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Contains fulltext : 233810.pdf (Publisher’s version ) (Closed access), BACKGROUND AND AIMS: The impact of advanced age on the optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary revascularization (PCI) is still greatly debated. Therefore, the aim of the present sub-analysis of the REDUCE trial was to assess the impact of age on the comparison between a short 3 months vs standard 12 months DAPT in ACS patients treated with the COMBO Dual Stent Therapy. METHODS: The REDUCE trial is a prospective, multicenter, investigator-initiated study that randomized ACS patients undergoing PCI with the COMBO drug eluting stent to either 3 or 12 months of DAPT. The study population was divided according to age (

Contains fulltext : 233810.pdf (Publisher’s version ) (Closed access), BACKGROUND AND AIMS: The impact of advanced age on the optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary revascularization (PCI) is still greatly debated. Therefore, the aim of the present sub-analysis of the REDUCE trial was to assess the impact of age on the comparison between a short 3 months vs standard 12 months DAPT in ACS patients treated with the COMBO Dual Stent Therapy. METHODS: The REDUCE trial is a prospective, multicenter, investigator-initiated study that randomized ACS patients undergoing PCI with the COMBO drug eluting stent to either 3 or 12 months of DAPT. The study population was divided according to age (

Contains fulltext : 233810.pdf (Publisher’s version ) (Closed access), BACKGROUND AND AIMS: The impact of advanced age on the optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary revascularization (PCI) is still greatly debated. Therefore, the aim of the present sub-analysis of the REDUCE trial was to assess the impact of age on the comparison between a short 3 months vs standard 12 months DAPT in ACS patients treated with the COMBO Dual Stent Therapy. METHODS: The REDUCE trial is a prospective, multicenter, investigator-initiated study that randomized ACS patients undergoing PCI with the COMBO drug eluting stent to either 3 or 12 months of DAPT. The study population was divided according to age (

Aim. The aim of this study was to compare the zinc and copper concentration in the group of patients with bipolar disorder (BD) and major depressive disorder (MDD). Method. 110 patients with the diagnosis of BD and 114 with MDD were qualified to the study. To assess the levels of microelements, the flame atomic absorption spectrometry (FAAS) was used in the case of zinc and the electrothermal atomic absorption spectrometry (ET AAS) was used in the case of copper. Results. There were no differences between concentration of zinc and copper in remission and depressive phase between patients with BD and MDD. Additionally, there were also no statistically significant differences in comparisons including type I and II, early or late phase of BD and MDD. Conclusions. The lack of differences in zinc and copper concentrations between patients with bipolar disorder and major depressive disorder might indicate that those disorders have similar etiology.

Background and aims: The impact of endothelial shear stress (ESS) on vessel remodeling in vessels implanted with bioresorbable scaffold (BRS) as compared to metallic drug-eluting stent (DES) remains elusive. The aim of this study was to determine whether the relationship between ESS and remodeling patterns differs in BRS from those seen in metallic DES at 3-year follow-up. Methods: In the ABSORB II randomized trial, lesions were investigated by serial coronary angiography and intravascular ultrasound (IVUS). Three-dimensional reconstructions of coronary arteries post-procedure and at 3 years were performed. ESS was quantified using non-Newtonian steady flow simulation. IVUS cross-sections in device segment were matched using identical landmarks. Results: Paired ESS calculations post-procedure and at 3 years were feasible in 57 lesions in 56 patients. Postprocedure, median ESS at frame level was higher in BRS than in DES, with marginal statistical significance (0.97 ± 0.48 vs. 0.75 ± 0.39 Pa, p = 0.063). In the BRS arm, vessel area and lumen area showed larger increases in the highest tercile of median ESS post-procedure as compared to the lowest tercile. In contrast, in DES, no significant relationship between median ESS post-procedure and remodeling was observed. In multivariate analysis, smaller vessel area, larger lumen area, higher plaque burden post-procedure, and higher median ESS post-procedure were independently associated with expansive remodeling in matched frames. Only in BRS, younger age was an additional significant predictor of expansive remodeling. Conclusions: In a subset of lesions with large plaque burden, shear stress could be associated with expansive remodeling and late lumen enlargement in BRS, while ESS had no impact on vessel dimension in metallic DES.

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To examine cytokine receptor biomarkers in bipolar disorder (BD), we recruited 133 well-phenotyped BD patients and 50 normal controls and measured serum levels of soluble interleukin 1 receptor antagonist (sIL-1RA), soluble interleukin-2 receptor (sIL-2R), sIL-6R, and tumor necrosis factor receptor 60 and 80 kDa (sTNFR60/80). sIL-1RA and sTNFR80 are significantly higher in BD than in controls and sTNFR80 and higher in melancholic than in non-melancholic patients and controls. Kapczinski’s stages 3 + 4 are characterized by lowered sIL-2R and increased sTNFR80 levels. Acute phase depression is characterized by increased sTNFR80 levels as compared with controls, manic, and euthymic patients. Both sTNFR60 and sTNFR80 levels are significantly and positively related with severity of depression but not mania. Logistic regression analysis showed that the significant predictors for BD are increased sIL-1RA levels, nicotine dependence and a family history of depression and alcoholism. The risk factors for stages 3 + 4 are lowered sIL-2R levels and nicotine dependence. Melancholia is predicted by higher sTNFR80 levels and female sex. Severity of depression is predicted by female sex, nicotine dependence, and increased sTNFR60 and sTNFR80 levels. Cell-mediated immunity is activated during a current episode of depression but not (hypo)mania or the euthymic state. There are no associations between the biomarkers and age at onset, duration of illness, severity of mania, bipolar (BP)2 or BP1 subtypes, rapid cycling, atypical depression, psychotic or suicidal symptoms, and a family history of psychiatric disease. The results show that increased sIL-1RA may be a trait marker of BD, increased sTNFR80 a state marker of the depressive phase, especially melancholia, while lower sIL-2R but higher sTNFR80 may be staging biomarkers.

Despite many clinical trials assessing the role of zinc in major depressive disorder (MDD), the conclusions still remain ambiguous. The aim of the present clinical study was to determine and comparison the zinc concentration in the blood of MDD patients (active stage or remission) and healthy volunteers (controls), as well as to discuss its potential clinical usefulness as a biomarker of the disease. In this study 69 patients with current depressive episode, 45 patients in remission and 50 controls were enrolled. The zinc concentration was measured by electrothermal atomic absorption spectrometry (ET AAS). The obtained results revealed, that the zinc concentration in depressed phase were statistically lower than in the healthy volunteers [0.89 vs. 1.06 mg/L, respectively], while the zinc level in patients achieve remission was not significantly different from the controls [1.07 vs. 1.06 mg/L, respectively]. Additionally, among the patients achieve remission a significant differences in zinc concentration between group with and without presence of drug-resistance in the previous episode of depression were observed. Also, patients in remission demonstrated correlation between zinc level and the average number of depressive episodes in the last year. Serum zinc concentration was not dependent on atypical features of depression, presence of psychotic symptoms or melancholic syndrome, age, age of onset or duration of disease, number of episodes in the life time, duration of the episode/remission and severity of depression measured by the Hamilton Rating Scale for Depression (HDRS), and the Montgomery-Asberg Depression Rating Scale (MADRS). Concluding, our findings confirm the correlation between zinc deficit present in the depressive episode, and are consistent with the majority of previous studies. These results may also indicate that serum zinc concentration might be considered as a potential biological marker of MDD.

