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Coronary Artery Disease: HELP
Articles by Marie-Angèle M. Morel
Based on 37 articles published since 2008
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Between 2008 and 2019, Marie-Angel Morel wrote the following 37 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Guideline Tissue characterisation using intravascular radiofrequency data analysis: recommendations for acquisition, analysis, interpretation and reporting. 2009

García-García, Héctor M / Mintz, Gary S / Lerman, Amir / Vince, D Geoffrey / Margolis, M Paulina / van Es, Gerrit-Anne / Morel, Marie-Angèle M / Nair, Anuja / Virmani, Renu / Burke, Allen P / Stone, Gregg W / Serruys, Patrick W. ·Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. ·EuroIntervention · Pubmed #20449928.

ABSTRACT: This document suggests standards for the acquisition, measurement, and reporting of radiofrequency data analysis (virtual histology - VH) intravascular ultrasound (IVUS) studies. Readers should view this document as the authors' best attempt in an area of rapidly evolving investigation, an area where rigorous evidence is not yet available or widely accepted. Nevertheless, this document is based on known pathologic data as well as previously reported imaging data; where practical, this data is summarised in the current document, a document which will also include recommendations for future evolution of the technology.

2 Editorial Counting the score: the SYNTAX Score and coronary risk. 2009

Dawkins, Keith D / Morel, Marie-Angèle M / Serruys, Patrick W. · ·EuroIntervention · Pubmed #19577980.

ABSTRACT: -- No abstract --

3 Guideline Consensus standards for acquisition, measurement, and reporting of intravascular optical coherence tomography studies: a report from the International Working Group for Intravascular Optical Coherence Tomography Standardization and Validation. 2012

Tearney, Guillermo J / Regar, Evelyn / Akasaka, Takashi / Adriaenssens, Tom / Barlis, Peter / Bezerra, Hiram G / Bouma, Brett / Bruining, Nico / Cho, Jin-man / Chowdhary, Saqib / Costa, Marco A / de Silva, Ranil / Dijkstra, Jouke / Di Mario, Carlo / Dudek, Darius / Falk, Erling / Feldman, Marc D / Fitzgerald, Peter / Garcia-Garcia, Hector M / Gonzalo, Nieves / Granada, Juan F / Guagliumi, Giulio / Holm, Niels R / Honda, Yasuhiro / Ikeno, Fumiaki / Kawasaki, Masanori / Kochman, Janusz / Koltowski, Lukasz / Kubo, Takashi / Kume, Teruyoshi / Kyono, Hiroyuki / Lam, Cheung Chi Simon / Lamouche, Guy / Lee, David P / Leon, Martin B / Maehara, Akiko / Manfrini, Olivia / Mintz, Gary S / Mizuno, Kyiouchi / Morel, Marie-angéle / Nadkarni, Seemantini / Okura, Hiroyuki / Otake, Hiromasa / Pietrasik, Arkadiusz / Prati, Francesco / Räber, Lorenz / Radu, Maria D / Rieber, Johannes / Riga, Maria / Rollins, Andrew / Rosenberg, Mireille / Sirbu, Vasile / Serruys, Patrick W J C / Shimada, Kenei / Shinke, Toshiro / Shite, Junya / Siegel, Eliot / Sonoda, Shinjo / Suter, Melissa / Takarada, Shigeho / Tanaka, Atsushi / Terashima, Mitsuyasu / Thim, Troels / Uemura, Shiro / Ughi, Giovanni J / van Beusekom, Heleen M M / van der Steen, Antonius F W / van Es, Gerrit-Anne / van Soest, Gijs / Virmani, Renu / Waxman, Sergio / Weissman, Neil J / Weisz, Giora / Anonymous6690720. ·The Massachusetts General Hospital and the Wellman Center for Photomedicine, Boston, Massachusetts 02114, USA. gtearney@partners.org ·J Am Coll Cardiol · Pubmed #22421299.

ABSTRACT: OBJECTIVES: The purpose of this document is to make the output of the International Working Group for Intravascular Optical Coherence Tomography (IWG-IVOCT) Standardization and Validation available to medical and scientific communities, through a peer-reviewed publication, in the interest of improving the diagnosis and treatment of patients with atherosclerosis, including coronary artery disease. BACKGROUND: Intravascular optical coherence tomography (IVOCT) is a catheter-based modality that acquires images at a resolution of ~10 μm, enabling visualization of blood vessel wall microstructure in vivo at an unprecedented level of detail. IVOCT devices are now commercially available worldwide, there is an active user base, and the interest in using this technology is growing. Incorporation of IVOCT in research and daily clinical practice can be facilitated by the development of uniform terminology and consensus-based standards on use of the technology, interpretation of the images, and reporting of IVOCT results. METHODS: The IWG-IVOCT, comprising more than 260 academic and industry members from Asia, Europe, and the United States, formed in 2008 and convened on the topic of IVOCT standardization through a series of 9 national and international meetings. RESULTS: Knowledge and recommendations from this group on key areas within the IVOCT field were assembled to generate this consensus document, authored by the Writing Committee, composed of academicians who have participated in meetings and/or writing of the text. CONCLUSIONS: This document may be broadly used as a standard reference regarding the current state of the IVOCT imaging modality, intended for researchers and clinicians who use IVOCT and analyze IVOCT data.

4 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.

5 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.

6 Clinical Trial Anatomic characteristics and clinical implications of angiographic coronary thrombus: insights from a patient-level pooled analysis of SYNTAX, RESOLUTE, and LEADERS Trials. 2015

Campos, Carlos M / Costa, Francesco / Garcia-Garcia, Hector M / Bourantas, Christos / Suwannasom, Pannipa / Valgimigli, Marco / Morel, Marie-Angele / Windecker, Stephan / Serruys, Patrick W. ·From the Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands (C.M.C., F.C., H.M.G.-G., C.B., P.S., M.V., P.W.S.) · Department of Interventional Cardiology Heart Institute (InCor), University of São Paulo Medical School, Sao Paulo, Brazil (C.M.C.) · Cardialysis, Rotterdam, The Netherlands (H.M.G.-G., M.-A.M.) · Department of Cardiology, Bern University Hospital, Bern, Switzerland (S.W.) · and Department of Cardiology, International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom (P.W.S.). ·Circ Cardiovasc Interv · Pubmed #25825008.

ABSTRACT: BACKGROUND: The distribution of thrombus-containing lesions (TCLs) in an all-comer population admitted with a heterogeneous clinical presentation (stable, ustable angina, or an acute coronary syndrome) and treated with percutaneous coronary intervention is yet unclear, and the long-term prognostic implications are still disputed. This study sought to assess the distribution and prognostic implications of coronary thrombus, detected by coronary angiography, in a population recruited in all-comer percutaneous coronary intervention trials. METHODS AND RESULTS: Patient-level data from 3 contemporary coronary stent trials were pooled by an independent academic research organization (Cardialysis, Rotterdam, the Netherlands). Clinical outcomes in terms of major adverse cardiac events (major adverse cardiac events, a composite of death, myocardial infarction, and repeat revascularization), death, myocardial infarction, and repeated revascularization were compared between patients with and without angiographic TCL. Preprocedural TCL was present in 257 patients (5.8%) and absent in 4193 (94.2%) patients. At 3-year follow-up, there was no difference for major adverse cardiac events (25.3 versus 25.4%; P=0.683); all-cause death (7.4 versus 6.8%; P=0.683); myocardial infarction (5.8 versus 6.0%; P=0.962), and any revascularizations (17.5 versus 17.7%; P=0.822) between patients with and without TCL. The comparison of outcomes in groups weighing the jeopardized myocardial by TCL also did not show a significant difference. TCL were seen more often in the first 2 segments of the right (43.6%) and left anterior descending (36.8%) coronary arteries. The association of TCL and bifurcation lesions was present in 40.1% of the prespecified segments. CONCLUSIONS: TCL involved mainly the proximal coronary segments and did not have any effect on clinical outcomes. A more detailed thrombus burden quantification is required to investigate its prognostic implications. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00114972, NCT01443104, NCT00617084.

