Bioresorbable Vascular Scaffold Implantation Research Articles

Bioresorbable vascular scaffolds versus everolimus-eluting stents: a biomechanical analysis of the ABSORB III Imaging substudy.

The Absorb bioresorbable vascular scaffold (BVS) has high rates of target lesion failure (TLF) at three years. Low wall shear stress (WSS) promotes several mechanisms related to device TLF. We investigated the impact of BVS compared to XIENCE V (XV) on coronary WSS after device deployment. In the prospective, randomised, controlled ABSORB III Imaging study (BVS [n=77] or XV [n=36]), computational fluid dynamics were performed on fused angiographic and intravascular ultrasound (IVUS) images of post-implanted vessels. Low WSS was defined as <1 Pa. There were no differences in demographics, clinical risks, angiographic reference vessel diameter or IVUS minimal lumen diameter between BVS and XV patients. A greater proportion of vessels treated with BVS compared to XV demonstrated low WSS across the whole device (BVS: 17/77 [22%] vs XV: 2/36 [6%], p<0.029). Compared to XV, BVS demonstrated lower median circumferential WSS (1.73 vs 2.21 Pa; p=0.036), outer curvature WSS (p=0.026), and inner curvature WSS (p=0.038). Similarly, BVS had lower proximal third WSS (p=0.024), middle third WSS (p=0.047) and distal third WSS (p=0.028) when compared to XV. In a univariable logistic regression analysis, patients who received BVS were 4.8 times more likely to demonstrate low WSS across the scaffold/stent when compared to XV patients. Importantly, in a multivariable linear regression model, hypertension (beta: 0.186, p=0.023), lower contrast frame count velocity (beta: -0.411, p<0.001), lower post-stent residual plaque burden (beta: -0.338, p<0.001), lower % underexpanded frames (beta: -0.170, p=0.033) and BVS deployment (beta: 0.251, p=0.002) remained independently associated with a greater percentage of stented coronary vessel areas exposed to low WSS. In this randomised controlled study, the Absorb BVS was 4.8 times more likely than the XV metallic stent to demonstrate low WSS. BVS implantation, lower blood velocity and lower residual post-stent plaque burden were independently associated with greater area of low WSS.

BVS stent optimisation based on a parametric model with a multistage validation process

Developing new polymer-based bioresorbable vascular scaffolds (BVS) requires a new structural geometry, as these polymer materials are characterised by substantially lower stiffness than metallic alloys. Sufficient radial strength of the stent is essential, as insufficient vessel wall support can lead to a significant recoil (reduction of the vessel lumen) and can cause dangerous complications. To assess the stress development and deformation of the stent, finite element analysis (FEA) was used. First, a complex FEA of the inflation and crimping processes of a bioresorbable coronary stent was performed. An optimisation procedure based on the simplified parametric FE model was subsequently performed to obtain the optimal geometric parameters of the analysed structure. The objective of the optimisation was to maximise the vessel diameter after the BVS implantation. The optimisation procedure was based on automatic model-generating scripts, numerical analyses and implementation of genetic algorithms. Finally, a comparison of the parametric and complex models results was performed, as well as a final validation at several stages (structural studies, computational fluid dynamics (CFD) simulations and in vivo testing). The validation confirmed that the presented optimisation methodology represents a valid and useful tool for the stent design process.

Three-year clinical outcomes with the ABSORB bioresorbable vascular scaffold in real life: Insights from the France ABSORB registry.

The aim of this study was to determine the 3-year outcomes of patients treated with Absorb bioresorbable vascular scaffold (BVS) implantation. Randomized trials and observational registries performed in patients undergoing percutaneous coronary intervention have demonstrated higher 1-year and midterm rates of device thrombosis and adverse events with BVS compared to contemporary drug eluting stent. Data on long-term follow-up of patients treated with BVS are scarce. All patients treated with BVS were included in a large nationwide prospective multicenter registry (FRANCE ABSORB). The primary endpoint was a composite of cardiovascular death, myocardial infarction, and target lesion revascularization at 3 years. Secondary endpoints were 3-year scaffold thrombosis and target vessel revascularization (TVR). Between September 2014 and April 2016, 2070 patients were included (mean age 55 ± 11 years; 80% men). The indication was acute coronary syndrome (ACS) in 49% of patients. At 3 years, the primary endpoint occurred in 184 patients (8.9%) and 3-year mortality in 43 patients (2.1%). Scaffold thrombosis and TVR rates through 3 years were, respectively, 3 and 7.6%. In a multivariable analysis, independent predictors of primary endpoint occurrence were diabetes, oral anticoagulation, active smoking, absence of initial angiographic success and the association of a total BVS length ≥30 mm with the use of 2.5 mm diameter BVS. Although 3-year mortality was low in this ACS population, device-related events were significant beyond 1year. Total BVS length and 2.5 mm BVS were associated with higher rates of MACE at long-term follow-up.

