A paradox in sex-specific clinical outcomes after bioresorbable scaffold implantation: 2-year results from the AIDA trial.

Background: Females are underrepresented in clinical trials evaluating new stent technologies whilst results may differ between the sexes. Females are known to have smaller, more tortuous coronary arteries and have generally more comorbidities. On the other hand, they may have smaller plaque burden.

Outcomes of bioresorbable vascular scaffolds versus everolimus-eluting stents by coronary complexity: a sub-analysis of the AIDA trial.

Aims: We aimed to evaluate the impact of the complexity of coronary disease as assessed by the SYNTAX score (SXscore) on the clinical outcomes in the AIDA trial.

Methods And Results: In the AIDA trial, we compared Absorb versus XIENCE in routine clinical practice. Clinical outcomes were stratified by SXscore tertiles: SXlow (SXscore ≤8), SXmid (SXscore >8 and ≤15) and SXhigh (>15).

Clinical outcomes at 2 years of the Absorb bioresorbable vascular scaffold versus the Xience drug-eluting metallic stent in patients presenting with acute coronary syndrome versus stable coronary disease-AIDA trial substudy.

Background: Patients with acute coronary syndrome (ACS) might represent a specific subgroup, in which bioresorbable scaffold implantation in percutaneous coronary intervention (PCI), might lead to better outcomes when compared to conventional treatment with metallic drug eluting stents. In this prespecified subgroup analysis of the Amsterdam Investigator-Initiated Absorb Strategy All-Comers (AIDA) trial, we evaluated the clinical outcomes of Absorb bioresorbable vascular scaffold (BVS) versus Xience everolimus eluting stent (EES) treated patients presenting either with or without ACS.

Methods And Results: We classified AIDA patients on the basis of clinical presentation of ACS or of no-ACS.

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.

Implantation techniques (predilatation, sizing, and post-dilatation) and the incidence of scaffold thrombosis and revascularisation in lesions treated with an everolimus-eluting bioresorbable vascular scaffold: insights from the AIDA trial.

Aims: Specific implantation strategies have been proposed for the Absorb bioresorbable vascular scaffold (Absorb BVS) to optimise outcomes. We aimed to analyse whether the occurrence of definite scaffold thrombosis (ScT) and target lesion revascularisation (TLR) in Absorb-treated AIDA patients was influenced by scaffold implantation techniques.

Methods And Results: Absorb BVS implantation in 1,074 lesions was graded according to definitions of optimal implantation based on predilatation, sizing, and post-dilatation (PSP).

Scaffold thrombosis following implantation of the ABSORB BVS in routine clinical practice: Insight into possible mechanisms from optical coherence tomography.

Objectives: To identify potential underlying mechanisms of early and (very) late scaffold thrombosis (ScT) by optical coherence tomography (OCT), in a frame-by-frame analysis.

Background: The absorb scaffold is associated with an increased risk of ScT compared with metallic stents. Several potential causes of bioresorbable ScT have been identified, however the precise etiology still remains unclear.

First-in-Man Trial of SiO Inert-Coated Bare Metal Stent System in Native Coronary Stenosis - The AXETIS FIM Trial.

Background: A novel bare metal stent with an SiOcoating was developed to prevent excessive neointimal hyperplasia by inertization of the metallic stent surface. The efficacy of the device was demonstrated in a preclinical model. The aim of this first-in-man trial was to assess the safety and feasibility of the new device.

Bioresorbable Scaffolds versus Metallic Stents in Routine PCI.

Background: Bioresorbable vascular scaffolds were developed to overcome the shortcomings of drug-eluting stents in percutaneous coronary intervention (PCI). We performed an investigator-initiated, randomized trial to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent in the context of routine clinical practice.

Methods: We randomly assigned 1845 patients undergoing PCI to receive either a bioresorbable vascular scaffold (924 patients) or a metallic stent (921 patients).

Evaluation of the MiStent sustained sirolimus eluting biodegradable polymer coated stent for the treatment of coronary artery disease: does uniform sustained abluminal drug release result in earlier strut coverage and better safety profile?

Treatment of coronary artery disease has made strides over the last decades. Development of drug eluting stents (DES), coated with a polymer layer and an anti-proliferative drug to reduce neointimal hyperplasia, has reduced the incidence of in-stent-restenosis relative to treatment with bare metal stents. Patients treated with first generation DES more likely suffer from (very) late events which can be cause by the permanent presence of a polymer.

The IMPACT Study (Influence of Sensor-Equipped Microcatheters on Coronary Hemodynamics and the Accuracy of Physiological Indices of Functional Stenosis Severity).

Background: The Navvus pressure sensor-equipped microcatheter allows to measure functional stenosis severity over a work-horse guidewire and is used as a more feasible alternative to regular sensor-equipped wires. However, Navvus is larger in diameter than contemporary sensor-equipped guidewires and may, thereby, influence functional measurements. The present study evaluates the hemodynamic influence of the Navvus microcatheter.

