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Coronary Artery Disease: HELP
Articles by Javier Escaned
Based on 50 articles published since 2008
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Between 2008 and 2019, J. Escaned wrote the following 50 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Guideline Report of an ESC-EAPCI Task Force on the evaluation and use of bioresorbable scaffolds for percutaneous coronary intervention: executive summary. 2018

Byrne, Robert A / Stefanini, Giulio G / Capodanno, Davide / Onuma, Yoshinobu / Baumbach, Andreas / Escaned, Javier / Haude, Michael / James, Stefan / Joner, Michael / Jüni, Peter / Kastrati, Adnan / Oktay, Semih / Wijns, William / Serruys, Patrick W / Windecker, Stephan. ·Deutsches Herzzentrum München, Technische Universität München, Germany. ·EuroIntervention · Pubmed #28948934.

ABSTRACT: A previous Task Force of the European Society of Cardiology (ESC) and European Association of Percutaneous Cardiovascular Interventions (EAPCI) provided a report on recommendations for the non-clinical and clinical evaluation of coronary stents. Following dialogue with the European Commission, the Task Force was asked to prepare an additional report on the class of devices known as bioresorbable scaffolds (BRS). Five BRS have CE-mark approval for use in Europe. Only one device -the Absorb bioresorbable vascular scaffold- has published randomized clinical trial data and this data show inferior outcomes to conventional drug-eluting stents (DES) at 2-3 years. For this reason, at present BRS should not be preferred to conventional DES in clinical practice. The Task Force recommends that new BRS devices should undergo systematic non-clinical testing according to standardized criteria prior to evaluation in clinical studies. A clinical evaluation plan should include data from a medium sized, randomized trial against DES powered for a surrogate end point of clinical efficacy. Manufacturers of successful devices receive CE- mark approval for use and must have an approved plan for a large-scale randomized clinical trial with planned long-term follow-up.

2 Editorial Functional guidance with FFR: an effective and safe way to simplify percutaneous treatment of coronary bifurcations. 2012

Escaned, Javier / Koo, Bon-Kwon. · ·EuroIntervention · Pubmed #22334310.

ABSTRACT: -- No abstract --

3 Review The Evolving Future of Instantaneous Wave-Free Ratio and Fractional Flow Reserve. 2017

Götberg, Matthias / Cook, Christopher M / Sen, Sayan / Nijjer, Sukhjinder / Escaned, Javier / Davies, Justin E. ·Department of Cardiology, Clinical Sciences, Lund University, Skåne University Hospital, Lund, Sweden. Electronic address: Matthias.gotberg@med.lu.se. · Hammersmith Hospital, Imperial College London, London, United Kingdom. · Hospital Clínico San Carlos, Madrid, Spain. ·J Am Coll Cardiol · Pubmed #28882237.

ABSTRACT: In this review, the authors reflect upon the role of coronary physiology in the modern management of coronary artery disease. They critically appraise the scientific background of the instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR), from early experimental studies to validation studies against indexes of ischemia, to clinical trials assessing outcome. At this important juncture for the field, the authors make predictions for the future of physiological stenosis assessment, outlining developments for both iFR and FFR in new clinical domains beyond the confines of stable angina. With a focus on the evolving future of iFR and FFR, the authors describe how physiological assessment with iFR may advance its application from simply justifying to guiding revascularization.

4 Review Targeting the dominant mechanism of coronary microvascular dysfunction with intracoronary physiology tests. 2017

Mejía-Rentería, Hernán / van der Hoeven, Nina / van de Hoef, Tim P / Heemelaar, Julius / Ryan, Nicola / Lerman, Amir / van Royen, Niels / Escaned, Javier. ·Hospital Clínico Universitario San Carlos, 28040, Madrid, Spain. · Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain. · VU University Medical Centre, Amsterdam, The Netherlands. · AMC Heart Centre, Academic Medical Centre, Amsterdam, The Netherlands. · Mayo Clinic, Rochester, MN, USA. · Hospital Clínico Universitario San Carlos, 28040, Madrid, Spain. escaned@secardiologia.es. · Universidad Complutense de Madrid (UCM), Madrid, Spain. escaned@secardiologia.es. · Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), Madrid, Spain. escaned@secardiologia.es. ·Int J Cardiovasc Imaging · Pubmed #28501910.

ABSTRACT: The coronary microcirculation plays a key role in modulating blood supply to the myocardium. Several factors like myocardial oxygen demands, endothelial and neurogenic conditions determine its function. Although there is available evidence supporting microvascular dysfunction as an important cause of myocardial ischaemia, with both prognostic and symptomatic implications, its diagnosis and management in clinical practice is still relegated to a second plane. Both diagnostic and therapeutic approaches are hampered by the broadness of the concept of microvascular dysfunction, which fails addressing the plurality of mechanisms leading to dysfunction. Normal microcirculatory function requires both structural integrity of the microcirculatory vascular network and preserved signalling pathways ensuring adequate and brisk arteriolar resistance shifts in response to myocardial oxygen demands. Pathological mechanisms affecting these requirements include structural remodelling of microvessels, intraluminal plugging, extravascular compression or vasomotor dysregulation. Importantly, not every diagnostic technique provides evidence on which of these pathophysiological mechanisms is present or predominates in the microcirculation. In this paper we discuss the mechanisms of coronary microvascular dysfunction and the intracoronary tools currently available to detect it, as well as the potential role of each one to unmask the main underlying mechanism.

5 Review Coronary flow capacity: concept, promises, and challenges. 2017

van de Hoef, Tim P / Echavarría-Pinto, Mauro / Escaned, Javier / Piek, Jan J. ·AMC Heart Center, Academic Medical Center - University of Amsterdam, Room B2-250, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. t.p.vandehoef@amc.uva.nl. · AMC Heart Center, Academic Medical Center - University of Amsterdam, Room B2-250, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands. · Department of Cardiology, ISSSTE General Hospital, Querétaro, Mexico. · Faculty of Medicine, Autonomous University of Querétaro, Querétaro, Mexico. · Cardiovascular Institute, Hospital Universitario Clinico San Carlos, Madrid, Spain. ·Int J Cardiovasc Imaging · Pubmed #28353034.

ABSTRACT: The vasodilator capacity of the coronary circulation is an important diagnostic and prognostic characteristic, and its accurate assessment is therefore an important frontier. The coronary flow capacity (CFC) concept was introduced to overcome the limitations associated with the use of coronary flow reserve (CFR) for this purpose, which are related to the sensitivity of CFR to physiological alterations in systemic and coronary hemodynamics. CFC was developed from positron emission tomography, and was subsequently extrapolated to invasive coronary physiology. These studies suggest that CFC is a robust framework for the identification of clinically relevant coronary flow abnormalities, and improves identification of patients at risk for adverse events over the use of CFR alone. This Review will discuss the concept of CFC, its promises in the setting of ischaemic heart disease, and its challenges both in theoretical and practical terms.