Evolución de pacientes tratados con armazones coronarios bioabsorbibles liberadores de everolimus tras su disolución completa

Introduction and objectivesLong-term outcomes of unselected patients treated with bioresorbable vascular scaffold (BVS) implantation are lacking, especially for the period after complete dissolution of the BVS. This study sought to evaluate 5-year outcomes in patients treated with BVS in routine practice. MethodsConsecutive patients who underwent implantation of everolimus-eluting BVS during routine clinical practice at 2 high-volume centres in Germany were studied. The patients were followed-up for up to 5 years. The primary endpoints of interest were the composite of death, myocardial infarction and target lesion revascularization, as well as definite scaffold thrombosis. ResultsA total of 419 patients (mean age 66.6 ± 10.9 years; 31.5% had diabetes) were included, of whom 38.9% presented with an acute coronary syndrome. Of the 527 lesions treated, 49.0% were classified as complex and 13.1% were bifurcation lesions. At 5 years, the composite clinical endpoint occurred in 33.1% of patients and definite scaffold thrombosis occurred in 4.7%. Most definite scaffold thrombosis occurred within 2 years after BVS implantation. ConclusionsIn patients treated with BVS implantation in routine clinical practice the rates of adverse clinical events at 5 years were high, including a considerable incidence of scaffold thrombosis.

Scaffold underexpansion and late lumen loss after bioresorbable scaffold implantation: Insights from ABSORB JAPAN trial.

BackgroundDevice underexpansion is associated with late adverse outcomes after bioresorbable vascular scaffold (BVS) implantation. This study, representing official IVUS results of the ABSORB Japan trial, aimed to characterize IVUS findings, focusing specifically on acute device expansion, and to investigate its impact on late lumen loss (LLL) with Absorb-BVS compared with cobalt-chromium everolimus-eluting stents (CoCr-EES).MethodsABSORB Japan enrolled 148 patients (2:1 randomization) in the IVUS cohort. Serial IVUS was prescheduled at post-procedure and 3 years. Acute device expansion was evaluated with respect to the degree and uniformity of the implanted device.ResultsOverall, Absorb-BVS showed smaller and more nonuniform device expansion at post-procedure, compared with CoCr-EES, which was particularly prominent in small-vessel lesions. In serial analysis, Absorb-BVS showed unique associations of smaller device expansion (r = 0.40, p = 0.001) and more nonuniformity (r = 0.29, p = 0.007) at post-procedure with greater LLL at 3 years, primarily attributable to greater negative remodeling (r = 0.39, p = 0.006). In contrast, acute device expansion showed no relation with subsequent lumen change in CoCr-EES. In Absorb-BVS, ischemic-driven target lesion or vessel revascularization (ID-TLR or ID-TVR) at 3 years occurred more frequently in small- versus large-vessel lesions (12.5% vs. 0%, p = 0.04 for ID-TLR and 15.6% vs. 2.3%, p = 0.08 for ID-TVR). Conversely, Absorb BVS had no target lesion nor vessel failure, even in small-vessel lesions, when adequate device expansion was achieved at post-procedure.ConclusionsUnlike CoCr-EES, underexpansion was associated with greater negative remodeling and LLL in Absorb-BVS. This may in part account for the poorer outcomes of Absorb-BVS than CoCr-EES when under-expanded.