7 Clinical Trial Predictive Performance of SYNTAX Score II in Patients With Left Main and Multivessel Coronary Artery Disease-analysis of CREDO-Kyoto registry. 2014

Campos, Carlos M / van Klaveren, David / Iqbal, Javaid / Onuma, Yoshinobu / Zhang, Yao-Jun / Garcia-Garcia, Hector M / Morel, Marie-Angele / Farooq, Vasim / Shiomi, Hiroki / Furukawa, Yutaka / Nakagawa, Yoshihisa / Kadota, Kazushige / Lemos, Pedro A / Kimura, Takeshi / Steyerberg, Ewout W / Serruys, Patrick W. ·Department of Interventional Cardiology, Erasmus Medical Centre-University Medical Centre Rotterdam. ·Circ J · Pubmed #24998278.

ABSTRACT: BACKGROUND: SYNTAX score II (SSII) provides individualized estimates of 4-year mortality after coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) in order to facilitate decision-making between these revascularization methods. The purpose of the present study was to assess SSII in a real-world multicenter registry with distinct regional and epidemiological characteristics. METHODS AND RESULTS: Long-term mortality was analyzed in 3,896 patients undergoing PCI (n=2,190) or CABG (n=1,796) from the Coronary REvascularization Demonstrating Outcome Study in Kyoto (CREDO-Kyoto) PCI/CABG registry cohort-2. SSII discriminated well in both CABG and PCI patient groups (concordance index [c-index], 0.70; 95% CI: 0.68-0.72; and 0.75, 95% CI: 0.72-0.78) surpassing anatomical SYNTAX score (SS; c-index, 0.50; 95% CI: 0.47-0.53; and 0.59, 95% CI: 0.57-0.61). SSII had the best discriminative ability to separate low-, medium- and high-risk tertiles, and calibration plots showed good predictive performance for CABG and PCI groups. Use of anatomical SS as a reference improved the overall reclassification provided by SSII, with a net reclassification index of 0.5 (P<0.01). CONCLUSIONS: SSII has robust prognostic accuracy, both in CABG and in PCI patient groups and, compared with the anatomical SS alone, was more accurate in stratifying patients for late mortality in a real-world complex coronary artery disease Eastern population.

8 Clinical Trial Prognostic implications of coronary calcification in patients with obstructive coronary artery disease treated by percutaneous coronary intervention: a patient-level pooled analysis of 7 contemporary stent trials. 2014

Bourantas, Christos V / Zhang, Yao-Jun / Garg, Scot / Iqbal, Javaid / Valgimigli, Marco / Windecker, Stephan / Mohr, Friedrich W / Silber, Sigmund / Vries, Ton de / Onuma, Yoshinobu / Garcia-Garcia, Hector M / Morel, Marie-Angele / Serruys, Patrick W. ·Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. · Department of Cardiology, East Lancashire NHS Trust Blackburn, Lancashire, UK. · Department of Interventional Cardiology, Bern University Hospital, Bern, Switzerland. · Herzzentrum, Leipzig, Germany. · Heart Center at the Isar, Munich, Germany. · Cardialysis BV, Rotterdam, The Netherlands. · Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands International Centre for Circulatory Health, NHLI, Imperial College London, London, UK. ·Heart · Pubmed #24846971.

ABSTRACT: OBJECTIVE: To investigate the long-term prognostic implications of coronary calcification in patients undergoing percutaneous coronary intervention for obstructive coronary artery disease. METHODS: Patient-level data from 6296 patients enrolled in seven clinical drug-eluting stents trials were analysed to identify in angiographic images the presence of severe coronary calcification by an independent academic research organisation (Cardialysis, Rotterdam, The Netherlands). Clinical outcomes at 3-years follow-up including all-cause mortality, death-myocardial infarction (MI), and the composite end-point of all-cause death-MI-any revascularisation were compared between patients with and without severe calcification. RESULTS: Severe calcification was detected in 20% of the studied population. Patients with severe lesion calcification were less likely to have undergone complete revascularisation (48% vs 55.6%, p<0.001) and had an increased mortality compared with those without severely calcified arteries (10.8% vs 4.4%, p<0.001). The event rate was also high in patients with severely calcified lesions for the combined end-point death-MI (22.9% vs 10.9%; p<0.001) and death-MI- any revascularisation (31.8% vs 22.4%; p<0.001). On multivariate Cox regression analysis, including the Syntax score, the presence of severe coronary calcification was an independent predictor of poor prognosis (HR: 1.33 95% CI 1.00 to 1.77, p=0.047 for death; 1.23, 95% CI 1.02 to 1.49, p=0.031 for death-MI, and 1.18, 95% CI 1.01 to 1.39, p=0.042 for death-MI- any revascularisation), but it was not associated with an increased risk of stent thrombosis. CONCLUSIONS: Patients with severely calcified lesions have worse clinical outcomes compared to those without severe coronary calcification. Severe coronary calcification appears as an independent predictor of worse prognosis, and should be considered as a marker of advanced atherosclerosis.

9 Clinical Trial Impact of completeness of revascularization on the five-year outcome in percutaneous coronary intervention and coronary artery bypass graft patients (from the ARTS-II study). 2010

Sarno, Giovanna / Garg, Scot / Onuma, Yoshinobu / Gutiérrez-Chico, Juan-Luis / van den Brand, Marcel J B M / Rensing, Benno J W M / Morel, Marie-Angele / Serruys, Patrick W / Anonymous4880678. ·Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. ·Am J Cardiol · Pubmed #21059423.

ABSTRACT: The aim of this study was to compare clinical outcome at 5 years in patients with complete and incomplete revascularization treated with coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI) with drug-eluting stents. Baseline and procedural angiograms and surgical case-record forms were centrally assessed for completeness of revascularization. Patients treated with PCI for incomplete revascularization were stratified according to Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score tertiles. Complete revascularization was achieved in 360 of 588 patients (61.2%) in the PCI with sirolimus-eluting stent group and 477 of 567 patients (84.1%) in the CABG group (p <0.05). There was no significant difference in 5-year survival without major adverse cardiac and cerebrovascular events (MACCEs; death, cerebrovascular accident, myocardial infarction, and any revascularization) between patients with complete and incomplete revascularization treated with PCI or CABG. Survival free from MACCEs in patients with incomplete revascularization treated with PCI was significantly lower than those with complete revascularization treated with CABG (hazard ratio 1.66, 0.96 to 1.80, log-rank p = 0.001). The 5-year MACCE-free survival in patients with incomplete revascularization treated with PCI stratified according to SYNTAX score tertiles showed a significantly lower MACCE survival in the higher SYNTAX tertile compared to the low (hazard ratio 0.56, 0.32 to 0.96, log-rank p = 0.04) and intermediate (hazard ratio 0.50, 0.28 to 0.91, log-rank p = 0.02) tertiles, whereas survival between the low and intermediate SYNTAX tertiles was not significantly different (hazard ratio 1.13, 0.60 to 2.13, log-rank p = 0.71). In conclusion, this study suggests that patients with complex coronary disease, in whom complete revascularization cannot be achieved with PCI, should be offered surgical revascularization. However, in those patients with less complex disease, PCI is a valid alternative even if complete revascularization cannot be achieved.

