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Coronary Artery Disease: HELP
Articles by Javier Escaned
Based on 81 articles published since 2010
(Why 81 articles?)
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Between 2010 and 2020, J. Escaned wrote the following 81 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3 · 4
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 Percutaneous Treatment of Chronic Total Coronary Occlusions: The Light That Came From Japan. 2017

Escaned, Javier. ·Hospital Clinico San Carlos IDISSC and Complutense University of Madrid, Madrid, Spain. Electronic address: escaned@secardiologia.es. ·JACC Cardiovasc Interv · Pubmed #29055765.

ABSTRACT: -- No abstract --

3 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 --

4 Review Microcirculatory dysfunction in the heart and the brain. 2019

Mejía-Rentería, Hernán / Matias-Guiu, Jordi A / Lauri, Francesco / Yus, Miguel / Escaned, Javier. ·Interventional Cardiology Unit, Cardiology Department, Hospital Clínico San Carlos, IDISSC and Universidad Complutense de Madrid, Madrid, Spain. · Neurology Department, Hospital Clínico San Carlos, IDISSC and Universidad Complutense de Madrid, Madrid, Spain. · Neuroimaging Unit, Radiology Department, Hospital Clínico San Carlos, IDISSC and Universidad Complutense de Madrid, Madrid, Spain. · Interventional Cardiology Unit, Cardiology Department, Hospital Clínico San Carlos, IDISSC and Universidad Complutense de Madrid, Madrid, Spain - escaned@secardiologia.es. ·Minerva Cardioangiol · Pubmed #29687698.

ABSTRACT: Coronary microcirculatory dysfunction (CMD) is a major cause of myocardial ischemia that influences the outcomes of patients with coronary artery disease. The mechanisms of CMD are heterogeneous and may result from a spectrum of biological and cardiovascular risk factors that may affect also the microcirculation of other vital organs. Microcirculatory dysfunction of the brain, known as cerebral small vessel disease, is increasingly being recognized as a cause of cognitive decline and neurodegenerative disorders. Despite microvascular dysfunction of the heart and the brain may share underlying pathophysiological mechanisms (endothelial dysfunction, thrombosis, vascular remodeling and capillary rarefaction), the evidence about the potential link between both pathological processes is scarce. In this paper we discuss the mechanisms of microvascular dysfunction of the heart and the brain, their clinical impact on cardiac events, cognitive decline and neurodegenerative disorders, and the potential link between both vascular target organs at the level of the microcirculation.

5 Review Spontaneous coronary artery dissection: contemporary aspects of diagnosis and patient management. 2018

Macaya, Fernando / Salinas, Pablo / Gonzalo, Nieves / Fernández-Ortiz, Antonio / Macaya, Carlos / Escaned, Javier. ·Servicio de Cardiología, Hospital Clínico San Carlos, Universidad Complutense, IdISSC, Madrid, Spain. ·Open Heart · Pubmed #30487978.

ABSTRACT: Spontaneous coronary artery dissection is an increasingly recognised cause of acute coronary syndromes, especially in young and middle-age women. Recognising its particularities and differences with atherosclerotic disease is central for appropriately identifying and approaching these patients. The authors review the current state of knowledge on spontaneous coronary artery dissection and provide practical recommendations for the diagnosis and management of this condition, both in the acute and convalescence phases.

6 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.

7 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.

8 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.

9 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.

10 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.

11 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.

12 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.

13 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.

14 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.

