Bioresorbable Vascular Scaffold Group Research Articles

Safety and Efficacy of Everolimus-Eluting Bioresorbable Vascular Scaffold Versus Second-Generation Drug-Eluting Stents in Real-World Practice.

The risk of device thrombosis and device-oriented clinical outcomes with bioresorbable vascular scaffold (BVS) was reported to be significantly higher than with contemporary drug-eluting stents (DESs). However, optimal device implantation may improve clinical outcomes in patients receiving BVS. The current study evaluated mid-term safety and efficacy of Absorb BVS with meticulous device optimization under intravascular imaging guidance. The SMART-REWARD and PERSPECTIVE-PCI registries in Korea prospectively enrolled 390 patients with BVS and 675 patients with DES, respectively. The primary endpoint was target vessel failure (TVF) at 2 years and the secondary major endpoint was patient-oriented composite outcome (POCO) at 2 years. Patient-level pooled analysis evaluated 1,003 patients (377 patients with BVS and 626 patients with DES). Mean scaffold diameter per lesion was 3.24 ± 0.30 mm in BVS group. Most BVSs were implanted with pre-dilatation (90.9%), intravascular imaging guidance (74.9%), and post-dilatation (73.1%) at proximal to mid segment (81.9%) in target vessel. Patients treated with BVS showed comparable risks of 2-year TVF (2.9% vs. 3.7%, adjusted hazard ratio [HR], 1.283, 95% confidence interval [CI], 0.487-3.378, P = 0.615) and 2-year POCO (4.5% vs. 5.9%, adjusted HR, 1.413, 95% CI, 0.663-3.012, P = 0.370) than those with DES. The rate of 2-year definite or probable device thrombosis (0.3% vs. 0.5%, P = 0.424) was also similar. The sensitivity analyses consistently showed comparable risk of TVF and POCO between the 2 groups. With meticulous device optimization under imaging guidance and avoidance of implantation in small vessels, BVS showed comparable risks of 2-year TVF and device thrombosis with DES. ClinicalTrials.gov Identifier: NCT02601404, NCT04265443.

P79 FIRST GENERATION BIORESORBABLE VASCULAR SCAFFOLD VS NEXT GENERATION BIORESORBABLE VASCULAR SCAFFOLD: SINGLE CENTER, LONG–TERM FOLLOW UP EXPERIENCE

Abstract Background Previous randomized controlled trials demonstrated a higher rate of stent thrombosis with first generation (Absorb; Abbott Vascular, USA) bioresorbable vascular scaffold (BVS) implantation as compared with second–generation drug–eluting stent. Currently, with limited indications, others next generation BVS (NGB) are available (Magmaris; Biotronik AG, Switzerland and DESolve; Elixir Medical Corporation, USA). Real world long–term outcomes of such devices are limited. Methods and Results In our center from 27/09/2012 to 28/08/2018 in a cohort of 277 patients, a total of 259 BVS and 191 NGB (120 Magmaris and 71 DESolve) devices were implanted. The primary efficacy endpoint was a combined end point of target–lesion revascularization (TLR) and target lesion myocardial infarction (TLMI) the primary safety endpoint was scaffold thrombosis (ScT). At a median follow–up, of 83 months (interquartile range–IQR, 61–91 months) for BVS, and 48 months (IQR, 41–53.5 months) and 64.5 months (IQR, 58.5–69 months) for Magmaris and DESolve respectively, TLR/TLMI occurred in 17 patients (10.5%) in the BVS group and 4 patients (3.5%) in the NGB group (p value= 0.03), ScT occurred in 5 patient (3.1%) and 1 patient (0.9%), p–value=0.23, respectively. Median time of ScT occurrence in the BVS group was 12.5 months (IQR 9.75–16.75), ScT in the NGB group occurred after patient’s suspension of dual antiplatelet therapy 3 months later from the implantation date. Conclusion In a single center real world setting, the use of NGB appear safer compared to BVS at long–term follow–up.