10 Article Visual estimation versus different quantitative coronary angiography methods to assess lesion severity in bifurcation lesions. 2018

Grundeken, Maik J / Collet, Carlos / Ishibashi, Yuki / Généreux, Philippe / Muramatsu, Takashi / LaSalle, Laura / Kaplan, Aaron V / Wykrzykowska, Joanna J / Morel, Marie-Angèle / Tijssen, Jan G / de Winter, Robbert J / Onuma, Yoshinobu / Leon, Martin B / Serruys, Patrick W. ·Amsterdam Heart Center, Academic Medical Center, Amsterdam, The Netherlands. · Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. · Cardiovascular Research Foundation, New York. · Columbia University Medical Center, New York. · Morristown Medical Center, Morristown, New Jersey. · Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Québec, Canada. · Department of Cardiology, Fujita Health University Hospital, Toyoake, Japan. · Geisel School of Medicine/Dartmouth-Hitchcock Medical Center, New Hampshire, Lebanon. · Cardialysis B.V, Rotterdam, The Netherlands. · International Centre for Circulatory Health, NHLI, Imperial College London, United Kingdom. ·Catheter Cardiovasc Interv · Pubmed #28836339.

ABSTRACT: OBJECTIVES: To compare visual estimation with different quantitative coronary angiography (QCA) methods (single-vessel versus bifurcation software) to assess coronary bifurcation lesions. BACKGROUND: QCA has been developed to overcome the limitations of visual estimation. Conventional QCA however, developed in "straight vessels," has proved to be inaccurate in bifurcation lesions. Therefore, bifurcation QCA was developed. However, the impact of these different modalities on bifurcation lesion severity classification is yet unknown METHODS: From a randomized controlled trial investigating a novel bifurcation stent (Clinicaltrials.gov NCT01258972), patients with baseline assessment of lesion severity by means of visual estimation, single-vessel QCA, 2D bifurcation QCA and 3D bifurcation QCA were included. We included 113 bifurcations lesions in which all 5 modalities were assessed. The primary end-point was to evaluate how the different modalities affected the classification of bifurcation lesion severity and extent of disease. RESULTS: On visual estimation, 100% of lesions had side-branch diameter stenosis (%DS) >50%, whereas in 83% with single-vessel QCA, 27% with 2D bifurcation QCA and 26% with 3D bifurcation QCA a side-branch %DS >50% was found (P < 0.0001). With regard to the percentage of "true" bifurcation lesions, there was a significant difference between visual estimate (100%), single-vessel QCA (75%) and bifurcation QCA (17% with 2D bifurcation software and 13% with 3D bifurcation software, P < 0.0001). CONCLUSIONS: Our study showed that bifurcation lesion complexity was significantly affected when more advanced bifurcation QCA software were used. "True" bifurcation lesion rate was 100% on visual estimation, but as low as 13% when analyzed with dedicated bifurcation QCA software.

11 Article Non-invasive Heart Team assessment of multivessel coronary disease with coronary computed tomography angiography based on SYNTAX score II treatment recommendations: design and rationale of the randomised SYNTAX III Revolution trial. 2017

Cavalcante, Rafael / Onuma, Yoshinobu / Sotomi, Yohei / Collet, Carlos / Thomsen, Brian / Rogers, Campbell / Zeng, Yaping / Tenekecioglu, Erhan / Asano, Taku / Miyasaki, Yosuke / Abdelghani, Mohammad / Morel, Marie-Angèle / Serruys, Patrick W. ·Erasmus University Medical Center, Rotterdam, The Netherlands. ·EuroIntervention · Pubmed #27973335.

ABSTRACT: AIMS: The aim of this study was to investigate whether a Heart Team decision-making process regarding the choice of revascularisation strategy based on non-invasive coronary multislice computed tomography angiography (MSCT) assessment of coronary artery disease (CAD) is equivalent to the standard-of-care invasive angiography-based assessment in patients with multivessel CAD. METHODS AND RESULTS: The SYNTAX III Revolution trial is a prospective, multicentre, all-comers randomised trial that will randomise two Heart Teams to select between surgical and percutaneous treatment according to either an invasive conventional angiography or a non-invasive MSCT angiography assessment in patients with multivessel CAD. The treatment selection by each Heart Team will be guided by the SYNTAX score II calculation. The primary endpoint is the level of agreement according to kappa of the initial decision by the Heart Teams on the modality of the revascularisation based on MSCT and angiography assessments. Secondary endpoints include agreement on the number of vessels requiring treatment and the coronary segments in need of revascularisation. CONCLUSIONS: The SYNTAX III Revolution trial will provide valuable information regarding the ability of a purely non-invasive coronary anatomy assessment to select accurately the most appropriate revascularisation strategy for patients with multivessel CAD.

12 Article Tools and Techniques - Clinical: SYNTAX score II calculator. 2016

Sotomi, Yohei / Collet, Carlos / Cavalcante, Rafael / Morel, Marie-Angèle / Suwannasom, Pannipa / Farooq, Vasim / van Gameren, Menno / Onuma, Yoshinobu / Serruys, Patrick W. ·Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands. ·EuroIntervention · Pubmed #27173873.

ABSTRACT: -- No abstract --

13 Article Validation of the SYNTAX revascularization index to quantify reasonable level of incomplete revascularization after percutaneous coronary intervention. 2015

Généreux, Philippe / Campos, Carlos M / Farooq, Vasim / Bourantas, Christos V / Mohr, Friedrich W / Colombo, Antonio / Morel, Marie-Angèle / Feldman, Ted E / Holmes, David R / Mack, Michael J / Morice, Marie-Claude / Kappetein, A Pieter / Palmerini, Tullio / Stone, Gregg W / Serruys, Patrick W. ·New York-Presbyterian Hospital and Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York; Hôpital du Sacré-Coeur de Montréal, Université de Montréal, Montréal, Québec, Canada. · Department of Interventional Cardiology, Erasmus University Medical Center, Thoraxcenter, Rotterdam, The Netherlands; Department of Interventional Cardiology, Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil. · Department of Interventional Cardiology, Erasmus University Medical Center, Thoraxcenter, Rotterdam, The Netherlands. · Klinik fur Herzchirurgie, Leipzig, Germany. · Columbus Hospital/San Raffaele Hospital, Milan, Italy. · Cardiology Division, Evanston Hospital, Evanston, Illinois. · Mayo Clinic, Rochester, Minnesota. · Baylor Healthcare System, Dallas, Texas. · Institut Cardiovasculaire Paris Sud, Paris, France. · Istituto di Cardiologia, Policlinico S. Orsola, University of Bologna, Bologna, Italy. · New York-Presbyterian Hospital and Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York. · Department of Interventional Cardiology, Erasmus University Medical Center, Thoraxcenter, Rotterdam, The Netherlands; International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom. Electronic address: pg2295@columbia.edu. ·Am J Cardiol · Pubmed #25983123.