Outcomes after complete dissolution of everolimus-eluting bioresorbable scaffolds implanted during routine practice

Introduction and objectivesLong-term outcomes of unselected patients treated with bioresorbable vascular scaffold (BVS) implantation are lacking, especially for the period after complete dissolution of the BVS. This study sought to evaluate 5-year outcomes in patients treated with BVS in routine practice. MethodsConsecutive patients who underwent implantation of everolimus-eluting BVS during routine clinical practice at 2 high-volume centres in Germany were studied. The patients were followed-up for up to 5 years. The primary endpoints of interest were the composite of death, myocardial infarction and target lesion revascularization, as well as definite scaffold thrombosis. ResultsA total of 419 patients (mean age 66.6 ± 10.9 years; 31.5% had diabetes) were included, of whom 38.9% presented with an acute coronary syndrome. Of the 527 lesions treated, 49.0% were classified as complex and 13.1% were bifurcation lesions. At 5 years, the composite clinical endpoint occurred in 33.1% of patients and definite scaffold thrombosis occurred in 4.7%. Most definite scaffold thrombosis occurred within 2 years after BVS implantation. ConclusionsIn patients treated with BVS implantation in routine clinical practice the rates of adverse clinical events at 5 years were high, including a considerable incidence of scaffold thrombosis.

Scoring balloon predilation before bioresorbable vascular scaffold implantation in patients with in-stent restenosis: the RIBS VI ‘scoring’ study

Currently drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR). However, the efficacy of bioresorbable vascular scaffolds (BVS) after scoring balloon (SCB) predilation in these patients is unknown. RIBS VI (NCT02672878) and RIBS VI 'Scoring' (NCT03069066) are prospective multicentre studies assessing the value of BVS in patients with ISR. Inclusion and exclusion criteria were identical in both studies. Results of conventional BVS implantation (112 patients) were compared with those obtained with systematic SCB therapy before BVS (108 patients). Angiographic follow-up was scheduled for all patients. On late angiography (93% of eligible patients) the in-segment minimal lumen diameter (primary end-point) (1.88 ± 0.5 vs. 1.90 ± 0.4 mm, P = 0.81), % diameter stenosis (28 ± 17 vs. 29 ± 15%), late lumen loss (0.23 ± 0.4 vs. 0.22 ± 0.4 mm) and binary restenosis rate (8.5 vs. 9.3%) were similar in the conventional BVS and SCB + BVS groups, respectively. At 1-year follow-up (100% of patients) target lesion revascularization (TLR) requirement (9.8 vs. 11.1%) was similar with the two strategies. Freedom from cardiac death, myocardial infarction and TLR was 88% and 87%, respectively. Results remained unchanged after adjusting for potential baseline confounders and were consistent in 10 prespecified subgroups. This study suggests that results of conventional BVS implantation in patients with ISR are not improved by systematic predilation with SCB. ClinicalTrials.gov ID: NCT02672878 (RIBS VI) and NCT03069066 (RIBS VI 'Scoring').

Procedural microvascular activation in long lesions treated with bioresorbable vascular scaffolds or everolimus-eluting stents: the PROACTIVE trial.

Significant platelet activation after long stented coronary segments has been associated with periprocedural microvascular impairment and myonecrosis. In long lesions treated either with an everolimus-eluting bioresorbable vascular scaffold (BVS) or an everolimus-eluting stent (EES), we aimed to investigate (a) procedure-related microvascular impairment, and (b) the relationship of platelet activation with microvascular function and related myonecrosis. Patients (n=66) undergoing elective percutaneous coronary intervention (PCI) in long lesions were randomised 1:1 to either BVS or EES. The primary endpoint was the difference between groups in changes of pressure-derived corrected index of microvascular resistance (cIMR) after PCI. Periprocedural myonecrosis was assessed by high-sensitivity cardiac troponin T (hs-cTnT), platelet reactivity by high-sensitivity adenosine diphosphate (hs-ADP)-induced platelet reactivity with the Multiplate Analyzer. Post-dilatation was more frequent in the BVS group, with consequent longer procedure time. A significant difference was observed between the two groups in the primary endpoint of ΔcIMR (p=0.04). hs-ADP was not different between the groups at different time points. hs-cTnT significantly increased after PCI, without difference between the groups. In long lesions, BVS implantation is associated with significant acute reduction in IMR as compared with EES, with no significant interaction with platelet reactivity or periprocedural myonecrosis.

