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BACKGROUND No medium-term data are available on the random comparison between everolimus-eluting bioresorbable vascular scaffolds and everolimus-eluting metallic stents. The study aims to demonstrate two mechanistic properties of the bioresorbable scaffold: increase in luminal dimensions as a result of recovered vasomotion of the scaffolded vessel. METHODS The ABSORB II trial is a prospective, randomised, active-controlled, single-blind, parallel two-group, multicentre clinical trial. We enrolled eligible patients aged 18-85 years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels. We randomly assigned patients (2:1) to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (Xience; Abbott Vascular, Santa Clara, CA, USA). Randomisation was stratified by diabetes status and number of planned target lesions. At 3 year follow-up, the primary endpoint was superiority of the Absorb bioresorbable scaffold versus the Xience metallic stent in angiographic vasomotor reactivity after administration of intracoronary nitrate. The co-primary endpoint is the non-inferiority of angiographic late luminal loss. For the endpoint of vasomotion, the comparison was tested using a two-sided t test. For the endpoint of late luminal loss, non-inferiority was tested using a one-sided asymptotic test, against a non-inferiority margin of 0·14 mm. The trial is registered at ClinicalTrials.gov, number NCT01425281. FINDINGS Between Nov 28, 2011, and June 4, 2013, we enrolled 501 patients and randomly assigned them to the Absorb group (335 patients, 364 lesions) or the Xience group (166 patients, 182 lesions). The vasomotor reactivity at 3 years was not statistically different (Absorb group 0·047 mm [SD 0·109] vs Xience group 0·056 mm [0·117]; psuperiority=0·49), whereas the late luminal loss was larger in the Absorb group than in the Xience group (0·37 mm [0·45] vs 0·25 mm [0·25]; pnon-inferiority=0·78). This difference in luminal dimension was confirmed by intravascular ultrasound assessment of the minimum lumen area (4·32 mm(2) [SD 1·48] vs 5·38 mm(2) [1·51]; p

Objectives: The purpose of this study was to assess the diagnostic accuracy of coronary computed tomography angiography (CTA) for bioresorbable vascular scaffold (BVS) evaluation. Background: Coronary CTA has emerged as a noninvasive method to evaluate patients with suspected or established coronary artery disease. The diagnostic accuracy of coronary CTA to evaluate angiographic outcomes after BVS implantation has not been well established. Methods: In the ABSORB II (A Bioresorbable Everolimus-Eluting Scaffold Versus a Metallic Everolimus-Eluting Stent II) study, patients were randomized either to receive treatment with the BVS or everolimus-eluting metallic stent. At the 3-year follow-up, 238 patients (258 lesions) treated with BVS underwent coronary angiography with intravascular ultrasound (IVUS) evaluation and coronary CTA. The diagnostic accuracy of coronary CTA was assessed by the area under the receiver-operating characteristic curve with coronary angiography and IVUS as references. Results: The mean difference in coronary CTA-derived minimal luminal diameter was −0.14 mm (limits of agreement −0.88 to 0.60) with quantitative coronary angiography as reference, whereas the mean difference in minimal lumen area was 0.73 mm2 (limits of agreement −1.85 to 3.30) with IVUS as reference. The per-scaffold diagnostic accuracy of coronary CTA for detecting stenosis based on coronary angiography diameter stenosis of ≥50% revealed an area under the receiver-operating characteristic curve of 0.88 (95% confidence interval [CI]: 0.82 to 0.92) with a sensitivity of 80% (95% CI: 28% to 99%) and a specificity of 100% (95% CI: 98% to 100%), whereas diagnostic accuracy based on IVUS minimal lumen area ≤2.5 mm2 showed an area under the receiver-operating characteristic curve of 0.83 (95% CI: 0.77 to 0.88) with a sensitivity of 71% (95% CI: 44% to 90%) and a specificity of 82% (95% CI: 75% to 87%). The diagnostic accuracy of coronary CTA was similar to coronary angiography in its ability to identify patients with a significant lesion based on the IVUS criteria (p = 0.75). Conclusions: Coronary CTA has good diagnostic accuracy to detect in-scaffold luminal obstruction and to assess luminal dimensions after BVS implantation. Coronary angiography and coronary CTA yielded similar diagnostic accuracy to identify the presence and severity of obstructive disease. Coronary CTA might become the method of choice for the evaluation of patients treated with BVS.

Aims: To investigate the extent and the circumferential distribution of the neointima tissue developed following an Absorb bioresorbable vascular scaffold (BVS) implantation. Methods and results: Twenty-three patients who were treated with the Absorb BVS and had optical coherence tomographic examination after scaffold implantation, at six-month and at two-year follow-up, were included in the current analysis. The lumen and the scaffold borders were detected and the circumferential thickness of the neointima was measured at one degree intervals. The symmetry of the neointima was defined as: minimum/maximum thickness. The lumen area was decreased at six months compared to baseline but it did not change between six-month and two-year follow-up (baseline: 7.49 [6.13-8.00] mm(2), six months: 6.31 (4.75-7.06) mm(2), two years: 6.01 [4.67-7.11] mm(2), p=0.373). However, the mean neointima thickness (six months: 189 [173-229] mu m, two years: 258 [222-283] mu m, p

Objectives This study sought to describe the frequency and clinical impact of acute scaffold disruption and late strut discontinuity of the second-generation Absorb bioresorbable polymeric vascular scaffolds (Absorb BVS, Abbott Vascular, Santa Clara, California) in the ABSORB (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) cohort B study by optical coherence tomography (OCT) post-procedure and at 6, 12, 24, and 36 months. Background Fully bioresorbable scaffolds are a novel approach to treatment for coronary narrowing that provides transient vessel support with drug delivery capability without the long-term limitations of metallic drug-eluting stents. However, a potential drawback of the bioresorbable scaffold is the potential for disruption of the strut network when overexpanded. Conversely, the structural discontinuity of the polymeric struts at a late stage is a biologically programmed fate of the scaffold during the course of bioresorption. Methods The ABSORB cohort B trial is a multicenter single-arm trial assessing the safety and performance of the Absorb BVS in the treatment of 101 patients with de novo native coronary artery lesions. The current analysis included 51 patients with 143 OCT pullbacks who underwent OCT at baseline and follow-up. The presence of acute disruption or late discontinuities was diagnosed by the presence on OCT of stacked, overhung struts or isolated intraluminal struts disconnected from the expected circularity of the device. Results Of 51 patients with OCT imaging post-procedure, acute scaffold disruption was observed in 2 patients (3.9%), which could be related to overexpansion of the scaffold at the time of implantation. One patient had a target lesion revascularization that was presumably related to the disruption. Of 49 patients without acute disruption, late discontinuities were observed in 21 patients. There were no major adverse cardiac events associated with this finding except for 1 patient who had a non-ischemia-driven target lesion revascularization. Conclusions Acute scaffold disruption is a rare iatrogenic phenomenon that has been anecdotally associated with anginal symptoms, whereas late strut discontinuity is observed in approximately 40% of patients and could be viewed as a serendipitous OCT finding of a normal bioresorption process without clinical implications. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856)

