Bioresorbable Scaffold Implantation Research Articles

Acute interventional management of spontaneous coronary artery dissection: case series and literature review

Spontaneous coronary artery dissection (SCAD) treatment is currently a matter of debate as scarce data are available for the interventional cardiologists. In the present review, we introduce 4 representative clinical scenarios in which different interventional strategies were carried out. Subsequently, we discuss different tools and useful techniques for the treatment of SCAD, presenting the advantages and drawbacks of the conservative approach versus percutaneous coronary intervention with drug eluting stent or bioresorbable scaffolds implantation, and/or cutting balloon angioplasty.

Senescent endothelial cells' response to the degradation of bioresorbable scaffold induces intimal dysfunction accelerating in-stent restenosis.

Atherosclerotic cardiovascular disease is a typical age-related disease accompanied by stiffening arteries. We aimed to elucidate the influence of aged arteries on in-stent restenosis (ISR) after the implantation of bioresorbable scaffolds (BRS). Histology and optical coherence tomography showed increased lumen loss and ISR in the aged abdominal aorta of Sprague-Dawley rats, with apparent scaffold degradation and deformation, which induce lower wall shear stress (WSS). This was also the case at the distal end of BRS, where the scaffolds degraded faster, and significant lumen loss was followed by a lower WSS. In addition, early thrombosis, inflammation, and delayed re-endothelialization were presented in the aged arteries. Degradation of BRS causes more senescent cells in the aged vasculature, increasing endothelial cell dysfunction and the risk of ISR. Thus, profoundly understanding the mechanism between BRS and senescent cells may give a meaningful guide for the age-related scaffold design. STATEMENT OF SIGNIFICANCE: The degradation of bioresorbable scaffolds aggravates senescent endothelial cells and a much lower wall shear stress areas in the aged vasculature, lead to intimal dysfunction and increasing in-stent restenosis risk. Early thrombosis and inflammation, as well as delayed re-endothelialization, are presented in the aged vasculature after bioresorbable scaffolds implantation. Age stratification during the clinical evaluation and senolytics in the design of new bioresorbable scaffolds should be considered, especially for old patients.

Long-term multimodality imaging follow-up of ST-segment elevation myocardial infarction patients treated with bioresorbable vascular scaffold: advantages and challenges.

Multislice computed tomography (MSCT) offers a non-invasive method of imaging bioresorbable scaffolds (BRS). To investigate the advantages and challenges using MSCT in the follow-up after BRS implantation. The BRS cohort consisting of 31 patients in the 'BRS in STEMI' trial was examined by multimodality imaging and followed long-term. Minimum lumen area (MLA) and average lumen area (ALA) were examined 12 and 36 months after BRS implantation with MSCT. Optical coherence tomography (OCT) at 12 months was used as a reference. Measured by MSCT, the mean MLA was 0.05 ± 1.32 mm² ( P = 0.85), but ALA was 1.32 (±2.59 mm², P = 0.015) greater than by OCT. ALA and MLA did not change significantly from 12 to 36 months. MSCT identified all cases of restenosis but missed one patient with massive malapposition. Our data support using MSCT in the follow-up after BRS implantation. Invasive investigation should still be considered for patients with unexplained symptoms.

The standard versus prolonged dual antiplatelet therapy after the XINSORB bioresorbable scaffold implantation (SPARTA) trial: study protocol for a randomized controlled trial

BackgroundDual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is the standard of care after coronary stenting, including coronary stenting involving bioresorbable scaffolds (BRSs). Current clinical guidelines recommend at least 12 months of DAPT after BRS implantation. However, the correlation between prolonged DAPT and net clinical benefits remains unknown.MethodsThe SPARTA trial is designed to be a prospective, randomized, parallel-group, clinical trial. It aims to compare the benefits and risks of DAPT applied for either 12 or 36 months after XINSORB BRS implantation. The primary endpoints are the incidence of the composite endpoint of major adverse cardiac events (MACEs), including all-cause death, any myocardial infarction (MI), and all revascularizations, as well as Bleeding Academic Research Consortium Definition (BARC) type 3 or 5 bleeding events. The secondary endpoints of the study include the device-oriented composite endpoint of target lesion failure (defined as cardiac death, target vessel-related MI, or ischemia-driven target lesion revascularization), target vessel failure (defined as cardiac death, MI, or ischemia-driven target vessel revascularization), scaffold thrombosis, and minor bleeding events. This trial will enroll 2106 subjects treated with the XINSORB BRS only. All subjects will receive DAPT after the index procedure for 12 (± 1) months. Subjects without MACEs or major bleeding will be randomized to receive either 24 additional months of DAPT or aspirin alone.DiscussionThis trial is designed to investigate the impact of extending the duration of DAPT up to 3 years after XINSORB BRS implantation by investigating the balance of risks and benefits in a broad population of treated patients.Trial registrationClinicalTrials.gov NCT04501900. Registered on 6 August 2020.