Pre-Emptive OCT-Guided Angioplasty of Vulnerable Intermediate Coronary Lesions: Results from the Prematurely Halted PECTUS-Trial

Objectives To assess the safety and efficacy of pre-emptive treatment of optical coherence tomography- (OCT-) derived vulnerable, non-flow-limiting, non-culprit lesions in patients with myocardial infarction (MI). Background Intracoronary imaging with OCT can aid in the decision to treat non-flow-limiting lesions by identifying vulnerable plaques. Pre-emptive treatment of these lesions might improve patient outcome by “sealing” these plaques. Bioresorbable vascular scaffolds (BVS) have theoretical benefit for this treatment because they dissolve completely over time. Methods In patients presenting with MI, non-culprit lesions with a fractional flow reserve ≥0.8 were imaged with OCT. Vulnerable plaques were randomised to either percutaneous coronary intervention (PCI) with bioresorbable vascular scaffold (BVS) placement or optimal medicinal therapy (OMT). The primary outcome was a composite of all-cause mortality, non-fatal MI, and unplanned revascularisation at 1-year follow-up. Results The trial was stopped prematurely after retraction from the market of the Absorb BVS. At that time, a total of 34 patients were randomised. At two years, the composite endpoint occurred 3 times (18.8%) in the BVS group and 1 time (6.3%) in the OMT group. Apart from one elective PCI for stable angina in the OMT group, no target lesions in any group were revascularised. Conclusions Pre-emptive stenting of vulnerable plaques had no evident benefit compared to conservative treatment. However, due to the low number of included patients, no definite conclusions could be drawn. Identifying and potentially treating vulnerable plaques remains an important target for future research. This trial is registered under https://www.trialregister.nl/trial/NL4177 on 08-12-2015.

Long-term follow-up of therapeutic efficacy of everolimus-eluting bioresorbable vascular scaffold in comparison to everolimus-eluting stent in treatment of chronic total occlusion guided by intracoronary imaging

BackgroundWe hypothesized that 1st generation everolimus-eluting bioresorbable vascular scaffold (BVS) stent associated with less complication and less restenosis rate than everolimus-eluting stent (EES) in chronic total occlusion (CTO) recanalization guided by intracoronary imaging. Therefore, we aimed to assess the safety and performance of BVS stent in CTO revascularization in comparison to EES guided by intracoronary imaging.Our prospective comparative cross-sectional study was conducted on 60 CTO patients divided into two groups according to type of stent revascularization: group I (EES group): 40 (66.7%) patients and group II (BVS group): 20 (33.3%) patients. All patients were subjected to history taking, electrocardiogram (ECG), echocardiography, laboratory investigation, stress thallium study to assess viability before revascularization. Revascularization of viable CTO lesion guided by intracoronary imaging using optical coherence tomography (OCT). Then, long-term follow-up over 1 year clinically and by multi-slice CT coronary angiography (MSCT). Our clinical and angiographic endpoints were to detect any clinical or angiographic complications during the follow-up period.ResultsAt 6 months angiographic follow-up, BVS group had not inferior angiographic parameters but without statistically significant difference (p = 0.566). At 12 months follow-up, there was no difference at end points between the two groups (p = 0.476).No differences were found at angiographic or clinical follow-up between BVS and EES.ConclusionThis study shows that 1st generation everolimus-eluting BVS is non-inferior to EES for CTO revascularization. Further studies are needed to clearly state which new smaller footprint BVS, faster reabsorption, magnesium-based less thrombogenicity, and advanced mechanical properties is under development. We cannot dismiss the efficacy and safety of new BVS technology.Trial registrationZU-IRB#2498/3-12-2016 Registered 3 December 2016, email: IRB_123@medicine.zu.edu.eg

Bioresorbable vascular scaffold versus metallic drug-eluting stent in patients at high risk of restenosis: the COMPARE-ABSORB randomised clinical trial.

The aim of this study was to investigate clinical outcomes of patients at high risk of restenosis after implantation of a bioresorbable vascular scaffold (BVS). The COMPARE-ABSORB trial was an investigator-initiated, prospective randomised study. Patients at high risk of restenosis were randomly assigned to receive either a BVS or an everolimus-eluting stent (EES). A dedicated implantation technique was recommended for BVS. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (TVMI) or clinically indicated target lesion revascularisation at one year. The enrolment was discontinued prematurely because of a high thrombosis and TVMI rate in the BVS arm. A total of 1,670 patients were recruited (BVS 848 patients and EES 822 patients). TLF occurred in 43 patients (5.1%) of the BVS group and 34 patients (4.2%) of the EES group (absolute difference 0.9%, 95% confidence interval [CI]: -1.2%-3.0%, p non-inferiority <0.001). Definite or probable device thrombosis (2.0% vs 0.6%, hazard ratio [HR] 3.32, 95% CI: 1.22-8.99, p=0.012) and TVMI (4.0% vs 2.1%, HR 1.96, 95% CI: 1.10-3.51, p=0.02) were significantly higher in the BVS group than in the EES group. In patients at high risk of restenosis, non-inferiority of BVS compared with EES in terms of TLF was met at one year. BVS carried a higher risk of device thrombosis and TVMI than EES.

