Final 36-Month Outcomes from the Multicenter DynamX Study Evaluating a Novel Thin-Strut Novolimus-Eluting Coronary Bioadaptor System and Supporting Preclinical Data.

Background: The DynamX Novolimus-Eluting Coronary Bioadaptor System ( Bioadaptor) has uncaging elements that disengage after the resorption of the polymer coating, aiming to restore vessel function in the treated segment and to avoid long-term adverse outcomes associated with the permanent caging of the coronary artery seen with conventional stenting.

Methods: This prospective, multicenter, single-arm first-in-human study enrolled 50 patients in Belgium and Italy who were treated with the DynamX Bioadaptor. Eligible patients had lesions in coronary arteries measuring between 2.

Association between Clinical Risk Score (Heart, Grace and TIMI) and Angiographic Complexity in Acute Coronary Syndrome without ST Segment Elevation.

Background: GRACE, TIMI and HEART scores have been previously validated to predict serious untoward events among patients with non-ST elevation acute coronary syndrome (Non-ST ACS). However, the ability of these scores to discriminate the angiographic complexity of coronary artery disease has not been clearly established.

Objectives: We sought to evaluate the correlation between clinical scores (TIMI, GRACE and HEART) and the anatomical complexity assessed by SYNTAX score, among non-ST ACS patients undergoing cinecoronariography.

Imaging and 2-year clinical outcomes of thin strut sirolimus-eluting bioresorbable vascular scaffold: The MeRes-1 extend trial.

Objectives: This study explores the safety and efficacy of thin strut MeRes100 sirolimus-eluting bioresorbable vascular scaffold (BRS) in patients with de novo coronary artery lesions.

Background: In interventional cardiology, the emergence of BRS technology is catalyzing the next paradigm shift.

Methods: The MeRes-1 Extend was a multicenter, prospective, single-arm, open-label study enrolling 64 patients in Spain, Macedonia, Brazil, South Africa, Malaysia, and Indonesia.

Vascular Closure Devices Attenuate Femoral Access Complications of Primary Percutaneous Coronary Intervention.

Objectives: To compare severe complications related to radial access and those related to femoral access using vascular closure devices for patients undergoing primary percutaneous coronary intervention (PCI).

Background: Femoral artery access is still used for acute myocardial infarction management; studies comparing state-of-the-art radial and femoral techniques are required to minimize bias regarding the outcomes associated with operator preferences.

Methods: We performed a randomized study comparing radial access with a compression device and anatomic landmark-guided femoral access with a hemostatic vascular closure device.

Twelve-month clinical and imaging outcomes of the uncaging coronary DynamX bioadaptor system.

Aims: We aimed to assess the safety and efficacy of the DynamX Novolimus-Eluting Coronary Bioadaptor System, a novel device that initially acts as a second-generation drug-eluting stent, but after six months frees the vessel through uncaging elements.

Methods And Results: This multicentre study enrolled 50 patients with single de novo lesions. In-device acute lumen gain was 1.

Cardiovascular Risk Stratification for Patients Treated With Drug-Eluting Stents: Development and Validation of the DESIRE Score.

Background: We sought to develop a risk score to estimate the risk of major adverse cardiac event (MACE) occurrence during the in-hospital and long-term follow-up periods after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation.

Methods: This score was developed and validated in a single-center database encompassing all consecutive patients treated with DES between 2007 and 2014 (n = 4061). For the development of the score, we analyzed all patients treated between January 2007 and December 2012 (n = 2863) while the validation was conducted in a cohort treated between January 2013 and December 2014 (n = 1198).

Predictors of long-term adverse events after Absorb bioresorbable vascular scaffold implantation: a 1,933-patient pooled analysis from international registries.

Aims: The aim of this study was to investigate the predictors of long-term adverse clinical events after implantation of the everolimus-eluting Absorb bioresorbable vascular scaffold (BVS).

Methods And Results: We pooled patient-level databases derived from the large-scale ABSORB EXTEND study and five high-volume international centres. Between November 2011 and November 2015, 1,933 patients underwent PCI with a total of 2,372 Absorb BVS implanted.

Impact of PCI Appropriateness in the Long-Term Outcomes of Consecutive Patients Treated With Second-Generation Drug-Eluting Stents.

