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Coronary Artery Disease: HELP
Articles by Ton de Vries
Based on 17 articles published since 2010
(Why 17 articles?)
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Between 2010 and 2020, Ton de Vries wrote the following 17 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
1 Guideline Defining Staged Procedures for Percutaneous Coronary Intervention Trials: A Guidance Document. 2018

Spitzer, Ernest / McFadden, Eugène / Vranckx, Pascal / de Vries, Ton / Ren, Ben / Collet, Carlos / Onuma, Yoshinobu / Garcia-Garcia, Hector M / Lopes, Renato D / Stone, Gregg W / Cutlip, Donald E / Serruys, Patrick W. ·Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands; Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands. · Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands; Department of Cardiology, Cork University Hospital, Cork, Ireland. · Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Faculty of Medicine and Life Sciences Hasselt University, Hasselt, Belgium. · Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands. · Department of Cardiology, Academic Medical Center, Amsterdam, the Netherlands. · Department of Cardiology, MedStar Washington Hospital Center, Washington, DC. · Division of Cardiology, Duke University Medical Center/Duke Clinical Research Institute, Durham, North Carolina. · Clinical Trials Center, Cardiovascular Research Foundation and Division of Cardiology, Columbia University Medical Center, New York, New York. · Baim Institute for Clinical Research, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Boston, Massachusetts. · International Centre for Circulatory Health, NHLI, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com. ·JACC Cardiovasc Interv · Pubmed #29747912.

ABSTRACT: Patients in coronary intervention trials may require more than 1 procedure to complete the intended revascularization strategy. However, these staged interventions are not consistently defined. Standardized definitions are needed to allow meaningful comparisons of this outcome among trials. This document provides guidance on relevant parameters involving staged procedures, including minimum data collection and consistent classification of coronary procedures initially identified as staged; the aim is to achieve consistency among clinical trialists, sponsors, health authorities, and regulators. Definitions were developed jointly among representatives of academic institutions and clinical research organizations based on clinical trial experience and published literature. Reasons for staged procedures were identified and include baseline kidney function, contrast load and radiation exposure, lesion complexity, and patient or operator fatigue. Moreover, nonclinical reasons include procedure scheduling and reimbursement. Management of staged procedures should be a standalone section in clinical trial protocols and clinical events committee charters. These documents should clearly define a time window for staged procedures that allows latitude for local policies, while respecting accepted clinical guidelines, and consistency with study objectives. Investigators should document in the case report form the intent to stage a procedure, the lesions to be treated, and the reasons for staging, preferably before randomization. Ideally, all reinterventions, or at least all procedures performed after the recommended time window, those in which data suggest an anticipated procedure due to a worsening condition and those where a revascularization is attempted in the target vessel, should be reviewed by an independent clinical events committee.

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 Article Prediction of atherosclerotic disease progression using LDL transport modelling: a serial computed tomographic coronary angiographic study. 2017

Sakellarios, Antonis / Bourantas, Christos V / Papadopoulou, Stella-Lida / Tsirka, Zeta / de Vries, Ton / Kitslaar, Pieter H / Girasis, Chrysafios / Naka, Katerina K / Fotiadis, Dimitrios I / Veldhof, Susan / Stone, Greg W / Reiber, Johan H C / Michalis, Lampros K / Serruys, Patrick W / de Feyter, Pim J / Garcia-Garcia, Hector M. ·Unit of Medical Technology and Intelligent Information Systems, Department of Materials Science and Engineering, University of Ioannina, Ioannina, Greece. · Department of Cardiovascular Sciences, University College London, London, UK. · Department of Cardiology, Barts Health NHS Foundation Trust, London, UK. · Division of Image Processing, Department of Radiology, Leiden University Medical Center, Leiden, The Netherlands. · Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, z120 Dr Molerwaterplein 40, 3015 GD Rotterdam, The Netherlands. · Department of Cardiology, Medical School, University of Ioannina, Ioannina, Greece. · Abbott Vascular, Diegem, Belgium. · Columbia University Medical Center, New York, NY, USA. · Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, z120 Dr Molerwaterplein 40, 3015 GD Rotterdam, The Netherlands hect2701@gmail.com. ·Eur Heart J Cardiovasc Imaging · Pubmed #26985077.

