Superficial Femoral Artery in-Stent Restenosis Treated with Paclitaxel-Coated Balloon Angioplasty - Results of Three-Year Follow-Up.

BACKGROUND: In-stent restenosis remains a common and important complication after endovascular treatment of superficial femoral artery peripheral artery disease. It occurs in 14 to 35% of cases in 1 year and there is still no efficient treatment for this condition. Paclitaxel-coated balloons have shown promising results. OBJECTIVE: Investigate the 3 year results of superficial femoral artery in-stent restenosis treated with paclitaxel-coated balloon angioplasty, using the Lutonix™ 035 device. METHODS: We conducted a retrospective observational study with patients with symptomatic (Rutherford 2 to 5) superficial femoral artery in-stent restenosis, that were treated with paclitaxel-coated balloon angioplasty using the Lutonix™ 035 device, in a single center from January 2016 to December 2020. Duplex scan was used to follow the patients. Primary patency was obtained through Kaplan-Meier analysis. Mortality, and amputation rates were also evaluated. RESULTS: 105 patients were included. Two patients had technical failure and required an additional stent, and were thus excluded. 103 patients were analyzed. Primary patency was 91.26, 80.47, and 67.71%, respectively, in the first, second, and third year after the procedure. There were no deaths 30 days after the procedure. There were no major amputations during the 3 year follow-up. CONCLUSION: Paclitaxel-coated balloon angioplasty with the Lutonix™ 035 device was a safe and effective treatment to superficial femoral artery in-stent restenoses. The results were maintained along the 3 year follow-up.

Microarray meta-analysis reveals IL6 and p38ß/MAPK11 as potential targets of hsa-miR-124 in endothelial progenitor cells: Implications for stent re-endothelization in diabetic patients.

Circulating endothelial progenitor cells (EPCs) play an important role in the repair processes of damaged vessels, favoring re-endothelization of stented vessels to minimize restenosis. EPCs number and function is diminished in patients with type 2 diabetes, a known risk factor for restenosis. Considering the impact of EPCs in vascular injury repair, we conducted a meta-analysis of microarray to assess the transcriptomic profile and determine target genes during the differentiation process of EPCs into mature ECs. Five microarray datasets, including 13 EPC and 12 EC samples were analyzed, using the online tool ExpressAnalyst. Differentially expressed genes (DEGs) analysis was done by Limma method, with an | log2FC| > 1 and FDR < 0.05. Combined p-value by Fisher exact method was computed for the intersection of datasets. There were 3,267 DEGs, 1,539 up-regulated and 1,728 down-regulated in EPCs, with 407 common DEGs in at least four datasets. Kyoto Encyclopedia of Genes and Genomes (KEGG) analysis showed enrichment for terms related to "AGE-RAGE signaling pathway in diabetic complications." Intersection of common DEGs, KEGG pathways genes and genes in protein-protein interaction network (PPI) identified four key genes, two up-regulated (IL1B and STAT5A) and two down-regulated (IL6 and MAPK11). MicroRNA enrichment analysis of common DEGs depicted five hub microRNA targeting 175 DEGs, including STAT5A, IL6 and MAPK11, with hsa-miR-124 as common regulator. This group of genes and microRNAs could serve as biomarkers of EPCs differentiation during coronary stenting as well as potential therapeutic targets to improve stent re-endothelization, especially in diabetic patients.

Long Non-Coding RNAs Might Regulate Phenotypic Switch of Vascular Smooth Muscle Cells Acting as ceRNA: Implications for In-Stent Restenosis.

