PERFORMANCE 1 study: Novel carotid stent system with integrated post-dilation balloon and embolic protection device.

OBJECTIVES: The PERFORMANCE I study was designed to evaluate the safety and feasibility of the Neuroguard IEP® System, a novel carotid stent system with an integrated embolic filter and post-dilatation balloon, to treat clinically significant carotid artery stenosis. BACKGROUND: The risk of major adverse events during carotid artery stenting is comparable to carotid endarterectomy, however, the risk of minor stroke remains higher with stenting. METHODS: In total, 67 patients undergoing carotid artery stenting were enrolled at nine centers in Europe. Follow-up assessments included neurological exams, duplex ultrasound, 12-lead electrocardiogram, and cardiac enzyme analysis. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarctions versus a prespecified performance goal. Secondary endpoints included procedure success, device success, and target lesion revascularization. RESULTS: The study population was predominantly male (74.6%) with a mean age of 69.3 ± 8.9 years and 67% of subjects met at least one criterion placing them at an elevated risk for adverse events following carotid endarterectomy. All patients were treated successfully with the study device. There were no deaths or strokes within 30 days of the index procedure. One subject (1.5%) experienced a non-ST elevation myocardial infarction at day 17. The primary endpoint was met with a 30-day major adverse events rate of 1.5% (1/67). Through 12-month follow-up, there were no strokes, neurological deaths, target lesion revascularizations, or instances of in-stent-restenosis. CONCLUSIONS: Results from this study demonstrate the Neuroguard IEP system is safe and feasible with a stroke/death rate of 0% at 30 days. A large pivotal study is currently underway.

Transradial approach for carotid artery stenting: A position paper from the Italian Society of Interventional Cardiology (SICI-GISE).

Carotid artery stenting (CAS) is a valid and effective alternative to endoatherectomy when performed by experienced operators. The conventional approach used is the transfemoral one, but in the last 10 years a transradial (TR) approach, the standard access for cardiac catheterization, became widely adopted for peripheral vascular interventions, included the extracranial carotids. Preliminary experiences suggest this approach as safe and effective, especially in specific anatomical and clinical settings that have been shown to be associated with high risk of complications from the femoral route. Lacking international guidelines, this document, promoted by the Italian Society of Interventional Cardiology - Gruppo Italiano Studi Emodinamici (SICI-GISE), was drawn-up by a panel of interventional cardiologists with a documented experience on the subject, focusing on the indications, techniques and materials that should be used for this type of intervention and the most recent literature on the subject.

Interleukin-6 receptor blocking with intravenous tocilizumab in COVID-19 severe acute respiratory distress syndrome: A retrospective case-control survival analysis of 128 patients.

In cases of COVID-19 acute respiratory distress syndrome, an excessive host inflammatory response has been reported, with elevated serum interleukin-6 levels. In this multicenter retrospective cohort study we included adult patients with COVID-19, need of respiratory support, and elevated C-reactive protein who received intravenous tocilizumab in addition to standard of care. Control patients not receiving tocilizumab were matched for sex, age and respiratory support. We selected survival as the primary endpoint, along with need for invasive ventilation, thrombosis, hemorrhage, and infections as secondary endpoints at 30 days. We included 64 patients with COVID-19 in the tocilizumab group and 64 matched controls. At baseline the tocilizumab group had longer symptom duration (13 ± 5 vs. 9 ± 5 days) and received hydroxychloroquine more often than controls (100% vs. 81%). The mortality rate was similar between groups (27% with tocilizumab vs. 38%) and at multivariable analysis risk of death was not significantly influenced by tocilizumab (hazard ratio 0.61, 95% confidence interval 0.33-1.15), while being associated with the use at baseline of non invasive mechanical or invasive ventilation, and the presence of comorbidities. Among secondary outcomes, tocilizumab was associated with a lower probability of requiring invasive ventilation (hazard ratio 0.36, 95% confidence interval 0.16-0.83; P = 0.017) but not with the risk of thrombosis, bleeding, or infections. The use of intravenous tocilizumab was not associated with changes in 30-day mortality in patients with COVID-19 severe respiratory impairment. Among the secondary outcomes there was less use of invasive ventilation in the tocilizumab group.