15 Clinical Trial Impact of post-procedural minimal stent area on 2-year clinical outcomes in the SYNTAX II trial. 2019

Katagiri, Yuki / De Maria, Giovanni Luigi / Kogame, Norihiro / Chichareon, Ply / Takahashi, Kuniaki / Chang, Chun Chin / Modolo, Rodrigo / Walsh, Simon / Sabate, Manel / Davies, Justin / Lesiak, Maciej / Moreno, Raul / Cruz-Gonzalez, Ignacio / West, Nick E J / Piek, Jan J / Wykrzykowska, Joanna J / Farooq, Vasim / Escaned, Javier / Banning, Adrian P / Onuma, Yoshinobu / Serruys, Patrick W. ·Department of Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands. · Department of Cardiology, John Radcliffe Hospital, Oxford, United Kingdom. · ThoraxCenter, Erasmus Medical Center, Rotterdam, The Netherlands. · Department of Cardiology, Belfast Health & Social Care Trust, Belfast, United Kingdom. · Thorax Institute, Hospital Clinic I Provincial de Barcelona, Barcelona, Spain. · Department of Cardiology, Imperial College London, London, United Kingdom. · 1st Department of Cardiology, University of Medical Sciences, Poznañ, Poland. · Department of Cardiology, Hospital Universitario la Paz, Madrid, Spain. · Department of Cardiology, Hospital Universitario de Salamanca, Salamanca, Spain. · Department of Interventional Cardiology, Royal Papworth Hospital, Cambridge, United Kingdom. · Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals, Manchester, United Kingdom. · Hospital Cliinico San Carlos IDISSC and Universidad Complutense de Madrid, Madrid, Spain. · NHLI, Imperial College London, London, United Kingdom. ·Catheter Cardiovasc Interv · Pubmed #30702187.

ABSTRACT: OBJECTIVES: To investigate the impact of minimal stent area (MSA) evaluated by post-procedural intravascular ultrasound (IVUS) on clinical outcomes after contemporary PCI in patients with three-vessel disease (TVD). BACKGROUND: The impact of post-procedural MSA on clinical outcomes has not yet been extensively studied in patients with TVD. METHODS: The SYNTAX II study is a multicenter, all-comers, open-label, single arm study that investigated the impact of a state-of-the-art PCI strategy on clinical outcomes in patients with TVD (454 patients with 1,559 lesions). The relationships between post-procedural MSA and lesion-level outcomes at 2 years were investigated. Clinical events adjudicated per patient by clinical event committee were assessed per lesion. Lesion-oriented composite endpoint (LOCE) was defined as the composite of cardiac death, target-vessel myocardial infarction, and ischemia-driven target lesion revascularization. RESULTS: Eight hundred and nineteen lesions with post-procedural MSA available in 367 patients were included in the analysis. The post-procedural MSA per lesion was divided into terciles (smallest tercile: ≤5.0 mm CONCLUSIONS: In the SYNTAX II trial, larger post-procedural MSA was independently associated with the lower rate of TLR at 2 years.

16 Clinical Trial Serial 3-Dimensional Optical Coherence Tomography Assessment of Jailed Side-Branch by Second-Generation Drug-Eluting Absorbable Metal Scaffold (from the BIOSOLVE-II Trial). 2019

Ozaki, Yuichi / Garcia-Garcia, Hector M / Hideo-Kajita, Alexandre / Kuku, Kayode O / Haude, Michael / Ince, Hüseyin / Abizaid, Alexandre / Tölg, Ralph / Lemos, Pedro Alves / von Birgelen, Clemens / Christiansen, Evald Høj / Wijns, William / Escaned, Javier / Waksman, Ron. ·Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia; MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, District of Columbia. · Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia; MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, District of Columbia. Electronic address: hector.m.garciagarcia@medstar.net. · MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, District of Columbia. · Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany. · 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, Aarhus, Denmark. · Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium. · Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain. · Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, District of Columbia. ·Am J Cardiol · Pubmed #30683424.

