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Coronary Artery Disease: HELP
Articles by Friedrich Wilhelm Mohr
Based on 46 articles published since 2008
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Between 2008 and 2019, Friedrich W. Mohr wrote the following 46 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Editorial Revascularization strategy for proximal LAD disease: left internal mammary to LAD artery still rules the roost. 2014

Mohr, Friedrich W / Davierwala, Piroze M. ·Department of Cardiac Surgery, Heart Center, University of Leipzig, Leipzig, Germany. Electronic address: mohrf@medizin.uni-leipzig.de. · Department of Cardiac Surgery, Heart Center, University of Leipzig, Leipzig, Germany. ·J Am Coll Cardiol · Pubmed #25541123.

ABSTRACT: -- No abstract --

2 Editorial To beat or not to beat? From one size fits it all to an individual coronary revascularization strategy. 2010

Mohr, Friedrich-W. · ·Eur Heart J · Pubmed #20729225.

ABSTRACT: -- No abstract --

3 Review Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data. 2018

Head, Stuart J / Milojevic, Milan / Daemen, Joost / Ahn, Jung-Min / Boersma, Eric / Christiansen, Evald H / Domanski, Michael J / Farkouh, Michael E / Flather, Marcus / Fuster, Valentin / Hlatky, Mark A / Holm, Niels R / Hueb, Whady A / Kamalesh, Masoor / Kim, Young-Hak / Mäkikallio, Timo / Mohr, Friedrich W / Papageorgiou, Grigorios / Park, Seung-Jung / Rodriguez, Alfredo E / Sabik, Joseph F / Stables, Rodney H / Stone, Gregg W / Serruys, Patrick W / Kappetein, Arie Pieter. ·Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, Netherlands. Electronic address: s.head@erasmusmc.nl. · Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, Netherlands. · Department of Cardiology, Erasmus University Medical Center, Rotterdam, Netherlands. · Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. · Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. · Icahn School of Medicine at Mount Sinai, New York, NY, USA; Peter Munk Cardiac Centre and the Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, ON, Canada. · Norwich Medical School University of East Anglia and Norfolk and Norwich University Hospital, Norwich, UK. · Icahn School of Medicine at Mount Sinai, New York, NY, USA. · Stanford University School of Medicine, Stanford, CA, USA. · Heart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil. · Richard L Roudebush VA Medical Center, Indianapolis, IN, USA. · Department of Cardiology, Oulu University Hospital, Oulu, Finland. · Department of Cardiac Surgery, Herzzentrum Universität Leipzig, Leipzig, Germany. · Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, Netherlands; Department of Biostatistics, Erasmus University Medical Center, Rotterdam, Netherlands. · Cardiac Unit, Otamendi Hospital, Buenos Aires, Argentina. · Department Surgery, University Hospitals Cleveland Medical Center, Cleveland, OH, USA. · Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Liverpool, UK. · Columbia University Medical Center and the Center for Clinical Trials, Cardiovascular Research Foundation, New York, NY, USA. · Imperial College London, London, UK. ·Lancet · Pubmed #29478841.

ABSTRACT: BACKGROUND: Numerous randomised trials have compared coronary artery bypass grafting (CABG) with percutaneous coronary intervention (PCI) for patients with coronary artery disease. However, no studies have been powered to detect a difference in mortality between the revascularisation strategies. METHODS: We did a systematic review up to July 19, 2017, to identify randomised clinical trials comparing CABG with PCI using stents. Eligible studies included patients with multivessel or left main coronary artery disease who did not present with acute myocardial infarction, did PCI with stents (bare-metal or drug-eluting), and had more than 1 year of follow-up for all-cause mortality. In a collaborative, pooled analysis of individual patient data from the identified trials, we estimated all-cause mortality up to 5 years using Kaplan-Meier analyses and compared PCI with CABG using a random-effects Cox proportional-hazards model stratified by trial. Consistency of treatment effect was explored in subgroup analyses, with subgroups defined according to baseline clinical and anatomical characteristics. FINDINGS: We included 11 randomised trials involving 11 518 patients selected by heart teams who were assigned to PCI (n=5753) or to CABG (n=5765). 976 patients died over a mean follow-up of 3·8 years (SD 1·4). Mean Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score was 26·0 (SD 9·5), with 1798 (22·1%) of 8138 patients having a SYNTAX score of 33 or higher. 5 year all-cause mortality was 11·2% after PCI and 9·2% after CABG (hazard ratio [HR] 1·20, 95% CI 1·06-1·37; p=0·0038). 5 year all-cause mortality was significantly different between the interventions in patients with multivessel disease (11·5% after PCI vs 8·9% after CABG; HR 1·28, 95% CI 1·09-1·49; p=0·0019), including in those with diabetes (15·5% vs 10·0%; 1·48, 1·19-1·84; p=0·0004), but not in those without diabetes (8·7% vs 8·0%; 1·08, 0·86-1·36; p=0·49). SYNTAX score had a significant effect on the difference between the interventions in multivessel disease. 5 year all-cause mortality was similar between the interventions in patients with left main disease (10·7% after PCI vs 10·5% after CABG; 1·07, 0·87-1·33; p=0·52), regardless of diabetes status and SYNTAX score. INTERPRETATION: CABG had a mortality benefit over PCI in patients with multivessel disease, particularly those with diabetes and higher coronary complexity. No benefit for CABG over PCI was seen in patients with left main disease. Longer follow-up is needed to better define mortality differences between the revascularisation strategies. FUNDING: None.

4 Review Bilateral internal mammary artery grafting: rationale and evidence. 2015

Davierwala, Piroze M / Mohr, Friedrich W. ·Department of Cardiac Surgery, Heart Center, University Leipzig, Leipzig, Germany; Herzzentrum Leipzig, Universitätsklinik, Helios Kliniken, Struempellstraße 39, 04289 Leipzig, Germany. Electronic address: pirarm@hotmail.com. · Department of Cardiac Surgery, Heart Center, University Leipzig, Leipzig, Germany; Herzzentrum Leipzig, Universitätsklinik, Helios Kliniken, Struempellstraße 39, 04289 Leipzig, Germany. Electronic address: mohrf@medizin.uni-Leipzig.de. ·Int J Surg · Pubmed #25612853.