ABSTRACT: Incomplete revascularization is common after percutaneous coronary intervention (PCI). Whether a "reasonable" degree of incomplete revascularization is associated with a similar favorable long-term prognosis compared with complete revascularization remains unknown. We sought to quantify the proportion of coronary artery disease burden treated by PCI and evaluate its impact on outcomes using a new prognostic instrument-the Synergy Between PCI with Taxus and Cardiac Surgery (SYNTAX) Revascularization Index (SRI). The baseline SYNTAX score (bSS), the residual SYNTAX score, and the delta SYNTAX score (ΔSS) were determined from 888 angiograms of patients enrolled in the prospective SYNTAX trial. The SRI was then calculated for each patient using the following formula: SRI = (ΔSS/bSS]) × 100. Outcomes were examined according to the proportion of revascularized myocardium (SRI = 100% [complete revascularization], 50% to <100%, and <50%). The Youden index for the SRI was computed to identify the best cutoff for 5-year all-cause mortality. The mean bSS was 28.4 ± 11.5, and after PCI, the mean ΔSS was 23.8 ± 10.9 and the mean residual SYNTAX score was 4.5 ± 6.9. The mean SRI was 85.3 ± 21.2% and was 100% in 385 patients (43.5%), <100% to 50% in 454 patients (51.1%), and <50% in 48 patients (5.4%). Five-year adverse outcomes, including death, were inversely proportional to the SRI. An SRI cutoff of <70% (present in 142 patients [16.0%] after PCI) had the best prognostic accuracy for prediction of death and, by multivariable analysis, was an independent predictor of 5-year mortality (hazard ratio [HR] 4.13, 95% confidence interval [CI] 2.79 to 6.11, p <0.0001). In conclusion, the SRI is a newly described method for quantifying the proportion of coronary artery disease burden treated by PCI. The SRI is a useful tool in assessing the degree of revascularization after PCI, with SRI ≥70% representing a "reasonable" goal for patients with complex coronary artery disease.

14 Article Comparison between two- and three-dimensional quantitative coronary angiography bifurcation analyses for the assessment of bifurcation lesions: A subanalysis of the TRYTON pivotal IDE coronary bifurcation trial. 2015

Muramatsu, Takashi / Grundeken, Maik J / Ishibashi, Yuki / Nakatani, Shimpei / Girasis, Chrysafios / Campos, Carlos M / Morel, Marie-Angèle / Jonker, Hans / de Winter, Robbert J / Wykrzykowska, Joanna J / García-García, Hector M / Leon, Martin B / Serruys, Patrick W / Onuma, Yoshinobu / Anonymous1260828. ·Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. · Department of Cardiology, Fujita Health University Hospital, Toyoake, Japan. · Amsterdam Heart center, Academic Medical Center, Amsterdam, The Netherlands. · First Cardiology Department, Onassis Cardiac Surgery Center, Athens, Greece. · Department of Interventional Cardiology, Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil. · Cardialysis, B.V., Rotterdam, The Netherlands. · Cardiovascular Research Foundation/Columbia University Medical Center, New York Presbyterian Hospital, New York, New York. · International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom. ·Catheter Cardiovasc Interv · Pubmed #25914327.

ABSTRACT: BACKGROUND: Three-dimensional (3D) quantitative coronary angiography (QCA) provides more accurate measurements by minimizing inherent limitations of two-dimensional (2D) QCA. The aim of this study was to compare the measurements between 2D and 3D QCA analyses in bifurcation lesions. METHODS AND RESULTS: A total of 114 cases with non-left main bifurcation lesions in the TRYTON pivotal IDE Coronary Bifurcation Trial (ClinicalTrials.gov: NCT01258972) were analyzed using a validated bifurcation QCA software (CAAS 5.10, Pie Medical Imaging, Maastricht, the Netherlands). All cases were analyzed in matched projections between pre- and post-procedure. The 2D analysis was performed using one of two angiographic images used for 3D reconstruction showing a larger distal bifurcation angle. In the treated segments (stent and balloon), there were no differences in minimal luminal diameter (MLD) between 2D and 3D, while diameter stenosis (DS) was significantly higher in 2D compared to 3D both pre-procedure and post-procedure (53.9% for 2D vs. 52.1% for 3D pre-procedure, P < 0.01; 23.2% for 2D vs. 20.9% for 3D post-procedure, P = 0.01). In the sub-segment level analysis, lengths of proximal main branch, distal main branch, and side branch were consistently shorter in 2D compared to 3D both pre-procedure and post-procedure. Using 3D QCA, the anatomic location of the smallest MLD or the highest DS was relocated to a different bifurcation sub-segment in a considerable proportion of the patients compared to when 2D-QCA was used (kappa values: 0.50 for MLD, 0.55 for DS). CONCLUSIONS: Our data showed differences in addressing anatomical severity and location of coronary bifurcation lesions between in vivo 2D and 3D QCA analyses. More studies are needed to investigate potential clinical benefits in using 3D approach over 2D QCA for the assessment of bifurcation lesions.

15 Article Validity of SYNTAX score II for risk stratification of percutaneous coronary interventions: A patient-level pooled analysis of 5,433 patients enrolled in contemporary coronary stent trials. 2015

Campos, Carlos M / Garcia-Garcia, Hector M / van Klaveren, David / Ishibashi, Yuki / Cho, Yun-Kyeong / Valgimigli, Marco / Räber, Lorenz / Jonker, Hans / Onuma, Yoshinobu / Farooq, Vasim / Garg, Scot / Windecker, Stephan / Morel, Marie-Angele / Steyerberg, Ewout W / Serruys, Patrick W. ·Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands; Department of Interventional Cardiology Heart Institute (InCor), University of São Paulo Medical School, Sao Paulo, Brazil. · Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands; Cardialysis, Rotterdam, The Netherlands. Electronic address: h.garciagarcia@erasmusmc.nl. · Department of Public Health, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, The Netherlands. · Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands. · Department of Cardiology, Bern University Hospital, Bern, Switzerland. · Cardialysis, Rotterdam, The Netherlands. · Department of Cardiology, East Lancashire Hospitals NHS Trust, Blackburn, United Kingdom. · Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands; International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom. ·Int J Cardiol · Pubmed #25828327.

ABSTRACT: OBJECTIVES: To assess the clinical profile and long-term mortality in SYNTAX score II based strata of patients who received percutaneous coronary interventions (PCI) in contemporary randomized trials. BACKGROUND: The SYNTAX score II was developed in the randomized, all-comers' SYNTAX trial population and is composed by 2 anatomical and 6 clinical variables. The interaction of these variables with the treatment provides individual long-term mortality predictions if a patient undergoes coronary artery bypass grafting (CABG) or PCI. METHODS: Patient-level (n=5433) data from 7 contemporary coronary drug-eluting stent (DES) trials were pooled. The mortality for CABG or PCI was estimated for every patient. The difference in mortality estimates for these two revascularization strategies was used to divide the patients into three groups of theoretical treatment recommendations: PCI, CABG or PCI/CABG (the latter means equipoise between CABG and PCI for long term mortality). RESULTS: The three groups had marked differences in their baseline characteristics. According to the predicted risk differences, 5115 patients could be treated either by PCI or CABG, 271 should be treated only by PCI and, rarely, CABG (n=47) was recommended. At 3-year follow-up, according to the SYNTAX score II recommendations, patients recommended for CABG had higher mortality compared to the PCI and PCI/CABG groups (17.4%; 6.1% and 5.3%, respectively; P<0.01). CONCLUSIONS: The SYNTAX score II demonstrated capability to help in stratifying PCI procedures.