ABSTRACT: AIM: To investigate the efficacy of low-density lipoprotein (LDL) transport simulation in reconstructed arteries derived from computed tomography coronary angiography (CTCA) to predict coronary segments that are prone to progress. METHODS AND RESULTS: Thirty-two patients admitted with an acute coronary event who underwent 64-slice CTCA after percutaneous coronary intervention and at 3-year follow-up were included in the analysis. The CTCA data were used to reconstruct the coronary anatomy of the untreated vessels at baseline and follow-up, and LDL transport simulation was performed in the baseline models. The computed endothelial shear stress (ESS), LDL concentration, and CTCA-derived plaque characteristics were used to identify predictors of substantial disease progression (defined as an increase in the plaque burden at follow-up higher than two standard deviations of the intra-observer variability of the expert who performed the analysis). Fifty-eight vessels were analysed. High LDL concentration [odds ratio (OR): 2.16; 95% confidence interval (CI): 1.64-2.84; P = 0.0054], plaque burden (OR: 1.40; 95% CI: 1.13-1.72; P = 0.0017), and plaque area (OR: 3.46; 95% CI: 2.20-5.44; P≤ 0.0001) were independent predictors of a substantial disease progression at follow-up. The ESS appears as a predictor of disease progression in univariate analysis but was not an independent predictor when the LDL concentration was entered into the multivariate model. The accuracy of the model that included the LDL concentration was higher than the accuracy of the model that included the ESS (65.1 vs. 62.5%). CONCLUSIONS: LDL transport modelling appears a better predictor of atherosclerotic disease progression than the ESS, and combined with the atheroma characteristics provided by CTCA is able to detect with a moderate accuracy segments that will exhibit a significant plaque burden increase at mid-term follow-up.

4 Article First generation versus second generation drug-eluting stents for the treatment of bifurcations: 5-year follow-up of the LEADERS all-comers randomized trial. 2016

Grundeken, Maik J / Wykrzykowska, Joanna J / Ishibashi, Yuki / Garg, Scot / de Vries, Ton / Garcia-Garcia, Hector M / Onuma, Yoshinobu / de Winter, Robbert J / Buszman, Pawel / Linke, Axel / Ischinger, Thomas / Klauss, Volker / Eberli, Franz / Corti, Roberto / Wijns, William / Morice, Marie-Claude / di Mario, Carlo / Meier, Bernhard / Jüni, Peter / Yazdani, Ashkan / Copt, Samuel / Windecker, Stephan / Serruys, Patrick W. ·Heartcenter, Academic Medical Center, Amsterdam, The Netherlands. · Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands. · East Lancashire Hospitals NHS Trust, Blackburn, United Kingdom. · Cardialysis BV, Rotterdam, The Netherlands. · American Heart of Poland, Ustroń, Poland. · Herzzentrum Leipzig, Leipzig, Germany. · Kardiologie Im Zentrum, Munich, Germany. · Kardiologie Innenstadt, Munich, Germany. · Department of Cardiology, Triemli Spital, Zurich, Switzerland. · University Hospital Zurich, Zurich, Switzerland. · Department of Cardiology, Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium. · Institut Hospitalier Jacques-Cartier, Institut Cardiovasculaire Paris-Sud, Massy, France. · Royal Brompton Hospital, London, United Kingdom. · Department of Cardiology, University of Bern, Bern, Switzerland. · Department of Cardiology/University of Bern, CTU Bern and Institute of Social and Preventive Medicine, Bern, Switzerland. · Biosensors Europe SA, Morges, Switzerland. · International Centre for Circulatory Health, NHLI, Imperial College London, London, the United Kingdom. ·Catheter Cardiovasc Interv · Pubmed #26649651.

ABSTRACT: BACKGROUND: Historically, percutaneous coronary intervention (PCI) of bifurcation lesions was associated with worse procedural and clinical outcomes when compared with PCI of non-bifurcation lesions. Newer generation drug-eluting stents (DES) might improve long-term clinical outcomes after bifurcation PCI. METHODS AND RESULTS: The LEADERS trial was a 10-center, assessor-blind, non-inferiority, all-comers trial, randomizing 1,707 patients to treatment with a biolimus A9(TM) -eluting stent (BES) with an abluminal biodegradable polymer or a sirolimus-eluting stent (SES) with a durable polymer (ClinicalTrials.gov Identifier: NCT00389220). Five-year clinical outcomes were compared between patients with and without bifurcation lesions and between BES and SES in the bifurcation lesion subgroup. There were 497 (29%) patients with at least 1 bifurcation lesion (BES = 258; SES = 239). At 5-year follow-up, the composite endpoint of cardiac death, myocardial infarction (MI) and clinically-indicated (CI) target vessel revascularization (TVR) was observed more frequently in the bifurcation group (26.6% vs. 22.4%, P = 0.049). Within the bifurcation lesion subgroup, no differences were observed in (cardiac) death or MI rates between BES and SES. However, CI target lesion revascularization (TLR) (10.1% vs. 15.9%, P = 0.0495), and CI TVR (12.0% vs. 19.2%, P = 0.023) rates were significantly lower in the BES group. Definite/probable stent thrombosis (ST) rate was numerically lower in the BES group (3.1% vs. 5.9%, P = 0.15). Very late (>1 year) definite/probable ST rates trended to be lower with BES (0.4% vs. 3.1%, P = 0.057). CONCLUSIONS: In the treatment of bifurcation lesions, use of BES led to superior long-term efficacy compared with SES. Safety outcomes were comparable between BES and SES, with an observed trend toward a lower rate of very late definite/probable ST between 1 and 5 years with the BES. © 2015 Wiley Periodicals, Inc.