Association of acute kidney injury and bleeding events with mortality after radial or femoral access in patients with acute coronary syndrome undergoing invasive management: secondary analysis of a randomized clinical trial.

AIMS: In the Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX) trial, adults with acute coronary syndrome undergoing coronary intervention who were allocated to radial access had a lower risk of bleeding, acute kidney injury (AKI), and all-cause mortality, as compared with those allocated to femoral access. The mechanism of the mortality benefit of radial access remained unclear. METHODS AND RESULTS: We used multistate and competing risk models to determine the effects of radial and femoral access on bleeding, AKI and all-cause mortality in the MATRIX trial and to disentangle the relationship between these different types of events. There were large relative risk reductions in mortality for radial compared with femoral access for the transition from AKI to death [hazard ratio (HR) 0.55, 95% confidence interval (CI) 0.31-0.97] and for the pathway from coronary intervention to AKI to death (HR 0.49, 95% CI 0.26-0.92). Conversely, there was little evidence for a difference between radial and femoral groups for the transition from bleeding to death (HR 1.05, 95% CI 0.42-2.64) and the pathway from coronary intervention to bleeding to death (HR 0.84, 95% CI 0.28-2.49). CONCLUSION: The prevention of AKI appeared predominantly responsible for the mortality benefit of radial as compared with femoral access in the MATRIX trial. There was little evidence for an equally important, independent role of bleeding.

Long-Term Outcomes of Coronary and Carotid Artery Disease Revascularization in the FRIENDS Study.

OBJECTIVES: The aim of this study is to assess long-term-outcomes of patients with concomitant CAD and COD treated with different revascularization strategies. BACKGROUND: Multisite artery disease is common and patients with combined disease have poor prognosis. The best therapeutic strategy for patients with concomitant carotid obstructive disease (COD) and coronary artery disease (CAD) remains controversial. METHODS: This observational registry enrolled, between January 2006 and December 2012, 1022 consecutive patients from high volume institutions with concomitant CAD and COD suitable for endovascular, surgical, or hybrid revascularization in both territories selected by consensus of a multidisciplinary team. RESULTS: The cumulative incidence of 5-year major cardiovascular events (MACCE) including cardiovascular death, myocardial infarction (MI), or stroke in the overall population was 12%. The incidence of 5-year MACCE was not statistically different in the surgical, endovascular, or hybrid patients group (10.1% vs. 13.0% vs. 13.2%, P = .257, respectively). However, the hybrid group exhibited rates of myocardial infarction, chronic kidney disease, and cumulative incidence of all clinical events higher than the surgical group. After propensity score matching, the incidence of 5-year MACCE was similar in the three groups (13.0% vs. 15.0% vs. 16.0%, p = .947, respectively). CONCLUSIONS: An individualized revascularization approach of patients with combined CAD and COD yields very good results at long-term follow-up, despite the high risk of this multilevel population even when the baseline clinical features are equalized.

Successful percutaneous paravalvular leak closure followed by transfemoral aortic lotus valve-in-valve implantation in a degenerated surgical bioprosthesis.

Bioprosthesis degeneration is a relevant clinical issue that is increasingly developing with the higher expectancy of life. Its treatment may be further complicated by the presence of paravalvular leaks, which are usually consequence of tissue friability, annular calcification, and infection. The surgical treatment of such complex conditions may be too risky, so percutaneous techniques in selected centers are becoming an attracting option. We report the case of a 65-year-old gentleman with a previous aortic valve replacement (Perimount n.25) who was admitted with worsening heart failure and transoesophageal evidence of severe intraprosthetic regurgitation and a large paravalvular leak. Since he was judged at too high risk for surgery, he was treated by a fully percutaneous approach. First, he had his large paravalvular leak closed by implantation of two plugs from both retrograde and anterograde routes (arterial-venous loop created). After one month, he underwent a "valve-in-valve" transcatheter aortic valve implantation with a fully repositionable Lotus 23 mm valve, which was able to restore a completely normal aortic valve function and let to a dramatic improvement of his functional status at 6-month follow-up (from NYHA IV to NYHA I), when a transthoracic echocardiogram also confirmed the absence of any aortic regurgitation. This case shows how a tailored step-by-step fully percutaneous strategy is safe and feasible in high-risk patients with both bioprosthesis degeneration and large paravalvular leaks. This novel opportunity would need to be better evaluated in properly addressed long-term clinical studies. © 2016 Wiley Periodicals, Inc.

