Abstract :
Summary Background Patients with stable coronary artery disease and diabetes with previous percutaneous coronary intervention (PCI), particularly those with previous stenting, are at high risk of ischaemic events. These patients are generally treated with aspirin. In this trial, we aimed to investigate if these patients would benefit from treatment with aspirin plus ticagrelor. Methods The Effect of Ticagrelor on Health Outcomes in diabEtes Mellitus patients Intervention Study (THEMIS) was a phase 3 randomised, double-blinded, placebo-controlled trial, done in 1315 sites in 42 countries. Patients were eligible if 50 years or older, with type 2 diabetes, receiving anti-hyperglycaemic drugs for at least 6 months, with stable coronary artery disease, and one of three other mutually non-exclusive criteria: a history of previous PCI or of coronary artery bypass grafting, or documentation of angiographic stenosis of 50% or more in at least one coronary artery. Eligible patients were randomly assigned (1:1) to either ticagrelor or placebo, by use of an interactive voice-response or web-response system. The THEMIS-PCI trial comprised a prespecified subgroup of patients with previous PCI. The primary efficacy outcome was a composite of cardiovascular death, myocardial infarction, or stroke (measured in the intention-to-treat population). Findings Between Feb 17, 2014, and May 24, 2016, 11,154 patients (58% of the overall THEMIS trial) with a history of previous PCI were enrolled in the THEMIS-PCI trial. Median follow-up was 3*3 years (IQR 2*8--3*8). In the previous PCI group, fewer patients receiving ticagrelor had a primary efficacy outcome event than in the placebo group (404 [7*3%] of 5558 vs 480 [8*6%] of 5596; HR 0*85 [95% CI 0*74--0*97], p=0*013). The same effect was not observed in patients without PCI (p=0*76, p.sub.interaction=0*16). The proportion of patients with cardiovascular death was similar in both treatment groups (174 [3*1%] with ticagrelor vs 183 (3*3%) with placebo; HR 0*96 [95% CI 0*78--1*18], p=0*68), as well as all-cause death (282 [5*1%] vs 323 [5*8%]; 0*88 [0*75--1*03], p=0*11). TIMI major bleeding occurred in 111 (2*0%) of 5536 patients receiving ticagrelor and 62 (1*1%) of 5564 patients receiving placebo (HR 2*03 [95% CI 1*48--2*76], p Interpretation In patients with diabetes, stable coronary artery disease, and previous PCI, ticagrelor added to aspirin reduced cardiovascular death, myocardial infarction, and stroke, although with increased major bleeding. In that large, easily identified population, ticagrelor provided a favourable net clinical benefit (more than in patients without history of PCI). This effect shows that long-term therapy with ticagrelor in addition to aspirin should be considered in patients with diabetes and a history of PCI who have tolerated antiplatelet therapy, have high ischaemic risk, and low bleeding risk. Funding AstraZeneca. Author Affiliation: (a) Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School Boston, MA, USA (b) French Alliance for Cardiovascular Trials, Département Hospitalo-Universitaire FIRE, AP-HP, Hôpital Bichat, Université de Paris, Institut National de la Santé et de la Recherche Médicale U-1148, Paris, France (c) National Heart and Lung Institute, Royal Brompton Hospital, Imperial College London, London, UK (d) Department of Primary Care and Public Health, Imperial Centre for Cardiovascular Disease Prevention, Imperial College London, London, UK (e) Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada (f) McMaster University, Hamilton, ON, Canada (g) Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada (h) Department of Clinical