AIMS: The DIRECT study is a first-in-human evaluation of the safety and efficacy of the Svelte sirolimus-eluting coronary stent mounted on a fixed-wire, "all-in-one" integrated delivery system (IDS) in patients with de novo coronary artery lesions. The system permits easy delivery, deployment and post-dilatation of a cobalt-chromium stent eluting sirolimus from a fully bioabsorbable amino acid coating. The stent on its IDS has a very low profile, and is designed specifically to facilitate direct stenting. METHODS AND RESULTS: Patients with symptomatic ischaemic heart disease and a single de novo native coronary lesion suitable for percutaneous coronary intervention were prospectively enrolled at four New Zealand sites. The lesion length had to be

Background Adenosine induced hyperaemic fractional flow reserve (aFFR) is a validated predictor of clinical outcome and part of routine interventional practice. Protocol issues associated with the adenosine infusion limit the use of aFFR in clinical practice. Contrast medium induced hyperaemic FFR (cFFR) is a simpler procedure from a practical standpoint. We compared the two in a real world setting. Methods We analysed 76 patients that had both cFFR and aFFR assessment of 100 angiographically indeterminate coronary stenosis. cFFR was performed with intracoronary contrast medium injections (10 ml for left coronary lesions and 8 ml for right coronary lesions). The diagnostic performance of cFFR was analysed and compared to the gold standard aFFR. Results Mean cFFR was 0.87 (±0.07) and mean aFFR was 0.84 (±0.08). Bland-Altman analysis revealed a close agreement between cFFR and aFFR (0.035 ± 0.032; 95% CI: −0.028 to 0.098) and good linear correlation (r = 0.92, r2 = 0.86; p 0.80 yielded a sensitivity of 100%, specificity of 96.1%, positive predictive value of 92.3%, negative predictive value of 100% and diagnostic accuracy of 96%. Only 24% of cFFR values were in the 0.84 to 0.87 range. Conclusion Contrast medium induced hyperaemic FFR as an initial assessment may limit the need for adenosine to when cFFR falls in the 0.84 to 0.87 range. The use of adenosine infusion potentially could have been avoided in the majority of patients in this study.

Background— The long-term fate of Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, CA) struts jailing side branch ostia has not been clarified. We therefore evaluate serially (post-procedure and at 6 months, 1, 2, 3, and 5 years) the appearance and fate of jailed Absorb bioresorbable vascular scaffold struts. Methods and Results— We performed 3-dimensional optical coherence tomographic analysis of the ABSORB Cohort B trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) up to 5 years using a novel, validated cut-plane analysis method. We included 29 patients with a total of 85 side branch ostia. From the 12 ostia which could be assessed in true serial fashion, 7 showed a pattern of initial decrease in the ostial area free from struts, followed by an increase in strut-free ostial area toward the end of the 5 years of follow-up. In a repeated-measures analysis with time as fixed variable and ostial area free from struts as dependent variable, we showed a numeric decrease in the estimated ostial area free from struts from 0.75 mm 2 (baseline) to 0.68 mm 2 (first follow-up visit at 6 months or 1 year) and 0.63 mm 2 (second follow-up visit at 2 or 3 years). However, from the second visit to the 5-year follow-up visit, there was a statistically significant increase from 0.63 to 0.89 mm 2 ( P =0.001). Struts overlying an ostium divided the ostium into compartments, and the number of these compartments decreased over time. Conclusions— This study showed that in most cases, the side branch ostial area free from struts initially decreased. However, with full scaffold bioresorption, the ostial area free from scaffold increased between 2 to 3 years and 5 years in the vast majority of patients. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00856856.

Objectives This study sought to investigate in vivo the vascular response at the proximal and distal edges of the second-generation ABSORB everolimus-eluting bioresorbable vascular scaffold (BVS). Background The edge vascular response after implantation of the BVS has not been previously investigated. Methods The ABSORB Cohort B trial enrolled 101 patients and was divided into B 1 (n = 45) and B 2 (n = 56) subgroups. The adjacent (5-mm) proximal and distal vessel segments to the implanted ABSORB BVS were investigated at either 6 months (B 1 ) or 1 year (B 2 ) with virtual histology intravascular ultrasound (VH-IVUS) imaging. Results At the 5-mm proximal edge, the only significant change was modest constrictive remodeling at 6 months (Δ vessel cross-sectional area: −1.80% [−3.18; 1.30], p Conclusions The vascular response up to 1 year after implantation of the ABSORB BVS demonstrated some degree of proximal edge constrictive remodeling and distal edge increase in FF tissue resulting in nonsignificant plaque progression with adaptive expansive remodeling. This morphological and tissue composition behavior appears to not significantly differ from the behavior of metallic drug-eluting stents at the same observational time points.

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, ...

Aims: To investigate the safety and efficacy of everolimus-eluting stents (EES) in a real world population, including those with high-risk characteristics and complex lesions. Methods: In this report, we analyze 2-year outcomes in 500 consecutive unselected patients treated with EES between April 2007 and March 2008. All patients were followed for 2 years for adverse events. Results: There were 995 EES deployed in 792 lesions. The indication for the coronary procedure was acute coronary syndrome in 94.2% of patients. Bifurcations were involved in 21% of lesions, 3.5% degenerated vein grafts, 2.7% left main stem stenoses, 33% multivessel disease, 4.5% in-stent restenosis, and 79.1% AHA/ACC classification B2/C lesions. The major adverse cardiac event rate (composite of cardiovascular death, acute myocardial infarction, target lesion revascularization) was 10.6%. Target lesion revascularization was required in 4.0% patients, 1.4% for in-stent thrombosis. These event rates are comparable with studies involving lower risk patients and less complex coronary lesions. Conclusion: The use of EES, even in this real world, high-risk population, continues to demonstrate safety and efficacy rates comparable with current studies in more selected patient groups and, therefore, may justify current practice to utilize EES in “off label” situations. (J Interven Cardiol 2011;24:241–246)

