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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

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.

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]) x 100. The vasomotion test with intracoronary acetylcholine (10(-6) M) 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 methergine of 9 +/- A 7% (P = 0.06), while vasodilatation occurred in the 4 patients who underwent the acetylcholine test with a mean increase in lumen diameter after acetylcholine of 8 +/- A 5% (P = 0.125). Bioresorption of the BVS is accompanied by re-establishment of both endothelial and non-endothelial dependent vasomotion.

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 inter-observer 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 inter-observer 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.

Background: The second generation Bioresorbable Everolimus Eluting Vascular Scaffolds (BVS) are untested at the mid-term follow-up in the subset of small coronary vessels. We investigated the performance of the second generation BVS (Abbott Vascular, Santa Clara, CA) in small coronary arteries (<2.5mm) at 1-year follow-up Methods: The ABSORB Cohort B Trial is a multicentre single-arm, prospective, open-label trial enrolling 101 patients. In the present post-hoc analysis, the study population was sorted according to the pre-procedural reference vessel diameter (RVD) into two groups: 1) Small-vessel group with RVD <2.5mm (41 patients, 41 lesions) and 2) Large-vessel group with RVD >=2.5 mm (60 patients, 61 lesions). Clinical outcomes were assessed at one-year follow-up for the entire population and compared between the two groups. Out of the total population 45 patients were assigned to undergo 6-month coronary angiography and 56 patients (57 lesions) to have the procedure performed at one year. Result(s): At one-year after implantation no differences in Ischemia-Driven (ID) Major Adverse Cardiovascular Events (small vessels 3/41 cases, 7.3% vs. large vessels 4/60 cases, 6.7%,p=1.0000), Myocardial Infarction (small vessels 2/41 cases, 4.9% vs large vessels 1/60 case, 1.7%,p=0.5645) and ID-Target Lesion Revascularization (small vessels 1/41 case, 2.4% vs large vessels 3/60 cases, 5.0%, p=0.6445) were reported between the two groups. No Cardiac Death was observed. At 1-year angiographic follow-up, no differences were showed in late lumen loss (small vessels 0.27+/-0.32mm vs. large vessels 0.27+/-0.32mm, p=0.9852) and In-Scaffold Binary Restenosis (small vessels 0/21 cases, 0.0% vs large vessels 2/36 cases, 5.6% p=0.5263). Conclusion(s): The second generation BVS showed similar clinical and angiographic outcomes at 1-year follow-up in small and large vessels.

Implantation of a coronary stent results in a mechanical enlargement of the coronary lumen with stretching of the surrounding atherosclerotic plaque. Using intravascular ultrasound virtual-histology (IVUS-VH) we examined the temporal changes in composition of the plaque behind the struts (PBS) following the implantation of the everolimus eluting bioresorbable vascular scaffold (BVS). Using IVUS-VH and dedicated software, the composition of plaque was analyzed in all patients from the ABSORB B trial who were imaged with a commercially available IVUS-VH console (s5i system, Volcano Corporation, Rancho Cordova, CA, USA) post-treatment and at 6-month follow-up. This dedicated software enabled analysis of the PBS after subtraction of the VH signal generated by the struts. The presence of necrotic core (NC) in contact with the lumen was also evaluated at baseline and follow-up. IVUS-VH data, recorded with s5i system, were available at baseline and 6-month follow-up in 15 patients and demonstrated an increase in both the area of PBS (2.45 ± 1.93 mm2vs. 3.19 ± 2.48 mm2, P = 0.005) and the external elastic membrane area (13.76 ± 4.07 mm2vs. 14.76 ± 4.56 mm2, P = 0.006). Compared to baseline there was a significant progression in the NC (0.85 ± 0.70 mm2vs. 1.21 ± 0.92 mm2, P = 0.010) and fibrous tissue area (0.88 ± 0.79 mm2vs. 1.15 ± 1.05 mm2, P = 0.027) of the PBS. The NC in contact with the lumen in the treated segment did not increase with follow-up (7.33 vs. 6.36%, P = 0.2). Serial IVUS-VH analysis of BVS-treated lesions at 6-month demonstrated a progression in the NC and fibrous tissue content of PBS.