Coronary in-stent restenosis is a late complication of angioplasty. It is a multifactorial process that involves vascular smooth muscle cells (VSMCs), endothelial cells, and inflammatory and genetic factors. In this study, the transcriptomic landscape of VSMCs' phenotypic switch process was assessed under stimuli resembling stent injury. Co-cultured contractile VSMCs and endothelial cells were exposed to a bare metal stent and platelet-derived growth factor (PDGF-BB) 20 ng/mL. Migratory capacity (wound healing assay), proliferative capacity, and cell cycle analysis of the VSMCs were performed. RNAseq analysis of contractile vs. proliferative VSMCs was performed. Gene differential expression (DE), identification of new long non-coding RNA candidates (lncRNAs), gene ontology (GO), and pathway enrichment (KEGG) were analyzed. A competing endogenous RNA network was constructed, and significant lncRNA-miRNA-mRNA axes were selected. VSMCs exposed to "stent injury" conditions showed morphologic changes, with proliferative and migratory capacities progressing from G0-G1 cell cycle phase to S and G2-M. RNAseq analysis showed DE of 1099, 509 and 64 differentially expressed mRNAs, lncRNAs, and miRNAs, respectively. GO analysis of DE genes showed significant enrichment in collagen and extracellular matrix organization, regulation of smooth muscle cell proliferation, and collagen biosynthetic process. The main upregulated nodes in the lncRNA-mediated ceRNA network were PVT1 and HIF1-AS2, with downregulation of ACTA2-AS1 and MIR663AHG. The PVT1 ceRNA axis appears to be an attractive target for in-stent restenosis diagnosis and treatment.

Reestenosis de stents liberadores de paclitaxel frente a stents convencionales

RESUMEN Introducción: La reestenosis de los stents liberadores de paclitaxel utilizados en Cuba no ha sido estudiada. Objetivo: Evaluar la reestenosis de los stents liberadores de paclitaxel y los convencionales. Métodos: Se incluyeron 64 pacientes con reestenosis de stent, de un estudio prospectivo previo; en 318 pacientes seguidos por 3 años luego de intervención coronaria percutánea; 25 con stent liberador de paclitaxel y 39 stent metálico convencional. Se consideró reestenosis como nueva lesión ≥ 50 % de la luz del vaso con isquemia demostrada. Se describió el tiempo de aparición, patrón angiográfico y alternativa de revascularización. Resultados: La reestenosis en el grupo de stents liberadores de paclitaxel fue 15,7 % con tiempo medio de supervivencia sin reestenosis de 32,4 meses vs. 24,5 % en stents convencionales, con supervivencia sin reestenosis de 29,8 meses, (p= 0,047). En el grupo de stents liberadores de paclitaxel predominó el patrón IB, (30,3 %) y stent convencional el III (28,3 %). En el 28,0 % del grupo de stents liberadores de paclitaxel, se recurrió a la cirugía de revascularización vs. 5,1 % en el grupo de stent convencional. Conclusiones: El stent liberador de paclitaxel logra una supervivencia libre de reestenosis superior y más perdurable que el stent convencional. La reestenosis en los de stents liberadores de paclitaxel es focal, con mayor frecuencia de nueva revascularización por cirugía y en los stents convencionales es mayormente difusa.

ABSTRACT Introduction: The restenosis of the paclitaxel-eluting stents used in Cuba has not been studied. Objective: To evaluate the restenosis of paclitaxel-eluting stents and conventional stents. Methods: 64 patients with stent restenosis were included, from a previous prospective study; in 318 patients followed up for 3 years after percutaneous coronary intervention; 25 with a paclitaxel-eluting stent and 39 conventional metal stent. Restenosis was considered as a new lesion ≥ 50 % of the vessel lumen with proven ischemia. The time to onset, angiographic pattern and alternative revascularization were described. Results: Restenosis in the group with paclitaxel-eluting stents was 15.7 % with a mean survival time without restenosis of 32.4 months vs. 24.5 % in conventional stents, with restenosis-free survival of 29.8 months, (p = 0.047). In the group with paclitaxel-eluting stents, the IB pattern predominated (30.3 %) and the conventional stent III (28.3 %). In 28.0 % of the paclitaxel-eluting stent group, revascularization surgery was used vs. 5.1 % in the conventional stent group. Conclusions: The paclitaxel-eluting stent achieves a superior and more durable restenosis-free survival than the conventional stent. Restenosis in paclitaxel-eluting stents is focal, with a higher frequency of revascularization by surgery, and in conventional stents it is mostly diffuse.