Background: The advent of bioresorbable vascular scaffolds (BVS) was considered as a potential improvement in percutaneous coronary intervention (PCI) after the groundbreaking development of drug eluting stents (DES). However, the clinical performance,long-term safety and efficacy of BVSin complex coronary lesions remain uncertain. COMPARE ABSORB, a multicenter, single blind, prospective randomized trial, aims to compare the clinical outcomes between the Absorb BVS and Xience everolimus-eluting metallic stent (EES) in patients with coronary artery disease and a hi

Objectives We aimed to evaluate the mechanical properties and healing patterns 6 and 9 months after implantation of the sirolimus-eluting Fantom bioresorbable scaffold (BRS). Background The Fantom BRS (Reva Medical, San Diego, USA) has differentiating properties including radiopacity, strut thickness of 125 µm, high expansion capacity and has demonstrated favourable mid-term clinical and angiographic outcomes. Methods and results FANTOM II was a prospective, single arm study with implantation of the Fantom BRS in 240 patients with stable angina pectoris. Guidance by optical coherence tomography (OCT) was encouraged and was repeated at 6-month (cohort A) or 9-month follow-up (cohort B). Matched baseline and follow-up OCT recordings were available in 152 patients. In-scaffold mean lumen area in cohort A was 6.8±1.7mm2 and 5.7±1.4mm2 at baseline and follow-up (p<0.0001) and was 7.2±1.6mm2 and 5.6±1.4mm2 in cohort B (p<0.0001). Mean scaffold area remained stable from 7.1±1.5mm2 at baseline to 7.2±1.4mm2 at 6 months (p=0.12), and from 7.4±1.5mm2 to 7.3±1.4mm2 at 9 months. Strut malapposition was median 0.8 (IQR 0.0;3.5)% and 1.8 (IQR 0.3;6.0)% at baseline and was 0.0 (IQR 0.0;0.0)% in both groups at 6-month and 9-month follow-up. Strut tissue coverage was 98.1 (IQR 95.9;99.4)% at 6 months and 98.9 (IQR 98.3;100.0)% at 9 months. Conclusions The novel Fantom BRS had favourable healing patterns at 6-month and 9-month follow-up as malapposition was effectively resolved and strut coverage was almost complete. The scaffold remained stable through follow-up with no signs of systematic late recoil.

Background: The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. Methods: The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with ClinicalTrials.gov, NCT03417050. Findings: From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%) patients had died after PCI and 211 (24%) after CABG (hazard ratio 1·17 [95% CI 0·97–1·41], p=0·092). Among patients with three-vessel disease, 151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG (hazard ratio 1·41 [95% CI 1·10–1·80]), and among patients with left main coronary artery disease, 93 (26%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0·90 [0·68–

Background: Lowered antioxidant defense systems and increased oxidative stress are implicated in bipolar disorders (BD). Early and late stages of BD may present different biological features (including the level of oxidative stress) and may therefore require different treatment strategies. The aim of this study was to analyze serum levels of lipid peroxidation [measured as thiobarbituric acid-reactive substances (TBARS), a derivative of malondialdehyde] in BD patients at various stages and phases of the illness and compare their TBARS levels with those of healthy controls. Method: A total of 129 patients (58 in the depressive episode, 23 in the manic episode and 48 in remission) diagnosed with type I (n = 69) or type II (n = 60) BD and 50 healthy volunteers (control group) were enrolled in the study. The level of lipid peroxidation was measured in blood serum using a TBARS assay kit. Results: TBARS levels in the acute episode of mania/hypomania and depression (but not in remission) were significantly higher than in healthy controls. With regard to the BD stage, both early- and late-stage BD TBARS levels were significantly increased in patients in the depressive episode. In late-stage BD, the TBARS level in patients in remission remained elevated compared with controls. A multiple regression model confirmed the association between the TBARS level and BD stage or acute BD. Conclusion: Our findings indicate that TBARS levels reflect the oxidative stress state which increases both in the acute phase of BD (mania/hypomania and depression) and with BD progression (stage).

Objectives Zinc may be involved in the pathophysiology and treatment of depressive disorder. However, data on this issue in bipolar disorder (BD) are limited. The aim of the study was to assess zinc concentrations in the blood serum of patients at various phases and stages of bipolar disorder. Methods The study included 129 patients with a diagnosis of bipolar disorder type I (n=69) or type II (n=60). Fifty-eight were in a depressive episode, 23 in a manic episode and 48 in remission. Fifty healthy volunteers made a control group. Zinc concentration was measured using flame atomic absorption spectrometry. Results Serum zinc level in patients diagnosed with BD type I in the depressive phase was significantly reduced as compared with mania, remission and healthy subjects. In the BD type II, serum zinc level in hypomania, depression or remission phase was not significantly different from the control group. In the whole group, lower level of zinc in depression compared to remission and control subjects was found during late stage of the illness but not in the early stage. Zinc concentration was not dependent on the severity of manic or depressive symptoms and subtype of depression but correlated positively with the number of manic/hypomanic relapses in the past year. Limitations Lack of prospective model, heterogeneity of pharmacological treatment, small number of subgroups presenting specified clinical features. Conclusions Decreased serum zinc concentration occurs in depression in BD type I and probably in depression in the late stage of BD.

Copper may be involved in the pathophysiology of depression. Clinical data on this issue are very limited and not conclusive. The purpose of the study was to determine the copper concentration in the serum of patients with major depressive disorder and to discuss its potential clinical usefulness as a biomarker of the disease. A case-control clinical study included 69 patients with current depressive episode, 45 patients in remission and 50 healthy volunteers. Cu concentration was measured by electrothermal atomic absorption spectrometry (ETAAS). The mean serum copper level in depressed patients was slightly lower (by 11 %; not statistically significant) than in the control group. Furthermore, there was no significant difference in Cu2+ concentration between depressive episode and remission, nor between remission and control group. In the remission group were observed significant correlations between copper levels and the average number of relapses over the past years or time of remission. There was no correlation between serum copper and severity of depression, as measured by HDRS and MADRS. The obtained results showed no significant differences between the copper concentration in the blood serum of patients (both with current depressive episode and in remission) and healthy volunteers, as well as the lack of correlations between the copper level in the active stage of the disease and clinical features of the population. Our study is the first conducted on such a large population of patients, so the results may be particularly important and reliable source of knowledge about the potential role of copper in depression.