Treatment of In-Stent Restenosis Using Excimer Laser Coronary Atherectomy and Bioresorbable Vascular Scaffold Guided by Optical Coherence Tomography

The rate of in-stent restenosis (ISR) has become increasingly prevalent with the exponential growth in stent implantation due to an aging population and a higher life expectancy, in addition to the high rates of obesity and diabetes. In this prospective, single operator, all-comer study, we sought to analyze the performance of ELCA followed by bioresorbable vascular scaffold (BVS) placement in patients undergoing percutaneous coronary intervention (PCI) for ISR. A total of 13 patients had ISR treated with a combination of ELCA and BVS, with 9 patients having matched OCT pre, post ELCA and post BVS. Mean age was 65 ± 11.22 and 83% of the patients were male. Hypertension and dyslipidemia were present in 100% of the patients and smoking and diabetes in 50%. After the procedure, we did not detect residual stenosis over 10% in any patient, resulting in a technical success of 100%. No patients had MACE during their hospital stay or within the next six months, resulting in a procedure success of 100%. The mean lumen area increased 0.35 mm2 from pre procedure to post ELCA and 3.58 mm2 from post ELCA to post BVS. The final difference, from pre procedure to post BVS, was a 3.93 mm2 lumen area gain. The mean lumen diameter increased 0.11 mm from baseline to ELCA, 0.95 mm from post laser to BVS implantation and 1.06 mm from pre procedure to post BVS. The NIH area reduced 0.48 mm2 from pre to post ELCA, 1.13mm2 from post ELCA to BVS implantation and 1.61 mm2 from baseline to post BVS implantation. We conclude that ELCA is a safe and feasible debulking method to approach ISR, with high rates of post-procedural BVS success, within six months follow-up.

Randomized Comparison of Optical Coherence Tomography Versus Angiography to Guide Bioresorbable Vascular Scaffold Implantation: The OPTICO BVS Study

PurposeWe investigated whether optical coherence tomography (OCT)-guided bioresorbable vascular scaffolds (BVS) implantation can improve in-scaffold minimal lumen area (MLA) at 6-month compared with angiography guidance. MethodsThe OPTICO BVS was a randomized, international multicenter, assessor blind, superiority trial comparing OCT- versus angiography-guided percutaneous coronary intervention (PCI) (1:1 allocation) in patients with coronary artery disease undergoing Absorb BVS 1.1 implantation. The primary endpoint was in-scaffold MLA at 6-month. ResultsThe trial was prematurely stopped on May 31, 2017 after enrollment of 38 of 270 planned patients (14%) following the retraction of the device in Europe. Patients were randomly assigned to OCT- (n = 19) or angiography-guided PCI (n = 19). Scaffold diameter (OCT 3.0 ± 0.3 mm vs. angiography 3.1 ± 0.3 mm, P = .333) and length (28.8 ± 13.6 mm vs. 23.8 ± 12.3 mm, P = .223) were comparable. There was no significant difference in in-scaffold MLA at 6 months (4.47mm2 vs. 5.08mm2, P = .692). Scaffold expansion at 6-month was significantly higher in the OCT-guided PCI as compared with angiography-guided PCI (84.5% vs. 76.5%, P = .010). There was no significant difference in clinical outcomes. ConclusionsAlthough in-scaffold MLA at 6-month did not differ between groups, scaffold expansion was improved following OCT- as compared with angiography-guided PCI. The findings of this study must be interpreted in view of the premature termination with inclusion of 14% of the initially planned study sample.

Bioresorbable Vascular Scaffolds Versus Drug-Eluting Stents for Diffuse Long Coronary Narrowings

Clinical benefits of bioresorbable vascular scaffold (BVS) implantation for long coronary lesions were not sufficiently evaluated. The efficacy and safety of BVS and metallic everolimus-eluting stent (EES) were compared for the treatment of long coronary narrowings. A total of 341 patients with diffuse long lesions (requiring device length ≥28 mm) were randomized to receive either BVS (n = 171) or EES (n = 170) implantation. The primary endpoint was major adverse cardiovascular events which included death from cardiac cause, myocardial infarction, device thrombosis, or ischemia-driven target-lesion revascularization at 12 months. The trial was terminated early because the manufacturer stopped supplying BVS. The mean lesion length was 32.2 ± 13.1 mm in the BVS group and 35.3 ± 13.0 mm in the EES group. The 12-month follow-up was completed in 332 patients (97.4%). At 12 months, the primary endpoint events occurred in 2 patients (1.2%) in the BVS group and in 4 patients (2.4%) in the EES group (hazard ratio = 0.49, 95% confidence interval = 0.09 to 2.67, p = 0.398). Definite or probable device thrombosis occurred in 1 patient (0.6%) in the BVS group and 1 patient (0.6%) in the EES group (hazard ratio = 1.00, 95% confidence interval = 0.06 to 15.94, p = 0.998). In conclusion, in patients with long native coronary artery disease, significant differences between BVS and EES were not observed regarding the primary composite endpoint of death from cardiac cause, myocardial infarction, device thrombosis, or target-lesion revascularization at 12 months. However, due to the early termination of this trial and a low number of events, the results cannot be considered clinically relevant (clinicalTrials.gov Identifier: NCT02796157).