Pharmacology-Clinical Research Platform (URCEST-CRB-CRCEST), AP-HP, Hôpital Saint Antoine, Sorbonne-Université, Paris, France (i) Department of Medical Sciences, Cardiology, Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (j) AstraZeneca BioPharmaceuticals Research & Development, Late-stage Development, Cardiovascular, Renal and Metabolic, Mölndal, Sweden (k) AstraZeneca BioPharmaceuticals Research & Development, Late-stage Development, Cardiovascular, Renal and Metabolic, Gaithersburg, MD, USA (l) Baim Institute for Clinical Research, Boston, MA, USA (m) Department of Medicine, Estudios Clínicos Latino América, Rosario, Argentina (n) Department of Medicine (Cardiology), Tokai University School of Medicine, Isehara, Japan (o) Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden (p) Institute of Cardiology, Emergency Cardiology Department, Kiev, Ukraine (q) Saint Luke's Mid-America Heart Institute, University of Missouri--Kansas City, Kansas City, MO, USA (r) The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia (s) University of Texas Southwestern Medical Center, Dallas, TX, USA (t) Department of Medicine, Stanford University, Stanford, CA, USA * Correspondence to: Dr Deepak Bhatt, Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, MA 02115, USA (footnote)* Contributed equally (footnote)[Dagger] Members listed in the Byline: Prof Deepak L Bhatt, MD [dlbhattmd@post.harvard.edu] (a), Prof Philippe Gabriel Steg, MD (b,c), Prof Shamir R Mehta, MD (e,f), Prof Lawrence A Leiter, MD (g), Prof Tabassome Simon, MD (h), Prof Kim Fox, MD (c), Prof Claes Held, MD (i), Marielle Andersson, MSc (j), Anders Himmelmann, MD (j), Wilhelm Ridderstråle, MD (j), Jersey Chen, MD (k), Yang Song, MS (l), Rafael Diaz, MD (m), Prof Shinya Goto, MD (n), Prof Stefan K James, MD (o), Prof Kausik K Ray, FRCP (d), Prof Alexander N Parkhomenko, MD (p), Prof Mikhail N Kosiborod, MD (q,r), Prof Darren K McGuire, MD (s), Prof Robert A Harrington, MD (t), Vladimir Santos, Ashit Jain, Irina Lendel, Michael Russo, W H Haught, Manuel Bouza, Harinder Gogia, Supratim Banerjee, George Kichura, Louis Kantaros, Francisco Padron, Rakesh Passi, Jay Stone, Michael Pursley, Michael D'Urso, Timothy Gardner, James Bennett, Khaled Nour, Satinder Saini, Wenwu Zhang, Dharam Kumbhani, Dustin Thomas, Dominick Angiolillo, Barry Bertolet, Amaury Roman-Miranda, Robert Black, Ramin Manshadi, Carlos Vaca, Antonio Blanco, Mark Napoli, David Brabham, Ayim Akyea-Djamson, Pratik Desai, Sudhir Prasada, Ajit Khaira, Leslie Forgosh, Ira Lieber, Guillermo Umpierrez, Dinesh Singal, Juan Londono, Neil Fraser, Jose Ruiz, Damaris Vega, Lilia Rodriguez, Christopher Brown, Faizullah Syed, Guarav Aggarwala, William Eaves, Michael Foster, Dinesh Gupta, David Avino, Wail Asfour, Glen Tonnessen, Xue-Qiao Zhao, Narendra Singh, Andrew Brockmyre, Norman Lepor, Nicolas Shammas, David Blick, Steven Hearne, John Prodafikas, Edgar Carell, Mark Izzo, Amin Karim, Bosh Zakhary, Mahmoud Atieh, Steven Leichter, Charles Meadows, David Hotchkiss, Mazen Abu-Fadel, Alan Wiseman, Jeffrey Bander, Mahesh Shah, Subhash Banerjee, Ricky Ganim, Karen Sopko, Misal Khan, Ramon Lloret, Troy Weirick, Rajendra Mehta, Udho Thadani, Anuj Bhargava, Mikhail Kosiborod, Jaynier Moya, Cezar Staniloae, Yamirka D Guerra, Anil Chhabra, Douglas Kosmicki, Wassim Shaheen, Akber Mohammed, J'Cinda Bitters, Jan Pattanayak, Julian Javier, Sunny Srivastava, Roland Phillips, Jessie Al-Amin, Michael Lillestol, Patrick Simpson, Lydie Hazan, Amit Amin, Gopi Shah, Denes Korpas, Bruce Platt, Jim Dickert, Orlando Puente, Louis Hiotis, Timothy Doyle, Raj Rajan, Alan Meholick, Christian Gring, Elie Hage-Korban, Robert Feldman, Harry