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.

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).

Mid-term outcomes of bioresorbable vascular scaffolds vs second-generation drug-eluting stents in patients with acute coronary syndromes: A systematic review and meta-analysis.

Everolimus-eluting bioresorbable vascular scaffolds (BVS), which have the characteristics of scaffold absorption and vascular function recovery, are the latest innovation in the treatment of coronary artery disease. This new concept has become a hot topic in the field of interventional cardiology. Data regarding mid-term clinical outcomes of BVS in acute coronary syndromes are currently scarce. The aim of this systematic review and meta-analysis is to compare mid-term outcome data for BVS and second-generation drug-eluting stents (DES) in the treatment of acute coronary syndromes. We searched PubMed, Embase, the Cochrane Library, Web of Science, and relevant web sites for studies with a follow-up of ≥ 1 years that studied percutaneous coronary interventions with BVS vs second-generation DES in acute coronary syndromes. A meta-analysis was performed with the software RevMan following the standards of the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0. Five studies, 2 randomized controlled trials, and 3 observational studies, with a total of 1758 patients (BVS n = 917; DES n = 841) and a median follow-up duration of 24 months, were included. BVS, when compared with DES, resulted in higher rates of target lesion revascularization (TLR) (OR, 2.20; 95% CI, 1.12-3.64; P = .02) and stent/scaffold thrombosis (ST/ScT) (OR = 2.35, 95% CI: 1.13-4.89, P = .02). When TLR due to device thrombosis were excluded, the difference in risk estimates between the 2 groups was no longer significant (OR: 1.67, 95% CI: 0.73-3.82, P = .22). The risk for all-cause death (OR = 1.32 95% CI: 0.61-2.88, P = .48), cardiac death (OR = 1.29, 95% CI: 0.58-2.86 P = .52), target vessel myocardial infarction (OR = 1.50, 95% CI: 0.86-2.61, P = .15), and target lesion failure (OR = 1.34, 95% CI: 0.76-2.35, P = .31) did not differ between BVS and DES groups. At mid-term follow-up, BVS had a higher risk of TLR and ST/ScT than the second-generation DES in patients with acute coronary syndromes. ST/ScT was the key factor indicating the decreased safety and effectiveness of BVS relative to DES.

Comparison of percutaneous coronary intervention using bioresorbable vascular scaffold and minimally invasive direct coronary artery bypass for left anterior descending artery disease: 3-year clinical outcomes

Aim. Evaluates 3-year clinical outcomes of percutaneous coronary intervention (PCI) with bioresorbable vascular scaffold (BVS) versus minimally invasive direct coronary artery bypass (MIDCAB) surgery for the treatment of left anterior descending (LAD) lesions.Methods. In this single-center study were included 130 patients with stable angina and significant (≥70%) LAD disease. Patients were randomly assigned in a 1:1 ratio to PCI with everolimus-eluting bioresorbable vascular scaffold (Absorb) (n = 65) or MIDCAB (n = 65). The primary end-point was major adverse cerebrocardiovascular events (MACCE) and secondary was. Primary and secondary endpoints were, respectively, major adverse cerebro-cardiovascular events (MACCE) and target vessel failure at 3-year.Results.The groups of patients were comparable for all baseline demographic, clinical and angiographic parameters. The primary composite endpoint of MACCE through 3 years occurred in 16.9% of BVS patients and 9.2% of MIDCAB patients (p = 0.19). But 3-year any revascularization rates were higher with BVS (13.8% vs. 3.1%; p = 0.027). TVF was favor of the MIDCAB group (12,3% vs. 3,1%, p = 0.04), mainly triggered by high subsequent need for revascularization of the targeted vessel in the BVS group (9.2% vs. 1.5%; p = 0.05).Conclusion. At 3-year follow-up, PCI by BVS and MIDCAB in in patients with isolated LAD lesions yielded similar long-term outcomes regarding the primary composite clinical endpoint. The bioresorbable scaffold was associated with a higher incidence of reinterventions, TVF and TVR than the MIDCAB through 3 years of follow-up.