Distinct gene expression profiles associated with Notch ligands Delta-like 4 and Jagged1 in plaque material from peripheral artery disease patients: a pilot study.

BACKGROUND: The lack of early diagnosis, progression markers and effective pharmacological treatment has dramatic unfavourable effects on clinical outcomes in patients with peripheral artery disease (PAD). Addressing these issues will require dissecting the molecular mechanisms underlying this disease. We sought to characterize the Notch signaling and atherosclerosis relevant markers in lesions from femoral arteries of symptomatic PAD patients. METHODS: Plaque material from the common femoral, superficial femoral or popliteal arteries of 20 patients was removed by directional atherectomy. RNA was obtained from 9 out of 20 samples and analysed by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR). RESULTS: We detected expression of Notch ligands Delta-like 4 (Dll4) and Jagged1 (Jag1), of Notch target genes Hes1, Hey1, Hey2, HeyL and of markers of plaque inflammation and stability such as vascular cell adhesion molecule 1 (VCAM1), smooth muscle 22 (SM22), cyclooxygenase 2 (COX2), Bcl2, CD68 and miRNAs 21-5p, 125a-5p, 126-5p,146-5p, 155-5p, 424-5p. We found an "inflamed plaque" gene expression profile characterized by high Dll4 associated to medium/high CD68, COX2, VCAM1, Hes1, miR126-5p, miR146a-5p, miR155-5p, miR424-5p and low Jag1, SM22, Bcl2, Hey2, HeyL, miR125a-5p (2/9 patients) and a "stable plaque" profile characterized by high Jag1 associated to medium/high Hey2, HeyL, SM22, Bcl2, miR125a and low Dll4, CD68, COX2, VCAM1, miR126-5p, miR146a-5p, miR155-5p, miR424-5p (3/9 patients). The remaining patients (4/9) showed a plaque profile with intermediate characteristics. CONCLUSIONS: This study reveals the existence of a gene signature associated to Notch activation by specific ligands that could be predictive of PAD progression.

A propensity score matched comparative study between paclitaxel-coated balloon and everolimus-eluting stents for the treatment of small coronary vessels.

OBJECTIVES: To compare the long-term clinical outcomes of paclitaxel drug-coated-balloons (DCB) and everolimus-eluting-stents (EES) following the treatment of de novo small vessel coronary artery disease. BACKGROUND: It is currently unclear whether treatment of de novo small vessel coronary disease with DCB is comparable to second generation drug-eluting stents, which are the current standard of care. METHODS: The present study enrolled 90 patients with small vessel coronary disease from the DCB treatment arm of the BELLO (Balloon Elution and Late Loss Optimization) trial and 2,000 patients treated with EES at the San Raffaele Scientific Institute. Propensity score matching was performed to adjust for differences in baseline clinical and angiographic characteristics, yielding a total of 181 patients: 90 patients with 94 lesions receiving DCB and 91 patients with 94 lesions receiving EES. Major adverse cardiac events (MACE) were defined as the composite of cardiac death, recurrent non-fatal myocardial infarction, and target vessel revascularization. RESULTS: After propensity score matching, baseline clinical and angiographic characteristics were similar between the two groups. The cumulative MACE rate at 1-year was 12.2% with DCB and 15.4% with EES (P = 0.538). Patients in the DCB group had similar TLR rates as compared to EES over the same interval (4.4% vs. 5.6%; P = 0.720). There were no cases of definite or probable stent or vessel thrombosis. CONCLUSIONS: The use of paclitaxel-DCB appears to be associated with similar clinical outcomes when compared to second-generation-EES in small coronary artery disease. The findings of this study should be confirmed with larger prospective randomized studies with longer follow-up. © 2017 Wiley Periodicals, Inc.