In-stent chronic total occlusion angioplasty in the LATAM-CTO registry.

OBJECTIVES: To inform about contemporary PCI practice of in-stent (IS) chronic total occlusions (CTO) from a large international registry in Latin America. BACKGROUND: IS-CTO represent a distinctive challenge for PCI, but literature is limited and restricted to high-resource regions of the world. METHODS: Patients undergoing CTO PCI enrolled in the LATAM CTO registry from 42 centers in eight countries were included. We analyzed demographics, angiographic, procedure technique, success and postprocedural outcomes between IS-CTO and non-IS-CTO PCI. RESULTS: From 1,565 patients IS-CTO was present in 181 patients (11.5%). IS-CTO patients had higher prevalence of diabetes and hypertension than patients without IS-CTO. IS-CTOs had less calcification (32.5 vs. 46.7%, p < .001), lower prevalence of a proximal branch (36.3 vs. 50.1%, p < .001), more likely to be ostial (24.4 vs. 18.1%, p = .042), were longer (28.5 vs. 25.2 mm, p = .062), and had less interventional collaterals (49.1 vs. 57.3%, p = .038) compared with non-IS-CTO. CTO complexity scores were similar between both groups. There was no statistically significant difference in the initial or successful strategy between IS-CTO and non-IS-CTO PCI. Technical success rates remained high in IS-CTO (86.7%) and non-IS-CTO (83.1%, p = .230). There was no independent association between IS-CTO and technical success in multivariable analysis. There were no differences between IS-CTO and non-IS-CTO groups for in-hospital clinical outcomes. CONCLUSION: In a contemporary, multicenter, and international registry from Latin America, IS-CTO PCI is frequent and has comparable technical success and safety profile compared to non-IS-CTO PCI.

The Current State of MicroRNAs as Restenosis Biomarkers.

In-stent restenosis corresponds to the diameter reduction of coronary vessels following percutaneous coronary intervention (PCI), an invasive procedure in which a stent is deployed into the coronary arteries, producing profuse neointimal hyperplasia. The reasons for this process to occur still lack a clear answer, which is partly why it remains as a clinically significant problem. As a consequence, there is a vigorous need to identify useful non-invasive biomarkers to differentiate and follow-up subjects at risk of developing restenosis, and due to their extraordinary stability in several bodily fluids, microRNA research has received extensive attention to accomplish this task. This review depicts the current understanding, diagnostic potential and clinical challenges of microRNA molecules as possible blood-based restenosis biomarkers.

Outcomes of endovascular treatments for in-stent restenosis in patients with mesenteric atherosclerotic disease.

OBJECTIVE: Mesenteric angioplasty and stenting (MAS) has surpassed open revascularization as the treatment of choice for mesenteric ischemia. Despite the lower perioperative mortality associated with MAS, the need for reintervention is not infrequent. The purpose of this study was to review the outcomes of patients treated for mesenteric artery in-stent restenosis (MAISR). METHODS: Clinical data from a single center between 2004 and 2017 were retrospectively analyzed. Standard statistical analysis including Kaplan-Meier estimate for time-dependent outcomes, χ2 test for categorical variables, and two-sample t-test for continuous variables was performed. Primary end points included stent patency and reintervention rate. Secondary end points included mortality and morbidity. RESULTS: During the study period, 91 patients underwent primary MAS. In total, 113 mesenteric vessels were treated with 20 covered stents and 93 bare-metal stents. Overall primary patency was 69% at 2 years. At 2 years, primary patency was 83% for covered stents compared with 65% for bare-metal stents (P = .17). Of these 91 primary MAS patients, 27 (30%) were treated for MAISR (32 vessels). Two covered stent patients developed significant restenosis (11%) compared with 25 (34%) bare-metal stent patients (P = .02). The mean age of patients requiring reintervention was 69 years (36% male), with the majority having a history of tobacco use (85%), hypertension (75%), and hyperlipidemia (78%). Fourteen reintervention patients (52%) presented with recurrent symptoms, 10 (37%) had asymptomatic restenosis, and 3 (11%) developed intestinal ischemia. Twelve patients (44%) underwent reintervention with balloon angioplasty alone and 15 (56%) underwent repeated stent placement. Of the 15 patients who had repeated stent placement, 7 patients had covered stents placed. The 30-day mortality rate after reintervention for mesenteric stent restenosis was 0%. Postoperative complications occurred in 15% of patients (myocardial infarction, 4%; reversible kidney injury, 4%; and bowel ischemia requiring surgical exploration, 7%). There was no difference in the perioperative morbidity in comparing symptomatic and asymptomatic patients undergoing reintervention. Mean follow-up after mesenteric reintervention was 31 months, with one-third of patients (n = 9) requiring another reintervention because of either recurrence of symptoms or asymptomatic high-grade restenosis. Assisted primary patency at 2 years was 92% after reintervention with balloon angioplasty and 87% for repeated stent placement, with no statistically significant difference between the groups (P = .66). CONCLUSIONS: Treatment of MAISR is associated with low mortality and acceptable morbidity. The initial use of covered stents may reduce the need for reintervention.