Comparison of the everolimus-eluting bioresorbable vascular scaffold versus the everolimus-eluting metallic stent in real-world patients with ST-segment elevation myocardial infarction.

IntroductionDespite the withdrawal of the ABSORB bioresorbable vascular scaffold (BVS) from clinical use, continuous observation of BVS-treated patients is necessary. In the vast majority of clinical trials, patients with ST-segment elevation myocardial infarction (STEMI) were excluded from the analysis.AimTo compare the early and long-term outcomes of the BVS with the everolimus-eluting metallic stent (EES) in patients with STEMI.Material and methodsConsecutive patients treated with BVS or EES in our center were screened. For analysis, only patients with STEMI were enrolled. The primary endpoint was a comparison of the target lesion failure at 12 and 24 months. The secondary endpoints encompass occurrence of the patient-oriented cardiovascular endpoint (PoCE), stent thrombosis (ST), device, and procedural success.ResultsBetween 2012 and 2016, 2,137 patients were hospitalized for STEMI. Of these, 123 patients received the BVS (163 scaffolds; 151 lesions), whereas in 141 patients the EES (203 stents; 176 lesions) was implanted. The median follow-up was 931 ±514 days. The primary endpoint at 12 months occurred in 9.7% in the BVS group and in 8.5% in the EES group (hazard ratio (HR) = 2.61; 95% confidence interval (CI): 0.90–7.56; p = 0.076). At 24 months the incidence of the primary endpoint was 15.2% in the BVS group and 14.9% in the EES group (HR = 2.46; 95% CI: 0.85–7.07; p = 0.095). The rates of PoCE, ST, device, and procedural success were also comparable in both groups.ConclusionsSTEMI patients treated with the BVS showed statistically similar rates of primary and secondary endpoints compared with the EES.

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.

Different vascular healing process between bioabsorbable polymer-coated everolimus-eluting stents versus bioresorbable vascular scaffolds via optical coherence tomography and coronary angioscopy (the ENHANCE study: ENdothelial Healing Assessment with Novel Coronary tEchnology)

Recent clinical trials have raised concerns about the safety and efficacy of ABSORB™ bioresorbable vascular scaffolds (BVS). The difference in the vascular healing process between SYNERGY™ bioabsorbable polymer-coated everolimus-eluting stents (BP-EES) and BVS remains unclear. The aim of the ENHANCE study was to compare vascular healing on BP-EES versus BVS by optical coherence tomography (OCT) and coronary angioscopy (CAS) at 4- and 12-month follow-ups. This is a prospective, non-randomized, single center clinical trial. Thirteen eligible patients with multivessel disease were enrolled. BP-EES and BVS were simultaneously implanted in the same patients, but in different coronary vessels. Imaging follow-up with both OCT and CAS was completed in 11 patients at 12 months. Neointimal coverage rates were similar between the two groups based on OCT measurements. The neointimal thickness of BP-EES was significantly thicker at the 12th month than at the 4th month, whereas the neointimal thickness of BVS did not change between the measurements taken at the 4th and 12th month. Existence of intra-stent thrombus was significantly higher in the BVS group, compared to the BP-EES group. On the other hand, CAS revealed that red-thrombi and yellow-plaque were more frequently observed in BVS at 4 months and up to 12-month follow-ups than in BP-EES. These findings suggested that the evidence of instability remained up to 12 months in the vascular healing with BVS, compared to that with BP-EES. Vascular healing of the stented wall was recognized at the very early phase after BP-EES implantation. However, vascular healing with BVS was still incomplete after 12 months.

Early-Stage Vascular Response between Bare Metal Stent and Drug-Free Bioresorbable Vascular Scaffold in the Small-Sized Peripheral Artery: A Preclinical Study in Porcine Femoral Arteries