Objectives: The ABSORB cohort A trial using the bioresorbable everolimus-eluting scaffold (BVS revision 1.0, Abbott Vascular) demonstrated a slightly higher acute recoil with BVS than with metallic stents. To reinforce the mechanical strength of the scaffold, the new BVS scaffold (revision 1.1) with modified strut design was developed and tested in the ABSORB cohort B trial. This study sought to evaluate and compare the in vivo acute scaffold recoil of the BVS revision 1.0 in ABSORB cohort A and the BVS revision 1.1 in ABSORB cohort B with the historical recoil of the XIENCE V (R) everolimuseluting metal stent (EES, SPIRIT I and II). Methods: In the ABSORB cohort B trial, 101 patients with one or two de-novo lesions were enrolled at 10 sites. In ABSORB cohort A, 27 patients treated with a BVS 1.0 were analyzed and compared with EES. Acute absolute recoil, assessed by quantitative coronary angiography, was defined as the difference between mean diameter of the last inflated balloon at the highest pressure (X) and mean lumen diameter of the stent immediately after the last balloon deflation (Y). Acute percent recoil was defined as (X - Y)/X and expressed as a percentage. Results: Out of 101 patients enrolled in the ABSORB cohort B trial, 88 patients are available for complete analysis of acute recoil. Absolute recoil of BVS 1.1 (0.19 +/- 0.18 mm) was numerically higher than metallic EES (vs. 0.13 +/- 0.21 mm) and similar to BVS 1.0 (0.20 +/- 0.21 mm) but the differences did not reach statistical significance (P = 0.40). The acute percent recoil demonstrated the same trend (EES: 4.3% +/- 7.1%, BVS 1.0: 6.9% +/- 7.0%, BVS 1.1: 6.7% +/- 6.4%, P = 0.22). In the multivariate regression model, high balloon/artery ratio (>1.1) (OR 1.91 [1.34-2.71]) was the predictive for high absolute recoil (>0.27 mm) while (larger) preprocedural MLD was protective (OR 0.84 [0.72-0.99]). The stent/scaffold type was not a predictor of acute recoil. Conclusions: The average in vivo acute scaffold recoil of the BVS 1.1 is slightly higher than the metallic EES. However, the scaffold/stent type was not predictive of high acute recoil, while implantation in undersized vessels or usage of oversized devices might confound the results. (C) 2011 Wiley-Liss, Inc.

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 5.4% on intravascular ultrasound. OCT showed at follow-up that 96.8% of the struts were covered and that malapposition of at least 1 strut, initially observed in 12 scaffolds, was detected at follow-up in only 3 scaffolds. Mean neointimal growth measured by OCT between and on top of the polymeric struts equaled 1.25 mm 2 , or 16.6% of the scaffold area. Conclusion— Modified manufacturing process of the polymer and geometric changes in the polymeric platform have substantially improved the medium-term performance of this new generation of drug-eluting scaffold to become comparable to those of current drug eluting stents. Clinical Trial Registration— URL: http://clinicaltrials.gov . Unique identifier: NCT00856856.

OBJECTIVES: The purpose of this study is to assess jailing of side branches (SB) by the everolimus-eluting, bioresorbable vascular scaffold (BVS) with 3-dimensional (3D) optical coherence tomography (OCT) reconstruction. BACKGROUND: Because BVS struts at the SB orifice are suspected of being bioresorbed and/or forming a neointimal bridge, OCT has been used to evaluate the struts in detail at that particular site. Our understanding of the 3D relationship of the strut and the SB orifice is limited by the use of 2-dimensional OCT images. Fourier-domain OCT enables reliable 3D reconstruction of coronary vessels. METHODS: The ABSORB Cohort B (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions) trial is a multicenter single-arm trial to assess the safety and performance of the BVS. Fourier-domain OCT pullbacks (C7-XR system, LightLab Imaging Inc., Westford, Massachusetts) are obtained at pullback speed of 20 mm/s and 3D renderings are performed. The orifices of the SB are assessed visually. The area of SB orifice and the number of strut-free compartments delineated by the BVS struts are evaluated. RESULTS: Fifty-one OCT pullbacks were acquired: 33 pullbacks were imaged with Fourier-domain OCT and 27 treated segments had 46 side branches. Three-dimensional assessment was feasible in 87% (40 of 46) of pullbacks. The mean area of the SB orifice was 1.16 +/- 1.02 mm(2). The mean number of strut-free compartments was 2.0 +/- 1.1. The classification of the overhanging struts is proposed. CONCLUSIONS: This study demonstrates that 3D OCT reconstruction is feasible to evaluate the orifices of SB jailed with BVS. (ABSORB Clinical Investigation, Cohort B; NCT00856856).

Myeloperoxidase (MPO) is associated with risk in acute coronary syndromes. However, the precise role it plays in ST-elevation myocardial infarction (STEMI) remains unclear. In this study we tested the hypothesis that levels of MPO in plasma after a myocardial infarction are affected by its ability to bind to the endothelium and there is local release of the enzyme at the culprit lesion. We measured plasma MPO in systemic circulation and throughout the coronary circulation in patients with STEMI undergoing primary percutaneous coronary intervention (PCI). MPO levels at the femoral artery were higher (p0.001) in patients with STEMI (n = 67, median 45 ng/ml, interquartile range 34 to 83) compared to control patients (n = 12, 25 ng/ml, 19 to 30) with chronic stable angina undergoing elective PCI. After administration of the anticoagulant bivalirudin in 13 patients with STEMI, plasma MPO was increased only at the culprit coronary artery lesion before PCI (178 ng/ml, 91 to 245) versus all other sites (femoral artery 86 ng/ml, 54 to 139, p = 0.019). Administration of heparin caused a marked increase of plasma MPO. Even so, it was still possible to detect an increase of plasma MPO at culprit lesion in patients with STEMI (n = 54, 171 ng/ml, 122 to 230) versus controls (n = 12, 136 ng/ml, 109 to 151, p0.05) after heparin and before PCI. MPO levels were higher at the culprit lesion in patients with STEMI who presented early and in those with restricted flow (p0.05). In conclusion, our results demonstrate that, in addition to a systemic increase of MPO in patients presenting early with STEMI, levels of this leukocyte enzyme are increased at the culprit coronary lesion before PCI.

