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Coronary Artery Disease: HELP
Articles by Marie-Angele Morel
Based on 40 articles published since 2010
(Why 40 articles?)
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Between 2010 and 2020, Marie-Angel Morel wrote the following 40 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2
1 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.

2 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.

3 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.

4 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.

5 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.

6 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.

7 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.

8 Article Defining device success for percutaneous coronary intervention trials: a position statement from the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology. 2020

Chang, Chun Chin / Kogame, Norihiro / Onuma, Yoshinobu / Byrne, Robert A / Capodanno, Davide / Windecker, Stephan / Morel, Marie-Angèle / Cutlip, Donald E / Krucoff, Mitchell W / Stone, Gregg W / Lansky, Alexandra J / Mehran, Roxana / Spitzer, Ernest / Fraser, Alan G / Baumbach, Andreas / Serruys, Patrick W. ·Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands. ·EuroIntervention · Pubmed #31475907.

ABSTRACT: Percutaneous coronary intervention with implantation of drug-eluting stents has become the most commonly performed revascularisation procedure in patients with symptomatic coronary artery disease. Continuous iterations of coronary devices incorporating changes in platform materials, geometry, strut thickness, drug release mechanisms and antiproliferative drugs have progressively reduced the rate of device-related adverse clinical events. Objective performance criteria have been proposed for clinical and angiographic outcomes of drug-eluting stents. The rate of device success has been recognised as an intraprocedural endpoint to evaluate the mechanical ability to complete a procedure with the specific device assigned by protocol in randomised comparative trials. The European Commission and the U.S. Food and Drug Administration both provide guidance documents, including the mechanistic evaluation of coronary stents, which recommend operational definitions of device success. While the majority of clinical trials investigating drug-eluting stents have adopted this endpoint definition, inconsistencies in application limit the reliability of comparisons across different trials reporting device success rates. In addition, it is not uncommon that device success rates are not reported by investigators. A consistent definition of device success is essential to allow scientific comparisons of this technical performance endpoint between devices across different trials. Therefore, we performed a systematic evaluation of definitions and reporting of device success in clinical trials. We propose an extended definition as well as considerations for approaching the determination of the device success rates in future percutaneous coronary intervention trials.

9 Article A prospective multicentre randomised all-comers trial to assess the safety and effectiveness of the thin-strut sirolimus-eluting coronary stent SUPRAFLEX: rationale and design of the Thin Strut Sirolimus-eluting Stent in All Comers Population vs Everolimus-eluting Stent (TALENT) trial. 2019

Modolo, Rodrigo / Chichareon, Ply / Kogame, Norihiro / Asano, Taku / Chang, Chun-Chin / de Winter, Robbert J / Kaul, Upendra / Zaman, Azfar / Spitzer, Ernest / Takahashi, Kuniaki / Katagiri, Yuki / Soliman, Osama I I / van Es, Gerrit A / Morel, Marie-Angèle / Onuma, Yoshinobu / Serruys, Patrick W. ·Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. ·EuroIntervention · Pubmed #30066672.

ABSTRACT: AIMS: The aim of this study is to compare the SUPRAFLEX sirolimus-eluting stent (SES) with the XIENCE everolimus-eluting stent (EES) with respect to target lesion failure (TLF) at 12 months in a non-inferiority trial in a "real-world" patient population. METHODS AND RESULTS: This is a prospective, randomised, 1:1 balanced, controlled, single-blind, multicentre study comparing clinical outcomes at 12 months between SUPRAFLEX and XIENCE in an "all-comers" patient population, comprising a total of 1,430 enrolled subjects with symptomatic coronary artery disease who qualify for percutaneous coronary interventions at 23 centres in Europe. The primary endpoint is a non-inferiority comparison of the device-oriented composite endpoint target lesion failure (cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularisation) of the SUPRAFLEX group to the XIENCE group at 12 months post procedure. Secondary endpoints include the patient-oriented composite endpoint, target vessel failure, mortality, myocardial infarction, revascularisation and stent thrombosis rates (ARC classification). CONCLUSIONS: The TALENT trial aims to assess the safety and effectiveness of the thin-strut SUPRAFLEX compared to the current standard of care (XIENCE EES) in patients with atherosclerotic lesions. This will provide valuable information on the impact of this thin-strut device in an all-comers population.