The clinical benefits and outcomes of the interventional treatment of small-sized infrapopliteal arteries using stent implantation remain uncertain. The aim of this study was to compare the safety and efficacy of drug-free bioresorbable vascular scaffold (BVS) with that of bare metal stent (BMS) in endovascular treatment of small-sized peripheral arteries. In this study, drug-free BVS and BMS were used in eight porcine models. We compared the angiographic and histomorphometric findings in the two groups at 4weeks. In each pig, BVS and BMS of adequate sizes were implanted in the small branch (<3mm) of the femoral artery. Angiography, intravascular ultrasound (IVUS), and histomorphometric analysis were performed at 4weeks. In the 4-week follow-up angiography and IVUS examination, the minimal luminal diameter was smaller and diameter stenosis was more severe in the BVS group. Histomorphometric findings indicated that the lumen area in the BVS group was smaller (0.34±0.28mm2 vs. 1.40±0.52mm2, P<0.001), whereas the neointimal area (2.70±1.28mm2 vs. 1.76±0.66mm2, P=0.013), area stenosis (85.18±13.14 % vs. 54.99±16.13 %, P<0.001), inflammatory score (2.07±0.861 vs. 28±0.39, P=0.003), and fibrin scores (1.24±0.70 vs. 0.79±0.72, P=0.043) were significantly higher in the BVS group. The injury score was higher in the BMS group. In histopathologic findings, restenosis was mainly due to recoil and distortion of the scaffold in the BVS group. Compared with BMS, drug-free BVS was not feasible for small-sized peripheral arteries based on the angiographic, IVUS, and histomorphometric results primarily due to insufficient mechanical support.

Re-endothelialisation after Synergy stent and Absorb bioresorbable vascular scaffold implantation in acute myocardial infarction: COVER-AMI study

Background/aimsDrug eluting stent (DES) decrease the risk of restenosis by reducing the neointimal response. However, DES may impair strut coverage, and this has been associated with late stent/scaffold thrombosis. Bioresorbable vascular scaffold (BVS) may overcome the risk of stent/scaffold thrombosis when completely resorbed. The purpose of this randomised trial was to compare the arterial healing response in the short term, as a surrogate for safety and efficacy, between the metallic everolimus-eluting stent (Synergy; Boston Scientific, Marlborough, MA, USA) and the everolimus BVS (Absorb; Abbott Vascular, Santa Clara, CA, USA) in the particular setting of acute myocardial infarction (AMI). This pilot study sought to compare the neointimal response of metallic everolimus DES (Synergy) with polymeric everolimus BVS (Absorb) by optical coherence tomography (OCT) 3 months after an AMI.MethodsCOVER-AMI was a single-centre, single-blind, non-inferiority, randomised controlled trial. Patients with ST segment elevation myocardial infarction (STEMI) who underwent primary percutaneous coronary intervention were randomly allocated (1:1) to treatment with the Synergy DES or Absorb BVS. The primary endpoint was the 3-month neointimal response assessed as the percentage of uncovered struts, neointimal thickness, in-stent/scaffold area obstruction, and pattern of neointima. The main secondary endpoint included the device-oriented composite endpoint according to the Academic Research Consortium definition.ResultsTwenty patients without clinical and/or angiographic complications (Synergy (n = 10) or BVS (n = 10); mean age 59.0 years; 20% female) were enrolled in our centre. The stent diameter was higher in the Synergy group (3.7 ± 0.4 mm vs 3.4 ± 0.4 mm in the BVS group, p = 0.01). At 3 months, no significant differences in angiographic lumen loss were observed between the everolimus DES and everolimus BVS (0.04 mm (IQR 0.00–0.07) vs 0.11 mm (IQR 0.04–0.31), p = 0.165). OCT analysis of 420 cross-sections showed that the total neointimal area and in-stent obstruction were lower in the Synergy group, while OCT analysis at the strut level (n = 3942 struts) showed that the rate of uncovered struts was lower in the BVS group.ConclusionsStenting of culprit lesions in the setting of STEMI resulted in a nearly complete arterial healing for both the Synergy and the BVS devices. Lower neointimal thickness and in-stent obstruction but a higher rate of uncovered struts were observed in the Synergy group. These findings provide the basis for further exploration in clinically oriented outcome trials.