Aim. Few scientific reports indicate changes in the concentration of magnesium in the blood of patients with bipolar disorder (BD). So far very little studies concerning these issues have been conducted. Therefore, the aim of this study was to evaluate the serum magnesium level in patients with bipolar disorder (in different phases of the disease) in comparison to healthy volunteers. Methodology. The study included 129 patients (58 subjects in depressive episode, 23 in manic episode and 48 patients in remission) with the diagnosis of bipolar disorder type I or II. The control group consisted of 50 healthy people. Magnesium concentration was measured using flame atomic absorption spectrometry (FAAS). Results. Patients with a current depressive or manic/hypomanic episode had statistically significantly elevated serum magnesium levels compared to healthy volunteers. Moreover, a positive correlation between the duration of the manic/hypomanic episode and the relapse frequency in the last year was observed. The concentration of magnesium in patients in remission was unchanged in relation to the control group. Conclusions. Presented findings suggest a role of serum magnesium level as a potential state marker, reflecting the pathophysiological changes associated with acute episodes of bipolar disorder.

Aim. The growing body of evidence suggests that magnesium levels can serve as a marker of major depressive disorder (MDD), but findings from clinical trials remain inconclusive. The aim of the presented study was to determine the magnesium concentration in serum of patients with MDD (in the active stage of the disease or in remission) and to analyze the role of magnesium levels as a potential marker of the disease. Methods. Sixty-nine patients with current depressive episode, 45 patients in remission and 50 healthy volunteers were enrolled into the case-control study. The magnesium concentration was measured by flame atomic absorption spectrometry (FAAS). Results. The mean serum magnesium concentration of patients in the depressed phase was significantly higher, compared to the control group. Moreover, magnesium levels of patients in the remission were not significantly different from the concentrations recorded in the healthy volunteers. There was also a positive correlation between the magnesium levels and the severity of depression measured by the Hamilton Rating Scale for Depression (HDRS) and the Montgomery-Asberg Depression Rating Scale (MADRS). Conclusions. The obtained results may suggest a role of magnesium as a state marker reflecting the pathophysiological changes underlying MDD and accompanying severe depressive episodes.

Contains fulltext : 182263.pdf (Publisher’s version ) (Open Access), Aims: To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease. Methods and results: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries. The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bioresorbable-polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall 708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39-0.85, P = 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11-0.70, P = 0.007) and revascularisation (HR 0.57, 95% CI 0.37-0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27-1.73, P = 0.43) and stroke (HR 0.69, 95% CI 0.10-4.89, P = 0.71) were similar. The rate of definite stent thrombosis w

Item does not contain fulltext, Aims: Multimodality invasive imaging of the first-in-man cohort demonstrated at 5 years stable lumen dimensions and a low rate of major adverse cardiac events (MACE). However, the long-term non-invasive assessment of this device remains to be documented. The objective was to describe the 72-month multislice computed tomography (MSCT) angiographic and functional findings after the implantation of the second iteration of the fully resorbable everolimus-eluting polymeric scaffold. Methods and results: In the ABSORB Cohort B trial patients with non-complex de novo lesions were treated with second iteration bioresobable vascular scaffold (BVS). MSCT angiography was performed as an optional investigation at 18 months; patients were reconsented for a second investigation at 72 months. MSCT data were analysed at independent core laboratories for quantitative analysis of lumen dimensions and for calculation of fractional flow reserve derived from computed tomography (FFRCT). From the overall Cohort B (101 patients), 53 patients underwent MSCT imaging at 72 months. The MACE rate was 1.9% (1/53). At 72 months, the median minimal lumen area (MLA) was 4.05 mm2 (interquartile range [IQR]: 3.15-4.90) and the mean percentage area stenosis was 18% (IQR: 4.75-31.25), one scaffold was totally occluded. In 39 patients with paired MSCT analysis, the MLA significantly increased from the first to the second follow-up (Delta = 0.80 mm2, P = 0.002). The change in the median FFRCT scaffold gradient between time points was zero. Conclusion: The long-term serial non-invasive MSCT evaluation with FFRCT assessment after bioresorbable scaffold implantation confirmed in-scaffold late lumen enlargement with the persistence of normalization of the FFRCT. Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.

Aims Multimodality invasive imaging of the first-in-man cohort demonstrated at 5 years stable lumen dimensions and a low rate of major adverse cardiac events (MACE). However, the long-term non-invasive assessment of this device remains to be documented. The objective was to describe the 72-month multislice computed tomography (MSCT) angiographic and functional findings after the implantation of the second iteration of the fully resorbable everolimus-eluting polymeric scaffold. Methods and results In the ABSORB Cohort B trial patients with non-complex de novo lesions were treated with second iteration bioresobable vascular scaffold (BVS). MSCT angiography was performed as an optional investigation at 18 months; patients were reconsented for a second investigation at 72 months. MSCT data were analysed at independent core laboratories for quantitative analysis of lumen dimensions and for calculation of fractional flow reserve derived from computed tomography (FFRCT). From the overall Cohort B (101 patients), 53 patients underwent MSCT imaging at 72 months. The MACE rate was 1.9% (1/53). At 72 months, the median minimal lumen area (MLA) was 4.05 mm2 (interquartile range [IQR]: 3.15-4.90) and the mean percentage area stenosis was 18% (IQR: 4.75-31.25), one scaffold was totally occluded. In 39 patients with paired MSCT analysis, the MLA significantly increased from the first to the second follow-up (delta = 0.80 mm2, P = 0.002). The change in the median FFRCT scaffold gradient between time points was zero. Conclusion The long-term serial non-invasive MSCT evaluation with FFRCT assessment after bioresorbable scaffold implantation confirmed in-scaffold late lumen enlargement with the persistence of normalization of the FFRCT. Clinical trial URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.Copyright © 2017 The Author.

Aims: To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease. Methods and results: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries. The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bio-resorbable-polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall 708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39-0.85, P= 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11-0.70, P= 0.007) and revascularisation (HR 0.57, 95% CI 0.37-0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27-1.73, P = 0.43) and stroke (HR 0.69, 95% CI 0.10-4.89, P = 0.71) were similar. The rate of definite stent thrombosis wa