16 Article Inter-core lab variability in analyzing quantitative coronary angiography for bifurcation lesions: a post-hoc analysis of a randomized trial. 2015

Grundeken, Maik J / Ishibashi, Yuki / Généreux, Philippe / LaSalle, Laura / Iqbal, Javaid / Wykrzykowska, Joanna J / Morel, Marie-Angèle / Tijssen, Jan G / de Winter, Robbert J / Girasis, Chrysafios / Garcia-Garcia, Hector M / Onuma, Yoshinobu / Leon, Martin B / Serruys, Patrick W. ·Amsterdam Heart Center, Academic Medical Center, Amsterdam, the Netherlands. · Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. · Cardiovascular Research Foundation, New York, New York. · Cardialysis B.V., Rotterdam, the Netherlands. · Amsterdam Heart Center, Academic Medical Center, Amsterdam, the Netherlands; Cardialysis B.V., Rotterdam, the Netherlands. · Cardialysis B.V., Rotterdam, the Netherlands; First Cardiology Department, Onassis Cardiac Surgery Center, Athens, Greece. · Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Cardialysis B.V., Rotterdam, the Netherlands. · International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com. ·JACC Cardiovasc Interv · Pubmed #25700754.

ABSTRACT: OBJECTIVES: This study sought to evaluate inter-core lab variability in quantitative coronary angiography (QCA) analysis of bifurcation lesions. BACKGROUND: QCA of bifurcation lesions is challenging. To date there are no data available on the inter-core lab variability of bifurcation QCA analysis. METHODS: The randomized Tryton IDE (Tryton Pivotal IDE Coronary Bifurcation Trial) compared the Tryton Side Branch Stent (Tryton Medical, Durham, North Carolina) with balloon angioplasty as side branch treatment. QCA was performed in an angiographic subcohort (n = 326) at 9-month follow-up. Inter-core lab variability of QCA analysis between the Cardiovascular Research Foundation and the Cardialysis core labs was evaluated before and after alignment of the used QCA methodology using angiographic data derived from this angiographic follow-up cohort. RESULTS: In the original analysis, before alignment of QCA methodology, the mean difference between the core labs (bias) was large for all QCA parameters with wide 95% limits of agreement (1.96 × SD of the bias), indicating marked variability. The bias of the key angiographic endpoint of the Tryton trial, in-segment percentage diameter stenosis (%DS) of the side branch, was 5.5% (95% limits of agreement: -26.7% to 37.8%). After reanalysis, the bias of the in-segment %DS of the side branch reduced to 1.8% (95% limits of agreement: -16.7% to 20.4%). Importantly, after alignment of the 2 core labs, there was no longer a difference between both treatment groups (%DS of the side branch: treatment group A vs. group B: 34.4 ± 19.4% vs. 32.4 ± 16.1%, p = 0.340). CONCLUSIONS: Originally, a marked inter-core lab variability of bifurcation QCA analysis was found. After alignment of methodology, inter-core lab variability decreased considerably and impacted angiographic trial results. This latter finding emphasizes the importance of using the same methodology among different core labs worldwide. (Tryton Pivotal Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972).

17 Article Prognostic implications of severe coronary calcification in patients undergoing coronary artery bypass surgery: an analysis of the SYNTAX study. 2015

Bourantas, Christos V / Zhang, Yao-Jun / Garg, Scot / Mack, Michael / Dawkins, Keith D / Kappetein, Arie Pieter / Mohr, Friedrich W / Colombo, Antonio / Holmes, David R / Ståhle, Elisabeth / Feldman, Ted / Morice, Marie-Claude / de Vries, Ton / Morel, Marie-Angèle / Serruys, Patrick W. ·Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, the Netherlands. ·Catheter Cardiovasc Interv · Pubmed #24824456.

ABSTRACT: OBJECTIVES: To investigate the prognostic implications of the presence of severe lesion calcification in patients undergoing coronary artery bypass graft (CABG) operation. BACKGROUND: There is robust evidence that lesion calcification is a predictor of worse prognosis in patients undergoing percutaneous coronary intervention; however, there is limited data about the prognostic implication of lesion calcium in patients treated with CABG. METHODS: We retrospectively analyzed data from 1,545 patients who underwent CABG and were recruited in the SYNTAX study and CABG registry. Two experts reviewed the angiographic data and classified patients in two groups: those with severely calcified coronary arteries and those without severe lesion calcification. Clinical outcomes at 5-year follow-up were collected and compared in the two groups. RESULTS: One out of three patients exhibited severe lesion calcification (n = 588). Patients with calcified coronaries had an increased mortality at 5-year follow-up (17.1% vs. 9.9%, P < 0.001) and a higher event rate of death-myocardial infarction (MI) compared with those without (19.4% vs. 13.2%, P = 0.003), but there was no statistical significant difference between the two groups for major adverse cardiovascular events (MACE, 26.8% vs. 21.8%, P = 0.057). In multivariate Cox regression analysis severe lesion calcification was an independent predictor of an increased all-cause mortality (hazard ratio: 1.39, 95% confidence interval: 1.02-1.89; P = 0.037) but it was not an independent predictor of the combined end-points death-MI or MACE. CONCLUSIONS: Severe lesion calcification is associated with an increased mortality in patients undergoing CABG, but it is not an independent predictor of death-MI or MACE. This paradox can be attributed to the fact that CABG allows perfusion of the healthy coronaries bypassing the diseased arteries and thus it minimizes the risk of coronary events due to progressive atherosclerosis.

18 Article Prognostic value of site SYNTAX score and rationale for combining anatomic and clinical factors in decision making: insights from the SYNTAX trial. 2014

Zhang, Yao-Jun / Iqbal, Javaid / Campos, Carlos M / Klaveren, David V / Bourantas, Christos V / Dawkins, Keith D / Banning, Adrian P / Escaned, Javier / de Vries, Ton / Morel, Marie-Angèle / Farooq, Vasim / Onuma, Yoshinobu / Garcia-Garcia, Hector M / Stone, Gregg W / Steyerberg, Ewout W / Mohr, Friedrich W / Serruys, Patrick W. ·Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Nanjing First Hospital, Nanjing Medical University, Nanjing, China. · Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. · Department of Public Health, Erasmus Medical Center, Rotterdam, the Netherlands. · Boston Scientific Corporation, Natick, Massachusetts. · Oxford University Hospitals, Oxford, United Kingdom. · Clinico San Carlos University Hospital, Madrid, Spain. · Cardialysis BV, Rotterdam, the Netherlands. · Columbia University Medical Center/New York-Presbyterian Hospital, Cardiovascular Research Foundation, New York, New York. · Herzzentrum Universität Leipzig, Leipzig, Germany. · Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com. ·J Am Coll Cardiol · Pubmed #25082573.