ABSTRACT: Coronary artery bypass graft (CABG) surgery remains the preferred mode of revascularization in patients with complex multi-vessel coronary artery disease. The left internal mammary artery (IMA) and saphenous vein are the most commonly utilized conduits in CABG surgery and are still considered to be the gold standard by most surgeons. However, there is emerging evidence that use of bilateral IMAs is associated with significantly better long-term outcomes and the benefit increases with time from surgery. In spite of this incremental beneficiary effect, most surgeons are reluctant to use both IMAs, because it is technically more demanding, time-consuming and is associated with marginally higher sternal wound infection rates. This review highlights the histological features, physiological characteristics and genomics of IMAs that provide the basis for the use of these vessels during CABG surgery. Additionally, the superiority of the bilateral IMAs with regard to patency and long-term outcomes is also discussed in detail. Furthermore, the safety of using bilateral IMAs with regard to early postoperative outcomes with special reference to deep sternal wound infections has been addressed. The present review provides enough evidence to convince more surgeons about the advantages of bilateral IMA grafting.

5 Review Review of a 13-year single-center experience with minimally invasive direct coronary artery bypass as the primary surgical treatment of coronary artery disease. 2012

Holzhey, David M / Cornely, Jan P / Rastan, Ardawan J / Davierwala, Piroze / Mohr, Friedrich W. ·Department of Cardiac Surgery, Heart Center, Leipzig, Germany. dholzhey@web.de ·Heart Surg Forum · Pubmed #22543338.

ABSTRACT: BACKGROUND AND AIM OF THE STUDY: In this study, we review our experience with 1768 minimally invasive direct coronary artery bypass (MIDCAB) operations. The focus is on long-term outcome with more than 10 years of follow-up. METHODS: All patients undergoing standard MIDCAB between 1996 and 2009 were included. For all 1768 patients, pre-, intra-, and postoperative data could be completed. Long-term follow-up information about health status, major adverse cardiac and cerebrovascular events (MACCE), and freedom from angina was collected annually via questionnaire or personal contact. Five-year follow-up is available for 1313 patients, and 10-year-follow-up is available for 748 patients. A multivariate Cox regression analysis was performed to determine risk factors for long-term outcome. RESULTS: Mean age was 63.4 ± 10.8 years, mean ejection fraction was 60.0% ± 14.2%, and perioperative mortality risk calculated by logistic EuroSCORE was 3.8 ± 6.2%. In 31 patients (1.75%) intraoperative conversion to sternotomy was necessary. Early postoperative mortality was 0.8% (15 patients); 0.4% (7 patients) had a perioperative stroke. Seven hundred twelve patients received routine postoperative angiogram, showing 95.5% early graft patency. Short-term target vessel reintervention was needed in 59 patients (3.3%) (11 percutaneous transluminal coronary angioplasty (PTCA)/stent, 48 re-operation). Kaplan-Meyer analysis revealed a 5-year survival rate of 88.3% (95% confidence interval [CI], 86.6% to 89.9%) and a 10-year-survival rate of 76.6% (95% CI, 73.5% to 78.7%). The freedom from MACCE and angina after 5 and 10 years was 85.3% (95% CI, 83.5% to 87.1%) and 70.9% (95% CI, 68.1% to 73.7%), respectively. CONCLUSIONS: MIDCAB is a safe operation with low postoperative mortality and morbidity. With excellent short-term and long-term results, it is a very good alternative compared to both percutaneous coronary intervention (PCI) and conventional surgery.

6 Clinical Trial Does geographical variability influence five-year MACCE rates in the multicentre SYNTAX revascularisation trial? 2017

Roy, Andrew K / Chevalier, Bernard / Lefèvre, Thierry / Louvard, Yves / Segurado, Ricardo / Sawaya, Fadi / Spaziano, Marco / Neylon, Antoinette / Serruys, Patrick A / Dawkins, Keith D / Kappetein, Arie Pieter / Mohr, Friedrich-Wilhelm / Colombo, Antonio / Feldman, Ted / Morice, Marie-Claude. ·Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France. ·EuroIntervention · Pubmed #28320685.

ABSTRACT: AIMS: The use of multiple geographical sites for randomised cardiovascular trials may lead to important heterogeneity in treatment effects. This study aimed to determine whether treatment effects from different geographical recruitment regions impacted significantly on five-year MACCE rates in the SYNTAX trial. METHODS AND RESULTS: Five-year SYNTAX results (n=1,800) were analysed for geographical variability by site and country for the effect of treatment (CABG vs. PCI) on MACCE rates. Fixed, random, and linear mixed models were used to test clinical covariate effects, such as diabetes, lesion characteristics, and procedural factors. Comparing five-year MACCE rates, the pooled odds ratio (OR) between study sites was 0.58 (95% CI: 0.47-0.71), and countries 0.59 (95% CI: 0.45-0.73). By homogeneity testing, no individual site (X2=93.8, p=0.051) or country differences (X2=25.7, p=0.080) were observed. For random effects models, the intraclass correlation was minimal (ICC site=5.1%, ICC country=1.5%, p<0.001), indicating minimal geographical heterogeneity, with a hazard ratio of 0.70 (95% CI: 0.59-0.83). Baseline risk (smoking, diabetes, PAD) did not influence regional five-year MACCE outcomes (ICC 1.3%-5.2%), nor did revascularisation of the left main vs. three-vessel disease (p=0.241), across site or country subgroups. For CABG patients, the number of arterial (p=0.49) or venous (p=0.38) conduits used also made no difference. CONCLUSIONS: Geographic variability has no significant treatment effect on MACCE rates at five years. These findings highlight the generalisability of the five-year outcomes of the SYNTAX study.