Third-Generation Sirolimus-Eluting Bioresorbable Tyrocore Scaffold Implantation in Patients with ST-Segment Elevation Myocardial Infarction: Baseline and 6-Month OCT and Clinical Outcomes-a FANTOM STEMI Pilot Study.

The aim of this study was to evaluate the safety and efficacy of the Fantom BRS 6months after implantation using the optical coherence tomography (OCT) imaging. Twenty STEMI patients treated with a sirolimus-eluting Fantom BRS were enrolled into a prospective, single-arm, serial observational study. The scaffold sizing, positioning and optimisation were guided by OCT imaging. The primary endpoint was device-orientated composite endpoints (DOCE), comprised of cardiac death, target-vessel-related myocardial infarction and target lesion failure. To evaluate the device performance at the scaffold level, we performed a quantitative coronary angiography (QCA) and OCT imaging at 6months. The primary endpoint did not occur in any patient within the 6-month follow-up. There were no major adverse cardiac events (MACEs) or DOCEs, no cases of scaffold thrombosis, target lesion revascularization and no deaths. In QCA, we observed a decrease in the minimum and mean lumen diameter in the in-scaffold region and in the proximal and distal peri-scaffold region. Similarly, the minimum lumen area and reference vessel diameter had decreased in both QCA and OCT. The OCT imaging showed improvement in the expansion index and malposition rate. A serial 6-month OCT imaging after implantation of a third-generation Tyrocore-based bioresorbable coronary scaffold indicated good coverage of the struts with excellent healing of the scaffold, low neointima growth and no signs of neoatherosclerosis.

Calcified plaque detected on OCT with deep learning and cross-validated with optical and ultrasound signals: A complementary appraisal and preamble to combined IVUS-OCT catheter

Background: The optical coherence tomography (OCT)-deep learning (DL) emerged as a promising tool for automated plaque characterization. However, its findings have not been compared with optical and ultrasound signals.Objectives: The objective was to cross-validate the calcified plaque detected by OCT-DL, using comprehensive tissue characterization technologies including OCT-derived optical properties, intravascular ultrasound (IVUS)-virtual histology (VH) and echogenicity.Methods: Five years after bioresorbable scaffold (BRS) implantation, 15 patients underwent OCT and IVUS imaging. The unique platinum markers in BRS facilitated precise OCT-IVUS co-registration. Calcified plaque detected by OCT-DL were corroborated by/with optical properties, greyscale (GS)-IVUS, IVUS-VH and echogenicity. The concordance between OCT-DL and other modalities was assessed by kappa statistics. The calcium arc measured by different modalities were compared by orthogonal linear regression.Results: Forty-three calcified plaques were detected by DL in 72 matched anatomic slices, 41 (95%) were confirmed as pure (n = 29) or hybrid calcified plaque (n = 12) by optical properties. Weighted kappa between OCT-DL and GS-IVUS, IVUS-VH and echogenicity were 0.69, 0.60 and 0.60, respectively. After having excluded artifactual optical shadowing (n = 5) generated by guidewire or platinum marker, kappa increased to 0.77, 0.68 and 0.69, with agreement ranging between 90% and 93%. Calcium arc derived from OCT-DL showed moderate correlation and agreement with GS-IVUS (ICCa = 0.81, difference = 1.73 ± 15.25°), IVUS-VH (ICCa = 0.69, difference = -5.60 ± 21.19°) and echogenicity (ICCa = 0.65, difference = 10.28 ± 18.70°).Conclusion: OCT empowered by deep learning showed substantial agreement with optical and ultrasound signals. The comprehensive assessment provided by OCT and IVUS heralds the potential diagnostic value of combined IVUS-OCT catheters.

