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Aims: The aim of this study was to investigate the predictors of long-term adverse clinical events after implantation of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS)., Methods and Results: We pooled patient-level databases derived from the large-scale ABSORB EXTEND study and five high-volume international centres. Between November 2011 and November 2015, 1,933 patients underwent PCI with a total of 2,372 Absorb BVS implanted. The median age was 61.0 (IQR 53.0 to 68.6) years, 24% had diabetes, and 68.2% presented with stable coronary artery disease. At a median follow-up of 616 days, MACE occurred in 93 (4.9%) patients, all-cause death in 36 (1.9%) patients, myocardial infarction in 47 (2.5%) patients, and target vessel revascularisation in 72 (3.8%) patients. Definite or probable scaffold thrombosis occurred in 26 (1.3%) patients. On multivariable logistic regression analysis, acute coronary syndromes (hazard ratio [HR] 2.79, 95% confidence interval [CI]: 1.47 to 5.29; p=0.002), dyslipidaemia (HR 1.43, 95% CI: 1.23 to 1.79; p=0.007), scaffold/reference diameter ratio >1.25 (HR 1.49, 95% CI: 1.18 to 1.88; p=0.001), and residual stenosis >15% (HR 1.67, 95% CI: 1.34 to 2.07; p<0.001) were independent predictors of MACE, whereas the use of intravascular imaging was independently associated with a reduction in MACE (HR 0.13, 95% CI: 0.06 to 0.28; p<0.001)., Conclusions: Optimal Absorb BVS implantation and the use of intravascular imaging guidance are associated with lower rates of adverse events at long-term follow-up.

Background: The advent of bioresorbable vascular scaffolds (BVS) was considered as a potential improvement in percutaneous coronary intervention (PCI) after the groundbreaking development of drug eluting stents (DES). However, the clinical performance, long-term safety and efficacy of BVS in complex coronary lesions remain uncertain. COMPARE ABSORB, a multicenter, single blind, prospective randomized trial, aims to compare the clinical outcomes between the Absorb BVS and Xience everolimus-eluting metallic stent (EES) in patients with coronary artery disease and a high risk of restenosis., Design: COMPARE ABSORB is designed to enroll 2100 patients at up to 45 European sites. Enrolled patients will possess high risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent PCI. Once included in the study, patients will receive either Absorb BVS or Xience EES. Specific advice on implantation technique including mandatory pre-dilatation, sizing and post-dilatation (PSP), will be used in the Absorb BVS arm. The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization). The trial is powered to assess non-inferiority of Absorb BVS compared with Xience EES with a predetermined non-inferiority margin of 4.5% at 1 year after index procedure. The clinical follow-up will continue for 7 years., Conclusions: The prospective COMPARE ABSORB randomized trial (ClinicalTrials.govNCT02486068) will help to assess the long-term safety and efficacy of Absorb BVS compared with Xience EES in the treatments of patients with complex coronary artery disease and a high attendant risk of restenosis., (Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to identify independent correlates of very late scaffold thrombosis (VLST) from an analysis of consecutively treated patients from 15 multicenter studies., Background: Recent analyses suggest an increased risk for VLST with the Absorb Bioresorbable Vascular Scaffold compared with drug-eluting stents, but insights as to correlates of risk are limited., Methods: A total of 55 patients were identified with scaffold thrombosis. They were matched 2:1 with control subjects selected randomly from patients without thrombosis from the same study. Quantitative coronary angiography was available for 96.4% of patients. Multiple logistic and Cox regression analysis were used to identify significant independent outcome correlates from 6 pre-specified characteristics., Results: Patients had scaffold thrombosis at a median of 20 months (interquartile range: 17 to 27 months). Control subjects were followed for 36 months (interquartile range: 24 to 38 months). For the combined groups, reference vessel diameter (RVD) was 2.84 ± 0.50 mm, scaffold length was 26 ± 16 mm, and post-dilatation was performed in 56%. Univariate correlates of thrombosis were smaller nominal scaffold/RVD ratio (linear p = 0.001; ratio <1.18:1; odds ratio: 7.5; p = 0.002) and larger RVD (linear p = 0.001; >2.72 mm; odds ratio: 3.4; p = 0.001). Post-dilatation at ≥16 atm, post-dilatation balloon/scaffold ratio, final percentage stenosis, and dual antiplatelet therapy were not correlated with VLST. Only scaffold/RVD ratio remained a significant independent correlate of VLST (p = 0.001), as smaller ratio was correlated with RVD (p < 0.001). Post hoc analysis of 8 other potential covariates revealed no other correlates of outcome., Conclusions: In the present analysis, the largest to date of its type, relative scaffold undersizing was the strongest determinant of VLST. Given current understanding of "scaffold dismantling," this finding likely has ramifications for all bioresorbable scaffolds., (Copyright © 2018. Published by Elsevier Inc.)

The aim of this study was to determine if there are significant differences in curvature of the treated vessel after the deployment of a polymeric BRS or MPS in long lesions. The impact of long polymeric bioresorbable scaffolds (BRS) compared with metallic platform stents (MPS) on vessel curvature is unknown. This retrospective study compares 32 patients who received a single everolimus-eluting BRS with 32 patients treated with a single MPS of 28 mm. Quantitative coronary angiography (QCA) was used to evaluate curvature of the treatment and peri-treatment region before and after percutaneous coronary intervention (PCI). Baseline demographic and angiographic characteristics were similar between the BRS and MPS groups. Pretreatment lesion length was 22.19 versus 20.38 mm in the BRS and MPS groups respectively (p = 0.803). After treatment, there was a decrease in median diastolic curvature in the MPS group (from 0.257 to 0.199 cm -1 , p = 0.001). A similar trend was observed in the BRS group but did not reach statistical significance (median diastolic curvature from 0.305 to 0.283 cm -1 , p = 0.056). Median Percentage relative change in diastolic curvature was lower in the BRS group compared with the MPS group (BRS vs. MPS: 7.48 vs. 29.4%, p = 0.013). By univariate analysis, use of MPS was an independent predictor of change in diastolic curvature (p = 0.022). In the deployment of long coronary scaffolds/stents (28 mm in length), BRS provides better conformability compared with MPS.