7 Clinical Trial Hierarchical testing of composite endpoints: applying the win ratio to percutaneous coronary intervention versus coronary artery bypass grafting in the SYNTAX trial. 2017

Milojevic, Milan / Head, Stuart J / Andrinopoulou, Eleni-Rosalina / Serruys, Patrick W / Mohr, Friedrich W / Tijssen, Jan G / Kappetein, A Pieter. ·Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands. ·EuroIntervention · Pubmed #28134125.

ABSTRACT: AIMS: The goal of the study was to compare long-term outcomes of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG), accounting for the clinical impact of individual components in the composite endpoints and prioritising these using the win ratio (Rw). METHODS AND RESULTS: The win ratio was compared with conventional methods of analyses (hazard ratio [HR] and relative risk) in the SYNTAX trial (n=1,800). For the composite of death/stroke/myocardial infarction (MI), the win ratio favoured CABG and was 1.37 (95% CI: 1.10-1.77) for matched analysis, 1.28 (95% CI: 1.11-1.53) for unmatched analysis, while the conventional HR was 1.29 (95% CI: 1.11-1.53). The largest number of winners in favour of CABG over PCI were based on MI (n=39 vs. n=19, respectively). Death was significantly reduced with CABG in matched (Rw=1.39, 95% CI: 1.04-1.86) and unmatched win ratio analyses (Rw=1.27, 95% CI: 1.01-1.42) as compared with non-significant conventional analysis (HR 1.19, 95% CI: 0.92-1.56). In subgroups, matched win ratio analyses had a larger treatment effect in favour of CABG compared with conventional analyses, especially in patients with three-vessel disease and intermediate SYNTAX scores, while unmatched win ratios had a smaller point estimate, but with narrower confidence intervals than matched analyses findings. CONCLUSIONS: This re-analysis of the SYNTAX trial using the win ratio shows that the most important benefit of CABG treatment is the reduction of hard clinical endpoints such as mortality and MI. Future trials using this approach can expect to maintain similar statistical power with smaller sample sizes, and thereby reduce the cost of a trial.

8 Clinical Trial A randomized, parallel group, double-blind study of ticagrelor compared with aspirin for prevention of vascular events in patients undergoing coronary artery bypass graft operation: Rationale and design of the Ticagrelor in CABG (TiCAB) trial: An Investigator-Initiated trial. 2016

de Waha, Antoinette / Sandner, Sigrid / von Scheidt, Moritz / Boening, Andreas / Koch-Buettner, Katharina / Hammel, Dieter / Hambrecht, Rainer / Danner, Bernhard C / Schöndube, Friedrich A / Goerlach, Gerold / Fischlein, Theodor / Schmoeckel, Michael / Oberhoffer, Martin / Schulz, Rainer / Walther, Thomas / Ziegelhöffer, Tibor / Knosalla, Christoph / Schönrath, Felix / Beyersdorf, Friedhelm / Siepe, Matthias / Attmann, Tim / Misfeld, Martin / Mohr, Friedrich-Wilhelm / Sievers, Hans-Hinrich / Joost, Alexander / Putman, Leon M / Laufer, Günther / Hamm, Christian / Zeymer, Uwe / Kastrati, Adnan / Radke, Peter W / Lange, Rüdiger / Cremer, Jochen / Schunkert, Heribert. ·German Heart Center Munich, Technische Universität München, Munich, Germany; DZHK (German Center for Cardiovascular Research), and partner site Munich Heart Alliance, Munich, Germany. Electronic address: dewaha@dhm.mhn.de. · Department of Cardiac Surgery, Vienna General Hospital, Medical University of Vienna, Vienna, Austria. · German Heart Center Munich, Technische Universität München, Munich, Germany; DZHK (German Center for Cardiovascular Research), and partner site Munich Heart Alliance, Munich, Germany. · Department of Cardiovascular Surgery, Justus-Liebig University Gießen, Germany. · Department of Cardiac Surgery, Klinikum Links der Weser, Bremen, Germany. · Department of Cardiology and Angiology, Klinikum Links der Weser, Bremen, Germany. · Department of Thoracic and Cardiovascular Surgery, Georg-August-University Goettingen, Goettingen, Germany. · Department of Cardiac Surgery, Paracelsus Medical University, Klinikum Nürnberg, Germany. · Department of Cardiac Surgery, Asklepios Klinik St. Georg/Cardioclinic Harburg, Hamburg, Germany. · Institute of Physiology, Justus-Liebig University, Giessen, Germany. · Department of Cardiac Surgery, Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany. · Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Germany. · Department of Cardiothoracic and Vascular Surgery, German Heart Institute Berlin, Germany; DZHK (German Center for Cardiovascular research)-partner side Berlin. · Department of Cardiovascular Surgery, Heart Center Freiburg University, Freiburg, Germany. · Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Kiel, Germany. · Department of Cardiac Surgery, Heart Center Leipzig, University of Leipzig, Leipzig, Germany. · Department of Cardiac and Thoracic Vascular Surgery, University of Lübeck, Lübeck, Germany. · Medical Clinic II, Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany. · Department of Cardiology, Kerckhoff Heart and Thorax Center, Germany Justus Liebig University of Giessen, Department of Internal Medicine I, Gießen, Germany. · Department of Cardiology, Heart Center Ludwigshafen, Ludwigshafen am Rhein, Germany. · Klinik für Innere Medizin, Schön Klinik Neustadt, Neustadt i.H., Germany. · Department of Cardiovascular Surgery, German Heart Center Munich, Germany. ·Am Heart J · Pubmed #27595681.