10 Article Coronary computed tomography angiography for heart team decision-making in multivessel coronary artery disease. 2018

Collet, Carlos / Onuma, Yoshinobu / Andreini, Daniele / Sonck, Jeroen / Pompilio, Giulio / Mushtaq, Saima / La Meir, Mark / Miyazaki, Yosuke / de Mey, Johan / Gaemperli, Oliver / Ouda, Ahmed / Maureira, Juan Pablo / Mandry, Damien / Camenzind, Edoardo / Macron, Laurent / Doenst, Torsten / Teichgräber, Ulf / Sigusch, Holger / Asano, Taku / Katagiri, Yuki / Morel, Marie-Angele / Lindeboom, Wietze / Pontone, Gianluca / Lüscher, Thomas F / Bartorelli, Antonio L / Serruys, Patrick W. ·Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ Amsterdam, the Netherlands. · Department of Cardiology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Laarbeeklaan 101, Jette, Brussel, Belgium. · Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Doctor Molewaterplein 40, GD Rotterdam, the Netherlands. · Cardialysis BV, Westblaak 98, KM Rotterdam, the Netherlands. · Centro Cardiologico Monzino, University of Milan, Via Carlo Parea, 4, Milano, Italy. · Department of Cardiology, University of Zurich, Rämistrasse 71, Zürich, Switzerland. · Department of Radiology, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Laarbeeklaan 101, Jette, Brussel, Belgium. · Department of Cardiovascular Surgery, University of Zurich, Rämistrasse 71, Zürich, Switzerland. · Department of Cardiovascular Surgery, CHRU Nancy and University of Lorraine, Avenue du Maréchal de Lattre, Rue Charles Welche, Nancy, France. · Department of Radiology, CHRU Nancy and University of Lorraine, Avenue du Maréchal de Lattre, Rue Charles Welche, Nancy, France. · Department of Cardiology, CHRU Nancy and University of Lorraine, Avenue du Maréchal de Lattre, Rue Charles Welche, Nancy, France. · Department of Cardiology, Centre cardiologique du nord, 36 Rue des Moulins Gémeaux, Saint-Denis, France. · Department of Cardiovascular Surgery, Jena University Hospital, Friedrich Schiller University of Jena, Fürstengraben 1, Jena, Germany. · Department of Radiology, Jena University Hospital, Friedrich Schiller University of Jena, Fürstengraben 1, Jena, Germany. · Department of Cardiology, Heinrich Braun Klinikum, Karl-Keil-Straße 35, Zwickau, Germany. · Department of Cardiology, Royal Brompton and Harefield Hospitals, Imperial College of London, Kensington, London, UK. · Department of Biomedical and Clinical Sciences "Luigi Sacco", University of Milan, Via Festa del Perdono, 7, Milano MI, Italy. ·Eur Heart J · Pubmed #30312411.

ABSTRACT: Aims: Coronary computed tomography angiography (CTA) has emerged as a non-invasive diagnostic method for patients with suspected coronary artery disease, but its usefulness in patients with complex coronary artery disease remains to be investigated. The present study sought to determine the agreement between separate heart teams on treatment decision-making based on either coronary CTA or conventional angiography. Methods and results: Separate heart teams composed of an interventional cardiologist, a cardiac surgeon, and a radiologist were randomized to assess the coronary artery disease with either coronary CTA or conventional angiography in patients with de novo left main or three-vessel coronary artery disease. Each heart team, blinded for the other imaging modality, quantified the anatomical complexity using the SYNTAX score and integrated clinical information using the SYNTAX Score II to provide a treatment recommendations based on mortality prediction at 4 years: coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), or equipoise between CABG and PCI. The primary endpoint was the agreement between heart teams on the revascularization strategy. The secondary endpoint was the impact of fractional flow reserve derived from coronary CTA (FFRCT) on treatment decision and procedural planning. Overall, 223 patients were included. A treatment recommendation of CABG was made in 28% of the cases with coronary CTA and in 26% with conventional angiography. The agreement concerning treatment decision between coronary CTA and conventional angiography was high (Cohen's kappa 0.82, 95% confidence interval 0.74-0.91). The heart teams agreed on the coronary segments to be revascularized in 80% of the cases. FFRCT was available for 869/1108 lesions (196/223 patients). Fractional flow reserve derived from coronary CTA changed the treatment decision in 7% of the patients. Conclusion: In patients with left main or three-vessel coronary artery disease, a heart team treatment decision-making based on coronary CTA showed high agreement with the decision derived from conventional coronary angiography suggesting the potential feasibility of a treatment decision-making and planning based solely on this non-invasive imaging modality and clinical information. Trial registration number: NCT02813473.