ABSTRACT: BACKGROUND: The results of SYNTAX trial have been reported based on "corelab" calculated SS (cSS). It has been shown that reproducibility of SS is better among the core laboratory technicians than interventional cardiologists. Thus, the prognostic value and clinical implication of the "site" SYNTAX SS (sSS) remain unknown. OBJECTIVES: The study sought to evaluate the prognostic value and clinical implication of the sSS after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery in the randomized SYNTAX trial. METHODS: The sSS was calculated by the site investigators before randomization in the SYNTAX trial. New tertiles based on the sSS were defined with low (0 to 19), intermediate (20 to 27), and high (≥28) scores. The clinical endpoints were compared between PCI and CABG by Kaplan-Meier estimates, log-rank comparison, and Cox regression analyses using the new tertiles. The sSS-based SS II was calculated and its predictive performance was evaluated. RESULTS: The mean difference in cSS and sSS is 3.8 ± 11.2, with a mean absolute difference of 8.9 ± 7.8. In the overall cohort, using sSS there was a higher incidence of major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up in the PCI group for low (31.9% vs. 24.5%; p = 0.054), intermediate (39.5% vs. 29.5%; p = 0.019), and high (43.0% vs. 31.4%; p = 0.003) tertiles, compared with the CABG group. Similarly, in the 3-vessel disease subgroup, 5-year MACCE rates were higher in PCI group in all tertiles. Conversely, in the left main subgroup, MACCE rates were similar for PCI and CABG groups in all tertiles. The sSS-based SS II (c-index: 0.736) had predictive performance similar to the cSS-based SS II (c-index: 0.744), with net reclassification index of -0.0062 (p = 0.79). CONCLUSIONS: Appropriate training and unbiased assessment are needed when using SS in clinical decision making. sSS and tertiles based on sSS showed poor discrimination among low, intermediate, and high-risk groups. However, combining clinical factors with sSS retained the predictive performance of SS II. (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries; NCT00114972).

19 Article Predicting 3-year mortality after percutaneous coronary intervention: updated logistic clinical SYNTAX score based on patient-level data from 7 contemporary stent trials. 2014

Iqbal, Javaid / Vergouwe, Yvonne / Bourantas, Christos V / van Klaveren, David / Zhang, Yao-Jun / Campos, Carlos M / García-García, Hector M / Morel, Marie-Angele / Valgimigli, Marco / Windecker, Stephan / Steyerberg, Ewout W / Serruys, Patrick W. ·Department of Interventional Cardiology, Thoraxcenter, Rotterdam, the Netherlands; Department of Cardiovascular Science, University of Sheffield, Sheffield, United Kingdom. · Department of Public Health, Erasmus Medical Center, Rotterdam, the Netherlands. · Department of Interventional Cardiology, Thoraxcenter, Rotterdam, the Netherlands. · Cardialysis, Rotterdam, the Netherlands. · Cardiology Department, Bern University Hospital, Bern, Switzerland. · Department of Cardiovascular Science, University of Sheffield, Sheffield, United Kingdom. · Department of Interventional Cardiology, Thoraxcenter, Rotterdam, the Netherlands; Department of Cardiology, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com. ·JACC Cardiovasc Interv · Pubmed #24852801.

ABSTRACT: OBJECTIVES: This study aimed to update the Logistic Clinical SYNTAX score to predict 3-year survival after percutaneous coronary intervention (PCI) and compare the performance with the SYNTAX score alone. BACKGROUND: The SYNTAX score is a well-established angiographic tool to predict long-term outcomes after PCI. The Logistic Clinical SYNTAX score, developed by combining clinical variables with the anatomic SYNTAX score, has been shown to perform better than the SYNTAX score alone in predicting 1-year outcomes after PCI. However, the ability of this score to predict long-term survival is unknown. METHODS: Patient-level data (N = 6,304, 399 deaths within 3 years) from 7 contemporary PCI trials were analyzed. We revised the overall risk and the predictor effects in the core model (SYNTAX score, age, creatinine clearance, and left ventricular ejection fraction) using Cox regression analysis to predict mortality at 3 years. We also updated the extended model by combining the core model with additional independent predictors of 3-year mortality (i.e., diabetes mellitus, peripheral vascular disease, and body mass index). RESULTS: The revised Logistic Clinical SYNTAX models showed better discriminative ability than the anatomic SYNTAX score for the prediction of 3-year mortality after PCI (c-index: SYNTAX score, 0.61; core model, 0.71; and extended model, 0.73 in a cross-validation procedure). The extended model in particular performed better in differentiating low- and intermediate-risk groups. CONCLUSIONS: Risk scores combining clinical characteristics with the anatomic SYNTAX score substantially better predict 3-year mortality than the SYNTAX score alone and should be used for long-term risk stratification of patients undergoing PCI.

20 Article Impact of 3-dimensional bifurcation angle on 5-year outcome of patients after percutaneous coronary intervention for left main coronary artery disease: a substudy of the SYNTAX trial (synergy between percutaneous coronary intervention with taxus and cardiac surgery). 2013

Girasis, Chrysafios / Farooq, Vasim / Diletti, Roberto / Muramatsu, Takashi / Bourantas, Christos V / Onuma, Yoshinobu / Holmes, David R / Feldman, Ted E / Morel, Marie-Angele / van Es, Gerrit-Anne / Dawkins, Keith D / Morice, Marie-Claude / Serruys, Patrick W. ·Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands. · Department of Cardiovascular Disease and Internal Medicine, Mayo Clinic, Rochester, Minnesota. · Division of Cardiology, Evanston Hospital, Evanston, Illinois. · Cardialysis B.V., Rotterdam, the Netherlands. · Boston Scientific Corporation, Natick, Massachusetts. · Department of Cardiology, Institut Cardiovasculaire Paris Sud, Massy, France. · Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands. Electronic address: p.w.j.c.serruys@erasmusmc.nl. ·JACC Cardiovasc Interv · Pubmed #24355115.

ABSTRACT: OBJECTIVES: This study sought to investigate the impact of left main coronary artery (LMCA) 3-dimensional (3D) bifurcation angle (BA) parameters on 5-year clinical outcomes of patients randomized to LMCA percutaneous coronary intervention (PCI) in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial. BACKGROUND: BA can affect outcome after bifurcation PCI; 3D angiographic analysis provides reliable BA measurements. METHODS: The diastolic distal BA (between left anterior descending and left circumflex) and its systolic-diastolic range were explored. A stratified post-hoc survival analysis was performed for 5-year major adverse cardiac and cardiovascular events (MACCE) (all-cause death, cerebrovascular accident, myocardial infarction, or repeat revascularization), a safety endpoint (all-cause death, cerebrovascular accident, or myocardial infarction), and repeat revascularization. Analysis was performed in patients where 3D BA was available pre- and post-PCI. RESULTS: Of 266 patients eligible for analysis, 185 underwent bifurcation PCI (group B); 1 stent was used in 75 patients (group B1), whereas ≥2 stents were used in 110 patients (group B2). Stratification across pre-PCI diastolic distal BA tertiles (<82°, 82° to 106°, ≥107°) failed to show any difference in MACCE rates either in the entire study population (p = 0.99) or in group B patients (p = 0.78). Group B patients with post-PCI systolic-diastolic range <10° had significantly higher MACCE rates (50.8% vs. 22.7%, p < 0.001); repeat revascularization and safety endpoint rates were also higher (37.4% vs. 15.5%, p = 0.002, and 25.4% vs. 14.1%, p=0.055, respectively). Post-PCI systolic-diastolic range <10° was an independent predictor of MACCE (hazard ratio: 2.65; 95% confidence interval: 1.55 to 4.52; p < 0.001) in group B patients. CONCLUSIONS: A restricted post-procedural systolic-diastolic distal BA range resulted in higher 5-year adverse event rates after LMCA bifurcation PCI. Pre-PCI BA value did not affect the clinical outcome.

