1. Percutaneous coronary intervention versus coronary artery bypass grafting in patients with three-vessel or left main coronary artery disease: 10-year follow-up of the multicentre randomised controlled SYNTAX trial
- Author
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Daniel J F M Thuijs, A Pieter Kappetein, Patrick W Serruys, Friedrich-Wilhelm Mohr, Marie-Claude Morice, Michael J Mack, David R Holmes, Nick Curzen, Piroze Davierwala, Thilo Noack, Milan Milojevic, Keith D Dawkins, Bruno R da Costa, Peter Jüni, Stuart J Head, Filip Casselman, Bernard de Bruyne, Evald Høj Christiansen, Juan M. Ruiz-Nodar, Paul Vermeersch, Werner Schultz, Manel Sabaté, Giulio Guagliumi, Herko Grubitzsch, Karl Stangl, Olivier Darremont, M. Bentala, Peter den Heijer, Istvan Preda, Robert Stoler, Michael J. Mack, Tamás Szerafin, John K. Buckner, Myles S. Guber, Niels Verberkmoes, Ferdi Akca, Ted Feldman, Friedhelm Beyersdorf, Benny Drieghe, Keith Oldroyd, Geoff Berg, Anders Jeppsson, Kimberly Barber, Kevin Wolschleger, John Heiser, Pim van der Harst, Massimo A. Mariani, Hermann Reichenspurner, Christoffer Stark, Mika Laine, Paul C. Ho, John C. Chen, Richard Zelman, Phillip A. Horwitz, Andrzej Bochenek, Agata Krauze, Christina Grothusen, Dariusz Dudek, George Heyrich, Philippe Kolh, Victor LeGrand, Pedro Coelho, Stephan Ensminger, Boris Nasseri, Richard Ingemansson, Goran Olivecrona, Javier Escaned, Reddy Guera, Sergio Berti, Alaide Chieffo, Nicholas Burke, Michael Mooney, Alvise Spolaor, Christian Hagl, Michael Näbauer, Maarten Jan Suttorp, Ronald A. Stine, Thomas McGarry, Scott Lucas, Knut Endresen, Andrew Taussig, Kevin Accola, Umberto Canosi, Ivan Horvath, Louis Cannon, John D. Talbott, Chris W. Akins, Robert Kramer, Michael Aschermann, William Killinger, Inga Narbute, David R. Holmes, Francesco Burzotta, Ad Bogers, Felix Zijlstra, Helene Eltchaninoff, Jacques Berland, Giulio Stefanini, Ignacio Cruz Gonzalez, Uta Hoppe, Stefan Kiesz, Bartlomiej Gora, Anders Ahlsson, Matthias Corbascio, Thomas Bilfinger, Didier Carrie, Didier Tchétché, Karl-Eugen Hauptman, Elisabeth Stahle, Stefan James, Sigrid Sandner, Günther Laufer, Irene Lang, Adam Witkowski, Vinod Thourani, Harry Suryapranata, Simon Redwood, Charles Knight, Philip MacCarthy, Adam de Belder, Adrian Banning, Anthony Gershlick, Cardiothoracic Surgery, Clinical sciences, and Cardiology
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Male ,medicine.medical_specialty ,medicine.medical_treatment ,Vascular damage Radboud Institute for Health Sciences [Radboudumc 16] ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,law.invention ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,cardiovascular diseases ,030212 general & internal medicine ,Myocardial infarction ,Coronary Artery Bypass ,610 Medicine & health ,Survival rate ,Aged ,Medicine(all) ,business.industry ,Hazard ratio ,Percutaneous coronary intervention ,Drug-Eluting Stents ,General Medicine ,Middle Aged ,medicine.disease ,Cardiac surgery ,Survival Rate ,Treatment Outcome ,surgical procedures, operative ,Settore MED/11 - MALATTIE DELL'APPARATO CARDIOVASCOLARE ,Conventional PCI ,Cardiology ,Female ,business ,360 Social problems & social services ,Follow-Up Studies - Abstract
Item does not contain fulltext BACKGROUND: The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. METHODS: The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with ClinicalTrials.gov, NCT03417050. FINDINGS: From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%) patients had died after PCI and 211 (24%) after CABG (hazard ratio 1.17 [95% CI 0.97-1.41], p=0.092). Among patients with three-vessel disease, 151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG (hazard ratio 1.41 [95% CI 1.10-1.80]), and among patients with left main coronary artery disease, 93 (26%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0.90 [0.68-1.20], pinteraction=0.019). There was no treatment-by-subgroup interaction with diabetes (pinteraction=0.66) and no linear trend across SYNTAX score tertiles (ptrend=0.30). INTERPRETATION: At 10 years, no significant difference existed in all-cause death between PCI using first-generation paclitaxel-eluting stents and CABG. However, CABG provided a significant survival benefit in patients with three-vessel disease, but not in patients with left main coronary artery disease. FUNDING: German Foundation of Heart Research (SYNTAXES study, 5-10-year follow-up) and Boston Scientific Corporation (SYNTAX study, 0-5-year follow-up).
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- 2019