Restenosis, Stent Thrombosis, and Bleeding Complications: Navigating Between Scylla and Charybdis.

The field of interventional cardiology has significantly evolved over 40 years by overcoming several challenges. The introduction of first-generation drug-eluting stents significantly reduced the rates of restenosis, but at the expense of an increase of late stent thrombosis. Prolonged antithrombotic therapy reduced rates of stent thrombosis, but at the cost of increased bleeding. Although the advent of second-generation drug-eluting stents subsequently reduced the incidence of late stent thrombosis, its permanent nature prevents full recovery of vascular structure and function with accordant risk of very late stent failure. In the present era of interventional cardiology, the tradeoff between stent thrombosis, restenosis, and bleeding presents as a particularly complex challenge. In this review, the authors highlight major contributors of late/very late stent thrombosis while targeting stent restenosis, and they discuss evolutionary advances in stent technology and antiplatelet therapy, to further improve upon the care of patients with coronary artery disease.

Evolución de los stents coronarios liberadores de fármacos, de la primera a la cuarta generación / Evolution of coronary drug-eluting stents, from the first to the fourth generation

Resumen Las enfermedades cardiovasculares son la principal causa de muerte a nivel mundial y dentro de éstas se encuentra la enfermedad obstructiva de las arterias coronarias. El tratamiento más común para dicha enfermedad es la angioplastia con stent, que busca recuperar la luz de la arteria y revascularizar al paciente. Desde la aprobación del primer stent metálico la cardiología intervencionista ha experimentado un desarrollo continuo, impulsado por la necesidad de tener alternativas de tratamiento más seguras y eficaces. Dichos avances se reflejan en cuatro generaciones de stents liberadores de fármacos. El presente artículo busca describir las principales características de cada una de estas generaciones.

Abstract Cardiovascular disease is the leading cause of death worldwide and within these the coronary artery disease. The most common treatment for this condition is angioplasty with stent, which seeks to recover the lumen of the artery and revascularization the patient. Since the adoption of the first bare metal stent the area of interventional cardiology has experienced continuous development driven by the need for a safe and effective alternative treatment. These advances are reflecting in four generations of drug-eluting stents. This article aims to describe the main features of each of these generations.

A novel drug-coated scoring balloon for the treatment of coronary in-stent restenosis: Results from the multi-center randomized controlled PATENT-C first in human trial.