Although serial changes in necrotic core and calcium are regarded as surrogates for the bioresorption process in patients treated with the bioresorbable everolimus-eluting vascular scaffolds (BVS), these temporal changes have not yet been fully investigated. Shin's method may be offer a more suitable technique for this analysis because it includes all the contents of both the lumen and vessel wall. The purpose of this study was to assess the serial changes of necrotic core and dense calcium content in coronary lesions that were treated with a BVS implant using Virtual Histology intravascular ultrasound (VH-IVUS) analyzed using Shin's method. A total of 29 patients (92 coronary segments) were imaged to evaluate the serial changes in necrotic core and dense calcium using Shin's method. Lesions treated with a BVS implant were analyzed with serial VH-IVUS assessments, i.e., pre- and post-stenting, and at 6 months and 2 years follow-up. In Shin's method contours are drawn around the IVUS catheter (instead of delineating the lumen) and the vessel. The mean necrotic core area decreased by 6.9% from post-stenting to 6 months (1.71 ± 1.03 mm2vs. 1.36 ± 0.91 mm2, P = 0.027), and by 20.5% (1.71 ± 1.03 mm2vs. 1.20 ± 0.70 mm2, P = 0.003) from post-steting to 2 years; while the mean dense calcium areas decreased by 27.2% (1.07 ± 0.55 mm2vs. 0.78 ± 0.64 mm2, P = 0.039) from post-stenting and 2 years. At 2 years, absolute necrotic core and dense calcium content were significantly decreased as compared to post-stenting values. The present study demonstrates that the bioresorption process in patients who undergoing BVS device implantation can be assessed using VH-IVUS analysed using Shin's method.

Aims: To compare the intravascular ultrasound virtual histology (IVUS-VH) appearance of the polymeric struts of the first (Revision 1.0) and the second (Revision 1.1) generation bioresorbable vascular scaffold (BVS). Methods and results: IVUS-VH misrepresents polymeric struts as dense calcium (DC) and necrotic core (NC) so that their presence and disappearance could be used as potential artifactual surrogate of bioresorption. DC and NC were assessed in both revisions of the BVS by analysing IVUS-VH from all patients in the ABSORB cohort A (Revision 1.0) and cohort B (Revision 1.1) study who had an IVUS-VH post-treatment and at 6-month follow-up. Post-treatment and 6-month follow-up IVUS-VH results, available in 60 patients (BVS 1.0 n=28; BVS 1.1 n=32), indicated an insignificant rise in DC+NC area compared to baseline with Revision 1.1 (0.10±0.46mm 2, p=0.2), whilst a significant reduction was seen with Revision 1.0 (-0.57±1.3 mm 2, p=0.02). A significant correlation has been found between the change in the DC+NC area and the change in external el

Implantation of a coronary stent results in a mechanical enlargement of the coronary lumen with stretching of the surrounding atherosclerotic plaque. Using intravascular ultrasound virtual-histology (IVUS-VH) we examined the temporal changes in composition of the plaque behind the struts (PBS) following the implantation of the everolimus eluting bioresorbable vascular scaffold (BVS). Using IVUS-VH and dedicated software, the composition of plaque was analyzed in all patients from the ABSORB B trial who were imaged with a commercially available IVUS-VH console (s5i system, Volcano Corporation, Rancho Cordova, CA, USA) post-treatment and at 6-month follow-up. This dedicated software enabled analysis of the PBS after subtraction of the VH signal generated by the struts. The presence of necrotic core (NC) in contact with the lumen was also evaluated at baseline and follow-up. IVUS-VH data, recorded with s5i system, were available at baseline and 6-month follow-up in 15 patients and demonstrated an increase in both the area of PBS (2.45 +/- A 1.93 mm(2) vs. 3.19 +/- A 2.48 mm(2), P = 0.005) and the external elastic membrane area (13.76 +/- A 4.07 mm(2) vs. 14.76 +/- A 4.56 mm(2), P = 0.006). Compared to baseline there was a significant progression in the NC (0.85 +/- A 0.70 mm(2) vs. 1.21 +/- A 0.92 mm(2), P = 0.010) and fibrous tissue area (0.88 +/- A 0.79 mm(2) vs. 1.15 +/- A 1.05 mm(2), P = 0.027) of the PBS. The NC in contact with the lumen in the treated segment did not increase with follow-up (7.33 vs. 6.36%, P = 0.2). Serial IVUS-VH analysis of BVS-treated lesions at 6-month demonstrated a progression in the NC and fibrous tissue content of PBS.