5 Article Prospective Assessment of the Diagnostic Accuracy of Instantaneous Wave-Free Ratio to Assess Coronary Stenosis Relevance: Results of ADVISE II International, Multicenter Study (ADenosine Vasodilator Independent Stenosis Evaluation II). 2015

Escaned, Javier / Echavarría-Pinto, Mauro / Garcia-Garcia, Hector M / van de Hoef, Tim P / de Vries, Ton / Kaul, Prashant / Raveendran, Ganesh / Altman, John D / Kurz, Howard I / Brechtken, Johannes / Tulli, Mark / Von Birgelen, Clemens / Schneider, Joel E / Khashaba, Ahmed A / Jeremias, Allen / Baucum, Jim / Moreno, Raul / Meuwissen, Martijn / Mishkel, Gregory / van Geuns, Robert-Jan / Levite, Howard / Lopez-Palop, Ramon / Mayhew, Marc / Serruys, Patrick W / Samady, Habib / Piek, Jan J / Lerman, Amir / Anonymous7390830. ·Cardiovascular Institute, Hospital Clinico San Carlos and Centro Nacional de Investigaciónes Cardiovasculares Carlos III (CNIC), Madrid, Spain; Faculty of Medicine, Complutense University of Madrid, Spain. Electronic address: escaned@secardiologia.es. · Cardiovascular Institute, Hospital Clinico San Carlos and Centro Nacional de Investigaciónes Cardiovasculares Carlos III (CNIC), Madrid, Spain; Erasmus MC, Department of Cardiology, Rotterdam, the Netherlands. · Erasmus MC, Department of Cardiology, Rotterdam, the Netherlands. · AMC Heart Center, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. · Cardialysis BV, Rotterdam, the Netherlands. · University of North Carolina at Chapel Hill, Chapel Hill, North Carolina. · Cardiovascular Division of the University of Minnesota, Minneapolis, Minnesota. · St. Anthony's Heart and Vascular Center and Colorado Heart and Vascular PC, Denver, Colorado. · Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, Missouri. · Regions Hospital, Saint Paul, Minnesota. · Cardiovascular Research of North Florida, Gainesville Florida. · Thoraxcentrum Twente, Department of Cardiology, Medisch Spectrum Twente, and Health Technology and Services Research, MIRA, University of Twente, Enschede, the Netherlands. · Wake Heart and Vascular Institute, Raleigh, North Carolina. · Al Dorrah Heart Care Hospital, Ain Shams University, Cairo, Egypt. · Stony Brook University Medical Center, Stony Brook, New York. · Greenville Memorial Hospital, Grenville, South Carolina. · Hospital Universitario la Paz, Madrid, Spain. · Department of Cardiology, Amphia Hospital, Breda, the Netherlands. · Prairie Heart Institute, St. John's Hospital, Springfield, Illinois. · AtlantiCare Regional Medical Center, Egg Harbor Township, New Jersey. · Hospital Universitario de San Juan de Alicante, Alicante, Spain. · Wellmont Holston Valley Medical Center, Kingsport, Tennessee. · Division of Cardiology, Department of Medicine, Andreas Gruentzig Cardiovascular Center, Emory University School of Medicine, Atlanta, Georgia. · Center for Coronary Physiology and Imaging, Division of Cardiovascular Diseases, and Department of Internal Medicine, Mayo Clinic and Mayo Foundation, Rochester, Minnesota. ·JACC Cardiovasc Interv · Pubmed #25999106.