EURObservational Research Programme: the Chronic Ischaemic Cardiovascular Disease Registry: Pilot phase (CICD-PILOT).

AIMS: Chronic ischaemic cardiovascular disease (CICD) is a major cause of mortality and morbidity worldwide. The primary objective of the CICD-Pilot registry was to describe the clinical characteristics and management modalities across Europe in a broad spectrum of patients with CICD. METHODS AND RESULTS: The CICD-Pilot registry is an international prospective observational longitudinal registry, conducted in 100 centres from 10 countries selected to reflect the diversity of health systems and care attitudes across Europe. From April 2013 to December 2014, 2420 consecutive CICD patients with non-ST-elevation acute coronary syndrome (n = 755) and chronic stable coronary artery disease (n = 1464), of whom 933 (63.7%) were planned for elective coronary intervention, or with peripheral artery disease (PAD) (n = 201), were enrolled (30.5% female patients). Mean age was 66.6 ± 10.9 years. The following risk factors were reported: smoking 54.6%, diabetes mellitus 29.2%, hypertension 82.6%, and hypercholesterolaemia 74.1%. Assessment of cardiac function was made in 69.5% and an exercise stress test in 21.2% during/within 1 year preceding admission. New stress imaging modalities were applied in a minority of patients. A marked increase was observed at discharge in the rate of prescription of angiotensin-converting enzyme-inhibitors/angiotensin receptor blockers (82.8%), beta-blockers (80.2%), statins (92.7%), aspirin (90.3%), and clopidogrel (66.8%). Marked differences in clinical profile and treatment modalities were observed across the four cohorts. CONCLUSION: The CICD-Pilot registry suggests that implementation of guideline-recommended therapies has improved since the previous surveys but that important heterogeneity exists in the clinical profile and treatment modalities in the different cohorts of patients enrolled with a broad spectrum of CICDs.

Carotid artery stenting: an update.

In patients with carotid disease, the purpose of carotid artery revascularization is stroke prevention. For >50 years, carotid endarterectomy has been considered the standard treatment for severe asymptomatic and symptomatic carotid stenoses. Carotid artery stenting (CAS) has emerged in the last 15 years as minimally invasive alternative to surgery. However, the value of the endovascular approach in the management of carotid disease patients remains highly controversial. The aims of this review are to elucidate the current role of CAS, to describe the major technology advancements in the field, and to speculate about the future of this therapy.

Suboptimal stent deployment is associated with subacute stent thrombosis: optical coherence tomography insights from a multicenter matched study. From the CLI Foundation investigators: the CLI-THRO study.

BACKGROUND: Acute or subacute stent thrombosis (ST) is a well-described complication usually causing acute coronary syndromes and, in the worst case scenario, sudden cardiac death. In this study, we aimed at exploring the potential role of optical coherence tomography (OCT) in the understanding of the mechanism of ST. METHODS: Twenty-one consecutive patients, after acute coronary syndromes due to a definite subacute ST, were assessed with OCT and matched 1:2 with 42 patients undergoing OCT for scheduled follow-up. Optical coherence tomography assessment was focused on features indicative of nonoptimal stent deployment: underexpansion, malapposition, edge dissection, and reference lumen narrowing. RESULTS: Optical coherence tomography revealed a minimum stent area sensibly smaller in the ST group (5.6 ± 2.6 vs 6.8 ± 1.7 mm(2); P = .03) with a higher incidence of stent underexpansion when compared with the control group (42.8% vs 16.7%; P = .05). Dissection at stent edges was more commonly detected in ST group (52.4% vs 9.5%; P < .01). No significant differences between the 2 groups were observed for malapposition (52.4% vs 38.1%; P = .651) and reference lumen narrowing (19.0% vs 4.8%; P = .172). At least 1 OCT finding indicative of suboptimal stent deployment was detectable in 95.2% of patients experiencing ST versus 42.9% of the control group (P < .01). CONCLUSIONS: Optical coherence tomography assessment in patients experiencing subacute ST revealed nonoptimal stent deployment in almost all cases with higher incidence of stent underexpansion and edge dissection, potentially explaining the cause of this adverse event. The adoption of an OCT-guided percutaneous coronary intervention protocol could have a potential for the prevention of ST in complex cases.

