022) with bibliographies of retrieved articles searched for additional articles. RCTs comparing NS and BSSs in critically ill adult patients. Recently published large RCTs comparing NS with BSSs in heterogeneous populations of intensive care unit patients did not find significant differences in mortality, despite positive findings in some end points in prior RCTs. However, there were a number of methodologic issues common to the RCTs including: varying study designs and end points, clinician discretion for the majority or all treatments other than the primary intervention fluid, heterogeneous patients with varying levels of acuity, and lack of power to investigate potential subgroup differences. In addition, there were problematic issues related to blinding and use of nonstudy fluids. Intravenous fluids are a mainstay of supportive care for critically ill patients. Similar to the so-called crystalloid-colloid debate, there has been a long-standing debate among critical care clinicians and researchers concerning the preferred crystalloid solution, NS versus one of the available BSSs. Despite the recent publication of large multicenter RCTs, the preferred resuscitation fluid, NS or a BSS, for critically ill patients is still open for debate, although the available investigations do provide some direction for clinicians and for future investigations.

Variation in bleeding risk estimates among online calculators: Cross-sectional study of apps used by and for patients with atrial fibrillation.

To assess the variation in bleeding risk estimates and risk stratification among Web and mobile applications for patients with atrial fibrillation. Cross-sectional study. Simulated patient population. Hypothetical patient cohorts that encompassed all possible binary risk factor combinations for each clinical prediction model. Twenty-five bleeding risk calculators (18 Web and 7 mobile apps), each of which used 1 of 4 clinical prediction models to predict an individual's 12-month bleed risk: ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation), HAS-BLED (hypertension [systolic blood pressure >160 mm Hg], abnormal renal or liver function, stroke [caused by bleeding], bleeding, labile international normalized ratio, elderly [age >65 years], drugs [acetylsalicylic acid or nonsteroidal anti-inflammatory drugs] or alcohol [≥8 drinks per week]), HEMORR2HAGES (hepatic or renal disease, ethanol abuse, malignancy, older [age >75 years], reduced platelet count or function, rebleeding risk [history of past bleeding], hypertension [uncontrolled], anemia, genetic factors, excessive fall risk, and stroke), and mOBRI (modified Outpatient Bleeding Risk Index). Four simulated cohorts were constructed. The coefficient of variation, relative difference (RD), and 95% CI for annual bleeding risk estimates were calculated for all hypothetical patient cohorts. Additionally, pairwise agreement between calculators across low- (<10%), moderate- (10% to 20%), and high-risk (>20%) categories of patients was determined. The risk estimates the calculators generated were imprecise, with coefficients of variation ranging from 14% for HEMORR2HAGES to 64% for mOBRI. Wide variation was observed in annual risk estimates for calculators using the mOBRI (maximum RD=4.3) and HAS-BLED (maximum RD=3.1) models. The 95% CI of mean annual bleeding risk varied among models; 1 calculator using the HAS-BLED model had a 95% CI of mean annual risk estimates of 5.4% to 6.2%, while another HAS-BLED calculator reported a 95% CI of 17.7% to 18.5%. Concordance for risk category stratification among calculators was high for those based on mOBRI and ATRIA (=1 for both). Poor agreement was observed in 1 calculator using HEMORR2HAGES (=0.54) and another using HAS-BLED ( range=-0.11 to 0.35). Inconsistencies and a lack of precision were observed in annual risk estimates and risk stratification produced by Web and mobile bleeding risk calculators for patients with atrial fibrillation. Clinicians should refer to annual bleeding risks observed in major randomized controlled trials to inform risk estimates communicated to patients.

Radial Artery Access for Acute Coronary Syndromes: a Review of Current Evidence.