6 Review Report of a European Society of Cardiology-European Association of Percutaneous Cardiovascular Interventions task force on the evaluation of coronary stents in Europe: executive summary. 2015

Byrne, Robert A / Serruys, Patrick W / Baumbach, Andreas / Escaned, Javier / Fajadet, Jean / James, Stefan / Joner, Michael / Oktay, Semih / Jüni, Peter / Kastrati, Adnan / Sianos, George / Stefanini, Giulio G / Wijns, William / Windecker, Stephan. ·Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. · Erasmus Medical Center Rotterdam, Rotterdam, The Netherlands. · Bristol Heart Institute, Bristol, UK. · Interventional Cardiology, Hospital San Carlos, Madrid, Spain. · Interventional Cardiology, Clinique Pasteur, Toulouse, France. · Clinical Research Center, Uppsala University, Uppsala, Sweden. · CVPath Institute, Inc., Gaithersburg, USA. · Cardio Med Device Consultants, Baltimore, USA. · Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland. · AHEPA University Hospital, Thessaloniki, Greece. · Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland. · Cardiovascular Center O.L.V.Z., Aalst, Belgium. · Swiss Cardiovascular Center Bern, Bern University Hospital, Bern, Switzerland stephan.windecker@insel.ch. ·Eur Heart J · Pubmed #26071600.

ABSTRACT: The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.

7 Review High prevalence at computed coronary tomography of non-calcified plaques in asymptomatic HIV patients treated with HAART: a meta-analysis. 2015

D'Ascenzo, Fabrizio / Cerrato, Enrico / Calcagno, Andrea / Grossomarra, Walter / Ballocca, Flavia / Omedè, Pierluigi / Montefusco, Antonio / Veglia, Simona / Barbero, Umberto / Gili, Sebastiano / Cannillo, Margherita / Pianelli, Martina / Mistretta, Elisa / Raviola, Alessio / Salera, Davide / Garabello, Domenica / Mancone, Massimo / Estrada, Vicente / Escaned, Javier / De Marie, Daniela / Abbate, Antonio / Bonora, Stefano / Zoccai, Giuseppe Biondi / Moretti, Claudio / Gaita, Fiorenzo. ·Division of Cardiology, Department of Medical Sciences, University of Turin, Italy; Cardiogroup.org Collaborative Group, Italy. Electronic address: fabrizio.dascenzo@gmail.com. · Division of Cardiology, Department of Medical Sciences, University of Turin, Italy; Cardiogroup.org Collaborative Group, Italy. · Division of Infectious Disease, Amedeo di Savoia Hospital, Turin, Italy. · Division of Cardiology, Department of Medical Sciences, University of Turin, Italy. · Division of Radiology, Turin, Italy. · Policlinico Umberto I "Sapienza", University of Rome, Italy. · Hospital Clinicos San Carlos, Madrid, Spain. · Hospital Clinicos San Carlos, Madrid, Spain; Cardiogroup.org Collaborative Group, Italy. · Division of Cardiology, Hospital Maria Vittoria, Italy. · VCU Pauley Heart Center, Richmond, VA, USA. · Department of Medico-Surgical Sciences and Biotechnologies, Sapienza University of Rome, Latina, Italy; Cardiogroup.org Collaborative Group, Italy. ·Atherosclerosis · Pubmed #25797313.

ABSTRACT: INTRODUCTION: Asymptomatic patients with human immunodeficiency virus (HIV) infection are at increased risk of vascular disease. Whether asymptomatic HIV patients have increased prevalence or structural differences in coronary artery plaques is not clear. METHODS: Pubmed, Cochrane and Google Scholar were searched for articles evaluating asymptomatic HIV patients evaluated with coronary computed tomography. The prevalence of coronary stenosis (defined as >30% and >50%), of calcified coronary plaques (CCP) viewed as more 'stable' plaques, and of non-calcified coronary plaques (NCP) viewed as more 'vulnerable' plaques were the end points of interest. RESULTS: 9 studies with 1229 HIV patients and 1029 controls were included. No significant differences were detected about baseline cardiovascular risk profile. The prevalence of significant coronary stenosis>30% or >50% did not differ between HIV+ and HIV- patients (42% [37-44] and 46% [35-52] with an Odds Ratio [OR] of 1.38 [0.86-2.20] for >30% stenosis) and (15% [9-21] and 14% [7-22] with an OR of 1.11 [0.81-1.52]), respectively. The prevalence of calcified coronary plaques (CCP) (31% [24-32] and 21% [14-30] with an OR of 1.17 [0.63-2.16]) also did not differ among HIV+ and HIV- patients. On the contrary rates of NCP were >3-fold higher in HIV-positive patients [58% (48-60) and 17% (14-27) with an OR of 3.26 (1-30-8.18)], with an inverse relationship with CD4 cell count at meta-regression (Beta -0.20 [-0.35-0.18], p 0.04). CONCLUSION: Asymptomatic HIV patients present a similar burden of coronary stenosis and calcified coronary artery plaques but significantly higher rates of non-calcific coronary plaques at computed tomography. The association between HIV infection, reduced CD4 cell counts and higher prevalence on non-calcific coronary artery plaques may shed light into the pathogenesis in HIV-associated coronary artery disease, stressing the importance of primary prevention in this population.

8 Review Impact of technological developments in drug-eluting stents on patient-focused outcomes: a pooled direct and indirect comparison of randomised trials comparing first- and second-generation drug-eluting stents. 2014

Colmenarez, Humberto / Fernández, Cristina / Escaned, Javier. ·Centro Cardiovascular Regional Ascardio, Barquisimeto, Venezuela. ·EuroIntervention · Pubmed #23771557.