ABSTRACT: BACKGROUND: For patients with coronary artery disease undergoing coronary bypass surgery, acetylsalicylic acid (ASA) currently represents the gold standard of antiplatelet treatment. However, adverse cardiovascular event rates in the first year after coronary artery bypass grafting (CABG) still exceed 10%. Graft failure, which is predominantly mediated by platelet aggregation, has been identified as a major contributing factor in this context. Therefore, intensified platelet inhibition is likely to be beneficial. Ticagrelor, an oral, reversibly binding and direct-acting P2Y12 receptor antagonist, provides a rapid, competent, and consistent platelet inhibition and has shown beneficial results compared with clopidogrel in the subset of patients undergoing bypass surgery in a large previous trial. HYPOTHESIS: Ticagrelor is superior to ASA for the prevention of major cardiovascular events within 1 year after CABG. STUDY DESIGN: The TiCAB trial (NCT01755520) is a multicenter, phase III, double-blind, double-dummy, randomized trial comparing ticagrelor with ASA for the prevention of major cardiovascular events within 12 months after CABG. Patients undergoing CABG will be randomized in a 1:1 fashion to either ticagrelor 90 mg twice daily or ASA 100 mg once daily. The study medication will be started within 24 hours after surgery and maintained for 12 months. The primary end point is the composite of cardiovascular death, myocardial infarction, stroke, and repeat revascularization at 12 months after CABG. The sample size is based on an expected event rate of 13% of the primary end point within the first 12 months after randomization in the control group, a 2-sided α level of .0492 (to preserve the overall significance level of .05 after planned interim analysis), a power of 0.80%, 2-sided testing, and an expected relative risk of 0.775 in the active group compared with the control group and a dropout rate of 2%. According to power calculations based on a superiority design for ticagrelor, it is estimated that 3,850 patients should be enrolled. SUMMARY: There is clinical equipoise on the issue of optimal platelet inhibition after CABG. The TiCAB trial will provide a pivotal comparison of the efficacy and safety of ticagrelor compared with ASA after CABG.

9 Clinical Trial The impact of a second arterial graft on 5-year outcomes after coronary artery bypass grafting in the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery Trial and Registry. 2015

Parasca, Catalina A / Head, Stuart J / Mohr, Friedrich W / Mack, Michael J / Morice, Marie-Claude / Holmes, David R / Feldman, Ted E / Colombo, Antonio / Dawkins, Keith D / Serruys, Patrick W / Kappetein, Arie Pieter / Anonymous5470832. ·Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands. · Department of Cardiac Surgery, Herzzentrum Universität Leipzig, Leipzig, Germany. · The Heart Hospital, Baylor Health Care Systems, Plano, Tex. · Department of Cardiology, Institut Cardiovasculaire Paris Sud, Massy, France. · Department of Cardiovascular Disease, Mayo Clinic, Rochester, Minn. · Department of Cardiology, North Shore University Health System, Evanston, Ill. · Department of Cardiology, San Raffaele Scientific Institute, Milan, Italy. · Boston Scientific Corporation, Natick, Mass. · Department of Cardiology, Erasmus University Medical Center, Rotterdam, The Netherlands. · Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands. Electronic address: a.kappetein@erasmusmc.nl. ·J Thorac Cardiovasc Surg · Pubmed #26055439.

ABSTRACT: OBJECTIVE: Despite various evidence supporting the advantages of multiple arterial grafting, inconsistencies in use of the procedure have resulted in high variability in the acceptance and practice of arterial grafting. The purpose of this study was to assess the effects of an arterial versus venous second grafts on outcomes at 5-year follow-up in the coronary artery bypass grafting population from the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial. METHODS: Patients (n = 1419) with an arterial graft to the left anterior descending artery and ≥1 other graft were included and divided according to the second graft's type: 2nd-graft-arterial group (n = 456) and 2nd-graft-venous group (n = 963). Five-year outcomes were compared between subgroups. Event rates were estimated with Kaplan-Meier analyses. Propensity-score matching was used, to control for selection bias due to nonrandom group assignment in a 1:1 manner, resulting in 432 pairs with balanced baseline characteristics. RESULTS: In unmatched groups, the 2nd-graft-arterial group had significantly lower rates of death (8.9% vs 13.1%; P = .02), and composite safety endpoint of death/stroke/myocardial infarction (13.3% vs 18.7%; P = .02), compared with the 2nd-graft-venous group. The rate of major adverse cardiac or cerebrovascular events was similar between groups (22.9% vs 25.5%; P = .30), because it includes the rate of repeat revascularization (12.6% in the 2nd-graft-arterial group vs 9.6% in the 2nd-graft-venous group; P = .10). After propensity-score matching, no statistically significant differences were found between groups. CONCLUSIONS: This study reveals comparable 5-year outcomes with arterial and venous conduits as second grafts after an arterial graft anastomosed to the left anterior descending artery. This study demonstrates the multi-institutional variation in patient selection and operator technique with regard to arterial revascularization, although extended follow-up beyond 5 years is required to estimate its impact on long-term outcomes. CLINICAL TRIAL NUMBER: NCT00114972.

10 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.

11 Article Influence of practice patterns on outcome among countries enrolled in the SYNTAX trial: 5-year results between percutaneous coronary intervention and coronary artery bypass grafting. 2017

Milojevic, Milan / Head, Stuart J / Mack, Michael J / Mohr, Friedrich W / Morice, Marie-Claude / Dawkins, Keith D / Holmes, David R / Serruys, Patrick W / Kappetein, Arie Pieter. ·Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, Netherlands. · Department of Cardiovascular Surgery, Heart Hospital Baylor Plano, Baylor Healthcare System, Plano, TX, USA. · Department of Cardiovascular Surgery, Herzzentrum Universität Leipzig, Leipzig, Germany. · Department of Cardiology, Institut Hospitalier Jacques Cartier, Massy, France. · Boston Scientific Corporation, Natick, MA, USA. · Division of Cardiovascular Disease and Internal Medicine, Mayo Clinic, Rochester, MN, USA. · Department of Cardiology, Erasmus University Medical Center, Rotterdam, Netherlands. ·Eur J Cardiothorac Surg · Pubmed #28520861.