ABSTRACT: OBJECTIVES: The purpose of this study was to assess the diagnostic accuracy of the instantaneous wave-free ratio (iFR) to characterize, outside of a pre-specified range of values, stenosis severity, as defined by fractional flow reserve (FFR) ≤0.80, in a prospective, independent, controlled, core laboratory-based environment. BACKGROUND: Studies with methodological heterogeneity have reported some discrepancies in the classification agreement between iFR and FFR. The ADVISE II (ADenosine Vasodilator Independent Stenosis Evaluation II) study was designed to overcome limitations of previous iFR versus FFR comparisons. METHODS: A total of 919 intermediate coronary stenoses were investigated during baseline and hyperemia. From these, 690 pressure recordings (n = 598 patients) met core laboratory physiology criteria and are included in this report. RESULTS: The pre-specified iFR cut-off of 0.89 was optimal for the study and correctly classified 82.5% of the stenoses, with a sensitivity of 73.0% and specificity of 87.8% (C statistic: 0.90 [95% confidence interval (CI): 0.88 to 0.92, p < 0.001]). The proportion of stenoses properly classified by iFR outside of the pre-specified treatment (≤0.85) and deferral (≥0.94) values was 91.6% (95% CI: 88.8% to 93.9%). When combined with FFR use within these cut-offs, the percent of stenoses properly classified by such a pre-specified hybrid iFR-FFR approach was 94.2% (95% CI: 92.2% to 95.8%). The hybrid iFR-FFR approach obviated vasodilators from 65.1% (95% CI: 61.1% to 68.9%) of patients and 69.1% (95% CI: 65.5% to 72.6%) of stenoses. CONCLUSIONS: The ADVISE II study supports, on the basis rigorous methodology, the diagnostic value of iFR in establishing the functional significance of coronary stenoses, and highlights its complementariness with FFR when used in a hybrid iFR-FFR approach. (ADenosine Vasodilator Independent Stenosis Evaluation II-ADVISE II; NCT01740895).

6 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.

7 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).

8 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.

9 Article Improved safety and reduction in stent thrombosis associated with biodegradable polymer-based biolimus-eluting stents versus durable polymer-based sirolimus-eluting stents in patients with coronary artery disease: final 5-year report of the LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) randomized, noninferiority trial. 2013

Serruys, Patrick W / Farooq, Vasim / Kalesan, Bindu / de Vries, Ton / Buszman, Pawel / Linke, Axel / Ischinger, Thomas / Klauss, Volker / Eberli, Franz / Wijns, William / Morice, Marie Claude / Di Mario, Carlo / Corti, Roberto / Antoni, Diethmar / Sohn, Hae Y / Eerdmans, Pedro / Rademaker-Havinga, Tessa / van Es, Gerrit-Anne / Meier, Bernhard / Jüni, Peter / Windecker, Stephan. ·Thoraxcenter, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, The Netherlands. p.w.j.c.serruys@erasmusmc.nl ·JACC Cardiovasc Interv · Pubmed #23968698.

ABSTRACT: OBJECTIVES: This study sought to report the final 5 years follow-up of the landmark LEADERS (Limus Eluted From A Durable Versus ERodable Stent Coating) trial. BACKGROUND: The LEADERS trial is the first randomized study to evaluate biodegradable polymer-based drug-eluting stents (DES) against durable polymer DES. METHODS: The LEADERS trial was a 10-center, assessor-blind, noninferiority, "all-comers" trial (N = 1,707). All patients were centrally randomized to treatment with either biodegradable polymer biolimus-eluting stents (BES) (n = 857) or durable polymer sirolimus-eluting stents (SES) (n = 850). The primary endpoint was a composite of cardiac death, myocardial infarction (MI), or clinically indicated target vessel revascularization within 9 months. Secondary endpoints included extending the primary endpoint to 5 years and stent thrombosis (ST) (Academic Research Consortium definition). Analysis was by intention to treat. RESULTS: At 5 years, the BES was noninferior to SES for the primary endpoint (186 [22.3%] vs. 216 [26.1%], rate ratio [RR]: 0.83 [95% confidence interval (CI): 0.68 to 1.02], p for noninferiority <0.0001, p for superiority = 0.069). The BES was associated with a significant reduction in the more comprehensive patient-orientated composite endpoint of all-cause death, any MI, and all-cause revascularization (297 [35.1%] vs. 339 [40.4%], RR: 0.84 [95% CI: 0.71 to 0.98], p for superiority = 0.023). A significant reduction in very late definite ST from 1 to 5 years was evident with the BES (n = 5 [0.7%] vs. n = 19 [2.5%], RR: 0.26 [95% CI: 0.10 to 0.68], p = 0.003), corresponding to a significant reduction in ST-associated clinical events (primary endpoint) over the same time period (n = 3 of 749 vs. n = 14 of 738, RR: 0.20 [95% CI: 0.06 to 0.71], p = 0.005). CONCLUSIONS: The safety benefit of the biodegradable polymer BES, compared with the durable polymer SES, was related to a significant reduction in very late ST (>1 year) and associated composite clinical outcomes. (Limus Eluted From A Durable Versus ERodable Stent Coating [LEADERS] trial; NCT00389220).

10 Article The negative impact of incomplete angiographic revascularization on clinical outcomes and its association with total occlusions: the SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial. 2013

Farooq, Vasim / Serruys, Patrick W / Garcia-Garcia, Hector M / Zhang, Yaojun / Bourantas, Christos V / Holmes, David R / Mack, Michael / Feldman, Ted / Morice, Marie-Claude / Ståhle, Elisabeth / James, Stefan / Colombo, Antonio / Diletti, Roberto / Papafaklis, Michail I / de Vries, Ton / Morel, Marie-Angèle / van Es, Gerrit Anne / Mohr, Friedrich W / Dawkins, Keith D / Kappetein, Arie-Pieter / Sianos, Georgios / Boersma, Eric. ·Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, Rotterdam, the Netherlands. ·J Am Coll Cardiol · Pubmed #23265332.