ABSTRACT: Second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) is used for treating coronary lesions. However, the natural history of the jailed side-branch (SB) after DREAMS 2G implantation remains to be elucidated. The aim of this study is to investigate the effect of scaffold struts on jailed SBs as assessed by 3-dimensional (3D) optical coherence tomography (OCT) after implantation of DREAMS 2G. We enrolled the patients who received a DREAMS 2G implantation and where OCT was performed at postprocedure and 12-month follow-up in the BIOSOLVE-II trial. The area of the ostium of jailed SBs and number of compartments divided by scaffold struts were assessed by cut-plane analysis using 3D OCT. A total of 24 patients with 61 jailed SBs were analyzed in this study. The number of compartments was significantly decreased (postprocedure; 1.98 ± 0.84 vs 12 months; 1.10 ± 0.30, p <0.001) during the 12 months. Since most of the struts disappeared, the ostium area was increased in 62% of jailed SBs at 12 months, however, not significantly different from postprocedure (postprocedure; 0.74 [0.34 to 1.46] mm

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 Integrated physiologic assessment of ischemic heart disease in real-world practice using index of microcirculatory resistance and fractional flow reserve: insights from the International Index of Microcirculatory Resistance Registry. 2015

Lee, Joo Myung / Layland, Jamie / Jung, Ji-Hyun / Lee, Hyun-Jung / Echavarria-Pinto, Mauro / Watkins, Stuart / Yong, Andy S / Doh, Joon-Hyung / Nam, Chang-Wook / Shin, Eun-Seok / Koo, Bon-Kwon / Ng, Martin K / Escaned, Javier / Fearon, William F / Oldroyd, Keith G. ·From the Department of Medicine, Seoul National University Hospital, Seoul, South Korea (J.M.L., J.-H.J., H.-J.L., B.-K.K.) · Department of Cardiology, West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, United Kingdom (J.L., S.W., K.G.O.) · BHF Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom (J.L., S.W., K.G.O.) · Servicio de Cardiología, Hospital Clinico San Carlos, Faculty of Medicine Complutense University of Madrid, Madrid, Spain (M.E.-P., J.E.) · Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC), Madrid, Spain (M.E.-P., J.E.) · Department of Cardiovascular Medicine, Stanford University Medical Center, Stanford, CA (A.S.Y., W.F.F.) · Department of Medicine, Inje University Ilsan Paik Hospital, Goyang, South Korea (J.-H.D.) · Department of Medicine, Keimyung University Dongsan Medical Center, Daegu, South Korea (C.-W.N.) · Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea (E.-S.S.) · Institute on Aging, Seoul National University, Seoul, South Korea (B.K.K.) · and Departments of Cardiology, Royal Prince Alfred and Concord Hospitals and University of Sydney, Sydney, Australia (M.K.N.). ·Circ Cardiovasc Interv · Pubmed #26499500.

ABSTRACT: BACKGROUND: The index of microcirculatory resistance (IMR) is a quantitative and specific index for coronary microcirculation. However, the distribution and determinants of IMR have not been fully investigated in patients with ischemic heart disease (IHD). METHODS AND RESULTS: Consecutive patients who underwent elective measurement of both fractional flow reserve (FFR) and IMR were enrolled from 8 centers in 5 countries. Patients with acute myocardial infarction were excluded. To adjust for the influence of collateral flow, IMR values were corrected with Yong's formula (IMRcorr). High IMR was defined as greater than the 75th percentile in each of the major coronary arteries. FFR≤0.80 was defined as an ischemic value. 1096 patients with 1452 coronary arteries were analyzed (mean age 61.1, male 71.2%). Mean FFR was 0.84 and median IMRcorr was 16.6 U (Q1, Q3 12.4 U, 23.0 U). There was no correlation between IMRcorr and FFR values (r=0.01, P=0.62), and the categorical agreement of FFR and IMRcorr was low (kappa value=-0.04, P=0.10). There was no correlation between IMRcorr and angiographic % diameter stenosis (r=-0.03, P=0.25). Determinants of high IMR were previous myocardial infarction (odds ratio [OR] 2.16, 95% confidence interval [CI] 1.24-3.74, P=0.01), right coronary artery (OR 2.09, 95% CI 1.54-2.84, P<0.01), female (OR 1.67, 95% CI 1.18-2.38, P<0.01), and obesity (OR 1.80, 95% CI 1.31-2.49, P<0.01). Determinants of FFR ≤0.80 were left anterior descending coronary artery (OR 4.31, 95% CI 2.92-6.36, P<0.01), angiographic diameter stenosis ≥50% (OR 5.16, 95% CI 3.66-7.28, P<0.01), male (OR 2.15, 95% CI 1.38-3.35, P<0.01), and age (per 10 years, OR 1.21, 95% CI 1.01-1.46, P=0.04). CONCLUSIONS: IMR showed no correlation with FFR and angiographic lesion severity, and the predictors of high IMR value were different from those for ischemic FFR value. Therefore, integration of IMR into FFR measurement may provide additional insights regarding the relative contribution of macro- and microvascular disease in patients with ischemic heart disease. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02186093.