ABSTRACT: OBJECTIVES: To examine differences among participating countries in baseline characteristics, clinical practice, medication strategies and outcomes of patients randomized to coronary artery bypass grafting and percutaneous coronary intervention in the SYNTAX trial. METHODS: In SYNTAX, centres in 18 different countries enrolled 1800 patients, of which 8 countries enrolled ≥80 patients, what was projected to be a large enough sample size to be included in the analysis. Baseline characteristics, practice patterns and clinical outcomes were compared between the USA (n = 245), the UK (n = 267), Italy (n = 197), France (n = 208), Germany (n = 179), Netherlands (n = 148), Belgium (n = 91) and Hungary (n = 83). The remaining patients from other participating countries were pooled together (n = 382). RESULTS: Five-year results demonstrated significantly different outcomes between countries. After adjustment, percutaneous coronary intervention patients in France had lower rates of major adverse cardiac and cerebrovascular events [hazard ratio (HR) = 0.60, 95% confidence interval (CI) 0.37-0.98], while the incidence of repeat revascularization was higher in Hungary (HR = 1.89, 95% CI 1.14-3.42). Coronary artery bypass grafting showed the lowest rate of repeat revascularization in the UK (HR = 0.32, 95% CI 0.12-0.85). There were numerous differences in the risk profile of patients between participating countries, as well as marked differences in surgical practice across countries in the use of blood cardioplegia (range 3.1-89.0%; P < 0.001), bilateral internal mammary artery usage (range 7.8-68.2%; P < 0.001) and off-pump procedures (range 3.9-44.4%; P < 0.001). Variation was also found for percutaneous coronary intervention in the number of implanted stents (range 4.0 ± 2.3 to 6.1 ± 2.6; P < 0.001) as well as for the entire stents length (range 69.0 ± 45.1 to 124.1 ± 60.9; P < 0.001). Remarkable differences were observed in the prescription of post-coronary artery bypass grafting medication in terms of acetylsalicylic acid (range 79.6-95.0%; P = 0.004), thienopyridine (6.8-31.1%; P < 0.001) and statins (41.3-89.1%; P < 0.001). CONCLUSIONS: Patient characteristics and clinical patterns are significantly different between countries, resulting in significantly different 5-year outcomes. This article presents specific data that can further improve outcomes in each country. Clinical Trials Registry: NCT00114972.

12 Article Incidence, Characteristics, Predictors, and Outcomes of Repeat Revascularization After Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting: The SYNTAX Trial at 5 Years. 2016

Parasca, Catalina A / Head, Stuart J / Milojevic, Milan / Mack, Michael J / Serruys, Patrick W / Morice, Marie-Claude / Mohr, Friedrich W / Feldman, Ted E / Colombo, Antonio / Dawkins, Keith D / Holmes, David R / Kappetein, Pieter A / Anonymous3770891. ·Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands. · Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, the Netherlands. Electronic address: s.head@erasmusmc.nl. · The Heart Hospital, Baylor Health Care Systems, Plano, Texas. · Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands. · Department of Cardiology, Institut Cardiovasculaire Paris Sud, Hopital Privé Jacques Cartier, Générale de Santé, Massy, France. · Department of Cardiac Surgery, Herzzentrum Universität Leipzig, Leipzig, Germany. · Department of Cardiology, North Shore University Health System, Evanston, Illinois. · Department of Cardiology, San Raffaele Scientific Institute, Milan, Italy. · Boston Scientific Corporation, Natick, Massachusetts. · Department of Cardiovascular Disease, Mayo Clinic, Rochester, Minnesota. ·JACC Cardiovasc Interv · Pubmed #28007201.

ABSTRACT: OBJECTIVES: The study sought to determine the incidence, predictors, characteristics, and outcomes of repeat revascularization during 5-year follow-up of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery) trial. BACKGROUND: Limited in-depth long-term data on repeat revascularization are available from randomized trials comparing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). METHODS: Incidence and timing of repeat revascularization and its relation to the long-term composite safety endpoint of death, stroke, and myocardial infarction were analyzed in the SYNTAX trial (n = 1,800) using Kaplan-Meier analysis. RESULTS: At 5 years, repeat revascularization occurred more often after initial PCI than after initial CABG (25.9% vs. 13.7%, respectively; p < 0.001), and more often consisted of multiple repeat revascularizations (9.0% vs. 2.8%, respectively; p = 0.022). Significantly more repeat PCI procedures were performed on de novo lesions in patients after initial PCI than initial CABG (33.3% vs. 13.4%, respectively; p < 0.001). At 5-year follow-up, patients who underwent repeat revascularization versus patients not undergoing repeat revascularization had significantly higher rates of the composite safety endpoint of death, stroke, and myocardial infarction after initial PCI (33.8% vs. 16.6%, respectively; p < 0.001), and a trend was found after initial CABG (22.4% vs. 15.8%, respectively; p = 0.07). After multivariate adjustment, repeat revascularization was an independent predictor of the composite safety endpoint after both initial PCI (hazard ratio [HR]: 2.2; 95% confidence interval [CI]: 1.6 to 3.0; p < 0.001) and initial CABG (HR: 1.8; 95% CI: 1.2 to 2.9; p = 0.011). CONCLUSIONS: Repeat revascularization rates are significantly higher after initial PCI than after initial CABG for complex coronary disease. Repeat revascularization is an independent predictor of death, stroke, and myocardial infarction for myocardial revascularization.