ABSTRACT: OBJECTIVES: The study sought to evaluate the clinical impact of angiographic complete (CR) and incomplete (ICR) revascularization and its association with the presence of total occlusions (TO), after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery in the "all-comers" SYNTAX (Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) trial. BACKGROUND: In patients with complex coronary artery disease undergoing PCI or CABG, the long-term prognostic implications of CR versus ICR is unsettled. METHODS: In this post hoc study, consisting of randomized (n = 1,800) and nested PCI (n = 198) and CABG (n = 649) registries, 4-year clinical outcomes were compared in groups, with and without angiographic CR, in the PCI and CABG arms. Clinical outcomes were analyzed with Kaplan-Meier estimates, log-rank comparisons, and Cox regression analyses. Multivariate predictors of ICR were determined. Similar analyses were undertaken in the TO and non-TO treated groups of both study arms. RESULTS: Angiographic CR was achieved in 52.8% of the PCI arm and 66.9% of the CABG arm. Within the PCI and CABG arms, ICR (compared with CR) seemed to be a surrogate marker of a greater burden of anatomical coronary complexity and clinical comorbidity and was associated with significantly higher frequencies of 4-year mortality, all-cause revascularization, stent thrombosis (PCI arm), and major adverse cardiac and cerebrovascular events. The presence of a TO was the strongest independent predictor of ICR after PCI (hazard ratio: 2.70, 95% confidence interval: 1.98 to 3.67, p < 0.001). Eight hundred and forty patients (PCI: 26.3%, CABG: 36.4%, p < 0.001) were identified to have 1,007 TOs, with 68.1% of TOs located in the proximal-mid coronary vasculature. The findings associating ICR (compared with CR) with higher frequencies of 4-year mortality and major adverse cardiac and cerebrovascular events remained consistent in the TO-treated groups in the PCI and CABG arms. CONCLUSIONS: Within the PCI and CABG arms of the all-comers SYNTAX trial, angiographically determined ICR has a detrimental impact on long-term clinical outcomes, including mortality. This effect remained consistent in patients with and without TOs.

11 Article Incidence and multivariable correlates of long-term mortality in patients treated with surgical or percutaneous revascularization in the synergy between percutaneous coronary intervention with taxus and cardiac surgery (SYNTAX) trial. 2012

Farooq, Vasim / Serruys, Patrick W / Bourantas, Christos / Vranckx, Pascal / Diletti, Roberto / Garcia Garcia, Hector M / Holmes, David R / Kappetein, Arie-Pieter / Mack, Michael / Feldman, Ted / Morice, Marie Claude / Colombo, Antonio / Morel, Marie-angèle / de Vries, Ton / van Es, Gerrit Anne / Steyerberg, Ewout W / Dawkins, Keith D / Mohr, Friedrich W / James, Stefan / Ståhle, Elisabeth. ·Department of Interventional Cardiology, Erasmus University Medical Centre, Thoraxcenter, s-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands. ·Eur Heart J · Pubmed #23103663.

ABSTRACT: AIMS: The aim of this investigation was to determine the incidence and multivariable correlates of long-term (4-year) mortality in patients treated with surgical or percutaneous revascularization in the synergy between percutaneous coronary intervention (PCI) with TAXUS Express and Cardiac Surgery (SYNTAX) trial. METHODS AND RESULTS: A total of 1800 patients were randomized to undergo coronary artery bypass graft (CABG) surgery (n = 897) or PCI (n = 903). Prospectively collected baseline and peri- and post-procedural data were used to determine independent correlates of 4-year all-cause death in the CABG and the PCI arms (Cox proportional hazards model). Four-year mortality rates in the CABG and the PCI arms were 9.0% [74 deaths (12 in-hospital)] and 11.8% [104 deaths (16 in-hospital)], respectively (log-rank P-value = 0.063). Censored data comprised 78 patients (8.7%) in the CABG arm, and 24 patients (2.7%) in the PCI arm (log-rank P-value < 0.001). Within the CABG arm, the strongest independent correlates of 4-year mortality were lack of discharge aspirin [hazard ratio (HR) 3.56; 95% CI: 2.04, 6.21; P < 0.001], peripheral vascular disease (PVD) (HR: 2.65; 95% CI: 1.49, 4.72; P = 0.001), chronic obstructive pulmonary disease, age, and serum creatinine. Within the PCI arm, the strongest independent correlate of 4-year mortality was lack of post-procedural anti-platelet therapy (HR: 152.16; 95% CI: 53.57, 432.22; P < 0.001), with 10 reported early (within 45 days) in-hospital deaths secondary to multifactorial causes precluding administration of anti-platelet therapy. Other independent correlates of mortality in the PCI arm included amiodarone therapy on discharge, pre-procedural poor left ventricular ejection fraction, a 'history of gastrointestinal bleeding or peptic ulcer disease', PVD (HR: 2.13; 95% CI: 1.26, 3.60; P = 0.005), age, female gender (HR: 1.60; 95% CI: 1.01, 2.56; P = 0.048), and the SYNTAX score (Per increase in 10 points: HR: 1.25; 95% CI: 1.06, 1.47; P = 0.007). CONCLUSION: Independent correlates of 4-year mortality in the SYNTAX trial were multifactorial. Lack of discharge aspirin and lack of post-procedural anti-platelet therapy were the strongest independent correlates of mortality in the CABG and the PCI arms, respectively. Peripheral vascular disease is a common independent correlate of 4-year mortality and may be a marker of the severity of baseline coronary disease and risk of future native coronary disease (and extra-cardiac disease) progression.