Abstract 14778: Combined Shear Stress-Molecular Imaging for the Evaluation of Early Arterial Healing Responses Following Implantation of Bioresorbable Scaffold With Different Strut Thickness

Introduction and Hypothesis: Arterial healing following stent implantation involves a series of biological reactions such as thrombosis, inflammation, neointimal regeneration. Clinical evidences have shown favorable arterial healing after thin-strut stents, however, there has been a lack of in vivo imaging evidence on how strut thickness affect vascular healing process. We evaluated local endothelial shear stress (ESS) and healing response of a thin-strut bioresorbable scaffold (BRS, 100μm) compared to first-generation 157μm-thickness ABSORB. Methods and Results: BRS and ABSORB were simultaneously implanted in left coronary arteries of the same pigs (n=7). Detailed scaffolded-artery 3D model was reconstructed based on OCT and angiography. Scaffold-related inflammation response was serially assessed by dual-modal OCT-near-infrared fluorescence (OCT-NIRF) molecular imaging using macrophage-mannose receptor-Cy7 as an inflammation-targeting agent. On ESS analysis, regions with athero-prone low ESS were significantly greater in thick-ABSORB compared to BRS. Dual-modal OCT-NIRF imaging visualized arterial inflammation activity at peri-strut regions in vivo (Figure). Based on coregistered ESS-NIRF data, we found a significant inverse correlation was found between ESS and NIRF activity (p<0.0001), suggesting immune-modulating effect of ESS during early stent healing phase. Arterial inflammation, quantified as target-to-background ratio, was significantly lower in thin-strut BRS than ABSORB at 2 weeks (p<0.01). At week 3, unlike ABSORB with residual peri-strut NIRF signals, inflammation activity dissipated significantly in BRS. Ex vivo confocal fluorescence microscopy (Figure) and immunohistochemical analysis well corroborated the findings in vivo . Conclusions: Thin-strut BRS was associated with less inflammation and rapid resolution of inflammation compared to thicker-strut ABSORB. This study provides in vivo imaging insights into how strut thickness affects early arterial healing and the importance of ESS as an inflammatory modulator. Our comprehensive imaging strategy enabling evaluation of complex interplay between scaffold, ESS, and artery is expected to enhance understanding of stent healing.

Everolimus-eluting bioresorabable scaffold system in the treatment of cardiac allograft vasculopathy: the cardiac allograft reparative therapy (CART) prospective multicentre pilot study

Abstract Background Cardiac allograft vasculopathy (CAV) is still the main drawback of heart transplantation (HTx) and percutaneous coronary intervention (PCI) is a palliative measure because of the high incidence of PCI failure. The bioresorbable scaffolds (BRS) could represent a potential novel therapeutic tool for the treatment of coronary obstructions in CAV. Purpose To investigates the effects of BRS implantation in CAV patients in a Nationwide prospective study. Methods Multicentre, single-arm, prospective, open-label study that included patients affected by advanced CAV treated with PCI and second-generation ABSORB BRS. The primary endpoint was the incidence of 12-month angiographic in-segment scaffold restenosis (ISSR). Secondary endpoints were the composite of cardiac death, myocardial infarction, and target lesion revascularisation at 12-and 36-month follow-up and the incidence of ISSR at 36 months. A paired analysis of intravascular ultrasound (IVUS) and optical coherence tomography (OCT) at baseline and follow-up was also performed. Results Between 2015–2017 35 HTx patients were enrolled and treated on 44 coronary lesions with 51 BRS. The primary endpoint occurred in 13.5% of the lesions (5/37), with a cumulative ISSR rate up to 3 years of 16.2% (6/37).Angiographic lumen loss was 0.40±0.62mm at 12 months and 0.53±0.57mm at 36 months. Overall survival was 91.4% and 74.3%, and MACEs 14.2% and 31.4% at 12 and 36 months, respectively. At the paired intracoronary imaging analysis a significant increase of the vessel external elastic membrane area in the treated segment of the BRS was described at the OCT, while some progression of CAV was detected proximally at the IVUS assessment. Conclusions BRS in CAV was feasible and safe, with an ISSR incidence similar to drug-eluting stents. For the first time, a positive remodeling was observed in HTx patients after PCI. Vessel enlargement and the lack of metallic stents may allow repeated PCI avoiding the vessel shrinkage caused by the addition of multiple metal layers, being CAV a complex clinical scenario with a high incidence of MACEs, mainly driven by PCI failure. Funding Acknowledgement Type of funding sources: Private grant(s) and/or Sponsorship. Main funding source(s): Partial funding by Abbott Vascular Italy

The endothelium permeability after bioresorbable scaffolds implantation caused by the heterogeneous expression of tight junction proteins.