BACKGROUND: Scoring balloons produce excellent acute results in the treatment of in-stent restenosis (ISR), fibro-calcific and bifurcation lesions but have not been shown to affect the restenosis rate. A novel paclitaxel-coated scoring balloon (SB) was developed and tested to overcome this limitation. METHODS AND RESULTS: SB were coated with paclitaxel admixed with a specific excipient. Patients at four clinical sites in Germany and one in Brazil with ISR of coronary bare metal stent (BMS) were randomized 1:1 to treatment with either a drug-coated or uncoated SB. Baseline and 6-month follow-up quantitative coronary angiography was performed by an independent blinded core lab and all patients will be evaluated clinically for up to one year. The primary endpoint was angiographic in-segment late lumen loss (LLL). Secondary endpoints included the rate of clinically driven target lesion revascularization (TLR), composite of major adverse cardiovascular events (MACE), stent thrombosis and other variables. Sixty-one patients were randomized (28 uncoated and 33 drug-coated SB); mean age 65 years, males 72%, and presence of diabetes 39%. At 6-month angiography, in-segment LLL was 0.48 ± 0.51 mm in the uncoated SB group versus 0.17 ± 0.40 mm in the drug-coated SB group (P = 0.01; ITT analysis). The rate of binary restenosis was 41% in the uncoated SB group versus 7% in the drug-coated SB group (P = 0.004). The MACE rate was 32% with the uncoated SB vs. 6% in the drug-coated SB group (P = 0.016). This difference was primarily due to the reduced need for clinically driven TLR in the coated SB group (3% vs. 32% P = 0.004). CONCLUSIONS: A novel paclitaxel-coated coronary SB has been developed and successfully used in a first-in-human randomized controlled trial [ClinicalTrials.gov Identifier: NCT01495533]. © 2015 Wiley Periodicals, Inc.

Valor de la tomografía de coherencia óptica en el tratamiento guiado de la falla del stent: Presentación de un caso / Value of the optical coherence tomography in the treatment guided of the stent failure: Case report

Desde la llegada de los stents convencionales y farmacoactivos han disminuido considerablemente los eventos de revascularización quirúrgica, sin embargo la trombosis y reestenosis son 2 factores que, aunque han disminuido, permanecen como complicaciones importantes. Existen varios factores que predisponen a la trombosis y a la reestenosis intrastent. La angiografía convencional tiene serias limitaciones para determinar las causas de la falla del stent. La tomografía de coherencia óptica es una técnica sumamente sensible para determinar las causas de trombosis y reestenosis del stent.

Since the advent of bare metal and drug-eluting stents, the surgical revascularization have declined considerably, however the thrombosis and in-stent restenosis are important complications of these devices. There are several factors that predispose to thrombosis and in-stent restenosis. Conventional angiography has serious limitations to determine the causes of stent failure. Optical coherence tomography is a very sensitive technique to determine the cause of thrombosis and in-stent restenosis.

[Value of the optical coherence tomography in the treatment guided of the stent failure. Case report]. / Valor de la tomografía de coherencia óptica en el tratamiento guiado de la falla del stent. Presentación de un caso.

Since the advent of bare metal and drug-eluting stents, the surgical revascularization have declined considerably, however the thrombosis and in-stent restenosis are important complications of these devices. There are several factors that predispose to thrombosis and in-stent restenosis. Conventional angiography has serious limitations to determine the causes of stent failure. Optical coherence tomography is a very sensitive technique to determine the cause of thrombosis and in-stent restenosis.

Síndrome coronario agudo como manifestación clínica de la reestenosis intrastent / Acute coronary syndrome as a clinical presentation of in-stent re-stenosis

