Bioresorbable Coronary Scaffold Research Articles

Degradation of a novel magnesium alloy-based bioresorbable coronary scaffold in a swine coronary artery model

The objective of the study is to investigate the safety, feasibility, and degradation profile of a novel Mg alloy-based bioresorbable coronary scaffold (JFK-PRODUCT BRS) with thin struts (110 μm). Polymer- or Mg alloy-based BRSs have not replaced nondegradable metal stents because of the higher prevalence of scaffold thrombosis and restenosis in clinical practice; these poor clinical outcomes were due to inadequate scaffold designs, including thick struts (more than 150 μm) and their inappropriate degradation processes. Fourteen healthy pigs received 17 JFK-PRODUCT BRSs in the coronary arteries and were sacrificed at 1, 6, 12, 18, and 26 months after implantation. Angiography, optical coherence tomography, microfocus X-ray computed tomography (µCT), scanning electron microscopy with energy-dispersive X-ray spectrometry (SEM–EDX), and histopathological evaluation were performed. The JFK-PRODUCT had a median percent late recoil of 11.28% at 1 month. The µCT observation confirmed that scaffold discontinuity reached 64.8% at 12 months with increased scaffold inner area thereafter, suggesting artery positive remodeling. The inflammation was mild, peaked at 18 months, and decreased thereafter. The SEM–EDX analysis demonstrated gradual degradation of the scaffold with formation of inorganic deposits, presumed to be calcium phosphates. It also revealed the disappearance of calcium phosphates at 26 months, achieving almost complete replacement of the scaffold by biocomponents. The current study demonstrated the safety and feasibility of JFK-PRODUCT with a lower acute recoil rate despite its thin struts. The scaffolds were almost completely disappeared at 26 months after implantation.Graphical abstract

Quality and transparency of evidence for implantable cardiovascular medical devices assessed by the CORE-MD consortium.

The European Union Medical Device Regulation 2017/745 challenges key stakeholders to follow transparent and rigorous approaches to the clinical evaluation of medical devices. The purpose of this study is a systematic evaluation of published clinical evidence underlying selected high-risk cardiovascular medical devices before and after market access in the European Union (CE-marking) between 2000 and 2021. Pre-specified strategies were applied to identify published studies of prospective design evaluating 71 high-risk cardiovascular devices in seven different classes (bioresorbable coronary scaffolds, left atrial appendage occlusion devices, transcatheter aortic valve implantation systems, transcatheter mitral valve repair/replacement systems, surgical aortic and mitral heart valves, leadless pacemakers, subcutaneous implantable cardioverter-defibrillator). The search time span covered 20 years (2000-21). Details of study design, patient population, intervention(s), and primary outcome(s) were summarized and assessed with respect to timing of the corresponding CE-mark approval. At least one prospective clinical trial was identified for 70% (50/71) of the pre-specified devices. Overall, 473 reports of 308 prospectively designed studies (enrolling 97 886 individuals) were deemed eligible, including 81% (251/308) prospective non-randomized clinical trials (66 186 individuals) and 19% (57/308) randomized clinical trials (31 700 individuals). Pre-registration of the study protocol was available in 49% (150/308) studies, and 16% (48/308) had a peer-reviewed publicly available protocol. Device-related adverse events were evaluated in 82% (253/308) of studies. An outcome adjudication process was reported in 39% (120/308) of the studies. Sample size was larger for randomized in comparison to non-randomized trials (median of 304 vs. 100 individuals, P < .001). No randomized clinical trial published before CE-mark approval for any of the devices was identified. Non-randomized clinical trials were predominantly published after the corresponding CE-mark approval of the device under evaluation (89%, 224/251). Sample sizes were smaller for studies published before (median of 31 individuals) than after (median of 135 individuals) CE-mark approval (P < .001). Clinical trials with larger sample sizes (>50 individuals) and those with longer recruitment periods were more likely to be published after CE-mark approval, and were more frequent during the period 2016-21. The quantity and quality of publicly available data from prospective clinical investigations across selected categories of cardiovascular devices, before and after CE approval during the period 2000-21, were deemed insufficient. The majority of studies was non-randomized, with increased risk of bias, and performed in small populations without provision of power calculations, and none of the reviewed devices had randomized trial results published prior to CE-mark certification.