Background: Appropriate use criteria (AUC) for coronary revascularization were developed to deliver high-quality care; however, the prognostic impact of these criteria remains unclear. We sought to assess the outcomes of patients treated with second-generation drug-eluting stent (DES) classified according to the updated American College of Cardiology Foundation/American Heart Association/Society for Cardiac Angiography and Intervention AUC for percutaneous coronary intervention (PCI).

Methods: Between January 2012 and December 2013, a total of 1108 consecutive patients treated only with second-generation DES were categorized according to the AUC in three groups, using the new proposed terminology: appropriate ("A"); uncertain ("U"); and inappropriate ("I").

Pressure-mediated versus pharmacologic treatment of radial artery spasm during cardiac catheterisation: a randomised pilot study.

Aims: The aim of the study was to determine the effectiveness of a novel strategy to treat radial artery spasm (RAS).

Methods And Results: We conducted a prospective, randomised, single-centre, open-label trial comparing a novel strategy of pressure-mediated dilatation versus intra-arterial administration of a combination of nitroglycerine plus verapamil for the treatment of RAS. The primary endpoint was radial artery intraluminal diameter acute gain assessed by quantitative radial angiography.

One-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds versus everolimus-eluting metallic stents: a propensity score comparison of patients enrolled in the ABSORB EXTEND and SPIRIT trials.

Aims: We sought to compare the outcomes of low/moderate complexity patients treated with the Absorb BVS from the ABSORB EXTEND trial with patients treated with the XIENCE everolimus-eluting stent (EES), using propensity score (PS) matching of pooled data from the SPIRIT trials (SPIRIT II, SPIRIT III, SPIRIT IV) and the XIENCE V USA trial.

Methods And Results: ABSORB EXTEND was a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and with a reference vessel diameter of 2.

Long-term clinical follow-up of patients undergoing percutaneous alcohol septal reduction for symptomatic obstructive hypertrophic cardiomyopathy.

Background: Alcohol septal ablation (ASA) is an alternative treatment for symptomatic hypertrophic obstructive cardiomyopathy (HOCM) patients refractory to pharmacological therapy. We sought to evaluate the immediate and long-term incidence of death and changes in life quality in a consecutive cohort submitted to ASA.

Methods And Results: Between October 1998 and December 2013, a total of 56 patients (mean age 53.

Metallic Limus-Eluting Stents Abluminally Coated with Biodegradable Polymers: Angiographic and Clinical Comparison of a Novel Ultra-Thin Sirolimus Stent Versus Biolimus Stent in the DESTINY Randomized Trial.

Aims: To evaluate the outcomes of patients treated with a new drug-eluting stent formulation with low doses of sirolimus, built in an ultra-thin-strut platform coated with biodegradable abluminal coating.

Methods: This study is a randomized trial that tested the main hypothesis that the angiographic late lumen loss of the novel sirolimus-eluting stent is noninferior compared with commercially available biolimus-eluting stent. A final study population comprising 170 patients with one or two de novo lesions was randomized in the ratio 2:1 for sirolimus-eluting stent or biolimus-eluting stent, respectively.

Impact of post-dilation on the acute and one-year clinical outcomes of a large cohort of patients treated solely with the Absorb Bioresorbable Vascular Scaffold.

Aims: We sought to determine the impact of post-dilation (PD) on clinical outcomes in a large cohort of patients treated only with the Absorb Bioresorbable Vascular Scaffold (BVS).

Methods And Results: We evaluated all consecutive patients enrolled in the multicentre, single-arm ABSORB EXTEND study up to June 2013. The study allowed treatment of up to two coronaries (diameter 2.

Very long-term follow-up of strut apposition and tissue coverage with Biolimus A9 stents analyzed by optical coherence tomography.

First generation drug-eluting stents (DES) are associated with reduced in-stent restenosis but significant increased risk of very late stent thrombosis (VLST). The absence of polymer in DES systems may reduce the occurrence of VLST. Optic coherence tomography (OCT) has been used for stent analysis as a surrogate safety endpoint.

Impact of intravascular ultrasound imaging on early and late clinical outcomes following percutaneous coronary intervention with drug-eluting stents.