[Vertebral-subclavian bifurcation treatment. "The wedding ring technique" for a vertebral in-stent restenosis associated with stent fracture].

This report describes a solution for a restenosis and for the fracture of a stent in the vertebral artery in a patient suffering from vertebrobasilar symptoms. Angiography demonstrates restenosis of a vertebral stent as well as its fracture and migration into the subclavian artery. This complication was managed percutaneously by passing a guide wire through the fractured stent. Pre-dilatation and kissing balloon techniques were applied in both the vertebral and subclavian arteries to modify the stent's dimensions and shape it into the form of a "ring." Postprocedural angiography demonstrated an excellent final result with the assistance of StentBoost visualization. Control angiography at six months also utilized StentBoost imaging and confirmed the patency of the bifurcation and that the stent was not displaced.

Drug-coated balloon treatment of coronary artery disease: a position paper of the Italian Society of Interventional Cardiology.

Drug-coated balloons are a new tool for the treatment of patients with coronary artery disease. The main feature of this technology is a rapid and homogenous transfer of an antiproliferative drug (paclitaxel) to the vessel wall just at the time of balloon inflation, when neointimal proliferation, in response to angioplasty, is the highest. Moreover, drug-coated balloons share adjuntive advantages over stents: the absence of permanent scaffold and polymer, the respect of the original coronary anatomy, and limited inflammatory stimuli, thereby allowing for short-term dual antiplatelet therapy. To this day, a lot of devices are available in the market, with limited scientific data for the vast majority of them. Thus, the Italian scientific society of interventional cardiologists GISE decided to coordinate the efforts of a group of reknown experts on the field, in order to obtain a Position Paper on the correct use of drug-coated balloons in all the settings of coronary artery disease, giving a class of indication to each one, based on the clinical evidence. This Position Paper represents a quick reference for operators, investigators, and manufactures to promote the understanding and the correct use of the drug-coated balloon technology in everyday clinical practice.

Carotid artery stenting: second consensus document of the ICCS/ISO-SPREAD joint committee.

BACKGROUND: A major debate in cerebrovascular medicine today is over the choice of the best treatment to implement for stenosis of the carotid artery. Carotid artery stenting is a less invasive technique than endarterectomy for the treatment of carotid stenosis, and is becoming more widely performed, particularly on patients with carotid artery stenosis who present also with comorbidities. To address the aspects related to the use of carotid artery stenting, an Italian multidisciplinary task force comprising the most representative scientific societies concerned with carotid artery disease was set up to provide neurologists, radiologists, cardiologists, vascular surgeons, and all those involved in stroke prevention and treatment with an updated, evidence-based consensus document. SUMMARY: The task force followed a structured methodology to assess the literature on carotid stenosis in order to provide a summary of the main issues related to carotid artery stenting, including the definition of the grade of symptomatic carotid artery stenosis, indications for intervening on the carotid artery stenosis, establishing whether to perform either a surgical or an endovascular procedure, the training, credentialization, and competency needed by physicians to perform carotid artery stenting, acceptable complication rates and risk certification for carotid artery stenting, management of stented patients, durability of carotid artery stenting, and future tasks. Here, we outline the main findings of this effort. KEY MESSAGES: As for any guideline or consensus statement, each point is valid as long as the evidence on which it is based remains up to date. In a fast-evolving field of medicine such as that of carotid artery stenosis management, and in particular carotid artery stenting, the stimulation of continuous and fruitful discussion among all professionals involved is mandatory. We hope that this document may provide a standardized basis for the application of carotid artery stenting as implemented today.

Procedural embolic protection strategies for carotid artery stenting: current status and future prospects.