Background Long-term benefits of coronary stenosis treatment with an everolimus-eluting bioresorbable scaffold are unknown. Objectives This study sought to evaluate clinical and imaging outcomes 5 years after bioresorbable scaffold implantation. Methods In the ABSORB multicenter, single-arm trial, 45 (B1) and 56 patients (B2) underwent coronary angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) at different times. At 5 years, 53 patients without target lesion revascularization underwent final imaging. Results Between 6 months/1 year and 5 years, angiographic luminal late loss remained unchanged (B1: 0.14 +/- 19 mm vs. 0.13 +/- 0.33 mm; p = 0.7953; B2: 0.23 +/- 0.28 mm vs. 0.18 +/- 0.32 mm; p = 0.5685). When patients with a target lesion revascularization were included, luminal late loss was 0.15 +/- 0.20 mm versus 0.15 +/- 0.24 mm (p = 0.8275) for B1 and 0.30 +/- 0.37 mm versus 0.32 +/- 0.48 mm (p = 0.8204) for B2. At 5 years, in-scaffold and -segment binary restenosis was 7.8% (5 of 64) and 12.5% (8 of 64). On IVUS, the minimum lumen area of B1 decreased from 5.23 +/- 0.97 mm2 at 6 months to 4.89 +/- 1.81 mm2 at 5 years (p = 0.04), but remained unchanged in B2 (4.95 +/- 0.91 mm2 at 1 year to 4.84 +/- 1.28 mm2 at 5 years; p = 0.5). At 5 years, struts were no longer discernable by OCT and IVUS. On OCT, the minimum lumen area in B1 decreased from 4.51 +/- 1.28 mm2 at 6 months to 3.65 +/- 1.39 mm2 at 5 years (p = 0.01), but remained unchanged in B2, 4.35 +/- 1.09 mm2 at 1 year and 4.12 +/- 1.38 mm2 at 5 years (p = 0.24). Overall, the 5-year major adverse cardiac event rate was 11.0%, without any scaffold thrombosis. Conclusions At 5 years, bioresorbable scaffold implantation in a simple stenotic lesion resulted in stable lumen dimensions and low restenosis and major adverse cardiac event rates.Copyright © 2016 American College of Cardiology Foundation.

Aims Multimodality invasive imaging of the first-in-man cohort demonstrated at 5 years stable lumen dimensions and a low rate of major adverse cardiac events (MACE). However, the long-term non-invasive assessment of this device remains to be documented. The objective was to describe the 72-month multislice computed tomography (MSCT) angiographic and functional findings after the implantation of the second iteration of the fully resorbable everolimus-eluting polymeric scaffold. Methods and results In the ABSORB Cohort B trial patients with non-complex de novo lesions were treated with second iteration bioresobable vascular scaffold (BVS). MSCT angiography was performed as an optional investigation at 18 months; patients were reconsented for a second investigation at 72 months. MSCT data were analysed at independent core laboratories for quantitative analysis of lumen dimensions and for calculation of fractional flow reserve derived from computed tomography (FFRCT). From the overall Cohort B (101 patients), 53 patients underwent MSCT imaging at 72 months. The MACE rate was 1.9% (1/53). At 72 months, the median minimal lumen area (MLA) was 4.05 mm2 (interquartile range [IQR]: 3.15-4.90) and the mean percentage area stenosis was 18% (IQR: 4.75-31.25), one scaffold was totally occluded. In 39 patients with paired MSCT analysis, the MLA significantly increased from the first to the second follow-up (delta = 0.80 mm2, P = 0.002). The change in the median FFRCT scaffold gradient between time points was zero. Conclusion The long-term serial non-invasive MSCT evaluation with FFRCT assessment after bioresorbable scaffold implantation confirmed in-scaffold late lumen enlargement with the persistence of normalization of the FFRCT. Clinical trial URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.Copyright © 2017 The Author.

Contains fulltext : 182263.pdf (Publisher’s version ) (Open Access), Aims: To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease. Methods and results: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries. The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bioresorbable-polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall 708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39-0.85, P = 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11-0.70, P = 0.007) and revascularisation (HR 0.57, 95% CI 0.37-0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27-1.73, P = 0.43) and stroke (HR 0.69, 95% CI 0.10-4.89, P = 0.71) were similar. The rate of definite stent thrombosis w

Item does not contain fulltext, Aims: Multimodality invasive imaging of the first-in-man cohort demonstrated at 5 years stable lumen dimensions and a low rate of major adverse cardiac events (MACE). However, the long-term non-invasive assessment of this device remains to be documented. The objective was to describe the 72-month multislice computed tomography (MSCT) angiographic and functional findings after the implantation of the second iteration of the fully resorbable everolimus-eluting polymeric scaffold. Methods and results: In the ABSORB Cohort B trial patients with non-complex de novo lesions were treated with second iteration bioresobable vascular scaffold (BVS). MSCT angiography was performed as an optional investigation at 18 months; patients were reconsented for a second investigation at 72 months. MSCT data were analysed at independent core laboratories for quantitative analysis of lumen dimensions and for calculation of fractional flow reserve derived from computed tomography (FFRCT). From the overall Cohort B (101 patients), 53 patients underwent MSCT imaging at 72 months. The MACE rate was 1.9% (1/53). At 72 months, the median minimal lumen area (MLA) was 4.05 mm2 (interquartile range [IQR]: 3.15-4.90) and the mean percentage area stenosis was 18% (IQR: 4.75-31.25), one scaffold was totally occluded. In 39 patients with paired MSCT analysis, the MLA significantly increased from the first to the second follow-up (Delta = 0.80 mm2, P = 0.002). The change in the median FFRCT scaffold gradient between time points was zero. Conclusion: The long-term serial non-invasive MSCT evaluation with FFRCT assessment after bioresorbable scaffold implantation confirmed in-scaffold late lumen enlargement with the persistence of normalization of the FFRCT. Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.

BACKGROUND: Long-term benefits of coronary stenosis treatment with an everolimus-eluting bioresorbable scaffold are unknown. OBJECTIVES: This study sought to evaluate clinical and imaging outcomes 5 years after bioresorbable scaffold implantation. METHODS: In the ABSORB multicenter, single-arm trial, 45 (B1) and 56 patients (B2) underwent coronary angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) at different times. At 5 years, 53 patients without target lesion revascularization underwent final imaging. RESULTS: Between 6 months/1 year and 5 years, angiographic luminal late loss remained unchanged (B1: 0.14 +/- 19 mm vs. 0.13 +/- 0.33 mm; p = 0.7953; B2: 0.23 +/- 0.28 mm vs. 0.18 +/- 0.32 mm; p = 0.5685). When patients with a target lesion revascularization were included, luminal late loss was 0.15 +/- 0.20 mm versus 0.15 +/- 0.24 mm (p = 0.8275) for B1 and 0.30 +/- 0.37 mm versus 0.32 +/- 0.48 mm (p = 0.8204) for B2. At 5 years, in-scaffold and -segment binary restenosis was 7.8% (5 of 64) and 12.5% (8 of 64). On IVUS, the minimum lumen area of B1 decreased from 5.23 +/- 0.97 mm(2) at 6 months to 4.89 +/- 1.81 mm(2) at 5 years (p = 0.04), but remained unchanged in B2 (4.95 +/- 0.91 mm(2) at 1 year to 4.84 +/- 1.28 mm(2) at 5 years; p = 0.5). At 5 years, struts were no longer discernable by OCT and IVUS. On OCT, the minimum lumen area in B1 decreased from 4.51 +/- 1.28 mm(2) at 6 months to 3.65 +/- 1.39 mm(2) at 5 years (p = 0.01), but remained unchanged in B2, 4.35 +/- 1.09 mm(2) at 1 year and 4.12 +/- 1.38 mm(2) at 5 years (p = 0.24). Overall, the 5-year major adverse cardiac event rate was 11.0%, without any scaffold thrombosis. CONCLUSIONS: At 5 years, bioresorbable scaffold implantation in a simple stenotic lesion resulted in stable lumen dimensions and low restenosis and major adverse cardiac event rates. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).Copyright © 2016 American College of Cardiology Foundati