Objectives: The aim of this study was to assess calcium growth with fused grayscale intravascular ultrasound (IVUS), IVUS-virtual histology, and optical coherence tomography (OCT) from baseline to 5-year follow-up in patients treated with bioresorbable vascular scaffolds., Background: IVUS and OCT have individual strengths in assessing plaque composition and volume. Fusion of images obtained using these methods could potentially aid in coronary plaque assessment., Methods: Anatomic landmarks and endoluminal radiopaque markers were used to fuse OCT and IVUS images and match baseline and follow-up., Results: Seventy-two IVUS-virtual histology and OCT paired matched cross-sectional in- and out-scaffold segments were fused at baseline and follow-up. In total, 46 calcified plaques at follow-up were detected using the fusion method (33 in-scaffold, 13 out-scaffold), showing either calcium progression (52.2%) or de novo calcifications (47.8%). On OCT, calcification volume increased from baseline to follow-up by 2.3 ± 2.4 mm 3 (p = 0.001). The baseline virtual histologic tissue precursors of dense calcium at follow-up were necrotic core in 73.9% and fibrous or fibrofatty plaque in 10.9%. In 15.2%, calcium was already present at baseline. Precursors on OCT were lipid pool in 71.2%, fibrous plaque in 4.3%, and fibrocalcific plaque in 23.9%., Conclusions: The use of OCT and IVUS fusion imaging shows similar calcium growth in- and out-scaffold segments. Necrotic core is the most frequent precursor of calcification. The scaffold resorption process creates a tissue layer that re-caps the calcified plaques. (Absorb Clinical Investigation, Cohort B [ABSORB B]; NCT00856856)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The authors sought to identify and verify independent correlates of device thrombosis from an analysis of multicenter trials and registries., Background: Recent analyses suggest an increased risk of device thrombosis with Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, California) implantation compared with metallic drug-eluting stents, and data from moderate size studies suggest a risk relationship to vessel size and technique., Methods: From 8,771 consecutively treated patients, 105 patients (1.2%) were identified with scaffold thrombosis within 1 year of implantation. They were matched 2:1 with controls selected randomly from nonthrombosis patients. Data-restricted multiple logistic analysis was used to identify significant independent covariates of the outcome., Results: Early (within 1 month) scaffold thrombosis occurred in 69 patients and late (1 to 12 months) thrombosis occurred in 36 patients. Modelling found significant correlations of thrombosis to be final minimal lumen diameter <1.85 mm (odds ratio [OR]: 3.1; p = 0.004), off dual antiplatelet therapy (DAPT) status (OR: 3.1 to 3.5; p = 0.006 to 0.053), no post-dilatation with >1.1:1 balloon/scaffold ratio (OR: 2.3; p = 0.022), and reference vessel diameter <2.40 mm (OR: 2.1; p = 0.036)., Conclusions: Suboptimal vessel sizing, procedural technique, angiographic outcomes, and dual antiplatelet therapy discontinuation appear to be the principal determinants of Absorb scaffold thrombosis risk through 12 months after implantation., (Copyright © 2017. Published by Elsevier Inc.)

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., (© 2017 American Heart Association, Inc.)

Background: Although previous observational studies have documented late luminal enlargement and expansive remodeling following implantation of a bioresorbable vascular scaffold (BVS), no comparison with metallic stents has been conducted in a randomized fashion., Objectives: This study sought to compare vessel remodeling patterns after either Absorb BVS or Xience metallic drug-eluting stent (DES) implantation (Abbott Vascular, Santa Clara, California) and determine the independent predictors of remodeling., Methods: In the ABSORB II randomized trial, 383 lesions (n = 359) were investigated by intravenous ultrasound both post-procedure and at 3-year follow-up. According to vessel and lumen area changes over 3 years, we categorized 9 patterns of vessel remodeling that were beyond the reproducibility of lumen and vessel area measurements., Results: The relative change in mean vessel area was significantly greater with the BVS compared to the DES (6.7 ± 12.6% vs. 2.9 ± 11.5%; p = 0.003); the relative change in mean lumen area was significantly different between the 2 arms (1.4 ± 19.1% vs. -1.9 ± 10.5%, respectively; p = 0.031). Multivariate analysis indicated that use of the BVS, female sex, balloon-artery ratio >1.25, expansion index ≥0.8, previous percutaneous coronary intervention, and higher level of low-density lipoprotein cholesterol were independent predictors of expansive remodeling. Furthermore, in the BVS arm, necrotic core pre-procedure was an independent determinant of expansive remodeling., Conclusions: Expansive vessel wall remodeling was more frequent and intense with the BVS than the metallic DES and could be determined by patient baseline characteristics and periprocedural factors. The clinical effect of the observed lumen and vessel remodeling must be investigated in further large clinical studies to optimize the clinical outcome of patients and lesions treated by bioresorbable scaffolds. (ABSORB II Randomized Controlled Trial; NCT01425281)., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Bioresorbable vascular scaffolds (BVS) represent a novel therapeutic option for the treatment of coronary artery diseases. The objective of this study was to evaluate the feasibility of BVS implantation in complex chronic total occlusions (CTO)., Methods and Results: The present report is a multicentre registry evaluating results after BVS deployment in challenging CTO lesions, defined as J-CTO score ≥2 (difficult or very difficult). A total of 105 patients were included in the present analysis. The mean J-CTO score was 2.61 (difficult 52.4%, very difficult 47.6%). Device success and procedural success rates were 98.1% and 97.1%, respectively. The retrograde approach was used in 25.7% of cases. After wire crossing, predilatation was performed in all cases with a mean predilatation balloon diameter of 2.73±0.43 mm. The mean scaffold length was 59.75±25.85 mm, with post-dilatation performed in 89.5% of the cases and a mean post-dilatation balloon diameter of 3.35±0.44 mm. Post-PCI minimal lumen diameter was 2.50±0.51 mm and percentage diameter stenosis 14.53±10.31%. At six-month follow-up, a total of three events were reported: one periprocedural myocardial infarction, one late scaffold thrombosis and one additional target lesion revascularisation., Conclusions: The present report suggests the feasibility of BVS implantation in complex CTO lesions, given adequate lesion preparation and post-dilatation, with good acute angiographic results and midterm clinical outcomes.