INTRODUCTION: Carotid artery angioplasty and stenting (CAS) is an established procedure to treat carotid artery stenosis for either primary or secondary prevention of stroke. Randomized clinical trials have shown an increased risk of periprocedural cerebrovascular events with CAS compared with carotid endarterectomy (CEA). Several strategies have been proposed to mitigate this risk, including alternative vascular access site, proximal/distal embolic protection devices, and dual-layer stents, among others. AREAS COVERED: This review provides a general overview of current embolic protection strategies for CAS. The phases of the procedure which can affect the early risk of stroke and how to reduce it with novel techniques and devices have been discussed. EXPERT OPINION: Innovations in device technologies have dramatically improved the safety and efficacy of CAS. To minimize the gap with surgery, a thorough, patient-oriented approach should be pursued. Endovascular technologies and techniques should be selected on an individual basis to address unique lesion characteristics and vascular anatomies. Meticulous pre-procedural planning, both clinical and anatomical, is needed to assess the embolic risk of each procedure. Only by having an in-depth understanding of the wide range of available endovascular devices and techniques, the operator will choose the most appropriate strategy to optimize CAS results.

Carotid artery revascularization using second generation stents versus surgery: a meta-analysis of clinical outcomes.

INTRODUCTION: Meta-analyses and emerging randomized data indicate that second-generation ('mesh') carotid stents (SGS) may improve outcomes versus conventional (single-layer) stents but clinically-relevant differences in individual SGS-type performance have been identified. No comparisons exist for SGS versus carotid endarterectomy (CEA). EVIDENCE ACQUISITION: Thirty-day death (D), stroke (S), myocardial infarction (M), and 12-month ipsilateral stroke and restenosis in SGS studies were meta-analyzed (random effect model) against CEA outcomes. Eligible studies were identified through PubMed/EMBASE/COCHRANE. Forest plots were formed for absolute adverse evet risk in individual studies and for relative outcomes with each SGS deign versus contemporary CEA outcomes as reference. Meta-regression was performed to identify potential modifiers of treatment modality effect. EVIDENCE SYNTHESIS: Data were extracted from 103,642 patients in 25 studies (14 SGS-treated, 41% symptomatic; nine randomized controlled trial (RCT)-CEA-treated, 37% symptomatic; and two Vascular Quality Initiative (VQI)-CEA-treated, 23% symptomatic). Casper/Roadsaver and CGuard significantly reduced DSM versus RCT-CEA (-2.70% and -2.95%, P<0.001 for both) and versus VQI-CEA (-1.11% and -1.36%, P<0.001 for both). Gore stent 30-day DSM was similar to RCT-CEA (P=0.581) but increased against VQI-CEA (+2.38%, P=0.033). At 12 months, Casper/Roadsaver ipsilateral stroke rate was lower than RCT-CEA (-0.75%, P=0.026) and similar to VQI-CEA (P=0.584). Restenosis with Casper/Roadsaver was +4.18% vs. RCT-CEA and +4.83% vs. VQI-CEA (P=0.005, P<0.001). CGuard 12-month ipsilateral stroke rate was similar to VQI-CEA (P=0.850) and reduced versus RCT-CEA (-0.63%, P=0.030); restenosis was reduced respectively by -0.26% and -0.63% (P=0.033, P<0.001). Twelve-month Gore stent outcomes were overall inferior to surgery. CONCLUSIONS: Meta-analytic integration of available clinical data indicates: 1) reduction in stroke but increased restenosis rate with Casper/Roadsaver, and 2) reduction in both stroke and restenosis with CGuard MicroNET-covered stent against contemporary CEA outcomes at 30 days and 12 months used as a reference. This may inform clinical practice in anticipation of large-scale randomized trials powered for low clinical event rates (PROSPERO-CRD42022339789).

Prospective, multicenter European study of the GORE flow reversal system for providing neuroprotection during carotid artery stenting.