The relationship of pre-procedural Dmax based sizing to lesion level outcomes in Absorb BVS and Xience EES treated patients in the AIDA trial

Due to expansion limits of the Absorb bioresorbable scaffold a meticulous implantation with correct sizing is required. We sought to investigate the clinical outcomes based on the sizing of the device related to the maximal lumen diameter measured by quantitative coronary angiography in Absorb BVS and Xience EES treated lesions in the AIDA trial. Sizing of Absorb bioresorbable vascular scaffold (BVS) and Xience everolimus eluting stent (EES) was graded according to the definitions of device non-oversize and device oversize on pre-procedural angiography. Lesion-oriented outcomes (LOCE) (device thrombosis, TLR and TVMI) that occurred during 2 years follow-up were related to device non-oversized or oversized status. In the Absorb BVS group, LOCE occurred in 48 (7.4%) lesions in the oversized group and in 32 (8.2%) lesions in the non-oversized group (HR 0.91; 95% CI 0.58–1.42; p = 0.681), whereas TLR occurred in 34 (5.3%) lesions and in 23 lesions (5.9%), respectively (HR 0.89; 95% CI 0.52–1.51; p = 0.666). Definite scaffold thrombosis occurred in 11 (1.7%) device oversized treated lesions against 16 (4.1%) device non-oversized treated lesions (HR 0.41; 95% CI 0.19–0.89; p = 0.020). There were no differences in event rates between oversized and non-oversized groups in lesions treated with Xience EES. There was no significant difference in LOCE between oversized and non-oversized treated Absorb BVS and Xience EES treated lesions. Non-oversized Absorb BVS implantation was associated with a higher risk of scaffold thrombosis at complete 2 years follow-up. The majority of very late scaffold thrombosis occurred in properly sized devices.

Clinical Outcomes of Successful Revascularization of Chronic Total Coronary Occlusions with Bioresorbable Vascular Scaffolds: A Systematic Review.

Revascularization of chronic total occlusions (CTO) with percutaneous coronary intervention is associated with favorable long-term clinical and echocardiographic outcomes. Whether bioresorbable vascular scaffolds (BVS) would be advantageous in the treatment of CTO is unknown as patients with these lesions were generally excluded from large BVS randomized trials. We performed a systematic review, which sought to summarize known data on mid- to long-term clinical outcomes for BVS in CTO. We searched MEDLINE, EMBASE, clinicaltrials.gov, and the Cochrane Library through April 2018 to look for studies on implantation of BVS in CTO. Outcomes of interest included myocardial infarction, cardiac death, all-cause mortality, major adverse cardiac events (MACE), vessel restenosis, scaffold thrombosis, and target lesion revascularization. A total of 13 articles met the inclusion criteria for analysis. All studies were observational with a total number of patients of 1,077. Only two studies included comparator groups which retrospectively compared BVS with drug-eluting stents (DES). The studies had variable size (21 to 537) and follow-up duration (3–23 months). The review showed favorable outcomes for BVS implantation in CTO with the reported incidence of MACE ranged from 0% to 6.7% with no significant differences between BVS and DES groups in double arm studies. Although data on the use of first-generation BVS in CTO are sporadic and limited by small sample observational studies, available evidence is promising and suggests of acceptable outcomes comparable with second generation DES. Further investigation with randomized clinical trials and use of newer generation scaffolds is required.

Immune–inflammatory response after bioresorbable vascular scaffold implantation in patients with acute myocardial infarction with ST elevation in a long-term perspective

A higher rate of bioresorbable vascular scaffold (BVS) thrombosis has been observed after device implantation compared to implantation of permanent metallic stents in recently published studies. The mechanism of BVS thrombosis is currently under debate. To assess whether the immune-inflammatory response after BVS implantation is a potential trigger of BVS thrombosis. The PRAGUE-19 study was an academic study that enrolled consecutive patients with ST-segment elevation myocardial infarction (STEMI) with the intention to implant a BVS. A laboratory sub-study included 49 patients with an implanted BVS (of which 38 underwent the complete 2-year follow-up) and 52 patients having an implanted permanent metallic stent as the control group (of which 30 underwent the complete 2-year follow-up). Samples for inflammatory markers [high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α)] were taken before BVS or stent implantation, on days 1 and 2 after device implantation and at 1month and 2years for a clinical control. The primary combined clinical endpoint of the sub-study (death, reinfarction or target vessel revascularization) occurred in 4.08% of the BVS group and 7.69% of the control group (p = 0.442) during the 2-year follow-up period, with overall mortality of 2.04% in the BVS group and 1.92% in the control group (p = 0.966). Definite BVS thrombosis occurred in one patient in the subacute phase; there was no late or very late thrombosis. Two definite stent thromboses were observed in the control group: one inthe subacute phase and the other inthe late phase. Baseline inflammatory marker levels did not differ between the groups. Lower levels of IL-6 and hs-CRP were observed in the BVS group compared to the control group (12.02 ± 5.94 vs. 15.21 ± 5.33pg/ml; p < 0.01; 3952.9 ± 1704.75ng/ml vs. 4507.49 ± 1190.01ng/ml; p = 0.037, respectively) on days 1 and 2 (12.01 ± 6.31 vs. 13.85 ± 6.01pg/ml; p = 0.089; 4447.92 ± 1325.31ng/ml vs. 4637.03 ± 1290.99ng/ml; p = 0.255, respectively). No differences in IL-6 or hs-CRP were observed after 1month or 2years in the clinical control. Levels of TNF-α did not differ between the groups in the early period after BVS or metallic stent implantation, nor during follow-up. The immune-inflammatory response is lower during the early phase after BVS implantation compared to that after metallic stent implantation, but the responses did not differ in the long term.