Background: Limited data are available on bioresorbable vascular scaffolds (BVS) performance in bifurcations lesions and on the impact of BVS wider struts on side-branch impairment., Methods: Patients with at least one coronary bifurcation lesion involving a side-branch ≥2mm in diameter and treated with at least one BVS were examined. Procedural and angiographic data were collected and a dedicated methodology for off-line quantitative coronary angiography (QCA) in bifurcation was applied (eleven-segment model), to assess side-branch impairment occurring any time during the procedure. Two- and three-dimensional QCA were used. Optical coherence tomography (OCT) analysis was performed in a subgroup of patients and long-term clinical outcomes reported., Results: A total of 102 patients with 107 lesions, were evaluated. Device- and procedural-successes were 99.1% and 94.3%, respectively. Side-branch impairment occurring any time during the procedure was reported in 13 bifurcations (12.1%) and at the end of the procedure in 6.5%. Side-branch minimal lumen diameter (Pre: 1.45±0.41mm vs Final: 1.48±0.42mm, p=0.587) %diameter-stenosis (Pre: 26.93±16.89% vs Final: 27.80±15.57%, p=0.904) and minimal lumen area (Pre: 1.97±0.89mm(2) vs Final: 2.17±1.09mm(2), p=0.334), were not significantly affected by BVS implantation. Mean malapposed struts at the bifurcation polygon-of-confluence were 0.63±1.11., Conclusions: The results of the present investigation suggest feasibility and relative safety of BVS implantation in coronary bifurcations. BVS wide struts have a low impact on side-branch impairment when considering bifurcations with side-branch diameter≥2mm., (Copyright © 2016. Published by Elsevier Ireland Ltd.)

Background: The hypothesized increased thrombus entrapment during bioresorbable vascular scaffold implantation in acute myocardial infarction, the so-called "snowshoe effect" has never been demonstrated., Methods: Patients enrolled in the BVS STEMI FIRST study matched with STEMI patients implanted with everolimus-eluting metal stents (EES) and undergoing optical coherence tomography (OCT) at the index procedure were compared. Quantitative coronary angiography analysis and optical coherence tomography data for evaluation of thrombotic prolapse were reported. Percentage maximal footprint (%MFP) analysis as an indicator of the snowshoe effect was performed., Results: A total of 302 patients were analyzed (151 with BVS and 151 with EES). Of those patients 30 implanted with BVS and 17 implanted with EES were imaged at the index procedure with OCT. Baseline clinical characteristics, TIMI-flow and thrombus burden were similar between groups. Aspiration thrombectomy was similarly performed in the two groups (BVS 83.3% vs 94.1% EES, p=0.405). At the end of the procedure, final TIMI 3 flow was achieved in 93.3% and 82.4% of BVS and EES patients respectively (p=0.296). The %MFP was significantly higher in the BVS treated patients (36.59±5.65% vs 17.61±4.30, p<0.001). The results of the OCT analysis showed a mean prolapse area (0.61±0.26mm(2) vs 0.90±0.31mm(2), p=0.001) and a percentage prolapse area (7.11±2.98mm(2) vs 9.98±2.90mm(2), p=0.002) significantly higher in the EES group., Conclusions: Scaffold structural characteristics such as strut width may play a role in terms of thrombus dislodgment patterns and acute prolapsing material., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Bioresorbable vascular scaffolds have been recently introduced as a novel paradigm for coronary artery disease treatment allowing temporary vessel support and drug delivery without indefinite coronary caging, potentially reducing the long-term limitation of metallic stents. The scientific community has rapidly embraced this concept and bioresorbable devices have been introduced in clinical practice. However, despite the fact that bifurcation lesions represent a large and challenging subset in the field of interventional cardiology, this subgroup of lesions have been avoided in the initial experience with bioresorbable scaffolds and clear recommendations on methodological approaches are lacking. In the present report, we describe the various techniques for bifurcation treatment with bioresorbable scaffolds and the theoretical advantages and disadvantages of this technology in different scenarios, with a glimpse to challenging subsets and possible complications. Therefore, we aim to provide experience based insights and practical guidance for bioresorbable scaffold implantation in bifurcation lesions. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Objectives: This study sought to report on clinical outcomes beyond 1 year of the BVS Expand registry., Background: Multiple studies have proven feasibility and safety of the Absorb bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, California). However, data on medium- to long-term outcomes are limited and available only for simpler lesions., Methods: This is an investigator-initiated, prospective, single-center, single-arm study evaluating performance of the BVS in a lesion subset representative of daily clinical practice, including calcified lesions, total occlusions, long lesions, and small vessels. Inclusion criteria were patients presenting with non-ST-segment elevation myocardial infarction, stable/unstable angina, or silent ischemia caused by a de novo stenotic lesion in a native previously untreated coronary artery. Procedural and medium- to long-term clinical outcomes were assessed. Primary endpoint was major adverse cardiac events, defined as a composite of cardiac death, myocardial infarction, and target lesion revascularization., Results: From September 2012 to January 2015, 249 patients with 335 lesions were enrolled. Mean number of scaffolds per patient was 1.79 ± 1.15. Invasive imaging was used in 39%. In 38.1% there were American College of Cardiology/American Heart Association classification type B2/C lesions. Mean lesion length was 22.16 ± 13.79 mm. Post-procedural acute lumen gain was 1.39 ± 0.59 mm. Median follow-up period was 622 (interquartile range: 376 to 734) days. Using Kaplan-Meier methods, the MACE rate at 18 months was 6.8%. Rates of cardiac mortality, myocardial infarction, and target lesion revascularization at 18 months were 1.8%, 5.2%, and 4.0%, respectively. Definite scaffold thrombosis rate was 1.9%., Conclusions: In our study, BVS implantation in a complex patient and lesion subset was associated with an acceptable rate of adverse events in the longer term, whereas no cases of early thrombosis were observed., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The everolimus eluting bioresorbable vascular scaffold (BVS) represents a novel technology and a novel paradigm for treatment of coronary artery disease, with the potential of improving the long-term clinical outcomes after complete bioresorption. The increasing amount of clinical data is adding in a gradual understanding of the appropriate implantation technique, but long-term results after BVS implantation are sparse. In addition, concern related to a possible increased rate of scaffold thrombosis has recently risen. The present article reviews the current status of knowledge on bioresorbable vascular scaffold from the preclinical phase and the first-in-man experience to the recently reported large randomized trials. Challenging subsets are discussed as well as possible factors impacting on the occurrence of thrombotic events, particularly focusing on clinical outcomes reported in the longest follow-ups currently available.