As one of the main functions of vascular endothelial cells, Vascular permeability is determined by four tight junction proteins (TJPs): Zonula Occludens-1 (ZO-1), Claudin-5, Occludin and Tricellulin. The barrier function of blood vessels will be reconstructed after they are damaged by endothelial mechanical injuries caused by vascular interventions. In this study, the effects of balloon expansion (transient mechanical injury) on four TJPs and vascular permeability were compared with those of poly-l-lactic acid bioresorbable scaffolds (BRSs) implantation (continuous mechanical stimulation). We found that BRSs do not affect vascular permeability, while the recovery of vascular barrier function was found to be only related to the mechanical injuries and repair of endothelium. Mechanical stimulation affects and accelerates the recovery process of vascular permeability with the heterogeneous expression levels of TJPs induced after BRSs implantation. Different TJPs have different sensitivity to different loyal mechanical stimuli. ZO-1 is more sensitive to shear stress and tension than to static pressure. Occludin is sensitive to static pressure and shear stress. Tricellulin is more sensitive to tension stretching. Compared with the other three TJPs, Claudin-5 can respond to mechanical stimulation, with relatively low sensitivity, though. This difference in sensitivity determines the heterogeneous expression of TJPs. Mechanical stimulation of different kinds and strengths can also cause different cell morphological changes and inflammatory reactions. As an important element affecting endothelial function, the mechanical factors emerging after BRSs implantation are worthy of more attention.

Efficacy and safety of bioresorbable scaffolds in patients with coronary bifurcation lesions: A systematic review and meta-analysis.

BackgroundBioresorbable scaffolds (BRS) were considered to be beneficial for coronary bifurcation lesions regarding the avoidance of lateral branch opening incarceration after complete absorption. However, data is limited in this setting. The aim of this meta-analysis was to evaluate the short (6-month) and medium-term (1-year) outcomes of BRS in patients with coronary bifurcation lesions.MethodsPubMed, EMBASE, Web of Science, Cochrane library databases were searched to find the studies of BRS implantation in patients with coronary bifurcation lesions. The effective outcome was target lesion revascularization. The safety outcomes included major adverse cardiovascular events, target vessel revascularization, myocardial infarction, definite or probable scaffold thrombosis, and cardiac death.ResultsA total of 1204 patients involved in 12 studies were included. The pooled estimate rate of target lesion revascularization as efficacy outcome was highly consistent between 6-month and 1-year follow-up, which was 4.74% (95% CI 2.36–9.54%, I2 = 41.5%, p = 0.14) and 4.37% (95% CI 3.05–5.69%, I2 = 4.6%, p = 0.39). The pooled estimated rate of major adverse cardiovascular events as safety outcome was 5.50% and 7.31% for both 6-month and 1-year follow-up. The pooled estimated rate of target vessel revascularization, myocardial infarction, definite or probable scaffold thrombosis, and cardiac death at 1-year follow-up was 5.92%, 2.52%, 1.69%, and 0.42%.ConclusionsThe application of BRS for coronary bifurcation lesions is acceptable in efficacy outcome, but the high rate of scaffold thrombosis remains of concern (Registered by PROSPERO, CRD42019140341).

Blinded by the Lights: OCT-Guidance for Implantation of Magnesium-Based Bioresorbable Scaffolds?

Blinded by the Lights: OCT-Guidance for Implantation of Magnesium-Based Bioresorbable Scaffolds?

Coronary artery perforation after bioresorbable scaffold implantation treated with a new generation covered stent\u2014OCT insights