Objectives The RESOLUTE trial examined the safety and efficacy of a next-generation zotarolimus-eluting coronary stent, Resolute (Medtronic CardioVascular Inc., Santa Rosa, California). Background Revascularization benefits associated with current drug-eluting stents are often diminished in the presence of complex coronary lesions and in certain patient cohorts. Resolute uses a new proprietary polymer coating that extends the duration of drug delivery to match the longer healing duration often experienced in more complex cases. Methods The RESOLUTE trial was a prospective, nonrandomized, multicenter study of the Resolute stent in 139 patients with de novo coronary lesions with reference vessel diameters ≥2.5 and ≤3.5 mm and lesion length ≥14 and ≤27 mm. The primary end point was 9-month in-stent late lumen loss by quantitative coronary angiography. Secondary end points included major adverse cardiac events (MACE) at 30 days, 6, 9, and 12 months; acute device, lesion, and procedure success; and 9-month target vessel failure (TVF), target lesion revascularization (TLR), stent thrombosis, neointimal hyperplastic (NIH) volume, and percent NIH volume obstruction. Results The 9-month in-stent late lumen loss was 0.22 ± 0.27 mm. Cumulative MACE were 4.3%, 4.3%, 7.2%, and 8.7% at 30 days, 6, 9, and 12 months, respectively. Acute lesion, procedure, and device success rates were 100.0%, 95.7%, and 99.3%, respectively. At 9 months, TLR was 0.0%, TVF was 6.5%, stent thrombosis was 0.0%, NIH volume was 6.55 ± 7.83 mm 3 , and percent NIH volume obstruction was 3.73 ± 4.05%. Conclusions In this feasibility study, the Resolute stent demonstrated low in-stent late lumen loss, minimal neointimal hyperplastic ingrowth, low TLR, no stent thrombosis, and acceptable TVF and MACE. (The RESOLUTE Clinical Trial; NCT00248079 )

Objectives This study was conducted to determine whether direct stenting with TAXUS Liberte is noninferior to stenting after pre-dilation. Background Direct stenting is performed in approximately 30% of patients, but data on clinical and angiographic outcomes with drug-eluting stents are limited. Methods The TAXUS ATLAS DIRECT STENT is a single-arm, multicenter study that enrolled patients with de novo coronary lesions visually estimated to be 10 to 28 mm in length in vessels 2.5 to 4.0 mm in diameter. The control group is the quantitative coronary angiography (QCA) subset of the TAXUS ATLAS trial, which used identical inclusion and exclusion criteria but mandated pre-dilation. The primary end point is 9-month analysis-segment percent diameter stenosis (%DS). Results Baseline patient characteristics were similar between the groups. On QCA analysis, significantly shorter lesions with larger lumen diameter and less calcification were observed in the direct stent group. Direct stenting was successful in 97.6% of patients and was associated with a shorter procedure time and fewer complications. Follow-up %DS was noninferior for direct stent (26.41%) versus pre-dilation (29.14%) with a 1-sided 95% confidence interval of the difference between the groups (−0.34%) well below the pre-specified noninferiority margin (6.75%). Additionally, significantly lower restenosis (5.9% vs. 11.4%, p = 0.0229) and target lesion revascularization (TLR) 2.9% vs. 7.8%, p = 0.0087) rates were seen for direct stent versus pre-dilation. Conclusions Direct stenting of TAXUS Liberte is feasible and highly successful in carefully selected lesions. Direct stenting is noninferior to stenting after pre-dilation on the basis of %DS and can significantly reduce procedural time, procedural complications, and possibly angiographic restenosis and TLR. (TAXUS Liberte-SR Paclitaxel-Eluting Coronary Stent System; NCT00371423).

Aims Our aim was to evaluate the two-year clinical results of a new sirolimus-eluting stent (MiStent SES) with a bioabsorbable coating designed for rapid polymer dissolution but sustained drug delivery. Methods and results Major adverse cardiac events (MACE), target lesion failure (TLF), target vessel failure (TVF), and stent thrombosis (ST) at two-year follow-up are reported for the DESSOLVE I and II trials. In DESSOLVE I, the MiStent SES (n=29) demonstrated a 3.4% two-year MACE rate without TLF or TVF. In DESSOLVE II, the MiStent group had a 6.7% (8/120) two-year MACE rate compared to 13.3% (8/60) for Endeavor (p=0.167). TLF was 5.0% in the MiStent and Endeavor groups (p=1.00). TVF was 5.0% for MiStent versus 11.7% for Endeavor (p=0.129). No probable or definite ST was reported with the MiStent up to two years. The median duration of dual antiplatelet therapy (DAPT) in DESSOLVE I and II was 364 and 366 days, respectively. Conclusions The MiStent SES demonstrated good long-term safety and effectiveness with low two-year MACE, TLF, and TVF rates.

OBJECTIVES This study sought to evaluate the mechanism of post-procedural cardiac biomarker (CB) rise following device implantation. BACKGROUND A fully bioresorbable Absorb scaffold, compared with everolimus-eluting metallic stents (EES), might be associated with a higher incidence of periprocedural myocardial injury. METHODS In 501 patients with stable or unstable angina randomized to either Absorb (335 patients) or EES (n = 166) in the ABSORB II trial, 3 types of CB (creatine kinase, creatine kinase-myocardial band, and troponin) were obtained before and after procedure. Per protocol, periprocedural myocardial infarction (PMI) was defined as creatine kinase rise >2x the upper limit of normal with creatine kinase-myocardial band rise. RESULTS Incidence of side branch occlusion and any anatomic complications assessed by angiography was similar between the 2 treatment arms (side branch occlusion: Absorb: 5.3% vs. Xience: 7.6%, p = 0.07; any anatomic complication: Absorb: 16.4% vs. EES: 19.9%, p = 0.39). Fourteen patients who presented with recent myocardial infarction at entry with normalized creatine kinase-myocardial band according to the protocol were excluded for post-CB analysis. The overall compliance for CB was 97.8%. The CB rise subcategorized in 7 different ranges was comparable between the 2 treatment arms. PMI rate was numerically higher in the Absorb arm according to the per-protocol definitions, and treatment with overlapping devices was the only independent determinant of per-protocol PMI (odds ratio: 5.07, 95% confidence interval: 1.78 to 14.41, p = 0.002). CONCLUSIONS There were no differences in the incidence of CB rise and PMI between Absorb and EES. Device overlap might be a precipitating factor of myocardial injury. (ABSORB II Randomized Clinical Trial: A Clinical Evaluation to Compare the Safety, Efficacy, and Performance of Absorb Everolimus Eluting Bioresorbable Vascular Scaffold System Against Xience Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by De Novo Native Coronary Artery Lesions [ABSORB II]; NCT01425281). (C) 2015 by the American College of Cardiology Foundation.