Colfer, Samuel Butman, Malcolm Foster, Terence Hart, Randall Huling, Shervin Eshaghian, Ofsman Quintana, Deanna Cheung, Franklin Handel, Mara Rodriguez, David Suh, Paul Gordon, Gregg Pressman, Michael Bauer, William French, Mark Barettella, Sridhar Chatrathi, Damodhar Suresh, Ronald Goldberg, Mark Huth, Liwa 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Robert Hagemeier, Gunnar Skjelvan, David Colquhoun, John Amerena, Claire Morbey, Christopher Hammett, Anthony Dart, Ronald Lehman, Andrew Hamilton, Matthew Worthley, Peter Purnell, Alan Whelan, Richard MacIsaac, Ktut Arya, Sultan Linjawi, Joseph Proietto, Lakshman Prasad, Aldo Rodriguez, Armando Godoy, Victor Rodriguez, Percy Berrospi, Carlos Chavez, Sandra Negron, Javier Heredia, Felix Medina, Helard Manrique, Walter Cabrera, Fernando Cordova, Trinidad Quinteros, Jaime M Haro, Susana Regalado, Javier Guitton, Hugo Arbanil, Michel Pansieri, Eric Decoulx, Pascal Goube, Axel de Labriolle, Jean N Labeque, Gregoire Range, Yves Cottin, Gilles Montalescot, Guillaume Cayla, Nicolas Danchin, Denis Angoulvant, Emile Ferrario, Meyer Elbaz, Olivier Dubreuil, Philippe G Steg, Caroline Fontaine, Emmanuel Sorbets, Hafiz Omer, Shukri Al-Saif, Hussam Al-Faleh, Abdullah Al-Shehri, Halia Alshehri, Rasha Bazari, Pak Hei, Man Ying, Michael Chan, Michelle Wong, Ronald Ma, Shing C Siu, Chiu C Tsang, Maurizio Ferrario, Emilio Assanelli, Michele Senni, Piermarco Piatti, Paolo Calabrò, Stefano Urbinati, Massimo Michisanti, Ferdinando Varbella, Salvatore de Cosmo, Roberto Trevisan, Sandro Bellotti, Giuseppe Di Pasquale, Angelo S Bongo, Massimo Uguccioni, Edoardo Mannucci, Ciro Mauro, Mauro Ragonese, Claudio Fresco, Maurizio Turturo, Rossella Marcucci, Manuel J Lievano Triana, Camilo Arana, Jose Accini, Rodrigo Botero, Marlena Muzyk-Osikowicz, Fredy T Dada, Gregorio S Vallejo, Fernando Manzur, Daniel Isaza, Dora Molina, Juan G Mesa, Alvaro Quintero, Kai Nyman, Jyrki Mäkelä, Jorma Strand, Sakari Nieminen, Jyrki Taurio, Matti Kuusela, Timo Valle, Mikko Pietilä, Sakari Kekki, Timo Strandberg, Marc Klutstein, Gabriel Greenberg, Yoseph Rozenman, Ehud Chorin, Ariel Roguin, Basil Lewis, Amir Bashkin, Edgar Tan, Jose P Prado, Arthur Ferrolino, Noe Babilonia, Benny Barbas, Generoso Matiga, Raul M Coching, Heinz Drexel, Helmut Brath, Christoph Schnack, Ursula Hanusch, Evelyn Fließer-Görzer, Bernhard Paulweber, Christoph Ebenbichler, Rudolf Prager, Kurt Huber, Michael Wolzt, Johann Auer, Rudolf Berger, Gerit-Holger Schernthaner, Gabriela Stanciulescu, Mihai Creteanu, Marilena Spiridon, Viorica Dobreanu, Dragos Vinereanu, Laura C Iosipescu, Octavian Istratoaie, Ioan Coman, Constantin Militaru, Mircea Cinteza, Deepak L Bhatt, Kim Fox, Robert A Harrington, Lawrence A Leiter, Shamir R Mehta, Tabassome Simon, Marielle Andersson, Anders Himmelmann, Philippe G Steg, Rafael Diaz, John Amerena, Kurt Huber, Peter R Sinnaeve, José C Nicolau, José F Kerr Saraiva, Ivo Petrov, Lawrence A Leiter, Shamir R Mehta, Ramón Corbalán, Junbo Ge, Qiang Zhao, Rodrigo Botero, Petr Widimský, Steen D Kristensen, Juha Hartikainen, Nicolas Danchin, Harald Darius, Hung F Tse, Robert G Kiss, Prem Pais, Eli Lev, Leonardo de Luca, Shinya Goto, Gabriel A Ramos López, Jan H Cornel, Frederic Kontny, Felix Medina, Noe A Babilonia, Grzegorz Opolski, Dragos Vinereanu, Dmitry A Zateyshchikov, Mikhail Ruda, Omer Elamin, Frantisek Kovár, Anthony J Dalby, Myung H Jeong, Héctor Bueno, Stefan K James, Chern-En Chiang, Damras Tresukosol, Zeki Ongen, Kausik K Ray, Alexander Parkhomenko, Darren K McGuire, Mikhail N Kosiborod, Tuan Q Nguyen, Marielle Andersson, Jersey Chen, Anders Himmelmann, Maria Leonsson-Zachrisson, Wilhelm Ridderstråle