21 Article Incidence, correlates, and significance of abnormal cardiac enzyme rises in patients treated with surgical or percutaneous based revascularisation: a substudy from the Synergy between Percutaneous Coronary Interventions with Taxus and Cardiac Surgery (SYNTAX) Trial. 2013

Farooq, Vasim / Serruys, Patrick W / Vranckx, Pascal / Bourantas, Christos V / Girasis, Chrysafios / Holmes, David R / Kappetein, Arie Pieter / Mack, Michael / Feldman, Ted / Morice, Marie Claude / Colombo, Antonio / Morel, Marie-angèle / de Vries, Ton / Dawkins, Keith D / Mohr, Friedrich W / James, Stefan / Ståhle, Elisabeth. ·Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands. ·Int J Cardiol · Pubmed #23993326.

ABSTRACT: AIMS: The aim of the present investigation was to determine the long-term prognostic association of post-procedural cardiac enzyme elevation within the randomised Synergy between Percutaneous Coronary Intervention (PCI) with TAXUS and Cardiac Surgery (SYNTAX) Trial. METHODS: 1800 patients with unprotected left main or de novo three-vessel coronary artery disease were randomised to undergo coronary artery bypass graft (CABG) surgery or PCI. Per protocol patients underwent post-procedural blood sampling with creatine kinase (CK), and the cardiac specific MB iso-enzyme (CK-MB) only if the preceding CK ratio was ≥ 2 × the upper limit of normal (ULN). An independent chemistry laboratory evaluated all collected blood samples. RESULTS: Post-procedural CK sampling was available in 1629 of 1800 patients (90.5%). As per protocol, CK-MB analyses were undertaken in 474 of 491 patients (96.5%) in the CABG arm, and 53 of 61 patients (86.9%) in the PCI arm. Within the CABG arm, despite the limitations of incomplete data, a post-procedural CK-MB ratio <3/≥3 ULN separated 4-year mortality into low- and high-risk groups (2.3% vs. 9.5%, p=0.03). Additionally, in the CABG arm, a post-procedural CK-MB ratio ≥3 ULN was associated with an increased frequency of a high SYNTAX Score (≥33) tertile (high [≥33] SYNTAX Score: 39.5%, intermediate [23-32] SYNTAX Score 31.0%, low [≤22] SYNTAX Score 29.5%, p=0.02). Within the PCI arm, a post-procedural CK ratio of <2 or ≥2 ULN separated 4-year mortality into low- and high-risk groups (10.8% vs. 23.3%, p=0.001). Notably, there was an early (within 6 months) and late (after 2 years) peak in mortality in patients with a post-PCI CK ratio of ≥2 ULN. Lack of pre-procedural thienopyridine, carotid artery disease, type 1 diabetes, and presence of coronary bifurcations were independent correlates of a CK ratio ≥2 ULN post-PCI. CONCLUSION: Cardiac enzyme elevations post-CABG or post-PCI are associated with an adverse long-term mortality; the causes of which are multifactorial.

22 Article Advanced three-dimensional quantitative coronary angiographic assessment of bifurcation lesions: methodology and phantom validation. 2013

Girasis, Chrysafios / Schuurbiers, Johan C H / Muramatsu, Takashi / Aben, Jean-Paul / Onuma, Yoshinobu / Soekhradj, Satishkumar / Morel, Marie-angèle / van Geuns, Robert-Jan / Wentzel, Jolanda J / Serruys, Patrick W. ·Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands. ·EuroIntervention · Pubmed #23680960.

ABSTRACT: AIMS: Validation of new three-dimensional (3-D) bifurcation quantitative coronary angiography (QCA) software. METHODS AND RESULTS: Cardiovascular Angiography Analysis System (CAAS 5v10) allows 3-D angiographic reconstructions based on two or more 2-D projection images. Measurements for minimal lumen diameter (MLD), reference vessel diameter (RVD), percent diameter stenosis (DS) and bifurcation angle (BA) were validated against precision manufactured phantom bifurcations. Length measurements were validated against angiographic measurement catheters inserted into a plexiglas bifurcation phantom. In 3-D reconstructions based on two 2-D images, acquired at variable rotation and angulation, accuracy and precision (mean difference ± SD) of the 11-segment model for MLD, RVD and DS were 0.013±0.131 mm, -0.052±0.039 mm and -1.08±5.13%, respectively; inter-observer variability was 0.141 mm, 0.058 mm and 5.42%, respectively. Adding the antero-posterior (optimal) projection to these basic reconstructions resulted in reduced variability (0.101 mm, 0.041 mm and 3.93% for MLD, RVD and DS, p<0.01 for all) and showed a trend towards improved precision (0.109 mm, 0.031 mm and 4.26%, respectively, p>0.05 for all). In basic reconstructions, accuracy and precision for BA was -1.3±5.0°, whereas inter-observer variability was 7.5°; respective measures for length were 0.15±0.26 mm and 0.54 mm. Adding the antero-posterior projection resulted in decreased precision (0.47 mm, p<0.01) and increased variability (1.03 mm, p<0.01) for length measurements; precision (5.4°) and variability (7.9°) for BA did not change significantly (p>0.30). CONCLUSIONS: Advances in the methodology of 3-D reconstruction and quantitative analysis for bifurcation lesions translated into highly accurate, precise and reproducible measures of diameter, length and BA.

23 Article The CABG SYNTAX Score - an angiographic tool to grade the complexity of coronary disease following coronary artery bypass graft surgery: from the SYNTAX Left Main Angiographic (SYNTAX-LE MANS) substudy. 2013

Farooq, Vasim / Girasis, Chrysafios / Magro, Michael / Onuma, Yoshinobu / Morel, Marie Angèle / Heo, Jung Ho / Garcia-Garcia, Hector / Kappetein, Arie Pieter / van den Brand, Marcel / Holmes, David R / Mack, Michael / Feldman, Ted / Colombo, Antonio / Ståhle, Elisabeth / James, Stefan / Carrié, Didier / Fournial, Gerard / van Es, Gerrit-Anne / Dawkins, Keith D / Mohr, Friedrich W / Morice, Marie-Claude / Serruys, Patrick W. ·Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands. ·EuroIntervention · Pubmed #23537954.

ABSTRACT: AIMS: The SYNTAX Score (SXscore) has established itself as an important prognostic tool in patients undergoing percutaneous coronary intervention (PCI). A limitation of the SXscore is the inability to differentiate outcomes in patients who have undergone prior coronary artery bypass graft (CABG) surgery. The CABG SXscore was devised to address this limitation. METHODS AND RESULTS: In the SYNTAX-LE MANS substudy 115 patients with unprotected left main coronary artery disease (isolated or associated with one, two or three-vessel disease) treated with CABG were prospectively assigned to undergo a 15-month coronary angiogram. An independent core laboratory analysed the baseline SXscore prior to CABG. The 15-month CABG SXscore was calculated by a panel of three interventional cardiologists. The CABG SXscore was calculated by determining the standard SXscore in the "native" coronary vessels ("native SXscore") and deducting points based on the importance of the diseased coronary artery segment (Leaman score) that have a functioning bypass graft anastomosed distally. Points relating to intrinsic coronary disease, such as bifurcation disease or calcification, remain unaltered. The mean 15-month CABG SXscore was significantly lower compared to the mean baseline SXscore (baseline SXscore 31.6, SD 13.1; 15-month CABG SXscore 21.2, SD 11.1; p<0.001). Reproducibility analyses (kappa [k] statistics) indicated a substantial agreement between CABG SXscore measurements (k=0.70; 95% CI [0.50-0.90], p<0.001), with the points deducted to calculate the CABG SXscore the most reproducible measurement (k=0.74; 95% CI [0.53-0.95], p<0.001). Despite the limited power of the study, four-year outcome data (Kaplan-Meier curves) demonstrated a trend towards reduced all-cause death (9.1% vs. 1.8%, p=0.084) and death/CVA/MI (16.4% vs. 7.0%, p=0.126) in the low compared to the high CABG SXscore group. CONCLUSIONS: In this pilot study the calculation of the CABG SXscore appeared feasible, reproducible and may have a long-term prognostic role in patients with complex coronary disease undergoing surgical revascularisation. Validation of this new scoring methodology is required.