12 Article Implantation of the biodegradable polymer biolimus-eluting stent in patients with high SYNTAX score is associated with decreased cardiac mortality compared to a permanent polymer sirolimus-eluting stent: two year follow-up results from the "all-comers" LEADERS trial. 2011

Wykrzykowska, Joanna J / Garg, Scot / Onuma, Yoshinobu / de Vries, Ton / Morel, Marie-Angele / van Es, Gerrit-Anne / Buszman, Pawel / Linke, Axel / Ischinger, Thomas / Klauss, Volker / Corti, Roberto / Eberli, Franz / Wijns, William / Morice, Marie-Claude / Di Mario, Carlo / van Geuns, Robert-Jan / Juni, Peter / Windecker, Stephan / Serruys, Patrick W. ·Department of Interventional Cardiology Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands. ·EuroIntervention · Pubmed #21930465.

ABSTRACT: BACKGROUND: The SYNTAX score (SXscore) has been shown to be an effective predictor of clinical outcomes in patients undergoing percutaneous coronary intervention (PCI). METHODS AND RESULTS: The SXscore was prospectively collected in 1,397 of the 1,707 patients enrolled in the "all-comers" LEADERS trial (patients post-surgical revascularisation were excluded). Post hoc analysis was performed by stratifying clinical outcomes at two-year follow-up, according to one of three SXscore tertiles: SXlow ≤8 (n=464), 816 (n=461). At two-year follow-up the rate of major adverse cardiovascular events was 18.4%, 12.0% and 9.4% in the SXhigh, SXmid, and SXlow tertile, respectively (HR 1.45; CI 1.21-1.74; p<0.01). There was a significantly higher rate of cardiac death in patients in the highest SXscore tertile (7% SXhigh versus 2.4% SXmid versus 1.8% SXlow; HR 2.22; CI 1.5-3.27; p<0.001). Within the SXhigh tertile the rate of cardiac death was significantly lower in patients treated with the biolimus-eluting stent compared with the sirolimus-eluting stent (4.7% versus 9.6%, HR 0.48; CI 0.23-0.99; p=0.046). CONCLUSIONS: The SXscore when applied to an "all-comers" patient population allows for prospective risk stratification of patients undergoing PCI up to two years follow-up. In addition, the SXscore appears to separate the performance of devices in high risk patient groups.

13 Article A patient-level pooled analysis assessing the impact of the SYNTAX (synergy between percutaneous coronary intervention with taxus and cardiac surgery) score on 1-year clinical outcomes in 6,508 patients enrolled in contemporary coronary stent trials. 2011

Garg, Scot / Sarno, Giovanna / Girasis, Chrysafios / Vranckx, Pascal / de Vries, Ton / Swart, Michael / Bressers, Marco / Garcia-Garcia, Hector M / van Es, Gerrit-Anne / Räber, Lorenz / Campo, Gianluca / Valgimigli, Marco / Dawkins, Keith D / Windecker, Stephan / Serruys, Patrick W. ·Department of Interventional Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands. ·JACC Cardiovasc Interv · Pubmed #21700251.