BACKGROUND: Long-term benefits of coronary stenosis treatment with an everolimus-eluting bioresorbable scaffold are unknown. OBJECTIVES: This study sought to evaluate clinical and imaging outcomes 5 years after bioresorbable scaffold implantation. METHODS: In the ABSORB multicenter, single-arm trial, 45 (B1) and 56 patients (B2) underwent coronary angiography, intravascular ultrasound (IVUS), and optical coherence tomography (OCT) at different times. At 5 years, 53 patients without target lesion revascularization underwent final imaging. RESULTS: Between 6 months/1 year and 5 years, angiographic luminal late loss remained unchanged (B1: 0.14 +/- 19 mm vs. 0.13 +/- 0.33 mm; p = 0.7953; B2: 0.23 +/- 0.28 mm vs. 0.18 +/- 0.32 mm; p = 0.5685). When patients with a target lesion revascularization were included, luminal late loss was 0.15 +/- 0.20 mm versus 0.15 +/- 0.24 mm (p = 0.8275) for B1 and 0.30 +/- 0.37 mm versus 0.32 +/- 0.48 mm (p = 0.8204) for B2. At 5 years, in-scaffold and -segment binary restenosis was 7.8% (5 of 64) and 12.5% (8 of 64). On IVUS, the minimum lumen area of B1 decreased from 5.23 +/- 0.97 mm(2) at 6 months to 4.89 +/- 1.81 mm(2) at 5 years (p = 0.04), but remained unchanged in B2 (4.95 +/- 0.91 mm(2) at 1 year to 4.84 +/- 1.28 mm(2) at 5 years; p = 0.5). At 5 years, struts were no longer discernable by OCT and IVUS. On OCT, the minimum lumen area in B1 decreased from 4.51 +/- 1.28 mm(2) at 6 months to 3.65 +/- 1.39 mm(2) at 5 years (p = 0.01), but remained unchanged in B2, 4.35 +/- 1.09 mm(2) at 1 year and 4.12 +/- 1.38 mm(2) at 5 years (p = 0.24). Overall, the 5-year major adverse cardiac event rate was 11.0%, without any scaffold thrombosis. CONCLUSIONS: At 5 years, bioresorbable scaffold implantation in a simple stenotic lesion resulted in stable lumen dimensions and low restenosis and major adverse cardiac event rates. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856).Copyright © 2016 American College of Cardiology Foundati

Item does not contain fulltext, AIMS: Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion therapy in ST-elevation myocardial infarction (STEMI). We conducted this study to evaluate the contemporary status on the use and type of reperfusion therapy in patients admitted with STEMI in the European Society of Cardiology (ESC) member countries. METHODS AND RESULTS: A cross-sectional descriptive study based on aggregated country-level data on the use of reperfusion therapy in patients admitted with STEMI during 2010 or 2011. Thirty-seven ESC countries were able to provide data from existing national or regional registries. In countries where no such registries exist, data were based on best expert estimates. Data were collected on the use of STEMI reperfusion treatment and mortality, the numbers of cardiologists, and the availability of PPCI facilities in each country. Our survey provides a brief data summary of the degree of variation in reperfusion therapy across Europe. The number of PPCI procedures varied between countries, ranging from 23 to 884 per million inhabitants. Primary percutaneous coronary intervention and thrombolysis were the dominant reperfusion strategy in 33 and 4 countries, respectively. The mean population served by a single PPCI centre with a 24-h service 7 days a week ranged from 31 300 inhabitants per centre to 6 533 000 inhabitants per centre. Twenty-seven of the total 37 countries participated in a former survey from 2007, and major increases in PPCI utilization were observed in 13 of these countries. CONCLUSION: Large variations in reperfusion treatment are still present across Europe. Countries in Eastern and Southern Europe reported that a substantial number of STEMI patients are not receiving any reperfusion therapy. Implementation of the best reperfusion therapy as recommended in the guidelines should be encouraged.

Item does not contain fulltext, AIMS: Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion therapy in ST-elevation myocardial infarction (STEMI). We conducted this study to evaluate the contemporary status on the use and type of reperfusion therapy in patients admitted with STEMI in the European Society of Cardiology (ESC) member countries. METHODS AND RESULTS: A cross-sectional descriptive study based on aggregated country-level data on the use of reperfusion therapy in patients admitted with STEMI during 2010 or 2011. Thirty-seven ESC countries were able to provide data from existing national or regional registries. In countries where no such registries exist, data were based on best expert estimates. Data were collected on the use of STEMI reperfusion treatment and mortality, the numbers of cardiologists, and the availability of PPCI facilities in each country. Our survey provides a brief data summary of the degree of variation in reperfusion therapy across Europe. The number of PPCI procedures varied between countries, ranging from 23 to 884 per million inhabitants. Primary percutaneous coronary intervention and thrombolysis were the dominant reperfusion strategy in 33 and 4 countries, respectively. The mean population served by a single PPCI centre with a 24-h service 7 days a week ranged from 31 300 inhabitants per centre to 6 533 000 inhabitants per centre. Twenty-seven of the total 37 countries participated in a former survey from 2007, and major increases in PPCI utilization were observed in 13 of these countries. CONCLUSION: Large variations in reperfusion treatment are still present across Europe. Countries in Eastern and Southern Europe reported that a substantial number of STEMI patients are not receiving any reperfusion therapy. Implementation of the best reperfusion therapy as recommended in the guidelines should be encouraged.

Item does not contain fulltext, AIMS: Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion therapy in ST-elevation myocardial infarction (STEMI). We conducted this study to evaluate the contemporary status on the use and type of reperfusion therapy in patients admitted with STEMI in the European Society of Cardiology (ESC) member countries. METHODS AND RESULTS: A cross-sectional descriptive study based on aggregated country-level data on the use of reperfusion therapy in patients admitted with STEMI during 2010 or 2011. Thirty-seven ESC countries were able to provide data from existing national or regional registries. In countries where no such registries exist, data were based on best expert estimates. Data were collected on the use of STEMI reperfusion treatment and mortality, the numbers of cardiologists, and the availability of PPCI facilities in each country. Our survey provides a brief data summary of the degree of variation in reperfusion therapy across Europe. The number of PPCI procedures varied between countries, ranging from 23 to 884 per million inhabitants. Primary percutaneous coronary intervention and thrombolysis were the dominant reperfusion strategy in 33 and 4 countries, respectively. The mean population served by a single PPCI centre with a 24-h service 7 days a week ranged from 31 300 inhabitants per centre to 6 533 000 inhabitants per centre. Twenty-seven of the total 37 countries participated in a former survey from 2007, and major increases in PPCI utilization were observed in 13 of these countries. CONCLUSION: Large variations in reperfusion treatment are still present across Europe. Countries in Eastern and Southern Europe reported that a substantial number of STEMI patients are not receiving any reperfusion therapy. Implementation of the best reperfusion therapy as recommended in the guidelines should be encouraged.