Bioresorbable coronary scaffolds are ready for a comeback: pros and cons.

Bioresorbable coronary scaffolds are ready for a comeback: pros and cons.

5-Year Outcomes After Bioresorbable Coronary Scaffolds Implanted With Improved Technique

BackgroundBioresorbable vascular scaffolds (BVS) were designed to improve late event-free survival compared with metallic drug-eluting stents. However, initial trials demonstrated worse early outcomes with BVS, in part due to suboptimal technique. In the large-scale, blinded ABSORB IV trial, polymeric everolimus-eluting BVS implanted with improved technique demonstrated noninferior 1-year outcomes compared with cobalt chromium everolimus-eluting stents (CoCr-EES). ObjectivesThis study sought to evaluate the long-term outcomes from the ABSORB IV trial. MethodsWe randomized 2,604 patients at 147 sites with stable or acute coronary syndromes to BVS with improved technique vs CoCr-EES. Patients, clinical assessors, and event adjudicators were blinded to randomization. Five-year follow-up was completed. ResultsTarget lesion failure at 5 years occurred in 216 (17.5%) patients assigned to BVS and 180 (14.5%) patients assigned to CoCr-EES (P = 0.03). Device thrombosis within 5 years occurred in 21 (1.7%) BVS and 13 (1.1%) CoCr-EES patients (P = 0.15). Event rates were slightly greater with BVS than CoCr-EES through 3-year follow-up and were similar between 3 and 5 years. Angina, also centrally adjudicated, recurred within 5 years in 659 patients (cumulative rate 53.0%) assigned to BVS and 674 (53.3%) patients assigned to CoCr-EES (P = 0.63). ConclusionsIn this large-scale, blinded randomized trial, despite the improved implantation technique, the absolute 5-year rate of target lesion failure was 3% greater after BVS compared with CoCr-EES. The risk period for increased events was limited to 3 years, the time point of complete scaffold bioresorption; event rates were similar thereafter. Angina recurrence after intervention was frequent during 5-year follow-up but was comparable with both devices.(Absorb IV Randomized Controlled Trial; NCT02173379)

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

PurposeThe aim of this study was to evaluate the safety and efficacy of the Fantom BRS 6 months after implantation using the optical coherence tomography (OCT) imaging.MethodsTwenty 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 6 months.ResultsThe 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.ConclusionA 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.

Exploring a parallel rheological framework to capture the mechanical behaviour of a thin-strut polymeric bioresorbable coronary scaffold

Computational modelling of bioresorbable scaffolds (BRS) has employed several different material property models, ranging from those based on simple elasto-plastic theory through to anisotropic parallel network models that capture the viscoelastic–plastic behaviour observed in poly-l-lactic acid (PLLA). The increased complexity of higher fidelity material models, particularly in terms of calibration to in-vitro data, can limit their use. Consequently, their suitability for predicting the mechanical response of next-generation BRS is not well understood. Therefore, we have used the Bergstrom–Boyce (BB) parallel network material model, implemented in Abaqus/Explicit (Dassault Systemes), to investigate the mechanical response of a scaffold based upon the ArterioSorbTM BRS (Arterius Ltd, Leeds, UK). In-silico crimping, balloon expansion and radial crushing were simulated and validated against an analogous in-vitro test. Calibration of the model to uniaxial tensile test data was considered given the model’s strain rate dependency and the inability to maintain the natural time period of the simulation when using the explicit solution method in finite element analysis. The isotropic limitations of this model were also explored. The model was also compared to an elasto-plastic model developed by the authors in previous work. Relative to bench-top measurements, prediction of the final diameter and radial strength of the scaffold by the BB model was found to be significantly more accurate than other models, within 2% of the in-vitro result. Additionally, the effect of the crimping strategy and an elevated ambient temperature upon the in-silico prediction of the post-crimping scaffold diameter were investigated. A multi-step crimping process with holding to facilitate stress relaxation and the lower stresses induced by the increased temperature were found to improve the accuracy of the predicted post-crimping scaffold diameter.