ABSTRACT: OBJECTIVES: This study sought to assess the impact of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SXscore) on clinical outcomes in patients undergoing percutaneous coronary intervention. BACKGROUND: The SXscore has been demonstrated to have an ability to predict clinical outcomes in patients undergoing percutaneous revascularization. Current studies are limited by the relatively small number of patients in each SXscore group. METHODS: Patient-level data from 7 contemporary coronary stent trials were pooled by an independent academic research organization (Cardialysis, Rotterdam, the Netherlands). Analysis was performed on a cohort of 6,508 patients treated with drug-eluting stents and who had calculated SXscores. Clinical outcomes in terms of death, myocardial infarction (MI), repeat revascularization, and major adverse cardiac events (MACE, a composite of death, MI, and repeat revascularization) were subsequently stratified according to SXscore quartiles: SXscore(Q1) ≤ 8 (n = 1,702); 8 < SXscore(Q2) < 15 (n = 1,528); 15 ≤ SXscore(Q3) < 23 (n = 1,620); and SXscore(Q4) ≥ 23 (n = 1,658). RESULTS: One-year outcomes were available in 6,496 patients (99.8%). At 1-year follow-up, all clinical outcomes including mortality, MI, repeat revascularization, MACE, and definite and any stent thrombosis were all significantly higher in patients in the highest SXscore quartile. Similar trends were observed in a subgroup of 2,093 patients (32.2%) who presented with an ST- or non-ST-segment elevation MI. The rate of MACE among patients with an SXscore > 32 and ≤ 32 was 24.9% and 14.0%, respectively (p < 0.001). The SXscore was identified as an independent predictor of all clinical outcomes including mortality, MACE, and stent thrombosis (p < 0.001 for all). CONCLUSIONS: This study confirms the consistent ability of the SXscore to identify patients who are at highest risk of adverse events.

14 Article The outcome of bifurcation lesion stenting using a biolimus-eluting stent with a bio-degradable polymer compared to a sirolimus-eluting stent with a durable polymer. 2011

Garg, Scot / Wykrzykowska, Joanna / Serruys, Patrick W / de Vries, Ton / Buszman, Pawel / Trznadel, Stanislaw / Linke, Axel / Lenk, Karsten / Ischinger, Thomas / Klauss, Volker / Eberli, Franz / Corti, Roberto / Wijns, William / Morice, Marie-Claude / di Mario, Carlo / Tyczynski, Pawel / van Geuns, Robert Jan / Eerdmans, Pedro / van Es, Gerrit-Anne / Meier, Bernhard / Jüni, Peter / Windecker, Stephan. ·Department of Interventional Cardiology, Erasmus MC, Rotterdam, The Netherlands. ·EuroIntervention · Pubmed #21330239.

ABSTRACT: AIMS: This study investigated the differences in clinical outcomes between patients with bifurcation lesions (BL) treated with a biolimus-eluting stent (BES) with a biodegradable polymer, and a sirolimus-eluting stent (SES) with a durable polymer. METHODS AND RESULTS: The clinical outcomes were assessed in the 497 patients (BES 258, SES 239) enrolled in the multicentre, randomised LEADERS trial who underwent treatment of ≥1 BL (total=534 BL). At 12-months follow-up there was no significant difference in the primary endpoint of MACE, a composite of cardiac death, myocardial infarction and clinically indicated target vessel revascularisation (BES 12.8% vs. SES 16.3%, p=0.31). Patients treated with BES had comparable rates of cardiac death (BES 2.7% vs. SES 2.9%, p=1.00), numerically higher rates of myocardial infarction (BES 8.9% vs. SES 5.4%, p=0.17), and significantly lower rates of clinically indicated target vessel revascularisation (4.3% vs. 11.3%, p=0.004) when compared to those treated with SES. The rate of stent thrombosis at 12-months was 4.3% and 3.8% for BES and SES, respectively (p=0.82). CONCLUSIONS: In the treatment of BL the use of BES lead to superior efficacy and comparable safety compared to SES.

15 Article Value of age, creatinine, and ejection fraction (ACEF score) in assessing risk in patients undergoing percutaneous coronary interventions in the 'All-Comers' LEADERS trial. 2011

Wykrzykowska, Joanna J / Garg, Scot / Onuma, Yoshinobu / de Vries, Ton / Goedhart, Dick / Morel, Marie-Angele / van Es, Gerrit-Anne / Buszman, Pawel / Linke, Axel / Ischinger, Thomas / Klauss, Volker / Corti, Roberto / Eberli, Franz / Wijns, William / Morice, Marie-Claude / di Mario, Carlo / van Geuns, Robert Jan / Juni, Peter / Windecker, Stephan / Serruys, Patrick W. ·Department of Interventional Cardiology, Thoraxcenter, Erasmus MC, 's Gravendijkwal 230, Rotterdam, Netherlands. ·Circ Cardiovasc Interv · Pubmed #21205944.