Background: The long-term results after second generation everolimus eluting bioresorbable vascular scaffold (Absorb BVS) placement in small vessels are unknown. Therefore, we investigated the impact of vessel size on long-term outcomes, after Absorb BVS implantation. Method(s): In ABSORB Cohort B Trial, out of the total study population (101 patients), 45 patients were assigned to undergo 6-month and 2-year angiographic follow-up (Cohort B1) and 56 patients to have angiographic follow-up at 1-year (Cohort B2). The prereference vessel diameter (RVD) was <2.5 mm (small-vessel group) in 41 patients (41 lesions) and >=2.5 mm (large-vessel group) in 60 patients (61 lesions). Outcomes were compared according to pre-RVD. Result(s): At 2-year angiographic follow-up no differences in late lumen loss (0.29+/-0.16 mm vs 0.25+/-0.22 mm, p=0.4391), and in-segment binary restenosis (5.3% vs 5.3% p=1.0000) were demonstrated between groups. In the small-vessel group, intravascular ultrasound analysis showed a significant increase in vessel area (12.25+/-3.47 mm2 vs 13.09+/-3.38 mm2 p=0.0015), scaffold area (5.76+/-0.96 mm2 vs 6.41+/-1.30 mm2 p=0.0008) and lumen area (5.71+/-0.98 mm2 vs 6.20+/-1.27 mm 2 p=0.0155) between 6-months and 2-year follow-up. No differences in plaque composition were reported between groups at either time point. At 2-year clinical follow-up, no differences in ischaemia-driven major adverse cardiac events (7.3% vs 10.2%, p=0.7335), myocardial infarction (4.9% vs 1.7%, p=0.5662) or ischaemia-driven target lesion revascularisation (2.4% vs 8.5%, p=0.3962) were reported between small and large vessels. No deaths or scaffold thrombosis were observed. Conclusion(s): Similar clinical and angiographic outcomes at 2-year follow-up were reported in small and large vessel groups. A significant late lumen enlargement and positive vessel remodelling were observed in small vessels.

Aims: To assess serially the edge vascular response (EVR) of a bioresorbable vascular scaffold (BVS) compared to a metallic everolimus-eluting stent (EES). Methods and results: Non-serial evaluations of the Absorb BVS at one year have previously demonstrated proximal edge constrictive re

Background The long-term results after second generation everolimus eluting bioresorbable vascular scaffold (Absorb BVS) placement in small vessels are unknown. Therefore, we investigated the impact of vessel size on long-term outcomes, after Absorb BVS implantation. Methods In ABSORB Cohort B Trial, out of the total study population (101 patients), 45 patients were assigned to undergo 6-month and 2-year angiographic follow-up (Cohort B1) and 56 patients to have angiographic follow-up at 1-year (Cohort B2). The prereference vessel diameter (RVD) was <2.5 mm (smallvessel group) in 41 patients (41 lesions) and ≥2.5 mm (large-vessel group) in 60 patients (61 lesions). Outcomes were compared according to pre-RVD. Results At 2-year angiographic follow-up no differences in late lumen loss (0.29±0.16 mm vs 0.25±0.22 mm, p=0.4391), and in-segment binary restenosis (5.3% vs 5.3% p=1.0000) were demonstrated between groups. In the small-vessel group, intravascular ultrasound analysis showed a significant increase in vessel area (12.25±3.47 mm2 vs 13.09±3.38 mm2 p=0.0015), scaffold area (5.76±0.96 mm2 vs 6.41±1.30 mm2 p=0.0008) and lumen area (5.71±0.98 mm2 vs 6.20 ±1.27 mm2 p=0.0155) between 6-months and 2-year follow-up. No differences in plaque composition were reported between groups at either time point. At 2-year clinical follow-up, no differences in ischaemia-driven major adverse cardiac events (7.3% vs 10.2%, p=0.7335), myocardial infarction (4.9% vs 1.7%, p=0.5662) or ischaemia-driven target lesion revascularisation (2.4% vs 8.5%, p=0.3962) were reported between small and large vessels. No deaths or scaffold thrombosis were observed. Conclusions Similar clinical and angiographic outcomes at 2-year follow-up were reported in small and large vessel groups. A significant late lumen enlargement and positiv

Background: The long-term results after second generation everolimus eluting bioresorbable vascular scaffold (Absorb BVS) placement in small vessels are unknown. Therefore, we investigated the impact of vessel size on long-term outcomes, after Absorb BVS implantation. Method(s): In ABSORB Cohort B Trial, out of the total study population (101 patients), 45 patients were assigned to undergo 6-month and 2-year angiographic follow-up (Cohort B1) and 56 patients to have angiographic follow-up at 1-year (Cohort B2). The prereference vessel diameter (RVD) was <2.5 mm (small-vessel group) in 41 patients (41 lesions) and >=2.5 mm (large-vessel group) in 60 patients (61 lesions). Outcomes were compared according to pre-RVD. Result(s): At 2-year angiographic follow-up no differences in late lumen loss (0.29+/-0.16 mm vs 0.25+/-0.22 mm, p=0.4391), and in-segment binary restenosis (5.3% vs 5.3% p=1.0000) were demonstrated between groups. In the small-vessel group, intravascular ultrasound analysis showed a significant increase in vessel area (12.25+/-3.47 mm2 vs 13.09+/-3.38 mm2 p=0.0015), scaffold area (5.76+/-0.96 mm2 vs 6.41+/-1.30 mm2 p=0.0008) and lumen area (5.71+/-0.98 mm2 vs 6.20+/-1.27 mm 2 p=0.0155) between 6-months and 2-year follow-up. No differences in plaque composition were reported between groups at either time point. At 2-year clinical follow-up, no differences in ischaemia-driven major adverse cardiac events (7.3% vs 10.2%, p=0.7335), myocardial infarction (4.9% vs 1.7%, p=0.5662) or ischaemia-driven target lesion revascularisation (2.4% vs 8.5%, p=0.3962) were reported between small and large vessels. No deaths or scaffold thrombosis were observed. Conclusion(s): Similar clinical and angiographic outcomes at 2-year follow-up were reported in small and large vessel groups. A significant late lumen enlargement and positive vessel remodelling were observed in small vessels.