22 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%.

23 Article Prognostic Implications of Resistive Reserve Ratio in Patients With Coronary Artery Disease. 2020

Lee, Seung Hun / Lee, Joo Myung / Park, Jonghanne / Choi, Ki Hong / Hwang, Doyeon / Doh, Joon-Hyung / Nam, Chang-Wook / Shin, Eun-Seok / Hoshino, Masahiro / Murai, Tadashi / Yonetsu, Taishi / Mejía-Rentería, Hernán / Kakuta, Tsunekazu / Escaned, Javier / Anonymous4781176. ·Division of Cardiology Department of Internal Medicine Heart Vascular Stroke Institute Samsung Medical Center Sungkyunkwan University School of Medicine Seoul Korea. · Department of Internal Medicine and Cardiovascular Center Seoul National University Hospital Seoul Korea. · Developmental Therapeutics Program of Division of Hematology Oncology Northwestern University Chicago IL. · Department of Medicine Inje University Ilsan Paik Hospital Goyang South Korea. · Department of Medicine Keimyung University Dongsan Medical Center Daegu South Korea. · Division of Cardiology Ulsan Hospital Ulsan Korea. · Department of Cardiology Ulsan University Hospital University of Ulsan College of Medicine Ulsan South Korea. · Division of Cardiovascular Medicine Tsuchiura Kyodo General Hospital Ibaraki Japan. · Department of Cardiovascular Medicine Tokyo Medical and Dental University Tokyo Japan. · Cardiovascular Institute Hospital Clinico San Carlos Madrid Spain. · Centro Nacional de Investigaciónes Cardiovasculares Carlos III (CNIC) Madrid Spain. ·J Am Heart Assoc · Pubmed #32306809.

ABSTRACT: Background Resistive reserve ratio is a thermodilution-based index which integrates both coronary flow and pressure. Resistive reserve ratio represents the vasodilatory capacity of interrogated vessels including both epicardial coronary artery and microvascular circulation. We evaluated the prognostic potential of resistive reserve ratio compared with pressure-derived index (fractional flow reserve [FFR]) or flow-derived index (coronary flow reserve [CFR]). Methods and Results A total of 1245 patients underwent coronary pressure and flow measurement using pressure-temperature wire. Resistive reserve ratio was calculated by CFR adjusted using the ratio between resting and hyperemic distal coronary pressure ([resting mean transit time/hyperemic mean transit time]×[resting distal coronary pressure/hyperemic distal coronary pressure]). Clinical outcome was assessed by patient-oriented composite outcome (POCO), a composite of any death, myocardial infarction, and revascularization at 5 years. At 5 years, the cumulative incidence of POCO was significantly different according to quartiles of resistive reserve ratio (9.9%, 11.3%, 17.2%, and 22.7% in quartiles 1 to 4, respectively, log rank

24 Article Impact of Kissing Balloon in Patients Treated With Ultrathin Stents for Left Main Lesions and Bifurcations: An Analysis From the RAIN-CARDIOGROUP VII Study. 2020