Aims: To evaluate the implications of an Absorb bioresorbable vascular scaffold (Absorb BVS) on the morphology of the superficial plaques. Methods and results: Forty-six patients who underwent Absorb BVS implantation and 20 patients implanted with bare metal stents (BMS) who had serial optical coherence tomographic examination at baseline and follow-up were included in this analysis. The thin-capped fibroatheromas (TCFA) were identified in the device implantation regions and in the adjacent native coronary segments. Within all regions, circumferential locations of TCFA and calcific tissues were identified, and the neointimal thickness was measured at follow-up. At six to 12-month follow-up, only 8% of the TCFA detected at baseline were still present in the Absorb BVS and 27% in the BMS implantation segment (p=0.231). Sixty percent of the TCFA in native segments did not change their phenotype at follow-up. At short-term follow-up, significant reduction in the lumen area of the BMS was noted, which was higher compared to that reported in the Absorb BVS group (-2.11 +/- 1.97 mm(2) vs. -1.34 +/- 0.99 mm(2), p=0.026). In Absorb BVS, neointima tissue continued to develop at midterm follow-up (2.17 +/- 0.48 mm(2) vs. 1.38 +/- 0.52 mm(2), p

Background Implantable cardiac pressure monitors require assurance of calibration. This study evaluated if airway pressure responses during Valsalva maneuver (VM) can be used for calibrating intracardiac pressure transducers. Methods and Results Thirty-eight heart failure patients performed VMs while cardiac and airway pressures were recorded. Patients were designated as Lower (L) if baseline PCW was

Objectives The aim of this study was to evaluate the effect of variable dose and release kinetics of paclitaxel on neointimal hyperplasia. Background Conventional paclitaxel-eluting stents use a durable polymer coating as a vehicle for drug delivery. The Conor stent (Conor Medsystems, Menlo Park, California) with intra-strut wells and erodable polymer is specifically designed for drug delivery with programmable pharmacokinetics. Methods Two hundred and forty-four patients with single vessel disease received either a bare metal Conor stent (n = 53) or one of six different release formulations that varied in dose (10 or 30 μg) and elution release kinetics (first order, zero order), direction (abluminal, luminal), and duration (5, 10, and 30 days). End points at six months (bare stent group) and at four months (eluting stent groups) were angiographic late loss and neointimal tissue volume by intravascular ultrasound and the rate of major adverse cardiac events (MACE). Results The lowest in-stent late loss (0.38 mm, p Conclusions This novel eluting stent platform, using an erodable polymer with complete elution of low doses of paclitaxel, is safe. The inhibition of the in-stent neointimal hyperplasia was best in the long release groups.

Background— Fixed drug release kinetics and vessel wall partitioning may limit the effectiveness of drug-eluting stents. We report preliminary experience using a new coronary stent with programmable pharmacokinetics. Methods and Results— A newly designed metallic stent contains honeycombed strut elements with inlaid stacked layers of drug and polymer. In vitro studies evaluated recipes for loading paclitaxel to establish the parameters for controlling drug release. Manipulation of the layers of biodegradable polymer and drug allowed varying of the initial 24-hour burst release of paclitaxel from 69% to 8.6% ( P P =0.04), a 28% increase in luminal volume (132±12 versus 103±21 mm 3 , P =0.02), and a 50% decrease in histological neointimal area (2.0±0.5 versus 4.0±1.6 mm 2 ; P Conclusions— Layered polymer/drug inlay stent technology permits flexible and controllable pharmacokinetic profiles. Programmable, complex chemotherapy using this approach may be feasible for the treatment of cardiovascular disease.

Aims: To assess observations with multimodality imaging of the Absorb bioresorbable everolimus-eluting vascular scaffold performed in two consecutive cohorts of patients who were serially investigated either at 6 and 24 months or at 12 and 36 months. Methods and results: In the ABSORB multicentre single-arm trial, 45 patients (cohort B1) and 56 patients (cohort B2) underwent serial invasive imaging, specifically quantitative coronary angiography (QCA), intravascular ultrasound (IVUS), radiofrequency backscattering (IVUS-VH) and optical coherence tomography (OCT). Between one and three years, late luminal loss remained unchanged (6 months: 0.19 mm, 1 year: 0.27 mm, 2 years: 0.27 mm, 3 years: 0.29 mm) and the in-segment angiographic restenosis rate for the entire cohort B (n=101) at three years was 6%. On IVUS, mean lumen, scaffold, plaque and vessel area showed enlargement up to two years. Mean lumen and scaffold area remained stable between two and three years whereas significant reduction in plaque behind the struts occurred with a trend toward adaptive restrictive remodelling of EEM. Hyperechogenicity of the vessel wall, a surrogate of the bioresorption process, decreased from 23.1% to 10.4% with a reduction of radiofrequency backscattering for dense calcium and necrotic core. At three years, the count of strut cores detected on OCT increased significantly, probably reflecting the dismantling of the scaffold; 98% of struts were covered. In the entire cohort B (n=101), the three-year major adverse cardiac event rate was 10.0% without any scaffold thrombosis. Conclusions: The current investigation demonstrated the dynamics of vessel wall changes after implantation of a bioresorbable scaffold, resulting at three years in stable luminal dimensions, a low restenosis rate and a low clinical major adverse cardiac events rate. Clinical Trial Registration Information: http://www.clinicaltrials.gov/ct2/show/NCT00856856.