Objectives: The study compared, by intravascular ultrasound (IVUS), acute gain (AG) at the site of the pre-procedural minimal lumen area (MLA) achieved by either the Absorb (Abbott Vascular, Santa Clara, California) scaffold or the Xience stent and identified the factors contributing to the acute performance of these devices., Background: It is warranted that the acute performance of Absorb matches that of metallic stents; however, concern exists about acute expansion and lumen gain with the use of Absorb., Methods: Of a total of 501 patients (546 lesions) in the ABSORB II (ABSORB II Randomized Controlled Trial) randomized trial, 445 patients with 480 lesions were investigated by IVUS pre- and post-procedure. Comparison of MLA pre- and post-procedure was performed at the MLA site by matching pre- and post-procedural IVUS pullbacks., Results: Lower AG on IVUS (lowest tertile) occurred more frequently in the Absorb arm than in the Xience arm (3.46 mm(2) vs. 4.27 mm(2), respectively; p < 0.001; risk ratio: 3.04; 95% confidence interval: 1.94 to 4.76). The plaque morphology at the MLA cross-section was not independently associated with IVUS acute gain. The main difference in AG in MLD by angiography was observed at the time of device implantation (Xience vs. Absorb, Δ+1.50 mm vs. Δ+1.23 mm, respectively), whereas the gain from post-dilation was similar between the 2 arms (Δ+0.16 mm vs. Δ+0.16 mm) when patients underwent post-dilation, although expected balloon diameter was smaller in the Absorb arm than in the Xience arm (p = 0.003) during post-dilation., Conclusions: At the site of the pre-procedural MLA, the increase of the lumen post-procedure was smaller in the Absorb-arm than in the Xience arm. To achieve equivalent AG to Xience, the implantation of Absorb may require more aggressive strategies at implantation, pre- and post-dilation than the technique used in the ABSORB II trial. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281)., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: Limited data are currently available on midterm outcomes after implantation of everolimus-eluting bioresorbable vascular scaffolds (BVS) for treatment of acute ST-elevation myocardial infarction (STEMI)., Methods and Results: Patients presenting with STEMI and undergoing primary percutaneous coronary intervention in the initial experience with BVS were evaluated and compared with patients treated with everolimus-eluting metal stents (EES) by applying propensity matching. Quantitative coronary angiography analysis, and 18-month clinical follow-up were reported. A total of 302 patients were analysed, 151 with BVS and 151 with EES. Baseline clinical characteristics were similar between groups. Final TIMI 3 flow was 87.4% vs. 86.1%, p=0.296. At 18-month follow-up, all-cause mortality was 2.8% vs. 3.0% in the BVS and EES groups respectively, p=0.99; the MACE rate was higher in the BVS group (9.8% vs. 3.6%, p=0.02); target lesion revascularisation was 5.7% vs. 1.3%, p=0.05. The 30-day MACE rate in BVS patients without post-dilatation was 6.8%, while in patients with post-dilatation it was 3.6%. Scaffold thrombosis (ST) occurred primarily in the acute phase (acute ST 2.1% vs. 0.7%, p=0.29; subacute 0.7% vs. 0.7%, p=0.99; late 0.0% vs. 0.0%; very late 1.5% vs. 0.0%, p=0.18). All three BVS cases with acute ST had no post-dilatation at the index procedure., Conclusions: STEMI patients treated during the early experience with BVS had similar acute angiographic results as compared with the EES group. Clinical midterm follow-up data showed a higher clinical events rate compared with metal stents. The majority of clinical events occurred in the early phase after implantation and mainly in cases without post-dilatation. Optimisation of the implantation technique in the acute clinical setting is of paramount importance for optimal short and mid-term outcomes.