BackgroundCoronary artery perforation is a rare but potentially lethal complication of percutaneous coronary intervention (PCI) with an associated mortality of 7–17%. We report the case of coronary artery perforation complicating Absorb bioresorbable vascular scaffold (BVS) implantation and the associated technical challenges with managing this life-threatening complication.Case reportA 46-year-old male was referred to our institution and underwent PCI with an Absorb bioabsorbable vascular scaffold (BVS) to a proximal LAD long segment bifurcation lesion. Following pre-dilation and deployment of the 3.5 × 28 mm Absorb BVS, high pressure post-dilation of the distal scaffold was complicated by a large, Ellis type III coronary perforation with no flow to the distal LAD beyond the rupture, and associated with a large pericardial effusion confirmed on bedside transthoracic echocardiogram (TTE). The insult was temporised with prolonged balloon inflation within the Absorb BVS immediately proximal to the site of perforation, permitting urgent insertion of a pericardial drain. After deflation of the balloon, a 3.0 × 21 mm BeGraft covered stent was deployed across the perforation, restoring normal LAD flow and abolishing the perforation. Cardio-pulmonary resuscitation was not required and the patient remained conscious throughout the procedure. TTE demonstrated normal left ventricular function and the patient was discharged 3 days later. Repeat angiography at 3 months showed patent stents with TIMI III flow, and optical coherence tomography (OCT) showed good expansion and apposition of the proximal Absorb BVS and BeGraft. The patient has remained well 4 years after PCI with no major cardiovascular events.ConclusionThe utility of bioresorbable scaffold technology remains controversial although meticulous implantation techniques are associated with improved clinical outcomes. Adoption of the Pre-dilatation, Sizing and Post-dilatation (‘PSP’) method of BVS implantation with routine aggressive vessel preparation and scaffold optimization however may contribute to a higher risk of vessel perforation. The case emphasises the importance of accurate sizing of the vessel with intracoronary imaging and demonstrates the value of newer generation covered stents with single-layer design and slimmer crossing profile producing improved deliverability and procedural success.

Comparison of diagnostic accuracy of immediate angiography derived residual quantitative flow ratio after bioresorbable scaffold and drug eluting stent implantation.

Quantitative flow ratio (QFR) is a novel angiography derived fractional flow reserve (FFR) technique. However, its diagnostic accuracy has only be validated in native coronary lesions but not in vessels after bioresorbable scaffold (BRS) implantation. This study aims to evaluate the diagnostic accuracy of residual QFR in coronary vessels immediately post-BRS implantation. This is a retrospective, two center, validation cohort study. 73 stable angina patients who received at least one de novo lesion of an everolimus eluting stent (EES)/BRS implantation with subsequent residual FFR assessment were screened. Patients with aorta-ostial stenoses, bridge vessels at the distal segment of targeted vessels, acute coronary syndrome, previous coronary artery bypass grafting, age <18 years, lack of ≥2 final angiographic projections were excluded. Contrast QFR assessment was performed blinded to FFR assessment. A good correlation (r = 0.680, p < 0.001) was found between residual QFR and FFR. In the EES implantation cohort, a good correlation (r = 0.769, p < 0.001) was found between residual QFR and FFR, and a moderate correlation (r = 0.446, p = 0.038) in the BRS cohort. The area under the Receiver operator characteristic (ROC) curve for detecting FFR ≤0.86 was 0.883 for all patients. Residual QFR assessment after BRS implantation is feasible, and has a moderate correlation and agreement with residual FFR. QFR may be a promising tool similar to FFR to evaluate post-BRS effect.

Optical Coherence Tomography- Versus Angiography-Guided Magnesium Bioresorbable Scaffold Implantation in NSTEMI Patients

BackgroundThe purpose of a bioresorbable scaffold (BRS) is to provide radial support during coronary healing. In this study, coronary artery healing after optical coherence tomography (OCT)- versus angiography-guided magnesium BRS (MBRS) implantation in patients with non-ST-segment-elevation myocardial infarction (NSTEMI) is compared. Methods75 patients were randomized 1:1 to OCT- or angiography-guided implantation of a MBRS with protocolled pre- and post-dilation. In the OCT-guided group, prespecified criteria indicating additional intervention were (1) scaffold under-expansion, (2) strut malapposition, (3) edge dissection, and (4) residual stenosis at distal or proximal reference segments. The primary endpoint was OCT-derived healing stage at 6 months. ResultsAt 6 months, there was no difference in average healing stage between OCT- and angiography-guided intervention (4.6 [interquartile range (IQR): 4.5–4.7] versus 4.5 [IQR: 4.3–4.7]; p = 0.54). The MBRSs were completely resolved in 77.0% [IQR: 68.5–85.5] versus 76.5% [IQR: 67.9–85.5]; (p = 0.97). Minimal lumen area (MLA) was reduced at 6 months in both the OCT- (32.3%; p < 0.01) and the angiography-guided group (21.3%; p < 0.01), however OCT-guided implantation was associated with a greater reduction of total lumen volume (−27.1 ± 32.5 mm3 versus −5.0 ± 32.9 mm3; p < 0.01) and MLA (−2.3 ± 1.6 mm2 vs. −1.4 ± 1.4 mm2; p = 0.02). ConclusionsIn NSTEMI patients, OCT-guidance with protocolled pre- and post-dilation of MBRS implantation showed similar healing pattern at 6 months compared to angiography-guidance alone. Clinical trial registrationThe Coronary Artery Healing Process after Optical Coherence Tomography Guided Percutaneous Coronary Intervention with Magmaris Bioresorbable Scaffold in Patients with Non-ST-Segment-Elevation Myocardial Infarction: (HONEST) trial is registered with ClinicalTrials.gov, NCT03016624.