13 Article Cost-effectiveness of percutaneous coronary intervention versus bypass surgery from a Dutch perspective. 2015

Osnabrugge, Ruben L / Magnuson, Elizabeth A / Serruys, Patrick W / Campos, Carlos M / Wang, Kaijun / van Klaveren, David / Farooq, Vasim / Abdallah, Mouin S / Li, Haiyan / Vilain, Katherine A / Steyerberg, Ewout W / Morice, Marie-Claude / Dawkins, Keith D / Mohr, Friedrich W / Kappetein, A Pieter / Cohen, David J / Anonymous3690848. ·Department of Cardiovascular Research, Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri, USA Department of Cardio-Thoracic Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands. · Department of Cardiovascular Research, Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri, USA. · Department of Cardiology, Erasmus University Medical Centre, Rotterdam, The Netherlands. · Department of Cardiology, Erasmus University Medical Centre, Rotterdam, The Netherlands Heart Institute (InCor), University of São Paulo Medical School, Sao Paulo, Brazil. · Department of Public Health, Erasmus University Medical Centre, Rotterdam, The Netherlands. · Department of Interventional Cardiology, Institut Jacques Cartier, Massy, France. · Boston Scientific Corporation, Natick, Massachusetts, USA. · Department of Cardiac Surgery, Herzzentrum Universität Leipzig, Leipzig, Germany. · Department of Cardio-Thoracic Surgery, Erasmus University Medical Centre, Rotterdam, The Netherlands. ·Heart · Pubmed #26552756.

ABSTRACT: AIMS: Recent cost-effectiveness analyses of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) have been limited by a short time horizon or were restricted to the US healthcare perspective. We, therefore, used individual patient-level data from the SYNTAX trial to evaluate the cost-effectiveness of PCI versus CABG from a European (Dutch) perspective. METHODS AND RESULTS: Between 2005 and 2007, 1800 patients with three-vessel or left main coronary artery disease were randomised to either CABG (n=897) or PCI with drug-eluting stents (DES; n=903). Costs were estimated for all patients based on observed healthcare resource usage over 5 years of follow-up. Health state utilities were evaluated with the EuroQOL questionnaire. A patient-level microsimulation model based on Dutch life-tables was used to extrapolate the 5-year in-trial data to a lifetime horizon. Although initial procedural costs were lower for CABG, total initial hospitalisation costs per patient were higher (€17 506 vs €14 037, p<0.001). PCI was more costly during the next 5 years of follow-up, due to more frequent hospitalisations, repeat revascularisation procedures and higher medication costs. Nevertheless, total 5-year costs remained €2465/patient higher with CABG. When the in-trial results were extrapolated to a lifetime horizon, CABG was projected to be economically attractive relative to DES-PCI, with gains in both life expectancy and quality-adjusted life expectancy. The incremental cost-effectiveness ratio (ICER) (€5390/quality-adjusted life year (QALY) gained) was favourable and remained <€80 000/QALY in >90% of the bootstrap replicates. Outcomes were similar when incorporating the prognostic impact of non-fatal myocardial infarction and stroke, as well as across a broad range of assumptions regarding the effect of CABG on post-trial survival and costs. However, DES-PCI was economically dominant compared with CABG in patients with a SYNTAX Score ≤22 or in those with left main disease. In patients for whom the SYNTAX Score II favoured PCI based on lower predicted 4-year mortality, PCI was also economically dominant, whereas in those patients for whom the SYNTAX Score II favoured surgery, CABG was highly economically attractive (ICER range, €2967 to €3737/QALY gained). CONCLUSIONS: For the broad population with three-vessel or left main disease who are candidates for either CABG or PCI, we found that CABG is a clinically and economically attractive revascularisation strategy compared with DES-PCI from a Dutch healthcare perspective. The cost-effectiveness of CABG versus PCI differed according to several anatomic factors, however. The newly developed SYNTAX Score II provides enhanced prognostic discrimination in this population, and may be a useful tool to guide resource allocation as well. TRIAL REGISTRATION NUMBER: Clinical trial unique identifier: NCT00114972 (http://www.clinical-trials.gov).

14 Article Coronary Artery Fistula: Two Rare Cases. 2015

Wehbe, Mahmoud Sleiman / Vondran, Maximilian / Sauer, Matthias / Mohr, Friedrich-Wilhelm / Schroeter, Thomas. ·Department of Cardiac Surgery, Heart Center Leipzig, University of Leipzig, Leipzig, Germany. Electronic address: mswehbe@gmail.com. · Department of Cardiac Surgery, Heart Center Leipzig, University of Leipzig, Leipzig, Germany. ·Ann Thorac Surg · Pubmed #26522575.

ABSTRACT: Coronary artery fistula (CAF) is an incidental finding in up to 0.2% of cardiac catheterization studies and is a rare pathologic condition affecting up to 1% of the general population. We report two cases of CAF diagnosed by coronary angiography and managed by surgical ligation, with excellent postoperative outcome. Anatomic location, clinical presentation, investigation, and treatment of CAF are discussed.

15 Article Coronary artery bypass surgery continues to remain the treatment of choice for multivessel coronary artery disease even in the era of new-generation drug-eluting stents. 2015

Mohr, Friedrich W / Davierwala, Piroze M. ·Department of Cardiac Surgery, Herzzentrum, Leipzig, Germany. ·Evid Based Med · Pubmed #26141180.

ABSTRACT: -- No abstract --

16 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.

17 Article Smoking is associated with adverse clinical outcomes in patients undergoing revascularization with PCI or CABG: the SYNTAX trial at 5-year follow-up. 2015

Zhang, Yao-Jun / Iqbal, Javaid / van Klaveren, David / Campos, Carlos M / Holmes, David R / Kappetein, Arie Pieter / Morice, Marie-Claude / Banning, Adrian P / Grech, Ever D / Bourantas, Christos V / Onuma, Yoshinobu / Garcia-Garcia, Hector M / Mack, Michael J / Colombo, Antonio / Mohr, Friedrich W / Steyerberg, Ewout W / Serruys, Patrick W. ·Thoraxcenter, Erasmus Medical Centre, Rotterdam, the Netherlands; Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China. · Sheffield Teaching Hospitals and the University of Sheffield, Sheffield, United Kingdom. · Department of Public Health, Erasmus Medical Centre, Rotterdam, the Netherlands. · Thoraxcenter, Erasmus Medical Centre, Rotterdam, the Netherlands. · Mayo Clinic, Rochester, Minnesota. · Institut Jacques Cartier, Massy, France. · Oxford University Hospitals, Oxford, United Kingdom. · The Heart Hospital, Plano, Texas. · San Raffaele Scientific Institute, Milan, Italy. · Herzzentrum Universität Leipzig, Leipzig, Germany. · Thoraxcenter, Erasmus Medical Centre, Rotterdam, the Netherlands; International Centre for Circulatory Health, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com. ·J Am Coll Cardiol · Pubmed #25790882.