11 Article Angiographic late lumen loss revisited: impact on long-term target lesion revascularization. 2018

Asano, Taku / Serruys, Patrick W / Collet, Carlos / Miyazaki, Yosuke / Takahashi, Kuniaki / Chichareon, Ply / Katagiri, Yuki / Modolo, Rodrigo / Tenekecioglu, Erhan / Morel, Marie-Angèle / Garg, Scot / Wykrzykowska, Joanna / Piek, Jan J / Sabate, Manel / Morice, Marie-Claude / Chevalier, Bernard / Windecker, Stephan / Onuma, Yoshinobu. ·Academic Medical Center, University of Amsterdam, Meibergdreef 9, AZ Amsterdam, The Netherlands. · St. Luke's International Hospital, 9-1 Akashicho, Chūō, Tokyo, Japan. · NHLI, Imperial College London, Dovehouse Street, Chelsea, London, UK. · Department of Cardiology, Universitair Ziekenhuis Brussel, Avenue du Laerbeek 101, Jette, Belgium. · ThoraxCenter, Erasmus Medical Center, Doctor Molewaterplein 40, GD Rotterdam, The Netherlands. · Cardialysis, Westblaak 98, KM Rotterdam, The Netherlands. · East Lancashire Hospitals NHS Trust, Casterton Ave, Burnley, UK. · Cardiovascular Institute, Hospital Clinic, IDIBAPS, University of Barcelona, Carrer del Rosselló, 149, Barcelona, Spain. · Institut Cardiovasculaire Paris Sud, 6 Avenue du Noyer Lambert, Massy, France. · Bern University Hospital, Freiburgstrasse 18, Bern, Switzerland. ·Eur Heart J · Pubmed #30124834.

ABSTRACT: Aim: In current device trials, the values of angiographic late lumen loss (LLL) have become extremely low and the relationship between LLL and clinical endpoints has not been recently re-evaluated. The impact of LLL on target lesion revascularization (TLR) in a patient- and study-level analysis of contemporary coronary devices was investigated. Methods and results: We performed a patient-level meta-analysis of seven randomized controlled trials including 2426 patients treated with first- and second-generation drug-eluting stents (DES) and a study-level meta-analysis of 40 studies including 19 199 patients treated with CE-marked DES. In the patient-level analysis, the probability regression curve showed an exponential relationship between in-stent LLL and 2-year incidence of TLR. The optimal cut-off value of LLL based on Youden's index for 2-year TLR event was 0.50 mm. In the Cox proportional hazard model, LLL >0.50 mm was independently associated with an increased incidence of TLR up to 4 years after angiographic follow-up {adjusted hazard ratio (HR) 6.62 [95% confidence interval (95% CI) 4.67-9.39], P < 0.001}. In the meta-regression analysis of the DES studies, pooled mean value of LLL was as low as 0.23 mm (95% CI 0.20-0.26), and there was a moderate correlation between the 1- and 5-year incidence of TLR and the percentage of the lesions with LLL >0.50 mm (R2 = 0.44, P < 0.001 at 1 year, R2 = 0.40, P < 0.001 at 5 years). Conclusion: An angiographic LLL ≤0.50 mm was not predictive of the incidence of TLR whereas a LLL >0.50 mm was. Low LLL in contemporary device trials may not be a sufficiently discriminating parameter for the comparative evaluation of devices.

12 Article Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. 2018

Garcia-Garcia, Hector M / McFadden, Eugène P / Farb, Andrew / Mehran, Roxana / Stone, Gregg W / Spertus, John / Onuma, Yoshinobu / Morel, Marie-Angèle / van Es, Gerrit-Anne / Zuckerman, Bram / Fearon, William F / Taggart, David / Kappetein, Arie-Pieter / Krucoff, Mitchell W / Vranckx, Pascal / Windecker, Stephan / Cutlip, Donald / Serruys, Patrick W / Anonymous3450951. ·Cardialysis, Rotterdam, The Netherlands. · Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, USA. · Interventional Cardiology, Cork University Hospital, Cork, Ireland. · US Food and Drug Administration, Washington, DC, USA. · Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, US. · Clinical Trials Center, Cardiovascular Research Foundation and Division of Cardiology, Columbia University Medical Center, New York, US. · Mid America Heart Institute, University of Missouri, Kansas City, USA. · Stanford University Medical Center, Stanford, CA, USA. · Nuffield Department of Surgery, University of Oxford, Oxford, UK. · Department of Cardiothoracic Surgery, Thoraxcenter, Erasmus Medical Canter, Rotterdam, The Netherlands. · Duke University Medical Center/Duke Clinical Research Institute, Durham, North Carolina, US. · Hartcentrum Hasselt and Faculty of Medicine and Life Sciences University of Hasselt, Hasselt, Belgium. · Bern University Hospital, Bern, Switzerland. · Harvard Clinical Research Institute, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA. · Centre for International Cardiovascular Health, Imperial College London UK. ·Eur Heart J · Pubmed #29897428.