Aims: To report the three-year clinical outcome of the Axxess™ stent, a nitinol self-expanding Biolimus A9™ eluting stent for treatment of de novo coronary bifurcation lesions. The Axxess stent is a new-generation drug-eluting stent that might offer advantages in terms of improved clinical outcomes and safety profile in bifurcation lesion stenting. Methods and results: The DIVERGE study was a multicentre, prospective, single-arm trial. The primary endpoint was the cumulative rate of major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and ischaemia-driven target lesion revascularisation (TLR) at one, two and three years. Secondary safety endpoints were cumulative stent thrombosis (ST). A total of 302 patients were included across 14 sites: 77.4% had a true bifurcation lesion, with the left anterior descending/diagonal as target vessel in 80.8%. The Axxess stent was placed in 299 patients (99.0%) and scored as optimal in 93.0%. Two hundred and ninety-eight patients (98.7%) returned for the three-year follow-up. The MACE rate was 9.3% at one year, 14.0% at two years and 16.1% at three years. Individual components at three years were 10.1% for ischaemia-driven TLR, 3.0% for death (2.0% cardiac death), and 7.4% for MI. In the secondary safety endpoint at three years, a total of seven patients (2.3%) had ST with six (2.0%) definite and two (0.7%) probable ST events. Conclusions: The present large study of the Axxess stent reports a good cumulative MACE rate during three years of long-term follow-up. The Axxess stent offers a promising treatment strategy for bifurcation lesions.

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 remodelling and distal edge changes in plaque composition with increase of the percent fibro-fatty (FF) tissue component. The 5 mm proximal and distal segments adjacent to the implanted devices were investigated serially with intravascular ultrasound (IVUS), post procedure, at six months and at two years, from the ABSORB Cohort B1 (n=45) and the SPIRIT II (n=113) trials. Twenty-two proximal and twenty-four distal edge segments were available for analysis in the ABSORB Cohort B1 trial. In the SPIRIT II trial, thirty-three proximal and forty-six distal edge segments were analysed. At the 5-mm proximal edge, the vessels treated with an Absorb BVS from post procedure to two years demonstrated a lumen loss (LL) of 6.68% (-17.33; 2.08) (p=0.027) with a trend toward plaque area increase of 7.55% (-4.68; 27.11) (p=0.06). At the 5-mm distal edge no major changes were evident at either time point. At the 5-mm proximal edge the vessels treated with a XIENCE V EES from post procedure to two years did not show any signs of LL, only plaque area decrease of 6.90% (-17.86; 4.23) (p=0.035). At the distal edge no major changes were evident with regard to either lumen area or vessel remodelling at the same time point. CONCLUSIONS The IVUS-based serial evaluation of the EVR up to two years following implantation of a bioresorbable everolimus-eluting scaffold shows a statistically significant proximal edge LL; however, this finding did not seem to have any clinical implications in the serial assessment. The upcoming imaging follow-up of the Absorb BVS at three years is anticipated to provide further information regarding the vessel wall behaviour at the edges.

To the Editor: Although metal stents revolutionized the treatment of coronary artery disease, concerns exist about their indefinite presence and the risk of late stent thrombosis. This may be resolved by biodegradable devices that provide initial support but dissolve over time to restore native

and EES arm no significant differences were observed in cardiac death 0.5% vs 1.3%, MI 4.5% vs 5.4%, TVR 3.5% vs 2.7% and TLR 2.7% vs 2.2, respectively. Definite and probable stent thrombosis rate was 0.74% in BES and 1.79% in EES (p 0.25). Conclusions: Despite high complexity of lesions in the LL subgroup, good clinical outcomes and low rate of revascularization were observed at 12 months post-procedure with both types of drug eluting stents. Stent thrombosis rate was relatively low despite multiple overlapping stents. Our findings confirm the safety efficacy of both drug-eluting stents for treatment of patients with long lesions in coronary arteries.

Serial intravascular ultrasound virtual histology (IVUS-VH) after implantation of metallic stents has been unable to show any changes in the composition of the scaffolded plaque overtime. The everolimus-eluting ABSORB scaffold potentially allows for the formation of new fibrotic tissue on the scaffolded coronary plaque during bioresorption. We examined the 12 month IVUS-VH changes in composition of the plaque behind the struts (PBS) following the implantation of the ABSORB scaffold. Using IVUS-VH and dedicated software, the composition of the PBS was analyzed in all patients from the ABSORB Cohort B2 trial, who were imaged with a commercially available IVUS-VH console (s5i system, Volcano Corporation, Rancho Cordova, CA, USA), immediately post-ABSORB implantation and at 12 month follow-up. Paired IVUS-VH data, recorded with s5i system, were available in 17 patients (18 lesions). The analysis demonstrated an increase in mean PBS area (2.39 +/- A 1.85 mm(2) vs. 2.76 +/- A 1.79 mm(2), P = 0.078) and a reduction in the mean lumen area (6.37 +/- A 0.90 mm(2) vs. 5.98 +/- A 0.97 mm(2), P = 0.006). Conversely, a significant decrease of 16 and 30% in necrotic core (NC) and dense calcium (DC) content, respectively, were evident (median % NC from 43.24 to 36.06%, P = 0.016; median % DC from 20.28 to 11.36%, P = 0.002). Serial IVUS-VH analyses of plaque located behind the ABSORB struts at 12-month demonstrated an increase in plaque area with a decrease in its NC and DC content. Larger studies are required to investigate the clinical impact of these findings.

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.

The metallic everolimus drug-eluting stents (DES) and polymeric everolimus bioresorbable vascular scaffolds (BVS) are coated with the same antiproliferative drug. It is uncertain if, during the bioresorption process, the neointimal response of everolimus BVS differs from that of everolimus DES. A total of 31 lesions treated with a single everolimus BVS, and 19 lesions treated with everolimus DES and imaged with optical coherence tomography at 1 year, were investigated. Neointimal response was assessed as a percentage of uncovered struts, neointimal thickness, in-stent/scaffold area obstruction, and pattern of neointima. Both scaffolds presented with similar neointimal response. However, the everolimus BVS presented with a trend toward higher proportion of intraluminal masses than everolimus DES did. Objectives This study sought to compare the neointimal response of metallic everolimus drug-eluting stents (DES) and polymeric everolimus bioresorbable vascular scaffolds (BVS) by optical coherence tomography at 1 year. Background DES decrease the risk of restenosis by reducing the neointimal response. However, DES may impair strut coverage, and this has been associated with late stent/scaffold thrombosis. BVS may overcome the risk of stent/scaffold thrombosis when completely resorbed. It is unknown if, during the bioresorption process, the neointimal response of the everolimus BVS (Absorb, Abbott Vascular, Santa Clara, California) differs from that of the metallic everolimus DES (Xience, Abbott Vascular). Methods A total of 19 lesions were treated with a single everolimus DES, and 31 lesions were treated with everolimus BVS and imaged with optical coherence tomography at 1 year. Neointimal response was assessed as percentage of uncovered struts, neointimal thickness, in-stent/scaffold area obstruction, and pattern of neointima. Results At 1 year, no significant differences in the angiographic lumen loss were seen for the everolimus DES and everolimus BVS (0.18 ± 0.20 mm vs. 0.29 ± 0.36 mm; p = 0.42). optical coherence tomography analysis of 951 cross sections and 8,385 struts demonstrated similar rates of uncovered struts (5.3% everolimus DES vs. 4.5% everolimus BVS; p = 0.11), mean neointimal thickness (120.6 ± 46.0 μm vs. 136.1 ± 71.4 μm; p = 0.82) and in-stent/scaffold area obstruction (12.5 ± 7.1% vs. 13.6 ± 9.7%; p = 0.91), respectively. There was a trend of higher heterogenic tissue pattern of neointima (21.1% vs. 6.5%; p = 0.12) and less intraluminal masses (0% vs. 12.9%; p = 0.10) with everolimus DES than with everolimus BVS. Conclusions The everolimus BVS (Absorb) demonstrated a similar neointimal response as the everolimus DES (Xience). However, the presence of intraluminal masses at 12 months in a small proportion of patients warranted watchful follow-up of these cases.