ABSTRACT: BACKGROUND: Cigarette smoking is a well-known risk factor for development of coronary artery disease (CAD). However, some studies have suggested a "smoker's paradox," meaning neutral or favorable outcomes in smokers who have developed CAD, especially myocardial infarction (MI). OBJECTIVES: The study aimed to examine the association of smoking status with clinical outcomes in the randomized controlled SYNTAX (SYNergy Between PCI With TAXUS and Cardiac Surgery) trial at 5-year follow-up. METHODS: Detailed smoking history was collected at baseline, 6-month, 1-year, 3-year, and 5-year follow-up. The composite endpoints included death/MI/stroke (primary endpoint) plus major adverse cardiac and cerebrovascular events (MACCE) (combination of death/MI/stroke and target lesion revascularization) according to patient smoking status. The comparison of 5-year clinical outcomes between the groups according to smoking status was performed with Cox regression using smoking status at baseline or smoking as a time-dependent covariate. RESULTS: A sizeable proportion (n = 322, 17.9%) of patients had changing smoking status during 5-year follow-up. One in 5 patients with complex CAD was smoking at baseline. However, 60% stopped after revascularization while others continued to smoke. Smokers had worse clinical outcomes due to a higher incidence of recurrent MI in both revascularization arms. Smoking was an independent predictor of the composite endpoint of death/MI/stroke (hazard ratio [HR]: 1.8; 95% confidence interval [CI]: 1.3 to 2.5; p = 0.001) and MACCE (HR: 1.4; 95% CI: 1.1 to 1.7; p = 0.02). CONCLUSIONS: Smoking is associated with poor clinical outcomes after revascularization in patients with complex CAD. This places further emphasis on efforts at smoking cessation to improve revascularization benefits. (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries; NCT00114972).

18 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.

19 Article Cost-effectiveness of percutaneous coronary intervention with drug-eluting stents versus bypass surgery for patients with 3-vessel or left main coronary artery disease: final results from the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial. 2014

Cohen, David J / Osnabrugge, Ruben L / Magnuson, Elizabeth A / Wang, Kaijun / Li, Haiyan / Chinnakondepalli, Khaja / Pinto, Duane / Abdallah, Mouin S / Vilain, Katherine A / Morice, Marie-Claude / Dawkins, Keith D / Kappetein, A Pieter / Mohr, Friedrich W / Serruys, Patrick W / Anonymous2180802. ·From Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City (D.J.C., R.L.O., E.A.M., K.W., H.L., K.C.) · Erasmus University Medical Center, Rotterdam, The Netherlands (R.L.O., A.P.K., P.W.S.) · Harvard School of Public Health, Boston, MA (D.P.) · Institut Jacques Cartier, Massy, France (M.-C.M.) · Boston Scientific, Natick, MA (K.D.D.) · and Herzzentrum Universität Leipzig, Leipzig, Germany (F.W.M.). ·Circulation · Pubmed #25085960.

ABSTRACT: BACKGROUND: The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial demonstrated that in patients with 3-vessel or left main coronary artery disease, coronary artery bypass graft surgery (CABG) was associated with a lower rate of cardiovascular death, myocardial infarction, stroke, or repeat revascularization compared with percutaneous coronary revascularization with drug-eluting stents (DES-PCI)). The long-term cost-effectiveness of these strategies is unknown. METHODS AND RESULTS: Between 2005 and 2007, 1800 patients with left main or 3-vessel coronary artery disease were randomized to CABG (n=897) or DES-PCI (n=903). Costs were assessed from a US perspective, and health state utilities were evaluated with the EuroQOL questionnaire. A patient-level microsimulation model based on the 5-year in-trial data was used to extrapolate costs, life expectancy, and quality-adjusted life expectancy over a lifetime horizon. Although initial procedural costs were $3415 per patient lower with CABG, total hospitalization costs were $10 036 per patient higher. Over the next 5 years, follow-up costs were higher with DES-PCI as a result of more frequent hospitalizations, revascularization procedures, and higher medication costs. Over a lifetime horizon, CABG remained more costly than DES-PCI, but the incremental cost-effectiveness ratio was favorable ($16 537 per quality-adjusted life-year gained) and remained <$20 000 per quality-adjusted life-year in most bootstrap replicates. Results were consistent across a wide range of assumptions about the long-term effect of CABG versus DES-PCI on events and costs. In patients with left main disease or a SYNTAX score ≤22, however, DES-PCI was economically dominant compared with CABG, although these findings were less certain. CONCLUSIONS: For most patients with 3-vessel or left main coronary artery disease, CABG is a clinically and economically attractive revascularization strategy compared with DES-PCI. However, among patients with less complex disease, DES-PCI may be preferred on both clinical and economic grounds. CLINICAL TRIAL REGISTRATION URL: www.clinicaltrials.gov. Unique identifier: NCT00114972.

20 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).