Optimal dual antiplatelet therapy duration for bioresorbable scaffolds: an individual patient data pooled analysis of the ABSORB trials.

Compared with everolimus-eluting metallic stents, the Absorb bioresorbable scaffold (BRS) results in increased rates of myocardial infarction (MI) and scaffold thrombosis (ST) during its three-year bioresorption phase. It is unknown whether prolonged dual antiplatelet therapy (DAPT) duration might decrease the risk of ischaemic events. We sought to evaluate the impact of DAPT duration on ischaemic and bleeding outcomes following BRS implantation. We conducted an individual patient data pooled analysis from four ABSORB randomised trials and one prospective ABSORB registry. Study endpoints were MI, ST, bleeding, and death up to three-year follow-up. Propensity score-adjusted Cox regression analysis was used to account for baseline differences related to DAPT duration. The five ABSORB studies included 2,973 patients. DAPT use was 91.7%, 53.2%, and 48.0% at 1, 2, and 3 years, respectively. DAPT use within the first year after BRS implantation was associated with markedly lower risks of MI (adjusted hazard ratio [aHR] 0.17, 95% CI: 0.10-0.32; p<0.0001) and ST (aHR 0.08, 95% CI: 0.03-0.19; p<0.0001). Conversely, DAPT use between 1 and 3 years did not significantly affect the risk of MI (aHR 1.04, 95% CI: 0.70-1.55; p=0.84) or ST (aHR 0.86, 95% CI: 0.42-1.75; p=0.67). DAPT did not have major effects upon bleeding or death in either period. DAPT use during the first year after BRS implantation was strongly associated with lower risks of ST and MI. However, a benefit of ongoing DAPT use between 1 and 3 years after BRS implantation was not apparent.

Clinical application progress of bioresorbable vascular scaffolds in lower extremities arteriosclerotic obliterans

Endovascular technology has become the first choice for the treatment of lower extremities arteriosclerotic obliterans. Bioresorbable vascular scaffolds have attracted more and more attention as a choice of endovascular technology. In the last decade, poly(L-lactic acid) bioresorbable scaffolds with or without drug coating have shown acceptable medium and long-term safety and efficacy in lower extremities arteriosclerotic obliterans, but the lesions of the subjects were relatively simple. Magnesium alloy bioresorbable scaffolds are safe but less effective in the treatment of lower extremities arteriosclerotic obliterans. Both iron and zinc alloy bioresorbable scaffolds have shown considerable results in animal experiments. In particular, the success of implantation of drug-coated iron alloy bioresorbable scaffolds in below-the-knee artery indicated that the iron alloy bioresorbable scaffolds have officially entered the clinical trial stage. Through the comprehensive summation of the previous clinical and experimental data of bioresorbable vascular scaffolds and the pathological characteristics of lower extremities arteriosclerotic obliterans, it is shown that the drug-coated poly(L-lactic acid) bioresorbable scaffolds and iron alloy bioresorbable scaffolds will have greater development potential in the treatment of lower extremities arteriosclerotic obliterans.