ABSTRACT: AIMS: To establish whether technological improvements in drug-eluting stent (DES) technology introduced in second-generation (G2) DES have contributed to improving patient-focused outcomes. METHODS AND RESULTS: We performed a systematic review of randomised clinical trials (RCT) comparing first-generation (G1) and G2 DES with a>9-month clinical follow-up. The primary endpoint for efficacy was ischaemia-driven target lesion revascularisation (ID-TLR); safety endpoints were all-cause death, myocardial infarction (MI) and stent thrombosis (ST). Sixteen RCTs involving 25,427 patients met eligibility criteria (17 comparisons). In these trials, paclitaxel (PES) and sirolimus (SES) were compared with everolimus (EES), zotarolimus (ZES) or biolimus A9 (BES) DES. G2 varied in metal alloy, strut thickness and type of drug-eluting matrix. Overall, G2 DES were associated with a 26% relative risk reduction (RRR) of MI (relative risk [RR]=0.74, 95% CI: 0.61-0.90, p=0.003) and ST (RR=0.70, 95% CI: 0.55-0.89, p=0.004), while no significant benefit was observed for ID-TLR and death. Use of 2G DES was associated with a significant reduction in the risk of ID-TLR (RR=0.66, 95% CI: 0.51-0.85, p=0.002), MI (RR=0.60, 95% CI: 0.49-0.72, p<0.001) and ST (RR=0.41, 95% CI: 0.26-0.65, p=0.001) when compared with PES. Strut thickness ≤91 µm in G2 DES was associated with a significantly lower risk of MI (RR=0.54, 95% CI: 0.51-0.86, p=0.002). CONCLUSIONS: The introduction of thinner stent struts and other technological improvements made in G2 DES technology have translated into better patient outcomes. Overall, the net benefit of G2 DES over G1 DES is expressed in terms of ID-TLR and ST risk reduction but it could be masked by heterogeneities in the use of G1 comparators and the use of non-inferiority study designs in RCTs.

9 Review [Optical coherence tomography. Bases and applications of a new intravascular imaging technique]. 2013

Macías, Enrico / Medina, Miguel Ángel / Gonzalo, Nieves / del Angel, Juan / Escaned, Javier. ·Servicio de Hemodinámica, Departamento de Cardiología Intervencionista, Hospital Universitario Clínico San Carlos, Madrid, España. Electronic address: enricomacias@hotmail.com. ·Arch Cardiol Mex · Pubmed #23648202.

ABSTRACT: Coronary angiography is the reference technique for the diagnosis of coronary disease. However, the majority of acute coronary syndromes involve angiographically non-significant lesions. It is also the technique of choice for guiding the implantation of endovascular prostheses and their later monitoring. Optical coherence tomography is an interferometric imaging technique that penetrates tissue approximately 2-3mm and provides axial and lateral resolution. It is able to distinguish different tissue types, such as fibrous, lipid-rich, necrotic, or calcified tissue. Optical coherence tomography is able to recognize a variety of features of atherosclerotic plaques that have been associated with rapid lesion progression and clinical events, such as thin cap fibroatheroma, fibrous cap thickness, dense macrophage infiltration, and thrombus formation. Currently, there is growing interest in the value of optical coherence tomography in the area of coronary intervention, where the technique offers significant advantages over more widespread intravascular diagnostic techniques such as intravascular ultrasound. Its higher resolution permits to recognize periprocedural complications, such as microdissection of the coronary artery, stent malapposition, and neointimal hyperplasia, making this tool one of the most promising techniques in the intravascular diagnosis.

10 Review Secondary revascularization after CABG surgery. 2012

Escaned, Javier. ·Cardiovascular Institute, Hospital Clínico San Carlos, Calle del Profesor Martín Lagos s/n, 28040 Madrid, Spain. escaned@secardiologia.es ·Nat Rev Cardiol · Pubmed #22776987.

ABSTRACT: CABG surgery is an effective way to improve symptoms and prognosis in patients with advanced coronary atherosclerotic disease. Despite multiple improvements in surgical technique and patient treatment, graft failure after CABG surgery occurs in a time-dependent fashion, particularly in the second decade after the intervention, in a substantial number of patients because of atherosclerotic progression and saphenous-vein graft (SVG) disease. Until 2010, repeat revascularization by either percutaneous coronary intervention (PCI) or surgical techniques was performed in these high-risk patients in the absence of specific recommendations in clinical practice guidelines, and within a culture of inadequate communication between cardiac surgeons and interventional cardiologists. Indeed, some of the specific technologies developed to reduce procedural risk, such as embolic protection devices for SVG interventions, are largely underused. Additionally, the implementation of secondary prevention, which reduces the need for reintervention in these patients, is still suboptimal. In this Review, graft failure after CABG surgery is examined as a clinical problem from the perspective of holistic patient management. Issues such as the substrate and epidemiology of graft failure, the choice of revascularization modality, the specific problems inherent in repeat CABG surgery and PCI, and the importance of secondary prevention are discussed.

11 Review Use of fractional flow reserve in contemporary scenarios of coronary revascularization. 2011

Echavarría-Pinto, M / Escaned, J. ·Cardiovascular Institute, San Carlos Clinical University Hospital, Madrid, Spain. ·Minerva Med · Pubmed #22193350.

ABSTRACT: Fractional flow reserve (FFR), an invasive pressure-derived index of stenosis severity, can be performed easily, rapidly, and safely in patients with coronary artery disease as a surrogate of non-invasive detection of ischemia. Over the last decades, profound clinical and scientific evaluation has demonstrated that FFR is one of the few diagnostic modalities that improve patient outcome and, at the same time, are cost-effective and cost-saving. The increasing use of PCI to treat multivessel disease and complex anatomical subsets has created new demands for accurate, "per stenosis" assessment, since revascularisation should be performed only in those stenosis that are ischaemia generating. Recent studies have demonstrated that this attitude results in better patient outcomes. Altogether, current evidence clearly supports the measurement of FFR in catheterization laboratories in order to provide objective and complementary data to coronary angiography. The purpose of this review is to discuss the value of FFR in the diagnosis and treatment of patients with different anatomical subsets, including intermediate stenosis, multivessel disease, left main disease, serial stenosis, ostial and bifurcation lesions, saphenous vein graft disease and in-stent restenosis, as well as in those presenting with acute coronary syndromes.

12 Review Rescue percutaneous intervention for acute complications of coronary artery surgery. 2009

Babiker, Anas / Del Angel, Juan Gustavo / Perez-Vizcayno, María José / Rodríguez, J Enrique / Macaya, Carlos / Hernández, Rosana / Escaned, Javier. ·Cardiovascular Institute, Hospital Clínico San Carlos, Madrid, Spain. ·EuroIntervention · Pubmed #19736075.

ABSTRACT: Although percutaneous interventions in the context of perioperative coronary artery surgery ischaemic complications are not unusual, this type of secondary revascularisation is rarely addressed in the literature. Information on aspects such as complications and clinical outcome is limited, in spite of this being a high-risk population. To shed light on the subject, the present article presents a systematic review of the literature on this topic, along with the analysis of the institutional experience at a centre with high surgical and percutaneous revascularisation case volume.

13 Review Secondary coronary revascularisation: an emerging issue. 2009

Escaned, Javier. ·Instituto Cardiovascular, Hospital Clinico San Carlos, 28040 Madrid, Spain. escaned@secardiologia.es ·EuroIntervention · Pubmed #19736074.