21 Article Coronary artery bypass grafting vs. percutaneous coronary intervention for patients with three-vessel disease: final five-year follow-up of the SYNTAX trial. 2014

Head, Stuart J / Davierwala, Piroze M / Serruys, Patrick W / Redwood, Simon R / Colombo, Antonio / Mack, Michael J / Morice, Marie-Claude / Holmes, David R / Feldman, Ted E / Ståhle, Elisabeth / Underwood, Paul / Dawkins, Keith D / Kappetein, A Pieter / Mohr, Friedrich W. ·Erasmus University Medical Center, Rotterdam, The Netherlands. · Herzzentrum Universität Leipzig, Strumpelstrasse 39, Leipzig 4289, Germany. · Guy's and St. Thomas' Hospital, London, UK. · San Raffaele Scientific Institute, Milan, Italy. · Medical City Hospital, Dallas, TX, USA. · Institut Hospitalier Jacques Cartier, Générale de santé, Massy, France. · Maro Clinic Rochester, Rochester, MN, USA. · Evanston Hospital, Evanston, IL, USA. · University Hospital Uppsala, Uppsala, Sweden. · Boston Scientific Corporation, Natick, MA, USA. · Herzzentrum Universität Leipzig, Strumpelstrasse 39, Leipzig 4289, Germany mohrf@medizin.uni-leipzig.de. ·Eur Heart J · Pubmed #24849105.

ABSTRACT: AIMS: Coronary artery bypass grafting (CABG) has been considered the standard of care for patients with three-vessel disease (3VD), but long-term comparative results from randomized trials of CABG vs. percutaneous coronary intervention (PCI) using drug-eluting stents (DES) remain limited. METHODS AND RESULTS: Patients with de novo 3VD or left main disease were randomly assigned to PCI with the paclitaxel-eluting first-generation stent or CABG in the SYNTAX trial. This pre-specified analysis presents the 5-year outcomes of patients with 3VD (n = 1095). The rate of major adverse cardiac and cerebrovascular events (MACCE) was significantly higher in patients with PCI compared with CABG (37.5 vs. 24.2%, respectively; P < 0.001). Percutaneous coronary intervention as opposed to CABG resulted in significantly higher rates of the composite of death/stroke/myocardial infarction (MI) (22.0 vs. 14.0%, respectively; P < 0.001), all-cause death (14.6 vs. 9.2%, respectively; P = 0.006), MI (9.2 vs. 4.0%, respectively; P = 0.001), and repeat revascularization (25.4 vs. 12.6%, respectively; P < 0.001); however, stroke was similar between groups at 5 years (3.0 vs. 3.5%, respectively; P = 0.66). Results were dependent on lesion complexity (P for interaction = 0.12); in patients with a low (0-22) SYNTAX score, PCI vs. CABG resulted in similar rates of MACCE (33.3% vs. 26.8%, respectively; P = 0.21) but significantly more repeat revascularization (25.4% vs. 12.6%, respectively; P = 0.038), while in intermediate (23-32) or high (≥ 33) SYNTAX score terciles, CABG demonstrated clear superiority in terms of MACCE, death, MI, and repeat revascularization. Differences in MACCE between PCI and CABG were larger in diabetics [hazard ratio (HR) = 2.30] than non-diabetics (HR = 1.51), although the P for interaction failed to reach significance for MACCE (P for interaction = 0.095) or any of the other endpoints. CONCLUSION: Five-year results of patients with 3VD treated with CABG or PCI using the first-generation paclitaxel-eluting DES suggest that CABG should remain the standard of care as it resulted in significantly lower rates of death, MI, and repeat revascularization, while stroke rates were similar. For patients with low SYNTAX scores, PCI is an acceptable revascularization strategy, although at a price of significantly higher rates of repeat revascularization. CLINICAL TRIAL REGISTRATION: NCT00114972.

22 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.

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

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

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

24 Article Analysis of stroke occurring in the SYNTAX trial comparing coronary artery bypass surgery and percutaneous coronary intervention in the treatment of complex coronary artery disease. 2013

Mack, Michael J / Head, Stuart J / Holmes, David R / Ståhle, Elisabeth / Feldman, Ted E / Colombo, Antonio / Morice, Marie-Claude / Unger, Felix / Erglis, Andrejs / Stoler, Robert / Dawkins, Keith D / Serruys, Patrick W / Mohr, Friedrich W / Kappetein, A Pieter. ·Division of Cardiothoracic Surgery, Baylor Healthcare System, The Heart Hospital, Plano, Texas 75075, USA. michaema@baylorhealth.edu ·JACC Cardiovasc Interv · Pubmed #23523456.

ABSTRACT: OBJECTIVES: This study sought to analyze stroke rates in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial's randomized and registry cohorts of patients being treated with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) for treatment of complex coronary artery disease. BACKGROUND: The SYNTAX trial compared PCI to CABG in patients with de novo 3-vessel and/or left main coronary disease. METHODS: The SYNTAX randomized trial was conducted at 85 U.S. and European sites (n = 1,800). All strokes (up to 4 years) were independently adjudicated by a clinical events committee that included a neurologist. An additional 1,077 (of which 644 were followed for 5 years) and 198 patients were included in the CABG and PCI registries, respectively. RESULTS: In the randomized cohort, 31 CABG and 19 PCI patients experienced 33 and 20 strokes post-randomization at 4-year follow-up, respectively (p = 0.062). Three strokes occurred pre-procedurally but following randomization in CABG-treated patients. After CABG, a large proportion of strokes occurred acutely (0 to 30 days: 9 of 33), whereas in the PCI arm, most strokes occurred >30 days after the procedure (18 of 20). Stroke resulted in death in 3 patients in both the PCI and CABG groups. Of the patients who developed stroke, 68% (21 of 31) in the CABG group had residual deficits at discharge; in the PCI group, 47% (9 of 19) had residual deficits. In a multivariate analysis, treatment with CABG was not significantly associated with increased stroke rates (odds ratio: 1.67, 95% confidence interval: 0.93 to 3.01, p = 0.089). The incidence and outcomes of stroke were similar in the randomized trial and registries. CONCLUSIONS: There is a higher risk of periprocedural stroke in patients undergoing CABG versus PCI; however, the risk converges over the first 4 years of follow-up. (SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries; NCT00114972).

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

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

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

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