LONG TERM CLINICAL OUTCOMES AFTER IMPLANTATION OF ABSORB BVS IN A REAL WORLD SETTING, WITH PRE DILATATION AND GUIDED BY INTRAVASCULAR IMAGING

The safety and performance of the Absorb Bioresorbable Vascular Scaffold (BVS) has been previously demonstrated with clinical data. However, these trials included patients with simple lesions. The Absorb III trial demonstrated an excess of adverse events following BVS implantation. Aiming to

Influence of Thickness and Width of Bioabsorbable Vascular Stent on Local Hemodynamics

The study reconstructed vascular model by the realistic Optical Coherence Tomography (OCT) data to investigate the influence of the local hemodynamics caused by different thickness and width of bioresorbable vascular scaffold (BRS) implantation in Left Anterior Descending (LAD) artery. The study explored the relationship between the stent structure and thrombus, and the result can provide a valuable reference for the optimal design of BRS.

Intracoronary Imaging for Assessment of Vascular Healing and Stent Follow-up in Bioresorbable Vascular Scaffolds.

Bioresorbable Vascular Scaffolds (BVS) are polymer-based materials implanted in the coronary arteries in order to treat atherosclerotic lesions, based on the concept that once the lesion has been treated, the material of the implanted stent will undergo a process of gradual resorption that will leave, in several years, the vessel wall smooth, free of any foreign material and with its vasomotion restored. However, after the first enthusiastic reports on the efficacy of BVSs, the recently published trials demonstrated disappointing results regarding long-term patency following BVS implantation, which were mainly attributed to technical deficiencies during the stenting procedure. Intracoronary imaging could play a crucial role for helping the operator to correctly implant a BVS into the coronary artery, as well as providing relevant information in the follow-up period. This review aims to summarize the role of intracoronary imaging in the follow-up of coronary stents, with a particular emphasis on the role of intravascular ultrasound and optical coherence tomography for procedural guidance during stent implantation and also for follow-up of bioabsorbable scaffolds.

The Absorb bioresorbable vascular scaffold in real-world practice: long-term follow-up of the AMC Single Centre Real World PCI Registry.

BackgroundBioresorbable scaffolds have been introduced to overcome the shortcomings of drug-eluting stents. Higher rates of device thrombosis, however, have been reported up to 3 years after implantation of the Absorb bioresorbable vascular scaffold (BVS). In the current article, we therefore report long-term clinical outcomes of the AMC Absorb Registry.Methods and resultsIn the AMC Absorb Registry, all patients who underwent a percutaneous coronary intervention with Absorb BVS implantation between 30 August 2012 and 5 August 2013 at the Amsterdam University Medical Centre—Academic Medical Centre were included. The composite endpoint of this analysis was target-vessel failure (TVF). The median follow-up of the study cohort of the AMC Absorb Registry was 1534 days. At the time of the cross-sectional data sweep the clinical status at 4 years was known in 124 of 135 patients (91.9%). At long-term follow-up, the composite endpoint of TVF had occurred in 27 patients. The 4‑year Kaplan-Meier estimate of TVF was 19.8%. At 4 years cardiac death had occurred in 4 patients (3.2%) and target-vessel myocardial infarction in 9 (6.9%) patients. Definite scaffold thrombosis occurred in 5 (3.8%) patients. We found 1 case of very late scaffold thrombosis that occurred at 911 days after device implantation in a patient who was not on dual anti-platelet therapy.ConclusionIn a patient population reflecting routine clinical practice, we found that cases of TVF continued to accrue beyond 2 years after Absorb BVS implantation.