Antecedentes: La reestenosis intrastent (RES) es considerada responsable sólo de una mayor necesidad de reintervención. Sin embargo, se ha reportado que 30-60 por ciento de las RES se presentan como un síndrome coronario agudo (SCA). Objetivo: Conocer las incidencias de SCA como manifestación de RES y su relación con mortalidad. Método: Se analizaron pacientes que presentaron SCA como manifestación de RES y se compararon con los de presentación estable (ECE) respecto de la edad, factores de riesgo, evento clínico inicial que motivó la angioplastía coronaria (AC), stent utilizado y las características de la RES. Se comparó mortalidad a 30 días y alejada. Resultados: Entre 2006 y 2011, analizamos 210 pacientes con RES, de los cuales 68 (32 por ciento) se presentaron como SCA y 142 (68 por ciento) como ECE. La edad fue similar en ambos grupos (62,6 vs 62,7 años, NS). La prevalencia de diabetes fue 30 por ciento vs 22 por ciento (p=0,02), respectivamente, sin diferencias en otras características. Del grupo con SCA, 21 pacientes (31 por ciento) tuvieron un infarto con supradesnivel ST (SDST), 20 (29 por ciento) un infarto sin SDST y 27 (40 por ciento) una Angina Inestable (AI). La mortalidad a 30 días fue 2,9 por ciento vs 2,1 por ciento (NS), y la mortalidad alejada fue 12,2 por ciento vs 6,4 por ciento (p=0.4). No se identificaron predictores independientes para la presentación como SCA. Conclusion: El SCA con todas sus manifestaciones clínicas es una presentación frecuente de RES. Estos resultados sugieren que la RES no es una entidad benigna.

In-stent re-stenosis (ISR) has been associated with a high incidence of reintervention, but in addition some reports indicate that acute coronary syndromes (ACS) are a frequent clinical presentation. In this study of 210 patients with ISR we found that ACS was the presenting event in 31 percent of patients while a stable clinical event occurred in 69 per cent. In the ACS group 21 patients (31 percent) had an STEMI, 20 (29 percent) an NSTE-MI and 27 (40 per cent) patients presented with unstable angina. Comparing ACS vs SE groups, clinical characteristics were similar, except for diabetes which was more frequent in ACS (30 percent vs 22 percent, p=0,02). Thirty day mortality was 2,9 percent vs 2,1 per cent (p=ns) and long term mortality was 12,2 per cent vs 6,4 percent, respectively (p=0.18). In multivariate analysis, there were no independent predictors of an SCA presentation. In conclusion, ACS is a frequent clinical presentation of ISR and it is not always a benign condition.

Caracterización de la restenosis de stents coronarios convencionales y liberadores de medicamentos en pacientes incluidos en el registro DRug Eluting STent (DREST) / Characterization of conventional coronary stents restenosis and drug eluting stents in patients included in the Drug Eluting Stent Registry (DREST)

Introducción y objetivos: los stents convencionales presentan tasas de restenosis intrastent entre 10% y 60%, mientras los stents liberadores de fármacos alcanzan el 10%. Para Latinoamérica, no hay reportes de restenosis intrastent en comparación con los stents convencionales y los stents liberadores de fármacos. En este estudio se describen aspectos asociados a este evento en pacientes atendidos en un centro de alta complejidad en Colombia. Métodos: análisis retrospectivo de pacientes con restenosis intrastent incluidos en el registro DRug ELuting STent (DREST) entre los años 1994 y 2011, en el que se compararon características basales, datos técnicos y supervivencia de los pacientes con stent convencional y stent liberador de fármacos. Resultados: se evidenció restenosis intrastent en 269 con stent convencional (11,5%) y en 65 con stent liberador de fármacos (12,2%), sin diferencias significativas al comparar por género (p=0,983) o edad (p=0,55). La dislipidemia fue el factor de riesgo más significativo asociado a la restenosis intrastent de los stents liberadores de fármacos (p<0,002). El diámetro menor del vaso comprometido como de los stents implantados, se encontró principalmente en los stents liberadores de fármacos asociados a restenosis intrastent (p=0,000). El patrón de restenosis intrastent focal fue mayor con los stents liberadores de fármacos, mientras el difuso en con el stent convencional (p=0,000). La supervivencia a un año fue mayor en pacientes con stent liberador de fármacos. Conclusiones: las tasas de restenosis intrastent y las características relacionadas encontradas, son similares a lo publicado. La dislipidemia aparece como factor asociado significativo. La restenosis intrastent se manifestó como síndrome coronario agudo en 60% de los casos; no puede considerarse como un proceso benigno en esta población.