Comparison between a novel sirolimus-eluting bioresorbable scaffold with everolimus-eluting metallic stent in patients with coronary artery disease: three-year follow-up from the neovas rct study

Abstract Background Previous trials and meta-analyses have demonstrated that risk of adverse clinical events, especially thrombosis and target vessel myocardial infarction is increasing between 1 and 3 years after Bioresorbable Scaffolds (BRS) implantation. Purpose We sought to evaluate the long-term clinical outcomes of a novel NeoVas BRS in comparison with cobalt chromium everolimus-eluting stent (EES) following implantation in patients with coronary artery disease by 3-year follow-up results from the NeoVas RCT. Methods Overall, 560 patients with a single de novo native coronary artery lesion with reference vessel diameter 2.5–3.75 mm and lesion length ≤20 mm were randomized 1:1 to NeoVas BRS vs. cobalt-chromium everolimus-eluting stents (CoCr-EES). Optical coherence tomography (OCT) and fractional flow reserve (FFR) were both performed in a pre-specified subgroup at 3-year follow-up. Clinical outcomes from NeoVas RCT were analyzed by randomized device (intention to treat) cumulative to 3 years. Results Over 3 years, the overall target lesion failure (TLF) rate was 6.9% in the NeoVas group and 6.1% in the CoCr-EES group (HR 1.13, 95% CI 0.59 to 2.18; p=0.71). There was no statistically significant difference of the definite or probable stent thrombosis between the NeoVas group and the CoCr-EES group (1.1% vs. 0.7%, HR 1.51, 95% CI 0.26 to 8.73, p=0.64). In a landmark analysis of TLF, we found no difference in rate of late events from 2 to 3 years between two groups. FFR was not significantly different between the two group at 3 years (NeoVas vs. CoCr-EES, 0.89±0.07 vs. 0.90±0.05). NeoVas was largely absorbed (72.26% ± 13.21%) examined by OCT follow-up. Of 55 patients who finished 3-year absorption analysis, NeoVas was totally absorbed in 4 patients. Conclusions At the 3-year follow-up in the Neovas RCT trial, overall TLF rates were comparable between Neovas BRS and CoCr-EES, and adverse event rates relating to device safety were not increased with Neovas BRS compared with CoCr-EES up to 3 years after implantation. Funding Acknowledgement Type of funding sources: None.

Comparison of neointimal healing with bioresorbable scaffolds and drug-eluting stents in patients with stable ischaemic heart disease

Aim. To examine the process of neointimal formation after bioresorbable scaffolds (BRS) implantation using optical coherence tomography (OCT) in patients with stable coronary artery disease (SCAD) and to determine relationship between neointimal healing and biochemical parameters of inflammation.Methods. Patients with SCAD (n = 20) who were indicated for percutaneous coronary intervention (PCI) were enrolled. Patients were randomised into two groups as per the stent type. The treatment group comprised 10 patients who were implanted with BRS ABSORB (Abbott Laboratories, Abbott Park, USA) during PCI. The comparison group comprised 10 patients who were implanted with DES XIENCE (Abbott Laboratories, Abbott Park, USA) during PCI. All the patients underwent OCT imaging during PCI. Subsequently, 18 patients were subjected to coronary angiography with OCT imaging in 12 mon. The primary endpoint was the 12-month neointimal healing (NIH) score. Secondary endpoints were clinical outcomes (all-cause hospitalisation, myocardial infarction, probable stent thrombosis and death), OCT parameters at the 12-month follow-up and biochemical markers dynamics.Results. Initial angiographic data analysis indicated a higher rate of balloon pre-dilatation (100% vs. 30%; р = 0,003) and post-dilatation (100% vs. 20% р = 0,001) in patients of the treatment group. According to OCT, the NIH score was significantly higher in the XIENCE group [0 versus 9,14 (1,63–17,55); р = 0,008] at 12 mon. There was no significant difference in the clinical outcomes between the two groups. However, the ABSORB group had an increased CD40 level after 4–5 d of PCI. In agreement with the results of correlation analysis, there was an inverse correlation between the NIH score and CD40 level at 4–5 d after PCI (r = −0,576; р = 0,016). The cut-off value of CD40 level at 4–5 d after PCI was 47,5 ng/mL for the detection of optimal neointimal healing.Conclusion. In patients with SCAD, BRS demonstrated higher rate of neointimal healing than everolimus-coated stents. There was a registered inverse correlation of the NIH score with the CD40 level at 4–5 days after PCI. CD40 level &gt; 47,5 ng/mL at 4–5 d after PCI increases the likelihood of optimal neointimal healing as per OCT data.Received 19 February 2021. Revised 7 June 2021. Accepted 16 June 2021.Funding: The study did not have sponsorship.Conflict of interest: The authors declare no conflicts of interests.Contribution of the authorsConception and study design: I.S. Bessonov, N.A. Musikhina, T.I. PetelinaData collection and analysis: S.S. Sapoznikov, I.S. Bessonov, N.А. Galeeva, A.O. DyakovaStatistical analysis: S.S. Sapoznikov, E.A. GorbatenkoDrafting the article: S.S. Sapoznikov, N.А. Galeeva, A.O. DyakovaCritical revision of the article: I.S. Bessonov, S.S. Sapoznikov, E.A. Gorbatenko, N.A. MusikhinaFinal approval of the version to be published: S.S. Sapoznikov, N.А. Galeeva, I.S. Bessonov, N.A. Musikhina, T.I. Petelina, A.O. Dyakova, E.A. Gorbatenko