Item does not contain fulltext, BACKGROUND: Although P2Y12 antagonists are effective in patients with non-ST-segment elevation (NSTE) acute coronary syndromes, the effect of the timing of administration--before or after coronary angiography--is not known. We evaluated the effect of administering the P2Y12 antagonist prasugrel at the time of diagnosis versus administering it after the coronary angiography if percutaneous coronary intervention (PCI) was indicated. METHODS: We enrolled 4033 patients with NSTE acute coronary syndromes and a positive troponin level who were scheduled to undergo coronary angiography within 2 to 48 hours after randomization. Patients were randomly assigned to receive prasugrel (a 30-mg loading dose) before the angiography (pretreatment group) or placebo (control group). When PCI was indicated, an additional 30 mg of prasugrel was given in the pretreatment group at the time of PCI and 60 mg of prasugrel was given in the control group. RESULTS: The rate of the primary efficacy end point, a composite of death from cardiovascular causes, myocardial infarction, stroke, urgent revascularization, or glycoprotein IIb/IIIa inhibitor rescue therapy (glycoprotein IIb/IIIa bailout) through day 7, did not differ significantly between the two groups (hazard ratio with pretreatment, 1.02; 95% confidence interval [CI], 0.84 to 1.25; P=0.81). The rate of the key safety end point of all Thrombolysis in Myocardial Infarction (TIMI) major bleeding episodes, whether related or not related to coronary-artery bypass grafting (CABG), through day 7 was increased with pretreatment (hazard ratio, 1.90; 95% CI, 1.19 to 3.02; P=0.006). The rates of TIMI major bleeding and life-threatening bleeding not related to CABG were increased by a factor of 3 and 6, respectively. Pretreatment did not reduce the rate of the primary outcome among patients undergoing PCI (69% of the patients) but increased the rate of TIMI major bleeding at 7 days. All the results were confirmed at 30 days and in prespecified sub

Item does not contain fulltext, BACKGROUND: Although P2Y12 antagonists are effective in patients with non-ST-segment elevation (NSTE) acute coronary syndromes, the effect of the timing of administration--before or after coronary angiography--is not known. We evaluated the effect of administering the P2Y12 antagonist prasugrel at the time of diagnosis versus administering it after the coronary angiography if percutaneous coronary intervention (PCI) was indicated. METHODS: We enrolled 4033 patients with NSTE acute coronary syndromes and a positive troponin level who were scheduled to undergo coronary angiography within 2 to 48 hours after randomization. Patients were randomly assigned to receive prasugrel (a 30-mg loading dose) before the angiography (pretreatment group) or placebo (control group). When PCI was indicated, an additional 30 mg of prasugrel was given in the pretreatment group at the time of PCI and 60 mg of prasugrel was given in the control group. RESULTS: The rate of the primary efficacy end point, a composite of death from cardiovascular causes, myocardial infarction, stroke, urgent revascularization, or glycoprotein IIb/IIIa inhibitor rescue therapy (glycoprotein IIb/IIIa bailout) through day 7, did not differ significantly between the two groups (hazard ratio with pretreatment, 1.02; 95% confidence interval [CI], 0.84 to 1.25; P=0.81). The rate of the key safety end point of all Thrombolysis in Myocardial Infarction (TIMI) major bleeding episodes, whether related or not related to coronary-artery bypass grafting (CABG), through day 7 was increased with pretreatment (hazard ratio, 1.90; 95% CI, 1.19 to 3.02; P=0.006). The rates of TIMI major bleeding and life-threatening bleeding not related to CABG were increased by a factor of 3 and 6, respectively. Pretreatment did not reduce the rate of the primary outcome among patients undergoing PCI (69% of the patients) but increased the rate of TIMI major bleeding at 7 days. All the results were confirmed at 30 days and in prespecified sub

Affective disorders are a medical condition with a complex biological pattern of etiology, involving genetic and epigenetic factors, along with different environmental stressors. Increasing numbers of studies indicate that induction of oxidative and nitrosative stress (O&NS) pathways, which is accompanied by immune-inflammatory response, might play an important role in the pathogenic mechanisms underlying many major psychiatric disorders, including depression and bipolar disorder. Reactive oxygen and nitrogen species have been shown to impair the brain function by modulating activity of principal neurotransmitter (e.g., glutamatergic) systems involved in the neurobiology of depression. Both preclinical and clinical studies revealed that depression is associated with altered levels of oxidative stress markers and typically reduced concentrations of several endogenous antioxidant compounds, such as glutathione, vitamin E, zinc and coenzyme Q10, or enzymes, including glutathione peroxidase, and with an impairment of the total antioxidant status. These oxidative stress parameters can be normalized by successful antidepressant therapy. On the other hand, some antioxidants (zinc, N-acetylcysteine, omega-3 free fatty acids) may exhibit antidepressant properties or enhance standard antidepressant therapy. These observations introduce new potential targets for the development of therapeutic interventions based on antioxidant compounds. The present paper reviews selected animal and human studies providing evidence that oxidative stress is implicated in the pathophysiology and treatment of depression and bipolar disorder.

Objectives: We investigated the 6-month clinical outcomes after implantation of second-generation 3.0-mm bioresorbable everolimus-eluting vascular scaffolds (BVS) in small coronary vessels (<2.5 mm). Background(s): BVS are a novel approach to treating coronary lesions and are untested in small vessels. Method(s): The ABSORB Cohort B Trial is a multicenter, single-arm, prospective, open-label trial assessing the performance of the second-generation BVS, in which 101 patients were enrolled. The pre-procedural reference vessel diameter (RVD) was assessed by quantitative coronary angiography during post hoc analysis. The vessel size was overestimated, by visual assessment, in 41 patients before implantation of 3.0-mm BVS in vessels with a pre-procedural RVD <2.5 mm. The study population was divided into 2 groups, group I (n = 41) with RVD <2.5 mm and group II (n = 60) with RVD <2.5 mm. The composite endpoint of ischemia-driven major adverse cardiac events, defined as ischemia-driven target lesion revascularization, myocardial infarction, or cardiac death, was assessed. Of the 45 patients scheduled for 6-month coronary angiography, 42 patients had the procedure performed, with intravascular ultrasound undertaken in 40 of these patients. Result(s): At 6 months, no significant differences in ischemia-driven major adverse cardiac events (3 of 41 [7.3%] cases vs. 2 of 60 [3.3%] cases; p = 0.3933) were observed in the small- and large-vessel groups, respectively. No cardiac deaths or episodes of in-scaffold thromboses were seen. Angiographic and intravascular ultrasound follow-up demonstrated no differences in late lumen loss (0.16 +/- 0.18 mm vs. 0.21 +/- 0.17 mm; p = 0.3525) or percentage lumen area stenosis (17.6 +/- 6.0% vs. 19.8 +/- 8.5%; p = 0.3643). Conclusion(s): The second-generation 3.0-mm BVS appears to be safe in small vessels, with similar clinical and angiographic outcomes compared with those of large vessels. © 2011 American College of Cardiology Foundation.