Gaido, Luca / D'Ascenzo, Fabrizio / Imori, Yoichi / Wojakowski, Wojciech / Saglietto, Andrea / Figini, Filippo / Mattesini, Alessio / Trabattoni, Daniela / Rognoni, Andrea / Tomassini, Francesco / Bernardi, Alessandro / Ryan, Nicola / Muscoli, Saverio / Helft, Gerard / De Filippo, Ovidio / Parma, Radoslaw / De Luca, Leonardo / Ugo, Fabrizio / Cerrato, Enrico / Montefusco, Antonio / Pennacchi, Mauro / Wańha, Wojciech / Smolka, Grzegorz / de Lio, Giulia / Bruno, Francesco / Huczek, Zenon / Boccuzzi, Giacomo / Cortese, Bernardo / Capodanno, Davide / Omedè, Pierluigi / Mancone, Massimo / Nuñez-Gil, Ivan / Romeo, Francesco / Varbella, Ferdiando / Rinaldi, Mauro / Escaned, Javier / Conrotto, Federico / Burzotta, Francesco / Chieffo, Alaide / Perl, Leor / D'Amico, Maurizio / di Mario, Carlo / Sheiban, Imad / Gagnor, Andrea / Giammaria, Massimo / De Ferrari, Gaetano Maria. ·Division of Cardiology, Ospedale Maria Vittoria, Turin (L.G., A.G., M.G.). · Division of Cardiology, Department of Medical Science, Città della Salute e della Scienza, Turin (F.D., A.S., F.F., A. Montefusco, G.d.L., F.B., P.O., M.R., F.C., M.D., G.M.D.F.). · Department of Cardiovascular Medicine, Nippon Medical School, 1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan (Y.I.). · Department of Cardiology, Medical University of Silesia, Katowice, Poland (W. Wojakowski, W. Wańha, G.S.). · Structural Interventional Cardiology, Careggi University Hospital, Florence, Italy (A. Mattesini, C.d.M.). · Department of Cardiovascular Sciences, IRCCS Centro Cardiologico Monzino, University of Milan, Italy (D.T.). · Coronary Care Unit and Catheterization laboratory, A.O.U. Maggiore della Carità, Novara, Italy (A.R.). · Department of Cardiology, Infermi Hospital, Rivoli, Italy (F.T., E.C., F.V.). · Department of Cardiology, San Luigi Gonzaga Hospital, Orbassano, Turin, Italy (F.T., E.C., F.V.). · Dipartimento di Cardiologia, Ospedale San Giovanni Bosco, Italy (A.B., F.U., G.B.). · Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain (N.R., I.N.-G., J.E.). · Department of Medicine, Università degli Studi di Roma 'Tor Vergata', Rome, Italy (S.M., F.R.). · Pierre and Marie Curie University, Paris, France (G.H.). · University Clinical Hospital, Warsaw, Poland (R.P., Z.H.). · Division of Cardiology, S. Giovanni Evangelista Hospital, Tivoli, Rome, Italy (L.D.L., M.P.). · San Carlo Clinic, Milano, Italy (B.C.). · Division of Cardiology, Cardio-Thoracic-Vascular Department, Azienda Ospedaliero Universitaria "Policlinico-Vittorio Emanuele," Catania, Italy (D.C.). · Università degli Studi di ROMA "La Sapienza" (M.M.), Lazio, Italia. · Università Cattolica del Sacro Cuore Roma (F.B.), Lazio, Italia. · San Raffaele Scientific Institute, Milan, Italy (A.C.). · Rabin Medical Center, Department of Cardiology, Tel Aviv, Israel (L.P.). · Pederzoli Hospital, Peschiera del Garda, Italy (I.S.). ·Circ Cardiovasc Interv · Pubmed #32102566.