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

Aims: Invasive imaging modalities have shown restoration of vasomotion, prevention of restenosis and, most importantly, increase in lumen area between six months and two years after first-generation everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) implantation. Our aim was to assess whether these positive findings were sustained in the long term., Methods and Results: Patients included in the ABSORB cohort A from the Thoraxcenter Rotterdam cohort underwent coronary catheterisation including angiography, intravascular ultrasound (IVUS), virtual histology, optical coherence tomography (OCT) and vasomotion testing at five years. Eight out of 16 patients underwent catheterisation and scaffold assessment with multiple imaging modalities. A trend towards an increase in minimum luminal diameter was observed between two and five years by angiography (1.95±0.37 mm vs. 2.14±0.38 mm; p=0.09). IVUS data showed an increase in mean lumen area at five years (6.96±1.13 mm2) compared to six months (6.17±0.74 mm2; p=0.06) and two years (6.56±1.16 mm2; p=0.12), primarily due to a persistent reduction in plaque area size between six months and five years (9.17±1.86 mm2 vs. 7.57±1.63 mm2; p=0.03). The necrotic core area was reduced at five years compared to post-procedural results. In OCT, an increase in mean and minimal luminal area was observed. Moreover, no scaffold struts could be identified and a smooth endoluminal lining was observed. The scaffolded coronary segment did not show signs of endothelial dysfunction with acetylcholine testing., Conclusions: At five years, the Absorb BVS is no longer discernible by any invasive imaging method and endothelial function is restored. Late luminal enlargement persists up to five years of follow-up without adaptive vessel remodelling.

Background: Few data are available on long-term follow-up of drug-eluting stents in the treatment of chronic total occlusion (CTO). The LEADERS CTO sub-study compared the long-term results in CTO and non-CTO lesions of a Biolimus A9™-eluting stent (BES) with a sirolimus-eluting stent (SES)., Methods: Among 1,707 patients enrolled in the prospective, multi-center, all-comers LEADERS trial, 81 with CTOs were treated with either a BES (n = 45) or a SES (n = 36). The primary endpoint was the occurrence of major adverse cardiac events (MACE): cardiac death, myocardial infarction (MI) and clinically-indicated target vessel revascularization (TVR)., Results: At 5 years, the rate of MACE was numerically higher in the CTO group than in the non-CTO group (29.6% vs. 23.3%; p = 0.173), with a significant increase in the incidence of target lesion revascularization (TLR) (21.0 vs. 12.6; p = 0.033), but no difference in stent thrombosis (ST). Patients with CTO receiving a BES demonstrated a lower incidence of MACE (22.2% vs. 38.9%; p = 0.147) with a significant reduction in TLR compared to patients receiving a SES (11.1% vs. 33.3%, p = 0.0214) with an incidence similar to that observed in the non-CTO group treated with BES (11.6%). Definite ST at 5 years nearly halved in the BES group (4.4% vs. 8.3%, p = 0.478) with no ST in the BES group after the first year (0% vs. 8.3%, p for interaction = 0.009)., Conclusions: The use of a BES showed a reduction in MACE, TVR, TLR, and ST over time in the CTO subset with similar outcome as for non-CTO lesions.

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 mm2 vs. -1.34±0.99 mm2, p=0.026). In Absorb BVS, neointima tissue continued to develop at midterm follow-up (2.17±0.48 mm2 vs. 1.38±0.52 mm2, p<0.0001) and covered the underlying tissues without compromising the luminal dimensions (5.93±1.49 mm2 vs. 6.14±1.49 mm2, p=0.571) as it was accommodated by the expanded scaffold (8.28±1.74 mm2 vs. 7.67±1.28 mm2, p<0.0001)., Conclusions: Neointimal tissue develops following either Absorb BVS or BMS implantation and shields lipid tissues. The neointimal response in the BMS causes a higher reduction of luminal dimensions compared to the Absorb BVS. Thus, Absorb BVS may have a value in the invasive re-capping of high-risk plaques.

Aims: We sought to determine the impact of post-dilation (PD) on clinical outcomes in a large cohort of patients treated only with the Absorb Bioresorbable Vascular Scaffold (BVS)., Methods and Results: We evaluated all consecutive patients enrolled in the multicentre, single-arm ABSORB EXTEND study up to June 2013. The study allowed treatment of up to two coronaries (diameter 2.0 to 3.8 mm) and the use of overlapping (lesion length ≤28 mm). Patients with severe lesion calcification/tortuosity were excluded. Aggressive lesion predilation (balloon to artery ratio of 0.9-1.0) was mandatory, and PD was left to the operator's discretion. Patients were grouped according to whether PD was performed or not, and the one-year incidences of MACE and scaffold thrombosis were compared. A total of 768 patients were enrolled in the study; PD was performed in 526 (68.4%). There were no significant differences between the PD group and non-PD group in the majority of baseline characteristics, including the presence of moderate calcification and of B2/C lesions. Lesion length was similar (12.3±5.1 mm vs. 12.1±5.3 mm, p=0.6), as was RVD (2.6 mm for both groups, p=0.2). Residual in-scaffold stenosis (15.5±6.4% with PD, 15.0±6% without PD, p=0.3) and the need for bail-out scaffold/stent (4.2% with PD, 4.6% without PD, p=0.8) were comparable. Acute gain was higher in the non-PD group (1.14±0.3 mm vs. 1.21±0.4 mm, p=0.02). Clinical device success was 98.9% in both groups. At one year, there was no difference in MACE (5.4% in the PD group vs. 2.5% in the non-PD group, p=0.1). All individual components of TLR, death, and MI were similar as well as definite/probable scaffold thrombosis between the two groups., Conclusions: These results reflect very similar final angiographic and clinical results achieved with or without post-dilation in the treatment of low to moderately complex coronary lesions. Therefore, post-dilation should be performed whenever needed to optimise acute results.