Introduction and Objectives: Bare metal stents have stent restenosis rates between 10% and 60%, while drug-eluting stents reach 10%. In Latin America, there are no reports of stent restenosis between bare-metal stents and drug eluting stents. This study describes aspects associated with this event in patients treated at a center of high complexity in Colombia. Methods: Retrospective analysis of patients with stent restenosis included in the Drug Eluting Stent Registry (DREST) between 1994 and 2011, which compared baseline characteristics, technical data and survival of patients with bare metal stents and drug eluting stents. Results: We found stent restenosis with bare metal stents in 269 patients (11.5%) and in 65 with drug-eluting stent (12.2%) without significant differences between gender (p = 0.983) or age (p = 0 , 55). Dyslipidemia was the most significant risk factor associated with stent restenosis of drug-eluting stents (p <0.002). We found smaller diameter of the vessel involved as well as smaller diameter of the implanted stent mainly in the drug-eluting stents associated with stent restenosis (p = 0.000). The focal pattern of stent restenosis was higher with drug eluting stents, while the diffuse pattern with standard stents (p = 0.000). The one-year survival was higher in patients with drug-eluting stent. Conclusions: The rates of stent restenosis and the related characteristics found are similar to those currently published. Dyslipidemia appears as a significant associated factor. The stent restenosis manifested as acute coronary syndrome in 60% of cases; it can not be regarded as a benign condition in this population.

The sirolimus-eluting cypher select coronary stent for the treatment of bare-metal and drug-eluting stent restenosis

Objectives This study sought to compare the 1-year safety and efficacy of Cypher Select or Cypher SelectPlus (Cordis Corporation, Bridgewater, New Jersey) sirolimus-eluting stents (SES) with the treatment of baremetalstents (BMS) and drug-eluting stent (DES) in-stent restenosis (ISR) in nonselected, real-world patients.Background There is paucity of consistent data on DES for the treatment of ISR, especially, DES ISR.Methods The e-SELECT (Multicenter Post-Market Surveillance) registry is a Web-based, multicenterand international registry encompassing virtually all subsets of patients and lesions treated with atleast 1 SES during the period from 2006 to 2008. We enrolled in this pre-specified subanalysis allpatients with at least 1 clinically relevant BMS or DES ISR treated with SES. Primary endpoint wasmajor adverse cardiac events and stent thrombosis rate at 1 year.Results Of 15,147 patients enrolled, 1,590 (10.5%) presented at least 1 ISR (BMS group, n 1,235,DES group, n 355). Patients with DES ISR had higher incidence of diabetes (39.4% vs. 26.9%,p 0.001), renal insufficiency (5.8% vs. 2.3%, p 0.003), and prior coronary artery bypass graft(20.5% vs. 11.8%, p 0.001). At 1 year, death (1.4% for BMS vs. 2.1% for DES, p 0.3) and myocardialinfarction (2.4% for BMS and 3.3% for DES, p 0.3) rates were similar, whereas ischemia-driven target lesion revascularization and definite/probable late stent thrombosis were higher inpatients with DES ISR (6.9% vs. 3.1%, p 0.003, and 1.8% vs. 0.5%, p 0.04, respectively).Conclusions Use of SES for either BMS or DES ISR treatment is safe and associated with low target lesionrevascularization recurrence and no apparent safety concern. (J Am Coll Cardiol Intv 2012;5:64–71) © 2012by the American College of Cardiology Foundation.

Puntos de vista sobre la prevención de la reestenosis dentro del stent después del implante de un stent de metal desnudo con valsartán más allá del ensayo VALVACE / Perspectives on prevention of in-stent-restenosis after baremetal stent implantation by valsartan beyond VALVACE trial