The aim of this study was to describe vaso-reactivity (by Acetylcholine and Methergine tests) at 2 year follow-up in parallel with the individual changes in the echogenicity characteristics of the polymer struts of the everolimus eluting bioresorbable vascular scaffold (BVS), from post-treatment to 2 year follow-up, in patients enrolled in the ABSORB Cohort A study. Intravascular ultrasound assessment was performed with a phased array catheter (EagleEye, Volcano Corporation, Cordova, CA, USA) with automated pullback at 0.5 mm per second. The % ratio at 6 months and 2 years [(Scaffold Area post PCI- Lumen Area)/Scaffold Area post PCI] was calculated as a measure of scaffold shrinkage. The % change of hyperechogenicity was defined as: ([post-procedural hyperechogenicity] - [2 year follow up hyperechogenicity])/[post-procedural hyperechogenicity]) × 100. The vasomotion test with intracoronary acetylcholine (10-6M) or intravenous methergine (0.4 mg) was performed at 2 years. Overall nine patients received all these analyses and were enrolled in the present analysis. A 50-96% reduction in hyperechogenicity was observed between baseline and 2 years, which corresponded to a change in vasoreactivity between 2 and 22%. A vasoconstriction of the scaffolded segment was observed in the 5 patients, who underwent the methergine test, with a mean decrease in lumen diameter after meth

Although Virtual Histology intravascular ultrasound (VH-IVUS) is increasingly used in clinical research, the reproducibility of plaque composition remains unexplored in significant coronary artery and stented lesions. The purpose of this study was to assess the reproducibility of necrotic core and calcium content in atherosclerotic coronary lesions that were treated with a bioresorbable everolimus-eluting vascular scaffold (BVS) using a new measurement method (Shin's method) by VH-IVUS. Eight patients treated with a BVS (Abbott Vascular, Santa Clara, CA, USA) were analyzed with serial VH-IVUS assessments, i.e., pre- and post-stenting, and at 6 months and 2 years follow-up. A total of 32 coronary segments were imaged to evaluate the reproducibility of volumetric VH-IVUS measurements. In Shin's method, contours are drawn around the IVUS catheter (instead of the lumen) and vessel. Overall, in the imaged coronary segment, for necrotic core and dense calcium volumes, the relative intra-observer differences were 0.30 ± 0.22, 0.19 ± 0.16% for observer 1 and 0.45 ± 0.41, 0.36 ± 0.47% for observer 2, respectively. The interobserver relative differences of necrotic core and dense calcium volumes were 0.51 ± 0.79 and 0.56 ± 1.01%, respectively. The present study demonstrates a good reproducibility for both, intra-observer and interobserver measurements using Shin's method. This method is suitable for the measurement of necrotic core and dense calcium using VH-IVUS in longitudinal studies, especially studies on bioresorbable scaffolds, because the degradation process will be fully captured independently of the location of the struts and their greyscale appearance.

Aims: The first-in-man ABSORB Cohort A trial demonstrated the bioresorption of the ABSORB BVS (Abbott Vascular, Santa Clara, CA, USA) at two years. This report describes the 4-year clinical outcomes. Methods and results: The ABSORB Cohort A trial enrolled 30 patients with a single de novo native coronary artery lesion. Clinical follow-up was available in 29 patients since one patient withdrew consent after the six month follow-up. At four years, the hierarchical ID-MACE of 3.4% remained unchanged. Clopidogrel therapy had been discontinued in all patients. Conclusions: Four-year clinical results demonstrate a sustained low MACE rate (3.4%) without any late complications such as stent thrombosis.

Aims: Bioresorbable vascular scaffolds (BVS) present different mechanical properties as compared to metallic platform stents. Therefore, the sta

Background: Implantation of a metallic prosthesis creates local stiffness with a subsequent mismatch in the compliance of the vessel wall, disturbances in flow and heterogeneous distribution of wall shear stress. Polymeric bioresorbable ABSORB scaffolds have less stiffness than metallic platform stents. We sought to analyze the mismatch in vascular compliance after ABSORB implantation and its long-term resolution with bioresorption. Methods and Results: A total of 83 patients from the ABSORB trials underwent palpography investigations (30 and 53 patients from ABSORB Cohorts A and B, respectively) to measure the compliance of the scaffolded and adjacent segments at various time points (from pre-implantation up to 24 months). The mean of the maximum strain values was calculated per segment by utilizing the Rotterdam Classification (ROC) score and expressed as ROC/ mm. Scaffold implantation lead to a significant decrease in vascular compliance (median [IQR]) at the scaffolded segment (from 0.37 [0.24-0.45] to 0.14 [0.09-0.23], P<0.001) with mismatch in compliance in a paired analysis between the scaffolded and adjacent segments (proximal: 0.23 [0.12-0.34], scaffold: 0.12 [0.07-0.19], distal: 0.15 [0.05-0.26], P=0.042). This reported compliance mismatch disappears at short- and mid-term follow-up. Conclusions: The ABSORB scaffold decreases vascular compliance at the site of scaffold implantation. A compliance mismatch is evident immediately post-implantation and in contrast to metallic stents disappears in the mid-term, likely leading to a normalization of the rheological behavior of the scaffolded segment.

Objectives: We investigated the 6-month clinical outcomes after implantation of second-generation 3.0-mm bioresorbable everolimus-eluting vascular scaffolds (BVS) in small coronary vessels (<2.5 mm). Background(s): BVS are a novel approach to treating coronary lesions and are untested in small vessels. Method(s): The ABSORB Cohort B Trial is a multicenter, single-arm, prospective, open-label trial assessing the performance of the second-generation BVS, in which 101 patients were enrolled. The pre-procedural reference vessel diameter (RVD) was assessed by quantitative coronary angiography during post hoc analysis. The vessel size was overestimated, by visual assessment, in 41 patients before implantation of 3.0-mm BVS in vessels with a pre-procedural RVD <2.5 mm. The study population was divided into 2 groups, group I (n = 41) with RVD <2.5 mm and group II (n = 60) with RVD <2.5 mm. The composite endpoint of ischemia-driven major adverse cardiac events, defined as ischemia-driven target lesion revascularization, myocardial infarction, or cardiac death, was assessed. Of the 45 patients scheduled for 6-month coronary angiography, 42 patients had the procedure performed, with intravascular ultrasound undertaken in 40 of these patients. Result(s): At 6 months, no significant differences in ischemia-driven major adverse cardiac events (3 of 41 [7.3%] cases vs. 2 of 60 [3.3%] cases; p = 0.3933) were observed in the small- and large-vessel groups, respectively. No cardiac deaths or episodes of in-scaffold thromboses were seen. Angiographic and intravascular ultrasound follow-up demonstrated no differences in late lumen loss (0.16 +/- 0.18 mm vs. 0.21 +/- 0.17 mm; p = 0.3525) or percentage lumen area stenosis (17.6 +/- 6.0% vs. 19.8 +/- 8.5%; p = 0.3643). Conclusion(s): The second-generation 3.0-mm BVS appears to be safe in small vessels, with similar clinical and angiographic outcomes compared with those of large vessels. © 2011 American College of Cardiology Foundation.