To review the evidence supporting the use of transradial access (TRA) for percutaneous coronary intervention (PCI) in acute coronary syndromes (ACS). There have been five major randomized controlled trials (RCTs) and two recent meta-analyses comparing outcomes of TRA and femoral access (FA) in ACS. Additional studies have explored the impact of TRA on STEMI door-to-balloon (D2B) times, TRA in high-risk ACS patients, the potential conflict between TRA and coronary artery bypass graft (CABG) surgery employing the radial artery, and distal radial artery (DRA) access. TRA is associated with a reduction in net adverse clinical events, major bleeding, acute renal injury, and access site complications compared to FA in ACS patients undergoing PCI. TRA is not associated with significant delays in STEMI D2B times that impact patient outcomes. Further studies are needed to evaluate the role of TRA in high-risk ACS patients, the interplay between TRA and radial artery CABG, and use of DRA in ACS.

Abstract WP86: Gender Disparities In Authorship Of Major Randomized Controlled Trials In Stroke Research

Introduction: Many medical specialties including vascular neurology have recently raised awareness of gender disparities among researchers. This study seeks to investigate patterns and yearly trends in authorship of randomized controlled trials (RCTs) in stroke research. Methods: This study included RCTs from the 2019 AHA/ASA Guidelines for the Early Management of Patients with Acute Ischemic Stroke. Studies that did not distinguish primary authors for publication and rather credited a collaborative group were excluded. Gender was determined for each author based on analysis of names with assistance of online references (institution directories, biographies, news articles, profile photos and professional social media platforms). Validated software (Genderize.io) was used to corroborate gender based on first names with a probability threshold of 60% as implemented in previous work. Chi-squared tests for observed frequencies and linear trend were performed. Differences were considered significant at p&lt;0.05. Results: One hundred eighty-six RCTs were included with a total 2451 authors (78% male, 22% female) covering 46 stroke topics. Publication dates were 1994 to 2019 (median 2014, IQR 2010-2016). Number of authors for each study ranged from 1 to 56, with a mean±SD of 13±10 authors. Of the 186 included studies, 145 (78%) had male first authors and 41 (22%) had female first authors (p&lt;0.0001). One hundred fifty-nine (85%) studies had male senior authors and 27 (15%) had female senior authors (p&lt;0.0001). Distribution of authorship by country revealed higher prevalence of male first and senior authors for all countries except the Netherlands (n=5 RCTs), Sweden (n=1) and India (n=1). Yearly trends in authorship distribution from 1994 to 2019 did not identify any significant shift in authorship for first or senior authors based on gender (p&gt;0.05). Conclusions: This study reveals that gender disparities are prevalent across the field of stroke research. Female authors are underrepresented in both roles of first and senior authors in major RCTs. This discrepancy is present across nearly all countries and has persisted over the past three decades. Continued research and targeted interventions are needed to alleviate gender disparities in stroke research.

Abstract WP193: Clinical Profile Of Patients With Non-cardioembolic Ischemic Stroke Or Transient Ischemic Attack Benefiting Most From Dual Antiplatelet Therapy

Introduction: The clinical profile of patients with non-cardioembolic ischemic stroke (IS) or transient ischemic attack (TIA) who benefit from dual antiplatelet therapy (DAPT) is not well established. The aim of this study is to identify those characteristics in this population. Methods: We performed a study-level random effects meta-analysis of major randomized controlled clinical trials comparing DAPT to monotherapy antiplatelet treatment (MAPT). Efficacy and safety outcomes were rates of recurrent stroke and major hemorrhage. Baseline demographic and clinical characteristics were recorded. Pooled statistics were calculated as odds ratios (ORs) with 95% confidence intervals (CIs). Heterogeneity was assessed by I 2 . The effects of baseline variables on the log odds ratio of efficacy and safety outcomes for MAPT and DAPT were determined by meta-regression analyses. Results: The analysis included 19 studies (N=76407; 50% on DAPT). There were no differences in baseline characteristics between the groups, except for a higher prevalence of previous antiplatelet use in the MAPT arm (OR=1.07; p=0.04). DAPT decreased the odds of recurrent stroke (OR, 0.74, 95% CI, 0.65-0.85, I 2 =66%) and increased odds of major hemorrhage (OR, 1.51, 95% CI, 1.11-2.07, I 2 =76%). In meta-regression analysis, both DAPT and MAPT benefitted patients irrespective of their baseline characteristics, except for patients with increased stroke severity (as measured by NIHSS at presentation) which reduced the risk of recurrent stroke in the DAPT group (r 2 =16%, p&lt;0.05), but not in the MAPT group (p&gt;0.05). Risk of major hemorrhage was increased in patients with history of congestive heart failure (DAPT: OR= -0.001, p=0.02; MAPT: OR= -0.001, p=0.02) and in those with prior antiplatelet use (DAPT: OR= -0.001, p=0.02; MAPT: OR= -0.001, p=0.02). Conclusions: MAPT and DAPT reduce the risk of recurrent stroke irrespective of baseline characteristics. However, DAPT, but not MAPT, benefits patients with increased stroke severity. History of congestive heart failure and prior use of antiplatelet have a modest incremental effect in the risk of major hemorrhage.