Nanoparticles-reinforced poly-l-lactic acid composite materials as bioresorbable scaffold candidates for coronary stents: Insights from mechanical and finite element analysis

Current generation of bioresorbable coronary scaffolds (BRS) posed thrombogenicity and deployment issues owing to its thick struts and overall profile. To this end, we hypothesize that the use of nanocomposite materials is able to provide improved material properties and sufficient radial strength for the intended application even at reduced strut thickness. The nanocomposite formulations of tantalum dioxide (Ta2O5), L-lactide functionalized (LA)-Ta2O5, hydroxyapatite (HA) and LA-HA with poly-l-lactic acid (PLLA) were evaluated in this study. Results showed that tensile modulus and strength were enhanced with non-functionalized nanofillers up until 15 wt% loading, whereas ductility was compromised. On the other hand, functionalized nanofillers/PLLA exhibited improved nanofiller dispersion which resulted higher tensile modulus, strength, and ductility. Selected nanocomposite formulations were evaluated using finite element analysis (FEA) of a stent with varying strut thickness (80, 100 and 150 μm). FEA data has shown that nanocomposite BRS with thinner struts (80–100 μm) made with 15 wt% LA-Ta2O5/PLLA and 10 wt% LA-HA/PLLA have increased radial strength, stiffness and reduced recoil compared to PLLA BRS at 150 μm. The reduced strut thickness can potentially mitigate issues such as scaffold thrombosis and promote re-endothelialisation of the vessel.

Safety and efficacy of new-generation coronary bioresorbable scaffolds.

The concept of bioresorbable scaffolds (BRS) was born with the aim to reduce the rate of late and very late cardiac events related to drug-eluting stents. However, first-generation BRS failed to prove their short-term safety and efficacy. Based on data derived from early investigations, new-generation BRS have been developed and tested in preliminary studies. The present review's focus was to summarize the mechanical characteristics of these new scaffolds and the clinical evidence of their safety and efficacy. This systematic review was performed following Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA). PUBMED, Google Scholar, and Biomed central databases were analyzed. Only papers published in English and in peer-reviewed journals were selected to summarize current evidence about new generation BRS, with CE mark approval. Overall, 23 studies were included. Data obtained from selected studies assessing the safety and efficacy of new generation BRS are encouraging. This is thanks to the progressive development of scaffolds with a different backbone structure and struts thickness that guarantee higher radial strength, flexibility, and resistance to fracture. These characteristics led to low rates of major adverse cardiac events and device-oriented composite endpoint at follow-up. New-generation BRS have a good safety profile in stable patients with simple lesions, supported by a meticulous implantation technique. The first studies were performed on a small population with short-term follow-up, therefore new randomized clinical trials and registries are needed to expand the preliminary findings.

Acute Inflammatory Response after Bioresorbable Coronary Scaffold Implantation and impact of Trimetazidine

Acute Inflammatory Response after Bioresorbable Coronary Scaffold Implantation and impact of Trimetazidine

Everolimus-eluting bioresorbable coronary scaffold in Asian patients: A 2-year follow-up.

Indo-Pakistan population has one of the highest risk of coronary artery disease (CAD) in the world. Percutaneous interventions with the use of stents has been the mainstay of treatment for CAD, evolving from balloon angioplasty to bare metal stents and then to drug eluting stents. However, there are a few drawbacks related to the metal implant in the coronary, leading to the development of bio-resorbable vascular scaffolds (BVS). This case series studies the implantation techniques and 24 month clinical outcome of bioresorbable stent Absorb at Rawalpindi Institute of Cardiology. From November 1, 2013 till June 30, 2018. Fifty patients undergoing angioplasty with Absorb BVS as elective or primary PCI were enrolled. Case selection was at the discretion of the operator. Patients were followed up clinically. Repeat angiogram was conducted if clinically indicated. The study population involved patients with mean age of 42±8.82. Fourty three (86%) were male and most had single or double vessel disease. The most common treated coronary was left anterior descending. Most of the lesions were predilated with 1:1 sizing. Most scaffolds were post dilated with 0.5mm larger diameter non-compliant balloon at nominal pressure. Angiographic success rate was 92%. On follow up, 4% had stent thrombosis (ST) (compared to <1% for latest generation drug eluting stents (DES) as per available literature). No death was reported. Majority of those with ST had longer median treated lesion length than those without stent thrombosis (32mm versus 28mm). Stent thrombosis occurred in 7.7% of cases with overlapping BVS while 2.8% in single BVS patients. To conclude, current generation Biovascular scaffold has higher thrombosis rates as compared to latest generation DES. Procedure/lesion related risk factors may predispose in addition to the thick stent struts.