CTA Evaluation of Bioresorbable Scaffolds versus Metallic Coronary Stents – a Feasibility Study

Abstract Background: Computed tomography angiography (CTA) presents important limits in in-stent restenosis (ISR) evaluation in case of metallic coronary stents, due to the artifacts determined by stent struts, which alter in-stent plaque analysis. In case of bioresorbable scaffolds, stent strut resorption allows accurate evaluation of the vessel wall. Aim of the study: This study aims to compare the feasibility of CTA as a follow-up imaging method for ISR diagnosis following elective PTCA procedures, between bioresorbable scaffolds and metallic coronary stents. Material and methods: We conducted a prospective, observational study on 73 patients with elective PTCA procedures in their medical history, in whom 113 stents were assessed via CTA in order to diagnose ISR. Based on stent type, the patients were divided into two groups: Group 1 – patients with bioresorbable vascular scaffolds (BVS) (n = 30); and Group 2 – patients with bare metal stents (BMS) (n = 43). Plaque analysis was possible only in the BVS group with a post-processing research-dedicated software, Syngo.via Frontier, which identified plaque morphology and virtual histology composition. Results: After CTA evaluation, the BVS group presented a significantly higher incidence of severe coronary artery disease (CAD) (Group 1 – 73% vs. Group 2 – 30%, p &lt;0.0001). The proximal part of the right coronary artery (RCA) presented a significantly higher percentage of metallic stents (14% BMS vs. 2% BVS, p = 0.0029). The comparative analysis of CTA sensibility for the visual evaluation of ISR identified a significantly higher percentage of diagnostic CT evaluations in the BVS group (Group 1 – 94% vs. Group 2 – 76.19%, p = 0.0006). CTA evaluation provided the most accurate results for the 3.0 and 3.5 mm devices. Regarding CTA sensibility for ISR diagnosis, the BVS group presented the smallest incidence of non-diagnostic CT evaluations. Conclusions: CTA evaluation of bioresorbable scaffolds is superior to metallic stent assessment, the latter being influenced by numerous sources of error dependent mainly on the presence of the metal structure.

Bioresorbable vascular scaffolds for complex chronic total occlusions.

This analysis of a consecutive series of bioresorbable vascular scaffolds (BVS) implanted for complex chronic total occlusions (CTOs) was done to evaluate the potential of this device to avoid a permanent full metal jacket with drug-eluting stents. We analyzed 52 young patients (50.8 ± 8.3 years) for the BVS group, and additionally we followed a subgroup of 17 patients where DES were combined with BVS mainly because severe calcification at the lesion site (hybrid group). BVS were successfully implanted in 69 of 70 patients. An average of 3.17 BVS were used per lesion in the BVS group, with a CTO length of 28 ± 20 mm, and a reference diameter of 2.92 ± 0.34 mm, 69% were J-CTO ≥ 2. The retrograde approach was used in 38%. The device length was 79 ± 25 mm with 3.65 ± 0.34 mm final balloon diameter. In the hybrid group BVS was used to cover the distal segment beyond the actual occlusion predominantly in LAD lesions. Patients were discharged with dual antiplatelet therapy prescribed for 12 months. At 12 months, no patient had died or experienced an acute myocardial infarction. Angiography or MSCT follow-up available in 67% showed no reocclusion within 12 months. The target revascularization was 7% at 12 months. Two patients experienced a late non-acute reocclusion at 17 and 19 months. The implantation of BVS for long complex CTOs was feasible with no stent thrombosis despite the high complexity of lesions and multiple BVS implanted. The lack of mechanical strength may lead to the need for focal reintervention, but still the long-term burden of full metal jacketed vessels could be avoided.