Objectives: This study sought to assess the impact of intravascular ultrasound (IVUS)-guided versus angiography-guided drug-eluting stent (DES) implantation.

Background: There are limited data on IVUS guidance in the DES era. Therefore, we investigated the impact of IVUS guidance on clinical outcomes in the MATRIX (Comprehensive Assessment of Sirolimus-Eluting Stents in Complex Lesions) registry.

Assessment of drug-eluting stents and bioresorbable stents by grayscale IVUS and IVUS-based imaging modalities.

Grayscale IVUS and IVUS-based imaging modalities during the last years have become useful in the assessment not only of drug eluting stent, but also of new bioresorbable vascular scaffolds. Although IVUS resolution is not sufficient for determining stent coverage (optical coherence tomography is the gold standard), serial IVUS can measure intimal hyperplasia, assess acute and late incomplete stent apposition, detect the presence and persistence of edge dissections, study edge effects and look for causes of restenosis and thrombosis. In addition other IVUS-based imaging modalities, such as IVUS-VH, iMAP or palpography, can be used to study the serial compositional and mechanical changes of the plaque behind stent struts and also to follow the bioresorption of the new bioresorbable scaffolds, analyzing the backscattering signal coming from the polymeric struts.

Comparison of the very long term (>1 year) outcomes of drug-eluting stents for the treatment of bare-metal and drug-eluting stent restenosis.

Aims: Drug-eluting stents (DES) have become the first choice to treat BMS restenosis (ISR), replacing brachytherapy and all other available percutaneous approaches. Although markedly reduced, DES ISR still occurs and has been frequently treated with another DES, despite the lack of robust data supporting the safety and efficacy of this approach. We sought to compare the long term clinical outcomes of patients with BMS and DES ISR treated with another DES deployment.

The revascular active percutaneous interventional device for coronary total occlusions study.

Background: Despite the well-documented benefit of recanalization of an occluded vessel in some symptomatic patients, attempt is only performed in a minority of them. Percutaneous coronary intervention (PCI) of CTO is associated with high incidence of complications and unsuccessful procedure, mainly due to inability to cross the lesion. We sought to evaluate the efficacy and safety of the novel RVT CTO Guidewire Device (RVT-GDW, ReVascular Therapeutics, Sunnyvale, CA) in this complex scenario.

Assessing intermediate left main coronary lesions using intravascular ultrasound.

Background: Angiographic assessment of a left main coronary artery stenosis (LMCS) is often difficult and unreliable. We aimed to evaluate the severity of ambiguous LMCSs by intravascular ultrasound (IVUS) and to clarify how frequently significant stenosis occurs in the "real world".

Methods: We retrospectively found 115 consecutive patients in our clinical IVUS database with a de novo, angiographically ambiguous, intermediate LMCS who underwent IVUS evaluation.

[Relationship between plasma C-reactive protein level and neointimal hyperplasia volume in patients with zotarolimus-eluting stents. Volumetric analysis by three-dimensional intracoronary ultrasound].

Introduction And Objectives: C-reactive protein (CRP) is an inflammatory marker that predicts cardiac events in patients with coronary syndromes. However, data on the relationship between the CRP level and in-stent restenosis are contradictory. The objective of this study was to investigate the relationship between the basal CRP level and the neointimal hyperplasia volume measured by intracoronary ultrasound 4 months after implantation of a zotarolimus-eluting stent.

Nonrandomized comparison of coronary stenting under intravascular ultrasound guidance of direct stenting without predilation versus conventional predilation with a semi-compliant balloon versus predilation with a new scoring balloon.

This study was conducted to determine the influence of lesion preparation using the AngioSculpt balloon on final stent expansion. Stent expansion remains an important predictor of restenosis and subacute thrombosis, even in the drug-eluting stent (DES) era. In these patients, the role of different predilation strategies has yet to be established.

Drug-eluting stents vs bare metal stents for the treatment of large coronary vessels.

Background: Lately drug-eluting stents (DES) have dramatically reduced restenosis rates and need for repeat revascularization in a wide subset of lesion and patients. However, their benefit for the treatment of large vessels (> 3.0 mm) has yet to be established.