Absorb bioresorbable vascular scaffold outcomes following implantation with routine intravascular imaging guidance.

We sought to describe the outcomes of BVS use from a single-center experience in which scaffold implantation was guided by intravascular imaging (ultrasound and/or optical coherence tomography) to identify and treat mechanical factors potentially related to BVS failure. The Absorb bioresorbable vascular scaffold (BVS) has been associated with an unexpectedly high incidence of thrombosis. Between 11/2014 and 10/2016, 100 patients were treated with BVS. Intravascular imaging assessment before and after BVS implantation was performed in all cases. Mean age was 58.1 years; 88% were male, 31% had diabetes, and 28% presented with acute coronary syndromes. A total of 171 lesions in 141 vessels were treated with 190 BVS (mean 1.9 scaffolds/patient). Further intervention following intravascular imaging to optimize BVS implantation was required in 31% of patients. Procedure success was 100%. All patients completed a 1-year follow-up. The 1-year rate of target lesion failure was 4%, and there were no cases (0%) of scaffold thrombosis, myocardial infarction, or death. In this real-world experience, the use of intravascular imaging to guide BVS implantation was associated with a high 1-year event-free survival rate, with no scaffold thrombosis.

Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years

ObjectivesThe aim of this study was to investigate the vascular responses and fates of the scaffold after bioresorbable vascular scaffold (BVS) implantation using multimodality imaging. BackgroundSerial comprehensive image assessments after BVS implantation in the context of a randomized trial have not yet been reported. MethodsIn the ABSORB Japan trial, 400 patients were randomized to a BVS (n = 266) or a cobalt-chromium everolimus-eluting stent (n = 134). Through 3 years, patients underwent serial angiography and intravascular ultrasound or optical coherence tomography (OCT). ResultsLuminal dimension at 3 years was consistently smaller with the BVS than with the cobalt-chromium everolimus-eluting stent (mean angiographic minimal luminal diameter 2.04 ± 0.63 mm vs. 2.40 ± 0.56 mm, mean difference −0.37 mm [95% confidence interval: −0.50 to −0.24 mm]; p < 0.001), mainly because of smaller device area (6.13 ± 2.03 mm2 vs. 7.15 ± 2.16 mm2, mean difference −1.04 mm2 [95% confidence interval: −1.66 to −0.42 mm2]; p < 0.001), and larger neointimal area (2.10 ± 0.61 mm2 vs. 1.86 ± 0.64 mm2, mean difference 0.24 mm2 [95% confidence interval: 0.06 to 0.43 mm2]; p = 0.01) by OCT. BVS-treated vessels did not show previously reported favorable vessel responses, such as positive vessel remodeling, late luminal enlargement, and restoration of vasomotion, although the OCT-based healing score was on average zero (interquartile range: 0.00 to 0.00). At 3 years, intraluminal scaffold dismantling (ISD) was observed in 14% of BVS. On serial OCT, ISD was observed in 6 lesions at 2 years, where the struts had been fully apposed at post-procedure, while ISD was observed in 12 lesions at 3 years, where 8 lesions were free from ISD on 2-year OCT. In 5 cases of very late scaffold thrombosis, strut discontinuities were detected in all 4 cases with available OCT immediately before reintervention. ConclusionsIn this multimodality serial imaging study, luminal dimension at 3 years was smaller with the BVS than with the cobalt-chromium everolimus-eluting stent. ISD, suspected to be one of the mechanisms of very late BVS thrombosis, was observed in a substantial proportion of cases at 3 years, which developed between post-procedure and 2 years and even beyond 2 years. (AVJ-301 Clinical Trial: A Clinical Evaluation of AVJ-301 [Absorb™ BVS] in Japanese Population [ABSORB JAPAN]; NCT01844284)

P1823 Feasibility of CCTA in assessment of luminal changes and coronary shear stress evolution after implantation of bioresorbable vascular scaffolds