Aims: Next to patient characteristics, the lack of a standardised approach for bioresorbable vascular scaffold (BVS) implantation is perceived as a potential explanation for the heterogeneous results reported so far. To provide some guidance, we sought to find a consensus on the best practices for BVS implantation and management across a broad array of patient and lesion scenarios., Methods and Results: Fourteen European centres with a high volume of BVS procedures combined their efforts in an informal collaboration. To get the most objective snapshot of different practices among the participating centres, a survey with 45 multiple choice questions was prepared and conducted. The results of the survey represented a basis for the technical advice provided in the document, whereas areas of controversy are highlighted., Conclusions: Consensus criteria for patient and lesion selection, BVS implantation and optimisation, use of intravascular imaging guidance, approach to multiple patient and lesion scenarios, and management of complications, were identified.

Background: As bioresorbable vascular scaffolds (BVSs) are being increasingly used in complex real-world lesions and populations, BVS thrombosis cases have been reported. We present angiographic and optical coherence tomography (OCT) findings in a series of patients treated in our center for definite bioresorbable scaffold thrombosis., Methods and Results: Up to June 2014, 14 patients presented with definite BVS thrombosis in our center. OCT was performed in 9 patients at the operator's discretion. Angiographic and OCT findings were compared with a control group comprising 15 patients with definite metallic stent thrombosis. In the BVS group, time interval from index procedure to scaffold thrombosis ranged from 0 to 675 days. Incomplete lesion coverage by angiography was identified in 4 of 14 cases, malapposition by OCT in 5 of 9 cases, strut discontinuity in 2 of 9 cases, and underexpansion in 2 of 9 cases. Five patients had discontinued dual antiplatelet therapy, and in 3 of them discontinued dual antiplatelet therapy discontinuation had occurred the week preceding the event. There were no significant differences in angiographic or OCT findings between BVS and metallic stent thrombosis., Conclusions: Suboptimal implantation with incomplete lesion coverage, underexpansion, and malapposition comprises the main pathomechanism for both early and late BVS thrombosis, similar to metallic stent thrombosis. Dual antiplatelet therapy discontinuation seems to also be a secondary contributor in several late events. Our observations suggest that several potential triggers for BVS thrombosis could be avoided., (© 2015 American Heart Association, Inc.)

Aims: The safety and performance of the Absorb Bioresorbable Vascular Scaffold (Absorb BVS) system (Abbott Vascular, Santa Clara, CA, USA) has been previously established in 131 patients from cohort A and cohort B of the first-in-man ABSORB trial. Following this trial, ABSORB EXTEND was initiated as a global continued access study (outside of the USA) to expand experience with the Absorb BVS system to different geographies with broader inclusion criteria to include the treatment of longer lesions and multiple vessels. We report in this manuscript the twelve-month clinical outcomes of the first 512 patients in this population., Methods and Results: ABSORB EXTEND is a prospective, single-arm, open-label clinical study which will enrol up to 800 patients at up to 100 sites. Included are patients with lesions ≤28 mm in length and reference vessel diameter of 2.0-3.8 mm (as assessed by on-line QCA or IVUS). Treatment of a maximum of two de novo native coronary artery lesions is permitted when each lesion is located in a different epicardial vessel. An independent clinical events committee adjudicates all endpoint-related events. At one year, for the first 512 patients enrolled in the study, the composite endpoints of ischaemia-driven MACE and ischaemia-driven target vessel failure were 4.3% and 4.9%, respectively. The cumulative rate of ARC defined definite and probable scaffold thrombosis for this population was 0.8% at one year., Conclusions: This interim analysis of the ABSORB EXTEND study shows low rates of MACE and scaffold thrombosis. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).

Aims: The long-term follow-up of the first-in-man ABSORB Cohort B trial showed that angiographic binary restenosis can occur early, late or very late after implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS). Since the mechanical support of the scaffold decreases during bioresorption, the mechanism of in-segment restenosis (ISR) of the Absorb BVS might be different from that of metallic stents. The objective of the current analysis was to review the multimodality imaging of cases with binary restenosis to elucidate the mechanism of ISR after Absorb BVS implantation., Methods and Results: The ABSORB Cohort B trial enrolled 101 patients with a maximum of two de novo coronary lesions. At the three-year imaging and clinical follow-up, there were six cases of in-segment binary restenosis: two early ISR (<6 months), one late ISR (6-12 months) and three very late ISR (>12 months). Three of these ISR cases seemed to be induced by anatomical or procedural factors. In the other three cases, intravascular imaging (IVUS/OCT) demonstrated that the main mechanism of restenosis was significant intra-scaffold tissue growth, while the structural circularity and diameter of the scaffold were not affected., Conclusions: Early and late restenosis after implantation of the Absorb bioresorbable scaffold could be related to anatomical or procedural factors. In this small cohort of patients late or very late restenosis seems to be attributed to pure intra-scaffold tissue growth without extrinsic encroachment of the scaffold.

Introduction: Although bioresorbable vascular scaffolds (BVS) have been used with promising results in patients with stable and unstable angina, little is known about the acute vascular response following BVS implantation in myocardial infarction. We present angiographic and OCT findings from the first patients undergoing bioresorbable vascular scaffold (BVS) implantation for non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI) in our institution., Methods: The first 5 patients with NSTEMI and the first 5 patients with STEMI who underwent BVS implantation in our institution, followed by optical coherence tomography (OCT) imaging of the treated culprit vessel, were included in this series. All patients underwent angiographic analysis pre- and post- BVS implantation, as well as OCT analysis, including qualitative and quantitative assessment., Results: Implantation was successful in all cases, as assessed by angiography and OCT. There were no cases with coronary spasm, distal embolization or no-reflow. No adverse clinical events were recorded in any patient at the 6-month follow up. Specific illustrative cases demonstrating the challenges of BVS implantation in myocardial infarction are presented., Conclusions: BVS implantation can potentially be used in the setting of thrombotic lesions encountered in myocardial infarction; however, the role of this treatment approach warrants systematic evaluation in prospective studies.