ABSTRACT: The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.

13 Article Fractional Flow Reserve Derived From Computed Tomographic Angiography in Patients With Multivessel CAD. 2018

Collet, Carlos / Miyazaki, Yosuke / Ryan, Nicola / Asano, Taku / Tenekecioglu, Erhan / Sonck, Jeroen / Andreini, Daniele / Sabate, Manel / Brugaletta, Salvatore / Stables, Rodney H / Bartorelli, Antonio / de Winter, Robbert J / Katagiri, Yuki / Chichareon, Ply / De Maria, Giovanni Luigi / Suwannasom, Pannipa / Cavalcante, Rafael / Jonker, Hans / Morel, Marie-Angèle / Cosyns, Bernard / Kappetein, Arie P / Taggart, David T / Farooq, Vasim / Escaned, Javier / Banning, Adrian / Onuma, Yoshinobu / Serruys, Patrick W. ·Department of Cardiology, Academic Medical Center of Amsterdam, Cardiology, Amsterdam, the Netherlands; Department of Cardiology, Universitair Ziekenhuis Brussel, Brussels, Belgium. · Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. · Hospital Clínico San Carlos IDISSC and Universidad Complutense de Madrid, Madrid, Spain. · Department of Cardiology, Academic Medical Center of Amsterdam, Cardiology, Amsterdam, the Netherlands. · Department of Cardiology, Universitair Ziekenhuis Brussel, Brussels, Belgium. · Centro Cardiologico Monzino, University of Milan, Milan, Italy. · Hospital Clinic I Provincial de Barcelona, Barcelona, Spain. · Liverpool Heart and Chest Hospital, Liverpool, United Kingdom. · John Radcliffe Hospital, Cardiology, Oxford, United Kingdom. · Cardialysis BV, Rotterdam, the Netherlands. · Manchester Heart Centre, Manchester Royal Infirmary, Central Manchester University Hospitals, Manchester, United Kingdom. · Department of Cardiology, Universitair Ziekenhuis Brussel, Brussels, Belgium; Cardialysis BV, Rotterdam, the Netherlands. · Department of Cardiology, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com. ·J Am Coll Cardiol · Pubmed #29802016.

ABSTRACT: BACKGROUND: The functional SYNTAX score (FSS) has been shown to improve the discrimination for major adverse cardiac events compared with the anatomic SYNTAX score (SS) while reducing interobserver variability. However, evidence supporting the noninvasive FSS in patients with multivessel coronary artery disease (CAD) is scarce. OBJECTIVES: The purpose of this study was to assess the feasibility of and validate the noninvasive FSS derived from coronary computed tomography angiography (CTA) with fractional flow reserve (FFR METHODS: The CTA-SS was calculated in patients with 3-vessel CAD included in the SYNTAX II (SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery II) study. The noninvasive FSS was determined by including only ischemia-producing lesions (FFR RESULTS: The CTA-SS was feasible in 86% of patients (66 of 77), whereas the noninvasive FSS was feasible in 80% (53 of 66). The anatomic SS was overestimated by CTA compared with conventional angiography (27.6 ± 6.4 vs. 25.3 ± 6.9; p < 0.0001) whereas the calculation of the FSS yielded similar results between the noninvasive and invasive imaging modalities (21.6 ± 7.8 vs. 21.2 ± 8.8; p = 0.589). The noninvasive FSS reclassified 30% of patients from the high- and intermediate-SS tertiles to the low-risk tertile, whereas invasive FSS reclassified 23% of patients from the high- and intermediate-SS tertiles to the low-risk tertile. The agreement on the classic SS tertiles based on Kappa statistics was slight for the anatomic SS (Kappa = 0.19) and fair for the FSS (Kappa = 0.32). The diagnostic accuracy of FFR CONCLUSIONS: Calculation of the noninvasive FSS is feasible and yielded similar results to those obtained with invasive pressure-wire assessment. The agreement on the SYNTAX score tertile classification improved with the inclusion of the functional component from slight to fair agreement. FFR

14 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.

15 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.

16 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 --

17 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.

18 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.

19 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.

20 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).

21 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.

22 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).

23 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.

24 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.

25 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.

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