ABSTRACT: Coronary revascularisation should be considered as a healthcare process rather than a series of episodic interventions. At a time when the number of surgical and interventional procedures worldwide continues to increase, secondary coronary revascularisation appears as an unavoidable subject. Atherosclerosis progression, long-term failure of surgical grafts or stents, and patient profile contribute to the increased risk of secondary revascularisation. The absence of a grouping category, however, has contributed to suboptimal implementation of evidence-based knowledge on the subject, which is scattered in the literature and scantily covered in clinical practice guidelines. Assembling a critical mass of expertise in the field results mandatory for comprehensive patient management and for highlighting avenues for future research. Knowledge sharing between physicians, interventionalists and surgeons appears indispensable to reduce unilateral decision-making. Awareness of all health professionals about the likelihood of repeated revascularisation appears as the first step towards a process-oriented and holistic management of patients requiring coronary revascularisation.

14 Review Multidetector computed tomography in previous coronary artery bypass grafting: implications for secondary revascularisation. 2009

Marcos-Alberca, Pedro / Zamorano, José Luis / Escaned, Javier / Pozo-Osinalde, Eduardo / Fernández-Golfín, Covadonga / Macaya, Carlos. ·Unidad de Imagen Cardiovascular, Servicio de Cardiología, Instituto Cardiovascular, Hospital Clínico San Carlos, Universidad Complutense, Madrid, Spain. pmarcosa.hcsc@salud.madrid.org ·EuroIntervention · Pubmed #19736069.

ABSTRACT: Coronary artery bypass grafting (CABG) is the most effective revascularisation treatment for advanced coronary heart disease. Atherosclerotic disease may compromise graft patency in the follow-up. As a result, it is not unusual for patients to present with angina requiring evaluation. When present, graft disease or progression of the disease in native vessels can be treated by means of percutaneous coronary intervention (PCI) or by repeated bypass surgery. The utility of modern helical ultrafast multidetector computed tomography (MDCT) in the evaluation of the patency of arterial or vein coronary grafts and thereby avoiding the need of a coronary angiography (CA) in the majority of patients is well established using 16 or 64-slice scanners. Although the accuracy of MDCT in the study of native coronary vessels in operated patients is more challenging, modern multislice computed tomography technology (64-slice) is especially useful in the non-invasive evaluation of patients with previous CABG with chest pain or equivalent symptoms, but with inconclusive or contradictory results in exercise or pharmacological stress tests. MDCT emerges as an attractive imaging technique, not only in the study of symptomatic patients with previous CABG, but also in the planning of secondary revascularisation procedures, either percutaneous, surgical or hybrid procedures.

15 Review The distinct role of secondary prevention in patients with prior coronary interventions. 2009

Colmenarez, Humberto / Escaned, Javier. ·Instituto Cardiovascular, Unidad de Hemodinámica, Hospital Clinico San Carlos, Madrid, Spain. sirius_stent@yahoo.com ·EuroIntervention · Pubmed #19736062.

ABSTRACT: Secondary prevention constitutes a key element in the management of coronary artery disease. In the subgroup of patients with prior coronary interventions, however, secondary prevention plays a distinct role derived from its effects on vessel native atherosclerosis progression, saphenous vein graft attrition and reduction of adverse events after percutaneous revascularisation. From this point of view, secondary prevention can be understood as a protective measure against repeat revascularisation. These benefits contrast with the yet suboptimal implementation of secondary prevention in clinical practice, stressing the importance of a comprehensive approach to coronary revascularisation.

16 Review Digital enhancement of stent images in primary and secondary percutaneous coronary revascularisation. 2009

Córdova, Julio / Aleong, Godfrey / Colmenarez, Humberto / Cruz, Angel / Canales, Eric / Jimenez-Quevedo, Pilar / Hernández, Rosana / Alfonso, Fernando / Macaya, Carlos / Bañuelos, Camino / den Hartog, Wilfred / Escaned, Javier. ·Instituto Cardiovascular, Hospital Clínico San Carlos, Madrid, Spain. ·EuroIntervention · Pubmed #19736057.

ABSTRACT: Inadequate stent expansion and apposition during percutaneous coronary intervention increases the risk of subsequent restenosis and thrombosis. In repeat and complex percutaneous interventions, such as treatment of stent restenosis or bifurcation techniques, these aspects present a renewed importance. Intravascular ultrasound (IVUS) constitutes the standard technique to assess stent expansion, but its use in clinical practice is far from being universal. Although most current stent designs are radiolucent, new radiological imaging modalities, specifically tailored to coronary stent imaging, can render images with enough quality to visualise stent sub-expansion. While this approach might be complementary to IVUS in clinical practice, few in vivo studies comparing both techniques are available. In this article we review the principles of digital enhancement of stent images and the available validation studies. Furthermore, we report on a comparison between IVUS and digital enhancement stent images performed after coronary stenting.

17 Clinical Trial In vivo serial invasive imaging of the second-generation drug-eluting absorbable metal scaffold (Magmaris - DREAMS 2G) in de novo coronary lesions: Insights from the BIOSOLVE-II First-In-Man Trial. 2018

Garcia-Garcia, Hector M / Haude, Michael / Kuku, Kayode / Hideo-Kajita, Alexandre / Ince, Hüseyin / Abizaid, Alexandre / Tölg, Ralph / Lemos, Pedro Alves / von Birgelen, Clemens / Christiansen, Evald Høj / Wijns, William / Escaned, Javier / Dijkstra, Jouke / Waksman, Ron. ·Department of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. Electronic address: hector.m.garciagarcia@medstar.net. · Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany. · Department of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. · Department of Cardiology, Vivantes Klinikum im Friedrichschain and Am Urban, Berlin, Germany. · Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil. · Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany. · Instituto do Coração - HCFMUSP, University of Sao Paulo, São Paulo, Brazil. · Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, The Netherlands. · Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. · Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium. · Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain. · LKEB, Leiden University, Leiden, The Netherlands. ·Int J Cardiol · Pubmed #29292064.