Sex Differences in the Clinical Features and Outcomes of Patients with Acute Coronary Syndrome Treated with Two Generations (Absorb and Magmaris) of Bioresorbable Vascular Scaffolds.

Background: Despite the developments in percutaneous coronary interventions (PCI), women are still more likely than men to have unfavorable outcomes after PCI performed in Acute Coronary Syndrome (ACS). The mechanisms of this phenomena are not fully understood. Potential benefits of bioresorbable scaffolds (BRS) may be particularly expressed in the female population. Nevertheless, the data available currently are inconsistent and limited. This study evaluated the gender-related differences in the short-term clinical outcomes in ACS patients treated with implantation of two generations of BRS (first generation, Absorb; second generation, Magmaris). Methods: The study was divided into two arms. To the first one, we qualified 160 patients with ACS treated with PCI who received 210 Absorb scaffolds. The second arm was composed of 193 patients with ACS who underwent PCI with Magmaris implantation. Results: There were no significant sex-related differences in primary endpoints (cardiovascular-death, myocardial infarction, in-stent thrombosis) or principal secondary endpoints (of target-lesion failure, scaffold restenosis, death from any reason, other cardiovascular events) in either generation of BRS in a 1-year follow-up. Conclusions: Both genders tended to have a similar outcome in routine clinical practice following BRS implantation due to ACS. The magnesium bioresorbable scaffold (Magmaris) early outcome seemed to be more favorable in comparison to the Absorb scaffold.

Optical coherence tomography tissue coverage and characterization at six months after implantation of bioresorbable scaffolds versus conventional everolimus eluting stents in the ISAR-Absorb MI trial

PurposeData regarding vessel healing by optical coherence tomography (OCT) after everolimus-eluting bioresorbable scaffolds (BRS) or everolimus-eluting metallic stent (EES) implantation in acute myocardial infarction (AMI) patients is scarce. We compared OCT findings after BRS or EES implantation in patients with AMI enrolled in a randomized trial.MethodsIn ISAR-Absorb MI, AMI patients were randomized to BRS or EES implantation, with 6–8 month angiographic follow-up. This analysis includes patients who underwent OCT during surveillance angiography. Tissue characterization was done using grey-scale signal intensity analysis. The association between OCT findings and target lesion failure (TLF) at 2 years was investigated.ResultsOCT was analyzed in 103 patients (2237 frames, 19,827 struts) at a median of 216 days post-implantation. Of these, 70 were treated with BRS versus 32 with EES. Pre-(92.8 vs. 68.7%, p = 0.002) and post-dilation (51.4 vs. 12.5%, p < 0.001) were more common in BRS as compared to EES. Strut coverage was higher in BRS vs. EES (97.5% vs. 90.9%, p < 0.001). Mean neointimal thickness was comparable in both groups [85.5 (61.9, 124.1) vs. 69.5 (32.7, 127.5) µm, respectively, p = 0.20]. Mature neointimal regions were numerically more common in BRS (43.0% vs. 24.6%; p = 0.35); this difference was statistically significant in ST-elevation myocardial infarction patients (40.9% vs. 21.1%, p = 0.03).At two-years, 8 (7.8%) patients experienced TLF. Mean neointimal area [0.61 (0.21, 1.33) vs. 0.41 (0.11, 0.75) mm2, p = 0.03] and mean neointimal coverage [106.1 (65.2, 214.8) vs. 80.5 (53.5, 122.1) µm, p < 0.01] were higher, with comparable tissue maturity, in lesions with versus without TLF.ConclusionsIn selected patients who underwent OCT surveillance 6–8 months after coronary intervention for AMI with differing implantation characteristics depending on the device type used, vessel healing was more advanced in BRS compared with EES, particularly in the STEMI subgroup.