The VALVACE trial suggests that prevention of in-stent-restenosis after implantation of bare-metal stents is possible by administration of 80mg valsartan exclusively in those patients with initial acute coronary syndrome and diabetes. The hypothesis was tested whether higher dosage valsartan is able to reduce in-stent restenosis rate even in patients with initial stable angina. 450 consecutive «real-world¼ patients (241 males, mean age 62.7 ± 9.1 years) with matched demographic and angiographic characteristics to patients of the VALVACE trial were treated with high-dose valsartan (160 to 320 mg). Angiographic restenosis rate and MACE rate were analysed after 6 months. Angiographic restenosis rate in 368 patients with control angiography was 7.3%, 7.5% in patients with initial stable angina and 7.2% in patients with initial acute coronary syndrome. Mean lumen late loss was 0.42 ± 0.3 mm and mean residual stenosis 13.8 ± 13.3%. MACE rate was 4.3%. In males in-stent restenosis rate was 23.8% under 80 mg, 13.6% under 160 mg, 5.7% under 240 mg and 4.9% under 320 mg. In females restenosis rate was 12.2% under 80 mg and 4% under 160 mg; no restenosis appeared under higher doses. High-dose administration of valsartan is able to reduce angiographic in-stentrestenosis rate to about 7% in patients with initial stable angina and acute coronary syndrome with a MACE rate below 5%

El ensayo VALVACE sugiere que es posible la prevención de la reestenosis dentro de la prótesis después del implante de prótesis endovasculares de metal desnudo mediante la administración de 80 mg de valsartán, exclusivamente en aquellos pacientes con síndrome coronario agudo y diabetes inicial. Se evaluó la hipótesis acerca de si el valsartán en una dosificación más alta puede reducir la tasa de reestenosis dentro de la prótesis, aun en pacientes con angina estable inicial. Cuatrocientos cincuenta pacientes «del mundo real¼ consecutivos (241 hombres, edad promedio 62.7 ± 9.1 años) con características demográficas y angiográficas equiparables a los pacientes del ensayo VALVACE fueron tratados con valsartán en altas dosis (160 a 320 mg). Se analizaron las tasas de reestenosis angiográfica y la tasa MACE después de 6 meses. La tasa de reestenosis angiográfica en 368 pacientes con angiografía de control fue de 7.3%, 7.5% en pacientes con angina estable inicial y 7.2% en pacientes con síndrome coronario agudo inicial. La pérdida media tardía de la luz fue de 0.42 ± 0.3 mm y la estenosis residual media del 13.8% ± 13.3%. La tasa MACE fue de 4.3%. En los hombres, la tasa de reestenosis dentro de la prótesis fue de 23.8% con 80 mg, 13.6% con 160 mg, 5.7% con 240 mg y 4.9% con 320 mg. En las mujeres, la tasa de reestenosis fue de 12.2% con 80 mg y de 4% con 160 mg; no se observó reestenosis con dosis más altas. La administración de valsartán en altas dosis puede reducir la tasa de reestenosis angiográfica hasta alrededor del 7% en pacientes con angina de pecho inicial y síndrome coronario agudo con una tasa de MACE por debajo del 5%

Segurança e eficácia dos stents farmacológicos: uma pausa para reflexão / Safety and efficacy of drug eluting stents: a pause for reflection

Estudos farmacológicos demonstraram, de forma inequívoca, que os stents farmacológicos são capazes de reduzir significativamente a ocorrência de reestenose intra-stent e de eventos cardíacos após a intervenção coronariana quando comparados aos stents convencionais, tornando-se rapidamente importantes instrumentos na rotina do Laboratório de Hemodinâmica. Contudo, os mesmos estudos randomizados falharam em demonstrar redução na taxa de mortalidade e da incidência de IAM. Neste artigo serão revistas as questões mais relevantes em relação à segurança e à eficácia dos stents farmacológicos a luz dos mais recentes resultados e das crescentes perocupações com a possibilidade de trombose tardia de stents.

Randomized clinical trials showed that drug eluting stents can reduce the occurrence of intra-stent restenosis and cardiac events after a coronary intervention compared to bare metal stents, thus becoming very important devices in the cat lab routine. However, the same studies failed to demonstratereduction in mortality or the incidence of acute MI. In this article we will review the most important issues concerning the safety and efficacy of the drug eluting stents in the light of more recent results and rising concerns about the possibility of late thrombosis of stent.