ABSTRACT: RATIONALE: Bioresorbable scaffolds may confer clinical benefit in long-term studies; early mechanistic studies using intravascular imaging have provided insightful information about the immediate and mid-term local serial effects of BRS on the coronary vessel wall. OBJECTIVES: We assessed baseline, 6- and 12-month imaging data of the drug-eluting absorbable metal scaffold (DREAMS 2G). METHODS AND RESULTS: The international, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to 2 de novo lesions (in vessels of 2.2 to 3.7mm). Angiographic based vasomotion, curvature and angulation were assessed; intravascular ultrasound (IVUS) derived radiofrequency (RF) data analysis and echogenicity were evaluated; optical coherence tomography (OCT) attenuation and backscattering analysis were also performed. There was hardly any difference in curvature between pre-procedure and 12months (-0.0019; p=0.48). The change in angulation from pre- to 12months was negligible (-3.58°; 95% CI [-5.97, -1.20]), but statistically significant. At 6months, the change in QCA based minimum lumen diameter in response to high dose of acetylcholine and IVUS-RF necrotic core percentage showed an inverse relationship (estimate of -0.489; p=0.055) and with fibrous volume a positive relationship (estimate of 0.53, p=0.035). Bioresorption analysis by OCT showed that the maximum attenuation values decreased significantly from post-procedure at 6months (Δ 6months vs. post-proc. is -13.5 [95% CI -14.6, -12.4]) and at 12months (Δ 12months vs. post-proc. is -14.0 [95% CI -15.4, -12.6]). By radiofrequency data, the percentage of dense calcium decreased significantly from post-procedure at 6months and at 12months. Likewise, by echogenicity, hyperechogenic structures decreased significantly from post-procedure at 6months; thereafter, they remained unchanged. CONCLUSION: Following implantation of DREAMS 2G, restoration of the vessel geometry, vasomotion and bioresorption signs were observed at up to 12months; importantly, these changes occurred with preservation of the lumen size between 6 and 12months. NCT01960504.

18 Clinical Trial Clinical outcomes of state-of-the-art percutaneous coronary revascularization in patients with de novo three vessel disease: 1-year results of the SYNTAX II study. 2017

Escaned, Javier / Collet, Carlos / Ryan, Nicola / De Maria, Giovanni Luigi / Walsh, Simon / Sabate, Manel / Davies, Justin / Lesiak, Maciej / Moreno, Raul / Cruz-Gonzalez, Ignacio / Hoole, Stephan P / Ej West, Nick / Piek, J J / Zaman, Azfar / Fath-Ordoubadi, Farzin / Stables, Rodney H / Appleby, Clare / van Mieghem, Nicolas / van Geuns, Robert Jm / Uren, Neal / Zueco, Javier / Buszman, Pawel / Iñiguez, Andres / Goicolea, Javier / Hildick-Smith, David / Ochala, Andrzej / Dudek, Dariusz / Hanratty, Colm / Cavalcante, Rafael / Kappetein, Arie Pieter / Taggart, David P / van Es, Gerrit-Anne / Morel, Marie-Angèle / de Vries, Ton / Onuma, Yoshinobu / Farooq, Vasim / Serruys, Patrick W / Banning, Adrian P. ·Hospital Cliinico San Carlos IDISSC and Universidad Complutense de Madrid, Madrid, Spain; Calle Profesor Martín Lagos s/n, 28040 Madrid, Spain. · Department of Cardiology, Academic Medical Center of Amsterdam, Cardiology, Amsterdam, the Netherlands; Meibergdreef 9, 1105 AZ Amsterdam-Zuidoost, the Netherlands. · Department of Cardiology, John Radcliffe Hospital, Cardiology, Oxford, UK; Headley Way, Headington, Oxford OX3 9DU, UK. · Department of Cardiology Belfast Health & Social Care Trust, Belfast, UK; Knockbracken Healthcare Park, Saintfield Rd, Belfast BT8 8BH, UK. · Hospital Clinic I Provincial de Barcelona, Barcelona, Spain; Carrer de Villarroel, 170, 08036 Barcelona, Spain. · Department of Cardiology, Imperial College London, London, UK; Kensington, London SW7 2AZ, UK. · 1st Department of Cardiology, University of Medical Sciences, Poznan, Poland; Collegium Maius, Fredry 10, 61-701 Poznan, Poland. · Department of Cardiology, Hospital Universitario la Paz, Madrid, Spain; Paseo de la Castellana, 261, 28046 Madrid, Spain. · Department of Cardiology, Hospital Universitario de Salamanca, IBSAL, Salamanca, Spain; Paseo de San Vicente, 58, 37007 Salamanca, Spain. · Department of Cardiology, Papworth Hospital NHS Foundation Trust, Cambridge, UK; Papworth Everard, Cambridge CB23 3RE, UK. · Department of Cardiology, Freeman Hospital and Newcastle University, Newcastle-upon-Tyne, UK; High Heaton, Newcastle upon Tyne NE7 7DN, UK. · Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals, Manchester, UK; Oxford Rd, Manchester M13 9WL, UK. · Liverpool Heart and Chest Hospital, Liverpool, UK; Thomas Dr, Liverpool L14 3PE, UK. · Thoraxcenter, Erasmus MC, the Netherlands; 's-Gravendijkwal 230, 3015 CE Rotterdam, the Netherlands. · The Royal Infirmary of Edinburgh, Edinburgh, UK; 51 Little France Dr, Edinburgh EH16 4SA, UK. · Department of Cardiology, Hospital Universitario Valdecilla, Cantabria, Spain; Av. Valdecilla, 25, 39008 Santander, Cantabria, Spain. · American Heart of Poland (PAK), Ustrón, Poland; Sanatoryjna 1, 43-450 Ustrón, Poland. · Department of Cardiology, Hospital Meixoeiro, Pontevedra, Spain; Camiño Meixoeiro, s/n, 36214 Vigo, Pontevedra, Spain. · Brighton & Sussex University Hospitals NHS Trust, Brighton, UK; Barry Building, Eastern Rd, Brighton BN2 5BE, UK. · Gornoslaskie Centrum Medycnze, Poland; 45/47, 40-635 Katowice, Poland. · Department of Interventional Cardiology, Jagiellonian University, Krakow, Poland; Gol?bia 24, 31-007 Kraków, Poland. · Cardialysis BV, Rotterdam, the Netherlands; Westblaak 98, 3012 KM, Rotterdam, the Netherlands. · European Cardiovascular Research Institute, Westblaak 98, 3012 KM, Rotterdam, the Netherlands. ·Eur Heart J · Pubmed #29020367.