Bioresorbable Coronary Scaffold Technologies: What's New?

To overcome the not negligible metallic drug-eluting stents adverse events rate, the polymeric or metallic bioresorbable scaffolds were designed to provide early drug delivery and mechanical support followed by complete resorption. However, the long-term evidence, focusing on the leading Absorb BVS technology, showed higher events compared with drug-eluting stents. This review discusses the lights and shadows of the current bioresorbable scaffolds according to their mechanical properties and biodegradation profile and suggests possible perspective on these technologies. Improved scaffold design and deployment techniques might mitigate early bioresorbable scaffolds risk enhancing the late benefit of complete resorption.

From plumbers to vascular restorers: has the Promethean promise of bioresorbable coronary scaffolds yet to be fulfilled?

From plumbers to vascular restorers: has the Promethean promise of bioresorbable coronary scaffolds yet to be fulfilled?

Chinese expert consensus on the clinical application of coronary bioresorbable scaffold

生物可吸收支架（BRS）因具有能够避免金属支架长期存在造成的冠状动脉金属化等优势，被誉为经皮冠状动脉介入治疗领域的第4次变革。近年来，来自中国的BRS数据陆续发布。国产首个BRS于2019年2月上市后，已开始在国内医院应用。为使此项新技术在我国冠心病介入治疗中获得规范应用，中华医学会心血管病学分会组织51位国内心血管疾病介入治疗领域专家，参考国内外BRS临床研究循证证据和欧美专家共识的相关推荐，特拟定首部《冠状动脉生物可吸收支架临床应用中国专家共识》，对BRS的适用范围、临床使用流程、术后双联抗血小板治疗、术者的培训、腔内影像学技术的应用及随访等给出了建议。.

Two-year longitudinal evaluation of a second-generation thin-strut sirolimus-eluting bioresorbable coronary scaffold with hybrid cell design in porcine coronary arteries.

The first commercially available bioresorbable scaffold (BRS) had a strut thickness of 156 microns. As such, it had the potential for delivery challenges and higher thrombogenicity. The aim herein, is to evaluate biomechanical performance, pharmacokinetics and vascular healing of a novel thin strut (100 μm) sirolimus eluting BRS (MeRes-100, Meril Life Sciences, Gujarat, India) against the once clinically used BRS (Absorb BVS, Abbott, Santa Clara, CA) in porcine coronary arteries. Following device implantation, angiographic and optical coherence tomography (OCT) evaluation were performed at 45, 90, 180 days, 1 year and 2 years. Histological evaluation was per-formed at 30, 90 and 180 days. At 2 years, both lumen (MeRes-100 7.07 ± 1.82 mm² vs. Absorb BVS 7.57 ± 1.39 mm2, p = NS) and scaffold areas (MeRes-100 9.73 ± 1.80 mm² vs. Absorb BVS 9.67 ± 1.25 mm², p = NS) were comparable between tested and control scaffolds. Also, the late lumen area gain at 2 years was similar in both groups tested (MeRes-100 1.03 ± 1.98 mm² vs. Absorb BVS 0.85 ± 1.56 mm², p = NS). Histologic examination up to 6 months showed comparable healing and inflammation profiles for both devices. The novel sirolimus-eluting BRS with thinner struts and hybrid cell design showed similar biomechanical durability and equivalent inhibition of neointimal proliferation when compared to the first-ever Absorb BVS up to 2 years in normal porcine coronary arteries.

Five Years Outcomes and Predictors of Events in a Single-Center Cohort of Patients Treated with Bioresorbable Coronary Vascular Scaffolds.