Review on concepts of hypertension treatment

The outcome of treatment in elderly hypertensives is examined in six major randomized controlled trials. Thiazide diuretics were first-or second-line drugs in each, and the development of a national database on normative blood pressure levels throughout childhood has contributed to the recognition of elevated blood pressure in children and adolescents. The epidemic of childhood obesity, the risk of developing left ventricular hypertrophy, and evidence of the early.

Statin Intolerance and Noncompliance: An Empiric Approach

Statin Intolerance and Noncompliance: An Empiric Approach

Timing of kidney replacement therapy initiation in acute kidney injury.

Over the past 5 years, four major randomized controlled trials were published informing our practice on the optimal timing for kidney replacement therapy (KRT) initiation in critically ill patients with acute kidney injury (AKI). In this review, we summarize the main findings of these trails and discuss the knowledge gaps that still need to be addressed. Four recent trials compared early versus delayed initiation of KRT in critically ill patients with acute kidney injury. Though each trial had unique design features, the three largest trials showed that earlier initiation of KRT did not reduce all-cause mortality. A preemptive strategy for initiation of kidney replacement therapy does not confer better survival in critically ill patients with severe AKI. However, early initiation of KRT was associated with a greater risk of iatrogenic complications and one trial showed a higher risk of persistent dialysis dependence. In the absence of absolute indications for KRT, clinicians should defer KRT initiation in patients with AKI. Further research is needed to examine the safety of prolonged KRT deferral and identify markers of fluid overload that may serve to trigger KRT initiation.

An update on CT screening for lung cancer: the first major targeted cancer screening programme.

Screening for lung cancer with low radiation dose CT has been shown to be effective in reducing lung cancer mortality by two major randomised controlled trials. Lung cancer screening is set to become the largest targeted cancer screening programme globally, but the effectiveness of the programme is dependent on many different factors. This article describes the key evidence for lung cancer screening, the key factors important for optimisation and the progress towards implementation.

Artificial Intelligence and Hypertension: Recent Advances and Future Outlook.

Prevention and treatment of hypertension (HTN) are a challenging public health problem. Recent evidence suggests that artificial intelligence (AI) has potential to be a promising tool for reducing the global burden of HTN, and furthering precision medicine related to cardiovascular (CV) diseases including HTN. Since AI can stimulate human thought processes and learning with complex algorithms and advanced computational power, AI can be applied to multimodal and big data, including genetics, epigenetics, proteomics, metabolomics, CV imaging, socioeconomic, behavioral, and environmental factors. AI demonstrates the ability to identify risk factors and phenotypes of HTN, predict the risk of incident HTN, diagnose HTN, estimate blood pressure (BP), develop novel cuffless methods for BP measurement, and comprehensively identify factors associated with treatment adherence and success. Moreover, AI has also been used to analyze data from major randomized controlled trials exploring different BP targets to uncover previously undescribed factors associated with CV outcomes. Therefore, AI-integrated HTN care has the potential to transform clinical practice by incorporating personalized prevention and treatment approaches, such as determining optimal and patient-specific BP goals, identifying the most effective antihypertensive medication regimen for an individual, and developing interventions targeting modifiable risk factors. Although the role of AI in HTN has been increasingly recognized over the past decade, it remains in its infancy, and future studies with big data analysis and N-of-1 study design are needed to further demonstrate the applicability of AI in HTN prevention and treatment.