ABSTRACT: BACKGROUND: There are limited data regarding the impact of final kissing balloon (FKI) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. METHODS: All patients undergoing left main or bifurcations percutaneous coronary intervention enrolled in the RAIN registry (Very Thin Stents for Patients With MAIN or BiF in Real Life: The RAIN, a Multicenter Study) evaluating ultrathin stents were included. Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) was the primary end point, while its components, along with target vessel revascularization, were the secondary end points. The main analysis was performed comparing patients with and without FKI after adjustment with inverse probability of treatment weighting. Subgroup analyses were performed according to FKI (short [<3 mm] versus long overlap), strategy (provisional versus 2-stent), routine versus bail-out FKI, and the use of imaging and proximal optimization technique. RESULTS: Two thousand seven hundred forty-two patients were included. At 16 months (8-20) follow-up, inverse probability of treatment weighting adjusted rates of major adverse cardiac event were similar between FKI and no-FKI group (15.1% versus 15.5%; CONCLUSIONS: In patients with bifurcations or unprotected left main treated with ultrathin stents, short overlap FKI is associated with less restenosis. In a 2-stent strategy, FKI was associated with less target vessel revascularization and restenosis. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03544294.

25 Article The CatLet score and outcome prediction in acute myocardial infarction for patients undergoing primary percutaneous intervention: A proof-of-concept study. 2020

Xu, Ming-Xing / Ruddy, Terrence D / Schoenhagen, Paul / Bartel, Thomas / Di Bartolomeo, Roberto / von Kodolitsch, Yskert / Escaned, Javier / Shen, Chengxing / He, Yong-Ming. ·Division of Cardiology, First Affiliated Hospital of Soochow University, Suzhou, China. · Division of Cardiology, Heart Institute, University of Ottawa, Ottawa, Canada. · Imaging Institute, Cleveland Clinic, Cleveland, Ohio. · Department of Cardiovascular Medicine, Heart & Vascular Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates. · Cardio-Thoracic and Vascular Department, Division of Cardiac Surgery, S. Orsola Hospital, University of Bologna, Bologna, Italy. · Department of Cardiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. · Department of Cardiology, Hospital San Carlos, Madrid, Spain. · Department of Cardiology, Shanghai Jiaotong University Affiliated Sixth People's Hospital, Shanghai, China. ·Catheter Cardiovasc Interv · Pubmed #31943728.

ABSTRACT: BACKGROUND: The Coronary Artery Tree description and Lesion EvaluaTion (CatLet) score accommodating the variability in coronary anatomy is a recently developed and comprehensive angiographic scoring system aimed at assisting in risk-stratification of patients with coronary artery disease. However, a validation of this angiographic scoring system is lacking. METHODS: The CatLet score was calculated retrospectively in 308 consecutively enrolled patients with acute myocardial infarction (AMI) undergoing primary percutaneous coronary intervention. The primary endpoint, major adverse cardiac or cerebrovascular events (MACCEs), was stratified according to CatLet tertiles: CatLetlow ≤14 (n = 124), CatLetmid 15-21 (n = 82) and CatLettop ≥22 (n = 102). RESULTS: The CatLet score alone or after adjusting for a broad spectrum of risk factors, significantly predicted clinical outcomes at a median 4.3-year follow-up. Multivariable-adjusted hazard ratios (95%CI)/unit higher score were 1.05 (1.04-1.07) for MACCE, 1.06 (1.04-1.07) for cardiac death, and 1.05 (1.04-1.07) for all-cause death. When compared to the SYNTAX score, improved discrimination and better calibration of this CatLet score resulted in a significantly refined risk stratification. The overall category-free net reclassification improvement afforded by this CatLet score was as follows: 37.2% (p = .008) for MACCEs, 35.5% (p = .0249) for cardiac death, and 31.8% (p = .0316) for all-cause death. CONCLUSIONS: The ability to integrate the variability in coronary anatomy into angiographic scoring makes the CatLet score a more specific tool for outcome predictions in AMI. (http://www.chictr.org.cn. Unique identifiers: ChiCTR-POC-17013536).

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