Introduction: We report outcome data of patients treated with coronary bioresorbable scaffolds up to 5 years and investigate predictors of adverse events. Methods: Consecutive patients treated with at least one coronary bioresorbable scaffold (BRS, Abbott Vascular, Santa Clara, USA) between May 2012 and May 2014 in our center were enrolled. Clinical/procedural characteristics and outcome data at 1868 (1641–2024) days were collected. The incidence of scaffold thrombosis (ScT), restenosis (ScR), and target lesion failure (TLF) and their predictors were investigated using Kaplan–Meier and Cox regression analysis. Results: 512 consecutive patients and 598 lesions were included in the database. A total of 30 ScT, 42 ScR, and 92 TLF were reported. The rate of ScT was 3.6% in the first year, 2.2% in the second–third year, and 0.6% in the fourth–fifth year after implantation. The corresponding rates of ScR were 2.5%, 5.7%, and 1.1%. The corresponding incidence of TLF was 8.8%, 8.0%, 3.8%. Procedural parameters (vessel size, scaffold footprint) and the technique used at implantation (including predilation, parameters of sizing, and postdilation) were predictors of ScT and TLF in the first three years after implantation. In contrast, only diabetes was predictive of events between 4–5 years (HR 6.21(1.99–19.40), p = 0.002). Conclusions: After device resorption, the incidence of very late adverse events in lesions/patients implanted with a BRS decreases. Procedural and device-related parameters are not predictors of events anymore.

Magnetic resonance (MR) safety and compatibility of a novel iron bioresorbable scaffold

Fully bioresorbable scaffolds have been designed to overcome the limitations of traditional drug-eluting stents (DESs), which permanently cage the native vessel wall and pose possible complications. The ultrathin-strut designed sirolimus-eluting iron bioresorbable coronary scaffold system (IBS) shows comparable mechanical properties to traditional DESs and exhibits an adaptive degradation profile during target vessel healing, which makes it a promising candidate in all-comers patient population. For implanted medical devices, magnetic resonance (MR) imaging properties, including MR safety and compatibility, should be evaluated before its clinical use, especially for devices with intrinsic ferromagnetism. In this study, MR safety and compatibility of the IBS scaffold were evaluated based on a series of well-designed in-vitro, ex-vivo and in-vivo experiments, considering possible risks, including scaffold movement, over-heating, image artifact, and possible vessel injury, under typical MR condition. Traditional ASTM standards for MR safety and compatibility evaluation of intravascular devices were referred, but not only limited to that. The unique time-relevant MR properties of bioresorbable scaffolds were also discussed. Possible forces imposed on the scaffold during MR scanning and MR image artifacts gradually decreased along with scaffold degradation/absorption. Rigorous experiments designed based on a scientifically based rationale revealed that the IBS scaffold is MR conditional, though not MR compatible before complete absorption. The methodology used in the present study can give insight into the MR evaluation of magnetic scaffolds (bioresorbable) or stents (permanent).

Long-term serial functional evaluation after implantation of the Fantom sirolimus-eluting bioresorbable coronary scaffold.

Quantitative flow ratio (QFR) has been validated as an accurate surrogate of standard wire-based fractional flow reserve. The clinical and angiographic outcomes of the Fantom sirolimus-eluting bioresorbable coronary scaffold (BRS) have been previously studied and reported. We investigate the functional performance of the Fantom BRS. The FANTOM II trial prospectively enrolled 240 patients with stable coronary artery disease or unstable angina, of which 235 patients received the Fantom BRS and were included in the present analysis. We performed an independent serial QFR analysis of the target vessel at baseline, post-percutaneous coronary intervention (PCI), and at 6- or 9-month and 24-month follow-up, using a QFR threshold ≤0.80 to define functional ischemia. QFR was analyzable in 178 patients at baseline, 185 post-PCI, 178 at 6- or 9-month follow-up, and 30 at 24-month follow-up. At baseline, 119 patients (66.9%) had a QFR ≤0.80, whereas 12 (6.5%) post-PCI, 13 (7.3%) at 6- or 9-month follow-up, and 3 (10.0%) at 24-month follow-up had a QFR ≤0.80. QFR improved from baseline to post-PCI, and decreased from post-PCI up to 24-month follow-up. During follow-up period, 28 patients (11.9%) had target vessel revascularization, of which 21 had analyzable QFR and 16 patients (76.1%) had QFR ≤0.80 at the time of revascularization. Off-line serial QFR assessment demonstrated that around 30% patients did not have functionally significant lesions at baseline and the time with target vessel revascularization. PCI with the Fantom BRS improved functional ischemia with a slight decrease in QFR values over 24 months.