Paradigm Shifts in the Management of Diabetes in Pregnancy: The Importance of Type 2 Diabetes and Early Hyperglycemia in Pregnancy: The 2020 Norbert Freinkel Award Lecture.

For over 50 years, the diagnosis of gestational diabetes mellitus (GDM) has been based upon an oral glucose tolerance test at 24-28 weeks' gestation. This is the time during pregnancy when insulin resistance is increasing and hyperglycemia develops among those with insufficient insulin secretory capacity to maintain euglycemia. The Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study and the two major randomized controlled trials of treating GDM are based upon recruitment of women at this time during pregnancy. Meanwhile, the increasing prevalence of type 2 diabetes in pregnancy, with its significant risk of adverse pregnancy outcomes, has led to a need to identify undiagnosed diabetes as near to conception as possible. Screening for undiagnosed diabetes early in pregnancy also identifies women with hyperglycemia less than overt diabetes, yet at increased risk of adverse pregnancy outcomes. Such women are more insulin resistant-with higher blood pressure, triglycerides, perinatal mortality, and neonatal hypoglycemia with a greater need for insulin treatment-than those with GDM diagnosed at 24-28 weeks' gestation. Currently, there is uncertainty over how to diagnose GDM early in pregnancy and the benefits and harms from using the current management regimen. Randomized controlled trials testing the criteria for, and treatment of, GDM early in pregnancy are urgently needed to address this existing equipoise. In the meantime, the importance of early or "prevalent GDM" (i.e., mild hyperglycemia present from early [before] pregnancy) warrants interim criteria and thresholds for medication, which may differ from those in use for GDM diagnosed at 24-28 weeks' gestation.

CRT-600.19 Short- and Long-Term Outcomes of Patients With and Without End-Stage Renal Disease on Dialysis Undergoing Transcatheter Aortic Valve Implantation: A Meta-Analysis

Transcatheter aortic valve implantation (TAVI) has become the main treatment for symptomatic, severe aortic stenosis, but patients on dialysis have been excluded from major randomized controlled trials. Our aim was to compare outcomes after TAVI of patients with end-stage renal disease (ESRD) on

Short- and Long-term Outcomes in Dialysis Patients Undergoing Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-analysis

BackgroundTranscatheter aortic valve implantation (TAVI) has become the main treatment for symptomatic severe aortic stenosis, but patients on dialysis have been excluded from major randomized controlled trials. Our aim was to compare mortality and procedure-related complications after TAVI in patients with end-stage renal disease (ESRD) on dialysis vs those without. MethodsEMBASE and MEDLINE were searched through November 2019 to investigate the comparative outcomes between patients with ESRD on dialysis and those without who underwent TAVI. The main outcomes were short-term (30-day/in-hospital) mortality and procedural complications, and long-term (>6 months) all-cause mortality. ResultsOur search identified 10 observational studies enrolling 128,094 (5399 on dialysis) patients who underwent TAVI. Dialysis patients had a significantly higher rate of short-term and long-term mortality than nondialysis patients (odds ratio [95% confidential interval]: 2.18 [1.64-2.89], P < 0.001, I2 = 60%; 1.91 [1.46-2.50], P < 0.001, I2 = 80%, respectively). In addition, dialysis patients had significantly higher rates of short-term life-threatening and/or major bleeding, permanent pacemaker implantation, and device failure compared with nondialysis patients (odds ratio [95% confidential interval]: 1.90 [1.24-2.90], P < 0.001, I2 = 67%; 1.33 [1.15-1.53], P < 0.001, I2 = 0%; 2.08 [1.05-4.10], P = 0.03, respectively), but did not have significantly higher rates of vascular complications and stroke. ConclusionDialysis patients had significantly higher rates of short- and long-term mortality, short-term life-threatening and/or major bleeding, permanent pacemaker implantation, and device failure compared with nondialysis patients. Careful selection of patients who would benefit from TAVI among patients with ESRD requiring dialysis is necessary to prevent high rates of postprocedural complications.