ABSTRACT: Aims: To investigate if recent technical and procedural developments in percutaneous coronary intervention (PCI) significantly influence outcomes in appropriately selected patients with three-vessel (3VD) coronary artery disease. Methods and results: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a contemporary PCI strategy on clinical outcomes in patients with 3VD in 22 centres from four European countries. The SYNTAX-II strategy includes: heart team decision-making utilizing the SYNTAX Score II (a clinical tool combining anatomical and clinical factors), coronary physiology guided revascularisation, implantation of thin strut bioresorbable-polymer drug-eluting stents, intravascular ultrasound (IVUS) guided stent implantation, contemporary chronic total occlusion revascularisation techniques and guideline-directed medical therapy. The rate of major adverse cardiac and cerebrovascular events (MACCE [composite of all-cause death, cerebrovascular event, any myocardial infarction and any revascularisation]) at one year was compared to a predefined PCI cohort from the original SYNTAX-I trial selected on the basis of equipoise 4-year mortality between CABG and PCI. As an exploratory endpoint, comparisons were made with the historical CABG cohort of the original SYNTAX-I trial. Overall 708 patients were screened and discussed within the heart team; 454 patients were deemed appropriate to undergo PCI. At one year, the SYNTAX-II strategy was superior to the equipoise-derived SYNTAX-I PCI cohort (MACCE SYNTAX-II 10.6% vs. SYNTAX-I 17.4%; HR 0.58, 95% CI 0.39-0.85, P = 0.006). This difference was driven by a significant reduction in the incidence of MI (HR 0.27, 95% CI 0.11-0.70, P = 0.007) and revascularisation (HR 0.57, 95% CI 0.37-0.9, P = 0.015). Rates of all-cause death (HR 0.69, 95% CI 0.27-1.73, P = 0.43) and stroke (HR 0.69, 95% CI 0.10-4.89, P = 0.71) were similar. The rate of definite stent thrombosis was significantly lower in SYNTAX-II (HR 0.26, 95% CI 0.07-0.97, P = 0.045). Conclusion: At one year, clinical outcomes with the SYNTAX-II strategy were associated with improved clinical results compared to the PCI performed in comparable patients from the original SYNTAX-I trial. Longer term follow-up is awaited and a randomized clinical trial with contemporary CABG is warranted. ClinicalTrials.gov Identifier: NCT02015832.

19 Clinical Trial Rationale and design of the SYNTAX II trial evaluating the short to long-term outcomes of state-of-the-art percutaneous coronary revascularisation in patients with de novo three-vessel disease. 2016

Escaned, Javier / Banning, Adrian / Farooq, Vasim / Echavarria-Pinto, Mauro / Onuma, Yoshinobu / Ryan, Nicola / Cavalcante, Rafael / Campos, Carlos M / Stanetic, Bojan M / Ishibashi, Yuki / Suwannasom, Pannipa / Kappetein, Arie-Pieter / Taggart, David / Morel, Marie-Angèle / van Es, Gerrit-Anne / Serruys, Patrick W. ·Hospital Clinico San Carlos/Faculty of Medicine Complutense University, Madrid, Spain. ·EuroIntervention · Pubmed #27290681.

ABSTRACT: AIMS: The applicability of the results of the SYNTAX trial comparing percutaneous coronary intervention (PCI) using first-generation drug-eluting stents (DES) with coronary artery bypass graft (CABG) surgery for the treatment of patients with complex coronary artery disease (CAD) has been challenged by recent major technical and procedural developments in coronary revascularisation. Functional assessment of coronary lesions has contributed to marked improvements in both safety and efficacy of DES implantation. In addition, the recent development of the SYNTAX score II, a clinical tool based on anatomical and clinical factors, allows individualised objective decision making regarding the optimal revascularisation modality in patients with complex CAD. The ongoing SYNTAX II trial is currently evaluating the effectiveness of the clinical and technological advances in the treatment of patients with complex (de novo three-vessel) CAD. METHODS AND RESULTS: The SYNTAX II trial is a multicentre, all-comers, open-label, single-arm trial aiming to recruit 450 patients with de novo three-vessel CAD in approximately 25 European interventional cardiology centres. All patients will be selected and treated following the SYNTAX II strategy, which includes: a) establishing the appropriateness of revascularisation utilising the SYNTAX score II as a clinical tool to allow objective decision making by the Heart Team, b) ischaemia-driven revascularisation based on functional intracoronary assessment, c) implantation of the new-generation everolimus-eluting platinum chromium coronary stent with thin struts and abluminal bioabsorbable polymer coating to promote rapid vessel healing, d) intravascular ultrasound-guided DES implantation, and e) treatment at centres with expertise in CTO recanalisation. The primary endpoint is a composite of the major adverse cardiac and cerebral events (MACCE) rate at one-year follow-up compared to the historical PCI arm of the SYNTAX trial. An exploratory endpoint will be MACCE at five-year follow-up compared to the historical surgical arm of the SYNTAX trial. CONCLUSIONS: The SYNTAX II trial will provide valuable information on outcomes of state-of-the-art PCI for the contemporary management of complex (de novo three-vessel) CAD. SYNTAX II will be of critical value in the design of future trials in this arena.

20 Clinical Trial Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial. 2016

Haude, Michael / Ince, Hüseyin / Abizaid, Alexandre / Toelg, Ralph / Lemos, Pedro Alves / von Birgelen, Clemens / Christiansen, Evald Høj / Wijns, William / Neumann, Franz-Josef / Kaiser, Christoph / Eeckhout, Eric / Lim, Soo Teik / Escaned, Javier / Onuma, Yoshinobu / Garcia-Garcia, Hector M / Waksman, Ron. ·Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Preussenstr. 84, 41464 Neuss, Germany mhaude@lukasneuss.de michael.haude@uni-due.de. · Department of Cardiology, Vivantes Klinikum im Friedrichschain and Am Urban, Berlin, Germany. · Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil. · Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany. · Instituto do Coração - HCFMUSP, University of Sao Paulo, São Paulo, Brazil. · Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, The Netherlands. · Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. · Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium. · Klinik für Kardiologie und Angiologie II, Universitäts-Herzzentrum Freiburg - Bad Krozingen, Bad Krozingen, Germany. · Department of Cardiology, University Hospital, Basel, Switzerland. · Department of Cardiology, Lausanne University Hospital, Lausanne, Switzerland. · Department of Cardiology, National Heart Center Singapore, Singapore, Singapore. · Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain. · Cardialysis BV, Rotterdam, The Netherlands. · Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. ·Eur Heart J · Pubmed #27190094.

ABSTRACT: AIMS: Metal absorbable scaffolds constitute a conceptually attractive alternative to polymeric scaffolds. Promising 6-month outcomes of a second-generation drug-eluting absorbable metal scaffold (DREAMS 2G), consisting of an absorbable magnesium scaffold backbone, have been reported. We assessed the 12-month safety and performance of this novel device. METHODS AND RESULTS: The prospective, international, multi-centre, first-in-man BIOSOLVE-II trial enrolled 123 patients with up to two de novo lesions with a reference diameter between 2.2 and 3.7 mm. All patients were scheduled for angiographic follow-up at 6 months, and-if subjects consented-at 12 months. Dual antiplatelet therapy was recommended for 6 months. Quantitative coronary angiography (QCA) parameters remained stable from 6 to 12 months [paired data of 42 patients: in-segment late lumen loss 0.20 ± 0.21 mm vs. 0.25 ± 0.22 mm, P = 0.117, Δ 0.05 ± 0.21 mm (95% CI: -0.01;0.12); in-scaffold late lumen loss 0.37 ± 0.25 mm vs. 0.39 ± 0.27 mm, P = 0.446, Δ 0.03 ± 0.22 (95% CI: -0.04;0.10), respectively]. Intravascular ultrasound and optical coherence tomography findings corroborated the QCA results. Target lesion failure occurred in four patients (3.4%), consisting of one death of unknown cause, one target-vessel myocardial infarction, and two clinically driven target lesion revascularization. No additional event occurred beyond the 6-month follow-up. During the entire follow-up of 12 months, none of the patients experienced a definite or probable scaffold thrombosis. CONCLUSION: The novel drug-eluting metal absorbable scaffold DREAMS 2G showed a continuous favourable safety profile up to 12 months and stable angiographic parameters between 6 and 12 months. CLINICALTRIALSGOV IDENTIFIER: NCT01960504.