Bioresorbable scaffolds (BRS) are a promising new interventional treatment strategy for coronary artery disease (CAD). They are intended to overcome some of the shortcomings of metal drug-eluting stents (DES), mainly late reinterventions which occur at a consistent rate after one year and have not been reduced by the use of local drug elution. Initial experience in non-complex lesions established efficacy in opening the vessel and the concept of bioresorption. However, with the use of BRS in more complex lesions, the incidence of BRS failure, including both scaffold restenosis and thrombosis, has also increased. Therefore, understanding of both the pathophysiology and of the available treatment options of scaffold failure remains an important issue in ensuring procedural and long-term clinical success.

Formation of a 'neo-carina' has been reported after bioresorbable vascular scaffolds (BVS) implantation over side-branches. However, as this 'neo-carina' could protrude into the main-branch, its hemodynamic impact remains unknown. We present two cases of BVS implantation for ostial side-branch lesions, and investigate the flow patterns at follow-up and their potential impact. Computational fluid dynamics analysis was performed, using a 3D mesh created by fusion of 3-dimensional angiogram with optical coherence tomography images. In our first case, mild disturbances were seen when 'neo-carina' did not protrude perpendicularly into the main branch. In the second case, extensive flow re-distribution was observed due to a more pronounced protrusion of the 'neo-carina'. Importantly, these areas of hemodynamic disturbance were observed together with lumen narrowing in a non-stenotic vessel segment. Our case observations highlight the importance of investigating the hemodynamic consequences of BVS implantation in bifurcation lesions and illustrate a novel method to do so in vivo., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Currently, the use of bioresorbable vascular scaffolds (BRS) for the treatment of left main (LM) coronary artery disease has to be considered investigational. However, some early evidence from case reports supports the feasibility of BRS implantation in selected cases and shows good angiographic and clinical results with current-generation BRS devices. However, before the routine use of BRS for LM disease can be advocated, more data on long-term safety and efficacy and larger scaffold designs are essential.

Background: Although recent observations suggest a favorable initial healing process of the everolimus-eluting bioresorbable vascular scaffold (BVS), little is known regarding long-term healing response., Objectives: This study assessed the in vivo vascular healing response using optical coherence tomography (OCT) 5 years after elective first-in-man BVS implantation., Methods: Of the 14 living patients enrolled in the Thoraxcenter Rotterdam cohort of the ABSORB A study, 8 patients underwent invasive follow-up, including OCT, 5 years after implantation. Advanced OCT image analysis included luminal morphometry, assessment of the adluminal signal-rich layer separating the lumen from other plaque components, visual and quantitative tissue characterization, and assessment of side-branch ostia "jailed" at baseline., Results: In all patients, BVS struts were integrated in the vessel and were not discernible. Both minimum and mean luminal area increased from 2 to 5 years, whereas lumen eccentricity decreased over time. In most patients, plaques were covered by a signal-rich, low-attenuating layer. Minimum cap thickness over necrotic core was 155 ± 90 μm. One patient showed plaque progression and discontinuity of this layer. Side-branch ostia were preserved with tissue bridge thinning that had developed in the place of side-branch struts, creating a neo-carina., Conclusions: At long-term BVS follow-up, we observed a favorable tissue response, with late luminal enlargement, side-branch patency, and development of a signal-rich, low-attenuating tissue layer that covered thrombogenic plaque components. The small size of the study and the observation of a different tissue response in 1 patient warrant judicious interpretation of our results and confirmation in larger studies., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to investigate the in-scaffold vascular response (SVR) and edge vascular response (EVR) after implantation of an everolimus-eluting bioresorbable scaffold (BRS) using serial optical coherence tomography (OCT) imaging., Background: Although studies using intravascular ultrasound have evaluated the EVR in metal stents and BRSs, there is a lack of OCT-based SVR and EVR assessment after BRS implantation., Methods: In the ABSORB Cohort B (ABSORB Clinical Investigation, Cohort B) study, 23 patients (23 lesions) in Cohort B1 and 17 patients (18 lesions) in Cohort B2 underwent truly serial OCT examinations at 3 different time points (Cohort B1: post-procedure, 6 months, and 2 years; B2: post-procedure, 1 year, and 3 years) after implantation of an 18-mm scaffold. A frame-by-frame OCT analysis was performed at the 5-mm proximal, 5-mm distal edge, and 2-mm in-scaffold margins, whereas the middle 14-mm in-scaffold segment was analyzed at 1-mm intervals., Results: The in-scaffold mean luminal area significantly decreased from baseline to 6 months or 1 year (7.22 ± 1.24 mm(2) vs. 6.05 ± 1.38 mm(2) and 7.64 ± 1.19 mm(2) vs. 5.72 ± 0.89 mm(2), respectively; both p < 0.01), but remained unchanged from then onward. In Cohort B1, a significant increase in mean luminal area of the distal edge was observed (5.42 ± 1.81 mm(2) vs. 5.58 ± 1.53 mm(2); p < 0.01), whereas the mean luminal area of the proximal edge remained unchanged at 6 months. In Cohort B2, the mean luminal areas of the proximal and distal edges were significantly smaller than post-procedure measurements at 3 years. The mean luminal area loss at both edges was significantly less than the mean luminal area loss of the in-scaffold segment at both 6-month and 2-year follow-up in Cohort B1 or at 1 year and 3 years in Cohort B2., Conclusions: This OCT-based serial EVR and SVR evaluation of the Absorb Bioresorbable Vascular Scaffold (Abbott Vascular, Santa Clara, California) showed less luminal loss at the edges than luminal loss within the scaffold. The luminal reduction of both edges is not a nosologic entity, but an EVR in continuity with the SVR, extending from the in-scaffold margin to both edges. (ABSORB Clinical Investigation, Cohort B [ABSORB B]; NCT00856856)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The clinical outcome of patients treated with the everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) in the ABSORB Cohort A and B studies using mandatory intravascular ultrasound (IVUS) imaging showed encouraging results. The ABSORB EXTEND study aimed to include longer lesions, allow overlap and did not oblige IVUS imaging. We assessed the procedural and short-term clinical outcomes in a cohort including these extended criteria., Methods and Results: Patients included in three study cohorts (ABSORB Cohort A, Cohort B and EXTEND) at two centres in Rotterdam were systematically followed for major adverse cardiac events (MACE). Clinical data were obtained for 88 patients (mean age 61.2 years, 73% male) with a total of 92 lesions. Lesion length was significantly longer in the ABSORB EXTEND cohort 11.34±4.01 mm (9.20±2.66 mm; p<0.01) and the reference vessel diameter was smaller 2.53±0.34 mm (2.87±0.38 mm; p<0.001) compared to previous cohorts. Predilatation was performed with a balloon diameter of 2.5±0.3 mm and inflated to a maximum pressure of 12.6±3.2 atm. The scaffold was successfully implanted in 90 of the 92 lesions (97.8%) with a maximum pressure of 14.1±2.8 atm. Post-dilatation was performed in 55% of the patients (53% EXTEND vs. 56% Cohort A and B; p=0.7). The acute gain was 1.21±0.37 mm. Absolute recoil was 0.16±0.20 mm with percentage acute recoil of 5.60±6.60%. At one month, none of the patients had a MACE., Conclusions: This study, which constitutes the largest combined study cohort of patients treated with the Absorb BVS in Rotterdam, shows that treatment of longer lesions and smaller vessels without obligatory IVUS use is safe and efficacious at one month.