Aims The 12-month results of RESOLUTE were favourable for the new Resolute stent. Two-year safety and efficacy results from RESOLUTE have been evaluated and are now reported. Methods and results RESOLUTE was a prospective, multicentre, non-randomised, single-arm, controlled trial of the Resolute stent in 139 participants with symptomatic ischaemic heart disease due to single de novo lesions in a native coronary artery. The 2-year rates of MACE (all-cause death, myocardial infarction, emergent cardiac bypass surgery, and target lesion revascularisation [TLR]), death, late stent thrombosis, target vessel revascularisation (TVR), and target vessel failure (TVF) were assessed. Clinical events included two MACE (one TLR; one non-cardiac death) occurring between year one and two resulting in cumulative 2-year TLR, TVR, and TVF rates of 1.4%, 1.4%, and 7.9%, respectively. One possible stent thrombosis event occurred in the first year after stent implantation however no late or very late ARC-defined definite and probable stent thromboses occurred through two years. Conclusions The 2-year data from RESOLUTE demonstrated no safety concerns including no late stent thrombosis or loss of effectiveness with the Resolute stent. The finding that few events occurred in year two is encouraging, yet requires verification in a larger population.

Objectives The aim of this study was to assess the differences in terms of curvature and angulation of the treated vessel after the deployment of either a metallic stent or a polymeric scaffold device. Background Conformability of metallic platform stents (MPS) is the major determinant of geometric changes in coronary arteries caused by the stent deployment. It is not known how bioresorbable polymeric devices perform in this setting. Methods This retrospective study compares 102 patients who received an MPS (Multi-link Vision or Xience V, Abbott Vascular, Santa Clara, California) in the SPIRIT FIRST and II trials with 89 patients treated with the Revision 1.1 everolimus-eluting bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California) from cohort B of the ABSORB (A bioabsorbable everolimus-eluting coronary stent system) trial. All patients were treated with a single 3 x 18 mm device. Curvature and angulation were measured with dedicated software by angiography. Results Both the MPS and BVS groups had significant changes in relative region curvature (MPS vs. BVS: 28.7% vs. 7.5%) and angulation (MPS vs. BVS: 25.4% vs. 13.4%) after deployment. The unadjusted comparisons between the 2 groups showed for BVS a nonsignificant trend for less change in region curvature after deployment (MPS vs. BVS: 0.085 cm(-1) vs. 0.056 cm(-1), p = 0.06) and a significantly lower modification of angulation (MPS vs. BVS 6.4 degrees vs. 4.3 degrees, p = 0.03). By multivariate regression analysis, the independent predictors of changes in curvature and angulation were the pretreatment region curvature, the pre-treatment region angulation, and the used device. Conclusions Bioresorbable vascular scaffolds have better conformability than conventional MPS. The clinical significance of the observed differences will require further investigation. (J Am Coll Cardiol Intv 2010;3:1190-8) (C) 2010 by the American College of Cardiology Foundation

Objective: The aim of this intravascular ultrasound (IVUS) study was to assess the efficacy of the AXXESS Plus stent system for the treatment of bifurcation coronary lesions. Background: The AXXESS Plus is a novel bifurcation drug-eluting stent, comprised of a self-expanding flare-shaped stent platform and bioabsorbable polymer coating that releases Biolimus A9. Methods: Data were obtained from the AXXESS PLUS trial, a prospective, multicenter, nonrandomized, single-arm study to evaluate safety and efficacy. Six-month follow-up IVUS analysis was available in 49 cases. Volumetric analysis using Simpson's method within the AXXESS stent, and cross-sectional analysis at the ostium of main branch and/or side branch was performed. Impact of bifurcation angle on stent expansion at the carina was also evaluated. Results: Within the AXXESS stent, neointimal volume obstruction percentage was 2.3% ± 2.2%, with a minimum lumen area of 7.9 ± 2.6 mm2. Lumen area was 5.2 ± 1.7 mm2 at main branch ostium, and 4.0 ± 1.5 mm2 at side branch ostium. In two cases, incomplete stent apposition was observed at the proximal edge of the AXXESS stent. In one case, a gap between the AXXESS stent and an additional stent was observed. Greater bifurcation angle inversely correlated with smaller stent area at side branch ostium (r = −0.54, P = 0.03) but not at main branch ostium (r = −0.2, P = 0.29). Conclusions: This novel self-expanding, drug-eluting bifurcation stent demonstrated effective lesion coverage along with significant neointimal suppression equivalent to current generation balloon-expandable drug-eluting stent technology. © 2007 Wiley-Liss, Inc.