Although serial changes in necrotic core and calcium are regarded as surrogates for the bioresorption process in patients treated with the bioresorbable everolimus-eluting vascular scaffolds (BVS), these temporal changes have not yet been fully investigated. Shin's method may be offer a more suitable technique for this analysis because it includes all the contents of both the lumen and vessel wall. The purpose of this study was to assess the serial changes of necrotic core and dense calcium content in coronary lesions that were treated with a BVS implant using Virtual Histology intravascular ultrasound (VH-IVUS) analyzed using Shin'smethod. A total of 29 patients (92 coronary segments) were imaged to evaluate the serial changes in necrotic core and dense calcium using Shin's method. Lesions treated with a BVS implant were analyzed with serial VH-IVUS assessments, i.e., pre- and post-stenting, and at 6 months and 2 years follow-up. In Shin's method contours are drawn around the IVUS catheter (instead of delineating the lumen) and the vessel. The mean necrotic core area decreased by 6.9% from post-stenting to 6 months (1.71 +/- 1.03 mm(2) vs. 1.36 +/- 0.91 mm(2), P = 0.027), and by 20.5% (1.71 +/- 1.03 mm(2) vs. 1.20 +/- 0.70 mm(2), P = 0.003) from post-steting to 2 years; while the mean dense calcium areas decreased by 27.2% (1.07 +/- 0.55 mm(2) vs. 0.78 +/- 0.64 mm(2), P = 0.039) from post-stenting and 2 years. At 2 years, absolute necrotic core and dense calcium content were significantly decreased as compared to post-stenting values. The present study demonstrates that the bioresorption process in patients who undergoing BVS device implantation can be assessed using VH-IVUS analysed using Shin's method.

Background-: The first generation of the bioresorbable everolimus drug-eluting vascular scaffold showed signs of shrinkage at 6 months, which largely contributed to late luminal loss. Nevertheless, late luminal loss was less than that observed with bare metal stents. To maintain the mechanical integrity of the device up to 6 months, the scaffold design and manufacturing process of its polymer were modified. Methods and results-: Quantitative coronary angiography, intravascular ultrasound with analysis of radiofrequency backscattering, and as an optional assessment, optical coherence tomography (OCT) were performed at baseline and at a 6-month follow-up. Forty-five patients successfully received a single bioresorbable everolimus drug-eluting vascular scaffold. One patient had postprocedural release of myocardial enzyme without Q-wave occurrence; 1 patient with OCT-diagnosed disruption of the scaffold caused by excessive postdilatation was treated 1 month later with a metallic drug-eluting stent. At follow-up, 3 patients declined recatheterization, 42 patients had quantitative coronary angiography, 37 had quantitative intravascular ultrasound, and 25 had OCT. Quantitative coronary angiography disclosed 1 edge restenosis (1 of 42; in-segment binary restenosis, 2.4%). At variance with the ultrasonic changes seen with the first generation of bioresorbable everolimus drug-eluting vascular scaffold at 6 months, the backscattering of the polymeric struts did not decrease over time, the scaffold area was reduced by only 2.0% with intravascular ultrasound, and no change was noted with OCT. On an intention-to-treat basis, the late lumen loss amounted to 0.19±0.18 mm with a limited relative decrease in minimal luminal area of 5

Previous studies with thrombectomy showed different results, mainly due to use of thrombectomy as an additional device not instead of balloon predilatation. The aim of the present study was to assess impact of aspiration thrombectomy followed by direct stenting. METHODS: Patients with ST elevation myocardial infarction (STEMI) <6 hours from pain onset and occluded infarct-related artery in baseline angiography were randomized into aspiration thrombectomy followed by direct stenting (TS, n = 100) or standard balloon predilatation followed by stent implantation (n = 96). The primary end point of the study was the electrocardiographic ST-segment elevation resolution >70% (STR > 70%) 60 minutes after primary angioplasty (percutaneous coronary intervention [PCI]). Secondary end points included angiographic myocardial blush grade (MBG) after PCI, combination of STR > 70% immediately after PCI and MBG grade 3 (optimal myocardial reperfusion), Thrombolysis In Myocardial Infarction flow after PCI, angiographic complications, and in-hospital major adverse cardiac events. RESULTS: Aspiration thrombectomy success rate was 91% (crossing of the lesion with thrombus reduction and flow restoration). There was no significant difference in STR ≥ 70% after 60 minutes (53.7% vs 35.1%, P = .29). STR > 70% immediately after PCI (41% vs 26%, P < .05), MBG grade 3 (76% vs 58%, P < .03), and optimal myocardial reperfusion (35.1% vs 11.8%, P < .001) were more frequent in TS. There was no difference in between the groups in 6-month mortality (4% vs 3.1%, P = .74) and reinfarction rate (1% vs 3.1%, P = .29). CONCLUSIONS: Aspiration thrombectomy and direct stenting is safe and effective in STEMI patients with early presentation (<6 hours). The angiographic parameters of microcirculation reperfusion and ECG ST-segment resolution directly after PCI were significantly better in thrombectomy group despite the lack of the difference in ST-segment resolution 60 minutes afte