Current Techniques of Intravascular Imaging and Implantation of Bioresorbable Coronary Vascular Scaffolds (Stents)

Introduction. The use of intravascular imaging techniques, in particular intravascular ultrasound, makes it possible to reduce the number of subsequent revascularisations. The method of optical coherence tomography (ОСТ), due to its high resolution accuracy, makes it possible to establish and assess the edge dissection, stent thrombosis, tissue prolapse, and strut fracture and malposition. This paper aims to assess the impact of routine use of OCT on long term outcomes in patients with scaffolds implanted.Materials and methods. 32 stenting procedures with the use of bioresorbable coronary intravascular scaffolds (Absorb, Abbot Vascular) were performed in 2014-2015 with subsequent visualisation and assessment with optical coherence tomography. In the control group (n=16) scaffolds were implanted without the use of OCT under traditional contrast enhanced X-ray imaging. The analysis of the combination of outcomes that included subsequent emergency revascularisation in the target artery, cardiac death, myocardial infarction and 12 months post-op OCT imaging data, served as the end.Results. The total of 55 BVS were implanted, 22 in the OCT group and 23 in control. Suboptimal results were registered in eight cases out of 16 in the OCT group (50%). These included: one dissection and atherosclerotic plaque prolapse — implantation of a second BVS and postdilatation, one eccentric stent expansion — a model for acute thrombosis, resolved with postdilatation, and stent underexpansion in the remaining six. Once the OCT revealed the intima dissection following predilatation; this was stabilised with the implantation of a second scaffold. The examination results at 12 months follow up established that there were 3.215 more scaffold restenoses in the control group.Conclusion. The cutting edge technique of intravascular revascularisation with bioresorbable coronary scaffolds requires careful preparation and intraoperative control. The results of our study support the use of intravascular imaging techniques as methods of choice for the assessment of the expansion, areas of dissection, thrombosis and scaffold eccentricity.

Second generation, sirolimus-eluting, bioresorbable Tyrocore scaffold implantation in patients with ST-segment elevation myocardial infarction: Baseline OCT and 30-day clinical outcomes - A FANTOM STEMI pilot study.

There is paucity of data on acute performance of Fantom (REVA Medical, CA), a second generation sirolimus-eluting bioresorbable scaffold (BRS), in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention. The aim of this study was to evaluate safety and efficacy of the Fantom BRS in the acute setting of STEMI characterized by thrombogenic milieu. Ten STEMI patients treated with a sirolimus-eluting Fantom BRS were enrolled into prospective, observational study. The scaffold sizing, positioning, and optimization were optical coherence tomography (OCT) guided. The primary end-point was the device-oriented composite endpoint (DOCE), additionally angiographic and OCT analysis were performed. The primary-end point, defined as DOCE, did not occur in any patient within the 30-day follow-up. The procedural and angiographic success rates were both 100%, there was no case of scaffold thrombosis, target lesion revascularization nor death. In QCA, an in-device minimum lumen diameter was 2.89 ± 0.24 mm and the residual diameter stenosis was 3.56 ± 3.17%. OCT revealed an incomplete scaffold apposition in five patients with an average of seven malapposed struts per scaffold and mean distance of 120 ± 30 μm. There was no proximal edge dissection, the distal edge dissection was recorded in one patient. This is the first pilot study evaluating safety and efficacy of the Fantom BRS, a second generation fully bioresorbable coronary scaffold, in STEMI patients undergoing primary PCI with OCT guidance. Fantom BRS showed adequate safety and efficacy in the acute 30-day angiographic, OCT, and clinical follow-up.

The Importance of Intravascular Image for Left Main Coronary Artery Disease and Bioresorbable Vascular Scaffold Implantation.

The Importance of Intravascular Image for Left Main Coronary Artery Disease and Bioresorbable Vascular Scaffold Implantation.