21 Clinical Trial Fractional flow reserve-guided revascularization: practical implications of a diagnostic gray zone and measurement variability on clinical decisions. 2013

Petraco, Ricardo / Sen, Sayan / Nijjer, Sukhjinder / Echavarria-Pinto, Mauro / Escaned, Javier / Francis, Darrel P / Davies, Justin E. ·International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London and Imperial College Healthcare NHS Trust, London, United Kingdom. rpetraco@imperial.ac.uk ·JACC Cardiovasc Interv · Pubmed #23517831.

ABSTRACT: OBJECTIVES: This study sought to evaluate the effects of fractional flow reserve (FFR) measurement variability on FFR-guided treatment strategy. BACKGROUND: Current appropriateness guidelines recommend the utilization of FFR to guide coronary revascularization based on a fixed cut-off of 0.8. This rigid approach does not take into account the intrinsic biological variability of a single FFR result and the clinical judgment of experienced interventional cardiologists. [corrected]. METHODS: FFR reproducibility data from the landmark Deferral Versus Performance of PTCA in Patients Without Documented Ischemia (DEFER) trial was analyzed (two repeated FFR measurements in the same lesion, 10 min apart) and the standard deviation of the difference (SDD) between repeated measurements was calculated. The measurement certainty (probability that the FFR-guided revascularization strategy will not change if the test is repeated 10 min later) was subsequently established across the whole range of FFR values, from 0.2 to 1. RESULTS: Outside the [0.75 to 0.85] FFR range, measurement certainty of a single FFR result is >95%. However, closer to its cut-off, certainty falls to less than 80% within 0.77 to 0.83, reaching a nadir of 50% around 0.8. In clinical practice, that means that each time a single FFR value falls between 0.75 and 0.85, there is a chance that the FFR-derived revascularization recommendation will change if the measurement is repeated 10 min later, with this chance increasing the closer the FFR result is to 0.8. CONCLUSIONS: A measurement FFR gray-zone is found between 0.75 and 0.85]. Therefore, clinicians should make revascularization decisions based on broadened clinical judgment when a single FFR result falls within this uncertainty zone, particularly between 0.77 and 0.83, when measurement certainty falls to less than 80%.

22 Article Network meta-analysis comparing iFR versus FFR versus coronary angiography to drive coronary revascularization. 2018

Verardi, Roberto / Fioravanti, Francesco / Barbero, Umberto / Conrotto, Federico / Omedè, Pierluigi / Montefusco, Antonio / Moretti, Claudio / D'Amico, Maurizio / Rinaldi, Mauro / Escaned, Javier / D'Ascenzo, Fabrizio. ·Division of Cardiology, Department of Medical Sciences, University of Torino, Torino, Italy. · Cardiovascular Institute, Hospital Clínico San Carlos, Madrid, Spain. · Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid, Spain. · Faculty of Medicine, Complutense University of Madrid, Madrid, Spain. ·J Interv Cardiol · Pubmed #30136420.

ABSTRACT: AIMS: Instantaneous free-wave ratio (iFR) has been recently demonstrated non-inferior to fractional flow reserve (FFR) to drive coronary revascularization; however, no study has compared iFR versus coronary angiography (CA). We performed a network meta-analysis to evaluate efficacy and safety of iFR- versus CA-guided strategy. METHODS AND RESULTS: We searched for randomized trials and studies with propensity score matching in The Cochrane Collaboration Central Register of Controlled Trials, EMBASE, and MEDLINE/Pubmed. CA, FFR, and iFR were the three competitive arms, MACE (a composite endpoint of death, myocardial infarction [MI], and target vessel revascularization [TVR]) was the primary endpoint, while its single components the secondary ones. Subgroup analysis was performed for patients presenting with stable coronary artery disease. Eight studies were selected: 4126 patients were evaluated with FFR, 2160 with iFR, and 2214 with CA, acute coronary syndrome (ACS) was the most frequent admission diagnosis. After 12 months, rates of MACE and all-cause death did not differ between groups (respectively OR 1.04 and OR 0.86 for iFR vs FFR). Both FFR and iFR reduced TVR compared to CA (respectively OR 0.68 and OR 0.70). In patients with stable CAD both FFR and iFR reduced risk of subsequent MI compared to CA (respectively OR 0.66 and OR 0.79). CONCLUSION: Compared to CA alone, both FFR and iFR are safe and effective in guiding coronary revascularization at 12 months. In patients with stable CAD, both FFR and iFR-guided revascularization reduce the risk of subsequent MI at 12 months.

23 Article Long-Term Outcomes of Different Two-Stent Techniques With Second-Generation Drug-Eluting Stents for Unprotected Left Main Bifurcation Disease: Insights From the FAILS-2 Study. 2018

Pavani, Marco / Conrotto, Federico / Cerrato, Enrico / D'Ascenzo, Fabrizio / Kawamoto, Hiroyoshi / Núñez-Gil, Ivan J / Pennone, Mauro / Garbo, Roberto / Tomassini, Francesco / Colombo, Francesco / Scacciatella, Paolo / Varbella, Ferdinando / Chieffo, Alaide / Colombo, Antonio / Escaned, Javier. ·Division of Cardiology, Città della Salute e della Scienza di Torino, Italy. marcopavani@alice.it. Website: www.cardiogroup.org. ·J Invasive Cardiol · Pubmed #30068784.