BACKGROUND: Embolic protection devices (EPDs) are used to provide protection against brain embolization during carotid artery stenting (CAS) to treat carotid artery stenosis, but the optimal type of EPD has not been determined. Distally positioned filters are commonly used but do not provide protection during crossing of the lesion. This prospective, multicenter study investigated a proximally placed device (GORE Flow Reversal System) that reverses blood flow in the internal carotid artery during CAS, thereby directing emboli away from the brain. METHODS: Outcomes in 122 patients (28% symptomatic), who underwent CAS using the flow reversal system were assessed (intention-to-treat analysis). The primary endpoint was a major adverse event (MAE; defined as death or stroke) within 30 days of CAS. The secondary endpoint was a myocardial infarction (MI) or nonstroke-related neurologic event within 30 days. RESULTS: The flow reversal system could not be used in one patient because of severe vessel tortuosity and in two patients (1.6%) because of intolerance. The 30-day MAE rate and the secondary endpoint rate were each 1.6%. No patient in the series died or had an MI within 30 days. No patient who was symptomatic before CAS had an MAE. One symptomatic and one asymptomatic patient had a transient ischemic attack. CONCLUSIONS: Use of the GORE Flow Reversal System during CAS had a high rate of technical success and low 30-day rates of adverse neurologic and cardiac events.

A meta-analysis of proximal occlusion device outcomes in carotid artery stenting.

BACKGROUND: The clinical risk predictors for adverse events in carotid stenting using distal embolic protection devices are well established and include patient age and symptomatic status. The risk predictors for adverse events with proximal occlusion devices are not as well established. This study is a meta-analysis of available data on proximal occlusion devices to determine the risk predictors of adverse events in carotid stenting. METHODS: Study-specific results on 2,397 patients from six independent databases of two different proximal occlusion devices were meta-analyzed by an independent statistical analysis organization for predictors of 30-day major adverse clinical events including stroke, myocardial infarction, and death using random effects models. The primary endpoint was the composite of total stroke, myocardial infarction, and death at 30 days. RESULTS: The incidence of stroke was 1.71%. The incidence of myocardial infarction was 0.02%. The incidence of death was 0.40%. The composite primary endpoint at 30 days was 2.25%. Age and diabetic status were found to be the only significant independent risk predictors; however, total stroke rates remained below 2.6% in all subgroups, including symptomatic octogenarians. The other baseline demographic variables including patient gender, symptomatic status, and contralateral carotid occlusion were not found to be independent risk predictors. CONCLUSIONS: A meta-analysis of CAS procedures performed with proximal occlusion devices demonstrated a very low incidence of adverse events at 30 days. The only independent risk predictors were age and diabetes. Patient gender, symptomatic status, and other baseline characteristics were not found to be risk predictors for CAS using proximal occlusion devices.

European Registry of Carotid Artery Stenting: results from a prospective registry of eight high volume EUROPEAN institutions.

BACKGROUND: Carotid endarterectomy (CEA) is the standard revascularization therapy to prevent stroke in patients with carotid artery disease. Carotid artery stenting (CAS) could be considered a potential alternative in patients at high surgical risk. Recent clinical trials have challenged this concept due a relatively high incidence of post-CAS adverse events, which occurred in low volume centers. The aim of this study was to evaluate the outcomes associated with neuroprotected CAS in selected high volume centers. METHODS: From January 2007 to December 2007, 1,611 patients underwent neuroprotected CAS in eight European Centers. For each patients, clinical, procedural, and one month follow-up data from all patients have been collected. An independent clinical events committee adjudicated the events. RESULTS: Overall in hospital death was 0.06% (one patient), whereas in-hospital stroke was 0.49% (eight patients). Between hospital discharge and 30 days three additional patients died (0.18%) and 10 patients experienced a stroke (0.67%). Overall 30 days mortality was 0.24% (four patients) and stroke incidence 1.12% (18 patients). The 30 day stroke/death rate was 1.36%. CONCLUSIONS: CAS is a reasonable alternative to CEA to treat carotid artery atherosclerosis in well-experienced high volume centers. These data suggest that future prospective trials comparing CAS and CEA outcomes should include only centers highly experienced in both treatment modalities.