Background: Bioresorbable Scaffolds (BRS) for the treatment of coronary stenosis involves the use of a temporary polymeric scaffold to maintain normal arterial curvature, allow return of vasomotion and enable positive remodelling without a longterm metallic cage. We aimed to determine short-medium term outcomes of patients undergoing percutaneous coronary intervention (PCI) with BRS. Methods: Consecutive patients undergoing PCI with ABSORB BRS at Christchurch Hospital/St George’s Hospital between 18/08/2011-07/02/2014 were followed for Major Adverse Cardiac Events (MACE death, non-fatal myocardial infarction (MI) and revascularisation). Results: Of 62 patients included: mean age 53.2 years, 83% male, 11.3%diabetic. 25.8%STEMIand19.4%NSTEMI.A total of 85 BRS were deployed in 71 vessels (49% LAD) 83.7% 1vessel and 16.3% 2-vessel. There were 56% type-B and 41% type-C lesions with 2 ostial, 2 in-stent restenosis, and 4 bifurcation lesions. Overlap stenting perfomed in 12 patients (6 = BVS/BVS, 6 = BVS/drug eluting stent (DES)). The median stent/scaffold length for overlap stenting was 46mm (20-88mm). The device/procedural success rates were 100%. During median follow up of 7.5 months (0.530.3months), MACE rate was 3.2% (2 cases with STEMI due to sub-acute scaffold thrombosis: one ostial lesion and one bifurcation lesion). No deaths were reported. Conclusions: BRS implantation appears safe in patients with stable angina and MI. Use of overlapping BRS or DES/ BRS appears feasible in treatment of long lesions.

assays have been developed which can detect much lower levels of troponin. Methods: 441 patients with chest pain suggestive of acutemyocardial infarction (AMI)were recruited between November 2006 and May 2007; all were followed for 2 years. Serial blood samples were analysed to compare Roche high sensitivity troponin T (hsTNT)with latest generation Abbott troponin I (TNI) and Roche TNT for the prediction of MACE, defined as composite of cardiovascular death, myocardial infarction or revascularization. Results: 91 patients (20.6%) experienced MACE at 2 years. ROC curve AUC for baseline hsTNT was 0.71 (0.66–0.75), TNI was 0.66 (0.61–0.71) and TNT was 0.62 (0.56–0.67). hsTNT out-performs TNT (p= 0.001) but there is no statistical difference between hsTNT and TNI or TNI andTNT.Hazard ratios (HR) forMACEwere 11.4 (2.8–46.9) for hsTNT, 2.9 (1.9–4.6) for TNI and 2.5 (1.6–3.8) for TNT. WhenHRareadjusted foranypatient characteristic shown to be independent predictors ofMACE (in this study independent predictors were age, prior history of ischaemic heart disease and index admission diagnosis of AMI), only hsTNTconveyedadditional risk,HR, 5.2 (1.2–23.1,p= 0.03). Conclusions: hsTNT outperforms conventional assays in prediction of MACE as seen by ROC curve analysis and Cox proportional hazards modelling and is the only troponin to add prognostic utility when adjusted for all baseline characteristics.

involved a 6-month observation period. Phase 2 involved strategies to expedite movement of the patient from the emergency department (ED) to the catheterization laboratory (10 months). Phase 3 involved initiation of a “Code MI” centralized paging system (11 months). We recorded door (D), call (C) and balloon (B) times. Results: Phase 1 (n= 33) Phase 2 (n= 65) Phase 3 (n= 71) DB—median 99 90 71** CB—median 82 59* 50** DB within 90min 33% 49% 75% DB 90th percentile 205min 185min 110min CB 90th percentile 109min 85min 74min ∗ p< 0.01 vs. Phase 1. ∗∗ p< 0.001 vs. Phase 1. Of the 169 consecutive patients, 105 presented outside normal operating hours, 30 were in cardiogenic shock (CS) and/or had required prolonged resuscitation prior to reaching the catheterization laboratory and there were 15 deaths at 30 days (15/30 in CS and 0/139 not in CS). The introduction of simple strategies to reduce DB times benefits all patients, particularly those for whom prolonged delays may remove the treatment advantage of PCI. doi:10.1016/j.hlc.2008.05.392

Background: With the development of permanently implanted intra-cardiac pressure monitoring devices the necessity to perform accurate noninvasive calibration is paramount to appropriate monitoring and management of patients with congestive heart failure. Our goal in this study was to see if airway pressures (AP) could accurately reflect intra-cardiac pressures. Methods: Valsalva’s maneuver was performed during right heart catheterization. The AP and pulmonary capillary wedge (PCW) were measured simultaneously during Valsalva. Patients with PCW greater than 20 were defined as decompensated and were treated with intravenous nitrates. Results: 34 of 39 patients successfully performed the maneuver. 14 patients were NYHA class III and 11 were class IV. 10 patients had a baseline PCW greater than 20 mm Hg. From seconds 4 to 9 of the plateau phase of the Valsalva maneuver the average difference in PCW and AP was 3.04( / 0.46) mm (N 34, 96 recordings). In patients with PCW greater than 20mm Hg the average difference in PCW and AP was 4.69 ( / 0.85) mm Hg. After treatment with intravenous nitrates the difference decreased to 2.06( / 0.72) mm Hg. In patients with PCW 20 the average difference in PCW and AP was 2.01 ( / 0.47) mm Hg. There was no difference in PCW-AP between compensated and decompensated patients after treatment with nitrates (P NS). Conclusions: During the plateau phase of the Valsalva maneuver, pressure is equally transmitted across all chambers of the heart and the great vessels. Airway pressure closely correlates with intra-cardiac pressure during the plateau phase of the Valsalva maneuver and can be utilized to calibrate permanently implanted intra-cardiac pressure monitoring devices. 039

Background: Earfy clinical trials with drug eluting stents have suggested limitations including edge restenosis and malaposition. Persistent bio-stable polymer and/or drug may be causal. Biodegradable polymers hold potential advantage if they are metabolized prior to tissue toxicity and deliver drug during the optimal window. Local delivery of active drug from a slowly biodegradable, high molecular weight polylactic acid (PLA) coated stent could lead to inhibition of intimal hyperplasia without impaired healing. Methods: We compared PLA polymer containing 160 or 220 ug of Everolimus(E), 180 ug Sirolimus(S), and bare metal stent. 40 stents were deployed in coronary artehes of 19 pigs with sacrifice at 28 days. Endpoints were assessed by quantitative coronary angiog raphy @CA), histomorphometry, and histology at 28 and 90 days. Results:There was reduction of intimal hyperplasia as assessed by QCA and histomorphometry by both E and S (Table 1). At both 28 and 90 days, there was complete reendothelialization and ho difference in inflammation or fibrin between the bare stent and druglpolymer groups. Conclusion: Everolimus and Sirolimus delivered via stent and thin layer biodegradable polymer are equally effective at inhibition of intimal hyperplasia. At follow-up evaluation. complete healing without toxic or inflammatory reaction was seen. A clinical trial to determine safety and efficacy of the Everolimus coated stent has commenced.