24 Article Anatomical and clinical characteristics to guide decision making between coronary artery bypass surgery and percutaneous coronary intervention for individual patients: development and validation of SYNTAX score II. 2013

Farooq, Vasim / van Klaveren, David / Steyerberg, Ewout W / Meliga, Emanuele / Vergouwe, Yvonne / Chieffo, Alaide / Kappetein, Arie Pieter / Colombo, Antonio / Holmes, David R / Mack, Michael / Feldman, Ted / Morice, Marie-Claude / Ståhle, Elisabeth / Onuma, Yoshinobu / Morel, Marie-angèle / Garcia-Garcia, Hector M / van Es, Gerrit Anne / Dawkins, Keith D / Mohr, Friedrich W / Serruys, Patrick W. ·Thoraxcenter, Erasmus University Medical Center, Rotterdam, Netherlands. ·Lancet · Pubmed #23439103.

ABSTRACT: BACKGROUND: The anatomical SYNTAX score is advocated in European and US guidelines as an instrument to help clinicians decide the optimum revascularisation method in patients with complex coronary artery disease. The absence of an individualised approach and of clinical variables to guide decision making between coronary artery bypass graft surgery (CABG) and percutaneous coronary intervention (PCI) are limitations of the SYNTAX score. SYNTAX score II aimed to overcome these limitations. METHODS: SYNTAX score II was developed by applying a Cox proportional hazards model to results of the randomised all comers SYNTAX trial (n=1800). Baseline features with strong associations to 4-year mortality in either the CABG or the PCI settings (interactions), or in both (predictive accuracy), were added to the anatomical SYNTAX score. Comparisons of 4-year mortality predictions between CABG and PCI were made for each patient. Discriminatory performance was quantified by concordance statistics and internally validated with bootstrap resampling. External validation was done in the multinational all comers DELTA registry (n=2891), a heterogeneous population that included patients with three-vessel disease (26%) or complex coronary artery disease (anatomical SYNTAX score ≥33, 30%) who underwent CABG or PCI. The SYNTAX trial is registered with ClinicalTrials.gov, number NCT00114972. FINDINGS: SYNTAX score II contained eight predictors: anatomical SYNTAX score, age, creatinine clearance, left ventricular ejection fraction (LVEF), presence of unprotected left main coronary artery (ULMCA) disease, peripheral vascular disease, female sex, and chronic obstructive pulmonary disease (COPD). SYNTAX score II significantly predicted a difference in 4-year mortality between patients undergoing CABG and those undergoing PCI (p(interaction) 0·0037). To achieve similar 4-year mortality after CABG or PCI, younger patients, women, and patients with reduced LVEF required lower anatomical SYNTAX scores, whereas older patients, patients with ULMCA disease, and those with COPD, required higher anatomical SYNTAX scores. Presence of diabetes was not important for decision making between CABG and PCI (p(interaction) 0·67). SYNTAX score II discriminated well in all patients who underwent CABG or PCI, with concordance indices for internal (SYNTAX trial) validation of 0·725 and for external (DELTA registry) validation of 0·716, which were substantially higher than for the anatomical SYNTAX score alone (concordance indices of 0·567 and 0·612, respectively). A nomogram was constructed that allowed for an accurate individualised prediction of 4-year mortality in patients proposing to undergo CABG or PCI. INTERPRETATION: Long-term (4-year) mortality in patients with complex coronary artery disease can be well predicted by a combination of anatomical and clinical factors in SYNTAX score II. SYNTAX score II can better guide decision making between CABG and PCI than the original anatomical SYNTAX score. FUNDING: Boston Scientific Corporation.

25 Article Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial. 2013

Mohr, Friedrich W / Morice, Marie-Claude / Kappetein, A Pieter / Feldman, Ted E / Ståhle, Elisabeth / Colombo, Antonio / Mack, Michael J / Holmes, David R / Morel, Marie-angèle / Van Dyck, Nic / Houle, Vicki M / Dawkins, Keith D / Serruys, Patrick W. ·Herzzentrum Universität Leipzig, Leipzig, Germany. mohrf@medizin.uni-leipzig.de ·Lancet · Pubmed #23439102.

ABSTRACT: BACKGROUND: We report the 5-year results of the SYNTAX trial, which compared coronary artery bypass graft surgery (CABG) with percutaneous coronary intervention (PCI) for the treatment of patients with left main coronary disease or three-vessel disease, to confirm findings at 1 and 3 years. METHODS: The randomised, clinical SYNTAX trial with nested registries took place in 85 centres in the USA and Europe. A cardiac surgeon and interventional cardiologist at each centre assessed consecutive patients with de-novo three-vessel disease or left main coronary disease to determine suitability for study treatments. Eligible patients suitable for either treatment were randomly assigned (1:1) by an interactive voice response system to either PCI with a first-generation paclitaxel-eluting stent or to CABG. Patients suitable for only one treatment option were entered into either the PCI-only or CABG-only registries. We analysed a composite rate of major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up by Kaplan-Meier analysis on an intention-to-treat basis. This study is registered with ClinicalTrials.gov, number NCT00114972. FINDINGS: 1800 patients were randomly assigned to CABG (n=897) or PCI (n=903). More patients who were assigned to CABG withdrew consent than did those assigned to PCI (50 vs 11). After 5 years' follow-up, Kaplan-Meier estimates of MACCE were 26·9% in the CABG group and 37·3% in the PCI group (p<0·0001). Estimates of myocardial infarction (3·8% in the CABG group vs 9·7% in the PCI group; p<0·0001) and repeat revascularisation (13·7%vs 25·9%; p<0·0001) were significantly increased with PCI versus CABG. All-cause death (11·4% in the CABG group vs 13·9% in the PCI group; p=0·10) and stroke (3·7%vs 2·4%; p=0·09) were not significantly different between groups. 28·6% of patients in the CABG group with low SYNTAX scores had MACCE versus 32·1% of patients in the PCI group (p=0·43) and 31·0% in the CABG group with left main coronary disease had MACCE versus 36·9% in the PCI group (p=0·12); however, in patients with intermediate or high SYNTAX scores, MACCE was significantly increased with PCI (intermediate score, 25·8% of the CABG group vs 36·0% of the PCI group; p=0·008; high score, 26·8%vs 44·0%; p<0·0001). INTERPRETATION: CABG should remain the standard of care for patients with complex lesions (high or intermediate SYNTAX scores). For patients with less complex disease (low SYNTAX scores) or left main coronary disease (low or intermediate SYNTAX scores), PCI is an acceptable alternative. All patients with complex multivessel coronary artery disease should be reviewed and discussed by both a cardiac surgeon and interventional cardiologist to reach consensus on optimum treatment. FUNDING: Boston Scientific.

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