Two-year clinical outcomes of Absorb bioresorbable vascular scaffold implantation in complex coronary artery disease patients stratified by SYNTAX score and ABSORB II study enrolment criteria.

Aims: This study presents the two-year clinical outcomes of the Amsterdam ABSORB registry stratified by lesion and patient characteristics complexity (SYNTAX score and ABSORB II study enrolment criteria).

Methods And Results: Patients treated with BVS were included in this prospective registry and stratified according to the ABSORB II trial inclusion and exclusion criteria and the SYNTAX score. The registry comprises 135 patients (59±11 years, 73% male, 18% diabetic) with 159 lesions.

Bioresorbable drug-eluting scaffolds for treatment of vascular disease.

Introduction: Theoretical advantages of fully bioresorbable scaffold (BRS) stem from transient vessel support without rigid caging. Therefore, it could reduce long-term adverse events associated with the presence of foreign materials.

Areas Covered: This article will provide an overview of: drug-eluting BRS for various applications in the treatment of vascular disease; The mechanisms of active agent release from such scaffolds; currently available drug-eluting BRS and their future applications are also discussed.

Coronary Artery Vessel Healing Pattern, Short and Long Term, After Implantation of the Everolimus-Eluting Bioresorbable Vascular Scaffold.

Background: Although the Absorb bioresorbable vascular scaffold is increasingly used in daily clinical practice for the treatment of coronary artery disease, the exact vascular healing pattern and the resorption process in humans is unknown because histological data are derived only from animal studies.

Methods And Results: We have obtained 4 autopsies (5 scaffolds) since August 2013. Duration of bioresorbable vascular scaffold implantation ranged from 3 to 501 days.

The future of BRS in bifurcations.

Bioresorbable scaffolds (BRS) provide a new tool for percutaneous treatment of coronary stenosis. Initially, relatively simple coronary artery lesions were treated with this novel technology; nowadays, we have gained more experience with a wide variety of lesions, including bifurcation lesions. Data are limited in terms of the use of BRS in coronary bifurcation lesions, although it has been demonstrated that over time the bioresorbable struts are replaced by a tissue bridge resembling a "neo-carina".

First report on long-term clinical results after treatment of coronary bifurcation lesions with the Tryton dedicated bifurcation stent.

Background: To improve clinical outcomes after percutaneous coronary interventions of coronary bifurcation lesions, the Tryton Side Branch Stent™ (Tryton Medical, Durham) was developed. Registry studies evaluating the Tryton stent has shown promisingclinical results and the stent is currently compared with the provisional single stent strategy in a randomized trial. However, clinical results beyond one year are lacking, and therefore, we investigated the one- and two-year outcomes after Tryton stent placement in a single-center registry study.

Treatment of coronary bifurcation lesions with the Absorb bioresorbable vascular scaffold in combination with the Tryton dedicated coronary bifurcation stent: evaluation using two- and three-dimensional optical coherence tomography.

Aims: The Tryton bifurcation stent has been developed to improve clinical outcomes after treatment of bifurcation lesions. Limited data are available on the use of the Absorb bioresorbable vascular scaffold (BVS) in bifurcation lesions with side branches >2 mm. We present here the acute procedural results and midterm clinical follow-up of the first-in-man combined use of the Tryton stent and the Absorb scaffold for the treatment of complex bifurcation lesions.

Initial experience and clinical evaluation of the Absorb bioresorbable vascular scaffold (BVS) in real-world practice: the AMC Single Centre Real World PCI Registry.

Aims: To report procedural and midterm clinical outcomes after the use of the second-generation Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) in a real-world percutaneous coronary intervention (PCI) registry.

Methods And Results: All patients assigned to treatment with the Absorb BVS in the Academic Medical Center, Amsterdam, between August 2012 and August 2013 were included in a prospective registry. A total of 135 patients were included in the study, including 53 (39%) acute coronary syndrome (ACS) patients (13% ST-segment elevation myocardial infarction [STEMI]).

Bioresorbable scaffolds for the treatment of coronary artery disease: current status and future perspective.

Bioresorbable scaffolds represent a novel approach in the treatment of coronary artery disease which allows for vessel wall support without leaving a permanent foreign body in the coronary artery. This technology has the potential to reduce some of the shortcomings of current standard treatment with metallic drug-eluting stents, such as late in-stent restenosis, impaired vasomotion of the stented segment and hindrance of surgical revascularizations. Currently, several bioresorbable scaffolds are available and undergoing clinical or preclinical evaluation.

Side branch healing patterns of the Tryton dedicated bifurcation stent: a 1-year optical coherence tomography follow-up study.

The bare-metal Tryton Side Branch (SB) Stent™ (Tryton Medical, Durham, NC, USA) is used with a drug-eluting stent (DES) in the main branch (MB) to treat bifurcation lesions. It is argued that a drug-eluting Tryton-version is needed to improve clinical outcomes, although previous registries have shown good clinical results. More insights in neo-intimal hyperplasia (NIH) growth patterns of the Tryton treatment strategy are needed to decide if and where to drug-coat the stent.