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Aims: The main objective was to use IVUS-backscatter radiofrequency (IVUS-RF) to assess the degradation of a bioabsorbable stent by measuring serial changes in dense calcium (DC) and necrotic core (NC) as assessed by intravascular ultrasound-Virtual Histology™ (IVUS-VH) and in the strain as assessed by palpography. Methods and results: In the ABSORB trial, 27 patients treated with a single bioabsorbable everolimuseluting stent (BVS, Abbott Vascular, Santa Clara, CA, USA) were all imaged with IVUS-RF post-s

Background: Available data from randomized trials on thrombectomy in patients with ST-elevation myocardial infarction (STEMI) have shown favorable trends in myocardial reper-fusion. However, few data are available on the effect of thrombectomy on clinical outcome. Thus we have designed a collaborative individual patient-data meta-analysis which aimed to assess the long-term clinical outcome in STEMI patients randomized to percutaneous coronary intervention (PCI) with or without thrombectomy. Method: After a thorough database search, the principal investigators of randomized trials comparing thrombectomy with standard PCI in patients with STEMI were contacted. Principal investigators as authors of 11 randomized studies agreed to participate and were asked to complete a structured database by providing a series of key pre-PCI clinical and angiographic data as well as the longest available clinical outcome of the patients enrolled in the corresponding trial. The primary end-point of this pooled analysis is the comparison of overall survival rates between patients randomized to PCI with thrombectomy or PCI without thrombectomy. The secondary end-points are survival free from myocardial infarction (MI), target lesion revascularization (TLR), major adverse coronary events (MACE: death + MI + TLR) and death + MI between patients randomized to PCI with thrombectomy or PCI without thrombectomy. A pre-defined subgroup analysis is planned considering the following variables: type of thrombectomy device used, diabetes, rescue PCI, IIb/IIIa-inhibitors use, time-to-reperfusion, infarct-related artery, and pre-PCI TIMI flow. Implications: This study will provide useful data on the effect of the reported improved myocardial perfusion associated with thrombectomy on the long-term clinical outcome in patients with STEMI. © 2009 De Vita et al, publisher and licensee Dove Medical Press Ltd.

Background - Lipoprotein-associated phospholipase A2 (Lp-PLA2) is expressed abundantly in the necrotic core of coronary lesions, and products of its enzymatic activity may contribute to inflammation and cell death, rendering plaque vulnerable to rupture. Methods and Results - This study compared the effects of 12 months of treatment with darapladib (an oral Lp-PLA2 inhibitor, 160 mg daily) or placebo on coronary atheroma deformability (intravascular ultrasound palpography) and plasma high-sensitivity C-reactive protein in 330 patients with angiographically documented coronary disease. Secondary end points included changes in necrotic core size (intravascular ultrasound radiofrequency), atheroma size (intravascular ultrasound gray scale), and blood biomarkers. Background therapy was comparable between groups, with no difference in low-density lipoprotein cholesterol at 12 months (placebo, 88±34 mg/dL; darapladib, 84±31 mg/dL; P=0.37). In contrast, Lp-PLA2 activity was inhibited by 59% with darapladib (P<0.001 versus placebo). After 12 months, there were no significant differences between groups in plaque deformability (P=0.22) or plasma high-sensitivity C-reactive protein (P=0.35). In the placebo-treated group, however, necrotic core volume increased significantly (4.5±17.9 mm; P=0.009), whereas darapladib halted this increase (-0.5±13.9 mm; P=0.71), resulting in a significant treatment difference of -5.2 mm (P=0.012). These intraplaque compositional changes occurred without a significant treatment difference in total atheroma volume (P=0.95). Conclusions - Despite adherence to a high level of standard-of-care treatment, the necrotic core continued to expand among patients receiving placebo. In contrast, Lp-PLA2 inhibition with darapladib prevented necrotic core expansion, a key determinant of plaque vulnerability. These findings suggest that Lp-PLA2 inhibition may represent a novel therapeutic approach.

BACKGROUND: The clinical impact of late incomplete stent apposition (ISA) for drug-eluting stents is unknown. We sought to prospectively investigate the incidence and extent of ISA after the procedure and at 6-month follow-up of paclitaxel-eluting stents in comparison with bare metal stents (BMS) and survey the clinical significance of ISA over a period of 12 months. METHODS AND RESULTS: TAXUS II was a randomized, double-blind study with 536 patients in 2 consecutive cohorts comparing slow-release (SR; 131 patients) and moderate-release (MR; 135 patients) paclitaxel-eluting stents with BMS (270 patients). This intravascular ultrasound (IVUS) substudy included patients who underwent serial IVUS examination after the procedure and at 6 months (BMS, 240 patients; SR, 113; MR, 116). The qualitative and quantitative analyses of ISA were performed by an independent, blinded core laboratory. M