ABSTRACT: OBJECTIVES: To investigate the long-term clinical outcomes of second-generation drug-eluting stent (2G-DES) implantation for the treatment of complex unprotected left main coronary artery (ULMCA) bifurcation lesions with different two-stent techniques. BACKGROUND: Several two-stent techniques for ULMCA bifurcation lesions have been described. However, a paucity of data exists regarding the optimal strategy, especially in the 2G-DES era. METHODS: The FAILS-2 registry enrolled 1270 consecutive patients treated for ULMCA stenosis with 2G-DES. We compared long-term outcomes of different two-stent strategies in patients who underwent PCI for complex ULMCA bifurcation disease. The primary endpoints were the incidence of death and major adverse cardiac events (MACE, defined as a composite of all-cause death, myocardial infarction [MI], target-lesion revascularization [TLR], and stent thrombosis [ST]) at long-term follow-up. RESULTS: A total of 238 patients were included in the present analysis. T-stenting strategy was used in 66 patients, mini-crush in 104 patients, and culotte in 68 patients. After a median follow-up of 2.27 years, death rates were comparable for the three techniques (9.3% T-stenting vs 9.0% mini-crush vs 4.5% culotte [P=.48]). MACE rates were also similar between the three groups (22% T-stenting vs 26% mini-crush vs 31% culotte [P=.50]). Finally, we showed no differences in MI, ST, and TLR rates between groups. At multivariate analysis, no significant advantage of one technique over the others was observed. CONCLUSION: T-stenting, mini-crush, and culotte techniques using 2G-DES for ULMCA bifurcation disease showed similar clinical outcomes at long-term follow-up. MACE rates were mainly driven by in-stent restenosis at the circumflex ostium.

24 Article Safety of FFR-guided revascularisation deferral in Anatomically prognostiC diseasE (FACE: CARDIOGROUP V STUDY): A prospective multicentre study. 2018

Barbero, Umberto / D'Ascenzo, Fabrizio / Campo, Gianluca / Kleczyński, Paweł / Dziewierz, Artur / Menozzi, Mila / Jiménez Díaz, Victor A / Cerrato, Enrico / Raposeiras-Roubín, Sergio / Ielasi, Alfonso / Rognoni, Andrea / Fineschi, Massimo / Kanji, Rahim / Jaguszewski, Milosz J / Picchi, Andrea / Andò, Giuseppe / Soraci, Emmanuele / Mancone, Massimo / Sardella, Gennaro / Calcagno, Simone / Gallo, Francesco / Huczek, Zenon / Krakowian, Marcin / Verardi, Roberto / Montefusco, Antonio / Omedè, Pierluigi / Lococo, Marco / Moretti, Claudio / D'Amico, Maurizio / Rigattieri, Stefano / Gaita, Fiorenzo / Rinaldi, Mauro / Escaned, Javier. ·Division of Cardiology, Cardio-Thoracic Department, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Corso A. M. Dogliotti, 14, 10126 Torino, Italy. Electronic address: ubarbero@unito.it. · Division of Cardiology, Cardio-Thoracic Department, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Corso A. M. Dogliotti, 14, 10126 Torino, Italy. ·Int J Cardiol · Pubmed #29937300.

ABSTRACT: BACKGROUND: FFR-guided coronary intervention is recommended for patients with intermediate stenoses. However, concerns exist with this approach in anatomically prognostic disease. METHODS: In this prospective, multicentre study, we consecutively enrolled patients found to have FFR negative lesions in anatomically significant sites: left main; proximal LAD; last remaining patent vessel; and multiple vessels with concomitant impaired left ventricular systolic function (EF < 40%). As per recommendation, revascularisation was deferred, and patients included into a registry. The primary endpoint was MACE (death, myocardial infarction and unplanned target lesion revascularization). Secondary endpoints were the above individual components. Subgroup analyses were performed for clinical presentation (stable vs. ACS), localization of lesion (ostial vs. non ostial) and renal function. RESULTS: The registry included 292 patients with 297 deferred stenoses. After 1-year, the primary endpoint occurred in 5% of patients, mainly driven by TLR (2.7%). Cardiovascular death occurred in 0.8% and AMI in 0.8%. During a follow-up of 22.2 ± 11 months, MACE occurred in 11.6%. Cardiovascular death occurred in 1.8% and AMI in 2.1%. After multivariate analysis, impaired renal function (OR 1.99; CI 95% 1.74-5.41; p = 0.046) and ostial disease (OR 2.88; CI 95% 1.04-7.38; p = 0.041) were found to be predictors of MACE. Impaired renal function also predicted TLR (OR 2.43; CI 95% 1.17-5.02; p = 0.017). CONCLUSION: FFR-guided revascularisation deferral is safe in the majority of anatomically prognostic disease. However, further evaluation is required in the risk stratification of those patients with ostial disease and renal disease. Registered on ClinicalTrials, NCT02590926.

25 Article Unprotected Left Main Coronary Artery Disease: Outcomes of Treatment With Second-Generation Drug-Eluting Stents - Insight From the FAILS-2 Study. 2018

Barbero, Umberto / Kanji, Rahim / Cerrato, Enrico / Di Summa, Roberto / Conrotto, Federico / Kawamoto, Hiroyoshi / Biondi-Zoccai, Giuseppe / Gili, Sebastiano / Ugo, Fabrizio / Iannaccone, Mario / Gagliardi, Marco / De Benedictis, Michele / Doronzo, Baldassare / Varbella, Ferdinando / D'Amico, Maurizio / Moretti, Claudio / Colombo, Antonio / Escaned, Javier / D'Ascenzo, Fabrizio. ·Invasive Cardiology Unit, "SS. Maria Annunziata" Hospital, Via Ospedali 14, Savigliano, Italy. ubarbero@unito.it. ·J Invasive Cardiol · Pubmed #29760284.

ABSTRACT: OBJECTIVE: To evaluate the outcome of patients undergoing PCI for unprotected left main coronary artery (ULMCA) disease with different drug-eluting stent (DES) types. BACKGROUND: Published literature suggests that second-generation DES options have differing vascular responses and outcomes, but there is a paucity of data in real-life patients in the LM setting. METHODS: This is a retrospective, multicenter study, including patients treated with a second-generation DES for ULMCA disease between 2007 and 2015. The primary endpoint was target-lesion revascularization (TLR). Secondary endpoints were major adverse cardiac events, myocardial infarction (MI), and stent thrombosis (ST). RESULTS: A total of 1209 patients were enrolled; 840 patients (69.5%) received an everolimus-eluting stent (EES), 133 patients (11.0%) received a zotarolimus-eluting stent (ZES), and 236 patients (19.5%) received a biodegradable polymer, biolimus-eluting stent (BP-BES). During a mean follow-up of 722 ± 640 days, TLR occurred in 47 patients (3.8%). At univariate analysis, EES patients had a lower TLR rate (3.6% vs 4.5% in ZES vs 4.2% in BP-BES), which was statistically significant at multivariate analysis (hazard ratio, 0.50; 95% confidence interval, 0.27-0.93; P=.03). No differences in major adverse cardiac events, death, MI, or ST were observed between groups. CONCLUSION: The safety profile of the stents used was comparable over the follow-up period. However, EES patients had lower restenosis rates, with a reduced need for repeat PCI.

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