Abstract Funding Acknowledgements PlaqueImage - financed by the National Authority of Scientific Research and Innovation and the Romanian Ministry of European Funding Background Coronary shear stress (CSS) is a well-established local mechanical factor in atherogenesis, progression and destabilization of atherosclerotic plaques. Analysis of CSS after coronary stent placement is still lacking of large clinical studies. Purpose: The aim of this study was to: (1) test the feasibility of Coronary Computed Tomography Angiography (CCTA) for assessment of local hemodynamic and luminal changes after implantation of bioresorbable vascular scaffolds (BVS), and (2) to investigate CSS modifications after BVS implantation. Methods: We conducted a single center, prospective pilot study on 73 patients with coronary artery disease who underwent elective percutaneous coronary intervention (PCI); group 1 (n = 30) – patients with BVS and group 2 (n = 43) – patients with bare metal stent (BMS) implanted. CCTA scanning was performed in all patients prior PCI and at 12 months after PCI. The mean CSS at proximal and at distal part of the stented segment and at the level of the minimal lumen area (MLA) was calculated at baseline and at 12 months after BVS placement. Results: CCTA revealed a higher incidence of severe coronary stenosis in group 1 (73%) than in group 2 (30%) (p &amp;lt; 0.0001). Sensibility of visual evaluation for identification of in-stent restenosis on CCTA was increased in BVS group (94%) than in BMS group (76.19%) (p = 0.0006), hence the group 1 had lower incidence of non-diagnostic evaluations. Mean CSS at the stented site was significantly lower at 12 months (1.9 +/- 0.68 Pa) that average CSS at baseline (2.87 +/- 3.08 Pa) (p = 0.0001). CSS analysis showed also a significantly decreased values at proximal level from 3.39 +/- 1.93 Pa at baseline to 1.91 +/- 0.68 Pa at follow up (p &amp;lt; 0.0001), but not a significant decrease at distal part – 1.3+/-0.72 Pa at baseline and 1.59 +/- 0.65 Pa at 12 months follow up (p = 0.9). Conclusions: CCTA is a feasible technique for assessment of luminal changes following BVS implantation. BVS implantation contribute to the improvement of local hemodynamics by restoring physiological pattern of coronary flow, as demonstrated by the computational fluid hemodynamics assessment of coronary circulation.

Very late coronary thrombosis following bioresorobable vascular scaffold implantation for spontaneous coronary artery dissection

Abstarct: We present a case of acute coronary syndrome 6 years after successful bioresorbable vascular scaffold (BVS) implantation for right coronary artery spontaneous coronary artery dissection (SCAD). OCT demonstrated neoatherosclerotic intermediate lesion with organized thrombus, whereas fractional flow reserve documented hemodynamically significant lesion at the place of previous BVS.

Long-term outcomes after bioresorbable scaffold implantation in patients with coronary artery stenosis

Aim. The present study aimed to demonstrate the long-term outcomes after Absorb (Abbott Vascular, USA) everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in real-world patients with coronary artery disease.Methods. This trial involved the largest registry of Absorb BVS implantation in patients with coronary artery disease from Russia, and it was conducted between 2014 and 2018 (n = 500). Safety and efficacy parameters (target vessel failure, defined as a composite of cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularisation; major adverse cardiac and cardiovascular events, defined as a composite of cardiac death, myocardial infarction, target vessel revascularisation and stroke, stent thrombosis according to the Academic Research Consortium definition) were assessed over a period of 2 years after the index procedure. Results. Lesion treatment success was achieved in 98.51% (n = 594) of patients. In the 2 years after Absorb BVS implantation, long-term outcomes were assessed via phone calls. Only 9.8% (n = 49) of patients were lost to follow-up. The rates of target vessel failure and major adverse cardiac and cerebrovascular events were 11.6% (n = 58) and 12.6% (n = 63), respectively. Definite/probable stent thrombosis was observed in 3.2% (n = 16) of patients. Conclusion. Using an optimal implantation technique during Absorb BVS implantation in routine clinical practice leads to a high level of lesion treatment success. However, despite this, Absorb BVS use is associated with an increased risk of device-related adverse events, particularly stent thrombosis. Absorb BVS use in long and bifurcated lesions and BVS implantation in the distal segment of the coronary artery are independent predictors of stent thrombosis. In addition, Absorb BVS use in patients with a high functional class of angina and heart failure, multivessel coronary artery disease as well as BVS implantation in the distal segment of the coronary artery are independent predictors of device-related adverse events.Received 22 July 2019. Revised 1 October 2019. Accepted 14 October 2019.Funding: The study did not have sponsorship.Conflict of interest: Authors declare no conflict of interest.