ABSTRACT: BACKGROUND: The age, creatinine, and ejection fraction (ACEF) score (age/left ventricular ejection fraction+1 if creatinine >2.0 mg/dL) has been established as an effective predictor of clinical outcomes in patients undergoing elective coronary artery bypass surgery; however, its utility in "all-comer" patients undergoing percutaneous coronary intervention is yet unexplored. METHODS AND RESULTS: The ACEF score was calculated for 1208 of the 1707 patients enrolled in the LEADERS trial. Post hoc analysis was performed by stratifying clinical outcomes at the 1-year follow-up according to ACEF score tertiles: ACEF(low) ≤1.0225, 1.0225< ACEF(mid) ≤1.277, and ACEF(high) >1.277. At 1-year follow-up, there was a significantly lower number of patients with major adverse cardiac event-free survival in the highest tertile of the ACEF score (ACEF(low)=92.1%, ACEF(mid)=89.5%, and ACEF(high)=86.1%; P=0.0218). Cardiac death was less frequent in ACEF(low) than in ACEF(mid) and ACEF(high) (0.7% vs 2.2% vs 4.5%; hazard ratio=2.22, P=0.002) patients. Rates of myocardial infarction were significantly higher in patients with a high ACEF score (6.7% for ACEF(high) vs 5.2% for ACEF(mid) and 2.5% for ACEF(low); hazard ratio=1.6, P=0.006). Clinically driven target-vessel revascularization also tended to be higher in the ACEF(high) group, but the difference among the 3 groups did not reach statistical significance. The rate of composite definite, possible, and probable stent thrombosis was also higher in the ACEF(high) group (ACEF(low)=1.2%, ACEF(mid)=3.5%, and ACEF(high)=6.2%; hazard ratio=2.04, P<0.001). CONCLUSIONS: ACEF score may be a simple way to stratify risk of events in patients treated with percutaneous coronary intervention with respect to mortality and risk of myocardial infarction.

16 Article A randomised comparison of novolimus-eluting and zotarolimus-eluting coronary stents: 9-month follow-up results of the EXCELLA II study. 2010

Serruys, Patrick W / Garg, Scot / Abizaid, Alexandre / Ormiston, John / Windecker, Stephan / Verheye, Stefan / Dubois, Christophe / Stewart, Jim / Hauptmann, Karl E / Schofer, Joachim / Stangl, Karl / Witzenbichler, Bernhard / Wiemer, Marcus / Barbato, Emanuele / de Vries, Ton / den Drijver, Anne-Marie / Otake, Hiromasa / Meredith, Lynn / Toyloy, Sara / Fitzgerald, Peter. ·Erasmus Medisch Centrum, Rotterdam, The Netherlands. p.w.j.c.serruys@erasmusmc.nl ·EuroIntervention · Pubmed #20562069.

ABSTRACT: AIMS: Novolimus, a macrocyclic lactone with anti-proliferative properties, has a similar efficacy to currently available agents; however it requires a lower dose, and less polymer, and is therefore conceivably safer. METHODS AND RESULTS: The EXCELLA II study was a prospective, multicentre, single-blind, non-inferiority clinical trial which randomised 210 patients with a maximum of two de novo coronary artery lesions in two different epicardial vessels in a ratio of 2:1 to treatment with either the Elixir DESyne Novolimus Eluting Coronary Stent System (NES n=139, Elixir Medical, Sunnyvale, CA, USA) or the Endeavor zotarolimus eluting stent (ZES n=71, Medtronic, Santa Rosa, CA, USA). The primary endpoint was in-stent mean late lumen loss (LLL) at 9-months follow-up. In-stent percent volume obstruction (%VO) was measured in a?sub-group of 65 patients having 9-month intravascular ultrasound (IVUS) follow-up. Clinical secondary endpoints included a device orientated composite of cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularisation (CI-TLR) assessed at 9-months follow-up. At 9-months, the in-stent LLL was 0.11+/-0.32 mm in the NES arm, as compared to 0.63+/-0.42 mm in the ZES (p<0.0001 non-inferiority, p<0.0001 superiority). In-stent%VO was 4.5+/-5.1% and 20.9+/-11.3% for NES and ZES, respectively (p<0.001). There was no significant difference between stent groups in the device orientated composite endpoint (NES 2.9% vs. ZES 5.6%, -2.8% [-8.8%, 3.3%], p=0.45) or its individual components of cardiac death, target vessel MI and CI-TLR. CONCLUSIONS: This non-inferiority randomised study not only met its primary endpoint, but also demonstrated superiority of NES compared to the ZES in terms of in-stent LLL.

17 Minor Noninvasive Prediction of Atherosclerotic Progression: The PROSPECT-MSCT Study. 2016

Bourantas, Christos V / Papadopoulou, Stella-Lida / Serruys, Patrick W / Sakellarios, Antonis / Kitslaar, Pieter H / Bizopoulos, Paschalis / Girasis, Chrysafios / Zhang, Yao-Jun / de Vries, Ton / Boersma, Eric / Papafaklis, Michail I / Naka, Katerina K / Fotiadis, Dimitrios I / Stone, Gregg W / Reiber, Johan H C / Michalis, Lampros K / de Feyter, Pim J / Garcia-Garcia, Hector M. · ·JACC Cardiovasc Imaging · Pubmed #26363836.

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