Objectives: The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS)., Background: Clinical outcomes of diabetic patients after BVS implantation have been unreported., Methods: This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up., Results: The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group)., Conclusions: In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and diabetic patients treated with EES at 1-year follow-up. (ABSORB Clinical Investigation, Cohort B; NCT00856856; ABSORB EXTEND Clinical Investigation; NCT01023789; Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT FIRST]; NCT00180453; A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT II]; NCT00180310; Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System [EECSS] [SPIRIT III]; NCT00180479; Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT IV Clinical Trial]; NCT00307047)., (Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

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.

Background: Quantitative light intensity analysis of the strut core by optical coherence tomography (OCT) may enable assessment of changes in the light reflectivity of the bioresorbable polymeric scaffold from polymer to provisional matrix and connective tissues, with full disappearance and integration of the scaffold into the vessel wall. The aim of this report was to describe the methodology and to apply it to serial human OCT images post procedure and at 6, 12, 24 and 36 months in the ABSORB cohort B trial., Methods and Results: In serial frequency-domain OCT pullbacks, corresponding struts at different time points were identified by 3-dimensional foldout view. The peak and median values of light intensity were measured in the strut core by dedicated software. A total of 303 corresponding struts were serially analyzed at 3 time points. In the sequential analysis, peak light intensity increased gradually in the first 24 months after implantation and reached a plateau (relative difference with respect to baseline [%Dif]: 61.4% at 12 months, 115.0% at 24 months, 110.7% at 36 months), while the median intensity kept increasing at 36 months (%Dif: 14.3% at 12 months, 75.0% at 24 months, 93.1% at 36 months)., Conclusions: Quantitative light intensity analysis by OCT was capable of detecting subtle changes in the bioresorbable strut appearance over time, and could be used to monitor the bioresorption and integration process of polylactide struts.

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 pre-reference 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., 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 mm(2) vs 13.09±3.38 mm(2) p=0.0015), scaffold area (5.76±0.96 mm(2) vs 6.41±1.30 mm(2) p=0.0008) and lumen area (5.71±0.98 mm(2) 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., 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 positive vessel remodelling were observed in small vessels.

Background: Nonserial observations have shown this bioresorbable scaffold to have no signs of area reduction at 6 months and recovery of vasomotion at 1 year. Serial observations at 6 months and 2 years have to confirm the absence of late restenosis or unfavorable imaging outcomes., Methods and Results: The ABSORB trial is a multicenter single-arm trial assessing the safety and performance of an everolimus-eluting bioresorbable vascular scaffold. Forty-five patients underwent serial invasive imaging, such as quantitative coronary angiography, intravascular ultrasound, and optical coherence tomography at 6 and 24 months of follow-up. From 6 to 24 months, late luminal loss increased from 0.16±0.18 to 0.27±0.20 mm on quantitative coronary angiography, with an increase in neointima of 0.68±0.43 mm(2) on optical coherence tomography and 0.17±0.26 mm(2) on intravascular ultrasound. Struts still recognizable on optical coherence tomography at 2 years showed 99% of neointimal coverage with optical and ultrasonic signs of bioresorption accompanied by increase in mean scaffold area compared with baseline (0.54±1.09 mm(2) on intravascular ultrasound, P=0.003 and 0.77±1.33 m(2) on optical coherence tomography, P=0.016). Two-year major adverse cardiac event rate was 6.8% without any scaffold thrombosis., Conclusions: This serial analysis of the second generation of the everolimus-eluting bioresorbable vascular scaffold confirmed, at medium term, the safety and efficacy of the new device., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.