Giuseppe De Luca1, Monica Verdoia1, Stefano Savonitto2, Luigi Piatti2, Daniele Grosseto3, Nuccia Morici4, Irene Bossi4, Paolo Sganzerla5, Giovanni Tortorella6, Michele Cacucci7, Ernesto Murena8, Anna Toso9, Sergio Bongioanni10, Amelia Ravera11, Elena Corrada12, Matteo Mariani13, Leonardo Di Ascenzo14, Anna S Petronio15, Claudio Cavallini16, Giancarlo Vitrella17, Roberto Antonicelli18, Renata Rogacka19, Stefano De Servi20. 1. Azienda Ospedaliera-Universitaria 'Maggiore della Carità', Eastern Piedmont University, Novara. 2. Ospedale Manzoni, Lecco. 3. Ospedale Infermi, Rimini. 4. ASST Grande Ospedale Metropolitano Niguarda, Milano. 5. Ospedale Treviglio-Caravaggio, Treviglio. 6. IRCCS Arcispedale S. Maria Nuova, Reggio Emilia. 7. Ospedale Maggiore, Crema, Italy. 8. Ospedale S. Maria delle Grazie, Pozzuoli, Italy. 9. Ospedale S. Stefano, Prato, Italy. 10. Ospedale Mauriziano, Torino, Italy. 11. Ospedale Ruggi D' Aragona, Salerno, Italy. 12. Humanitas Clinical and Research Center, Rozzano, Italy. 13. Ospedale Civile, Legnano, Italy. 14. Ospedale di San Donà di Piave-Portogruaro, Portogruaro, Italy. 15. Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. 16. Ospedale S. Maria della Misericordia, Perugia, Italy. 17. Ospedali Riuniti di Trieste, Trieste, Italy. 18. Istituto Nazionale di Ricerca e Cura per l' Anziano, Ancona, Italy. 19. Statistics and Biomathematics Unit, Department of Molecular and Transactional Medicine, University of Brescia, Brescia. 20. Multimedica IRCSS, Milan, Italy.
Abstract
BACKGROUND: Despite recent improvements in percutaneous coronary revascularization and antithrombotic therapies for the treatment of acute coronary syndromes, the outcome is still unsatisfactory in high-risk patients, such as the elderly and patients with diabetes. The aim of the current study was to investigate the prognostic impact of diabetes on clinical outcome among patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study carried out at 32 centers in Italy. METHODS: Our population is represented by 1443 patients included in the Elderly-ACS 2 trial. Diabetes was defined as known history of diabetes at admission. The primary endpoint of this analysis was cardiovascular mortality, while secondary endpoints were all-cause death, recurrent myocardial infarction, Bleeding Academic Research Consortium type 2 or 3 bleeding, and rehospitalization for cardiovascular event or stent thrombosis within 12 months after index admission. RESULTS: Diabetes was present in 419 (29%) out of 1443 patients. Diabetic status was significantly associated with major cardiovascular risk factors and history of previous coronary disease, presentation with non-ST segment elevation myocardial infarction (P = 0.01) more extensive coronary disease (P = 0.02), more advanced Killip class at presentation (P = 0.003), use at admission of statins (P = 0.004) and diuretics at discharge (P < 0.001). Median follow-up was 367 days (interquartile range: 337-378 days). Diabetic status was associated with an absolute increase in the rate of cardiovascular mortality as compared with patients without diabetes [5.5 vs. 3.3%, hazard ratio (HR) 1.7 (0.99-2.8), P = 0.054], particularly among those treated with clopidogrel [HR (95% confidence interval (CI)) = 1.89 (0.93-3.87), P = 0.08]. However, this difference disappeared after correction for baseline differences [Adjusted HR (95% CI) 1.1(0.4-2.9), P = 0.86]. Similar findings were observed for other secondary endpoints, except for bleeding complications, significantly more frequent in diabetic patients [HR (95% CI) 2.02 (1.14-3.6), P = 0.02; adjusted HR (95% CI) = 2.1 (1.01-4.3), P = 0.05]. No significant interaction was observed between type of dual antiplatelet therapy, diabetic status and outcome. CONCLUSION: Among elderly patients with acute coronary syndromes, diabetic status was associated with higher rates of comorbidities, more severe cardiovascular risk profile and major bleeding complications fully accounting for the absolute increase in mortality. In fact, diabetes mellitus did not emerge as an independent predictor of survival in advanced age.
RCT Entities:
BACKGROUND: Despite recent improvements in percutaneous coronary revascularization and antithrombotic therapies for the treatment of acute coronary syndromes, the outcome is still unsatisfactory in high-risk patients, such as the elderly and patients with diabetes. The aim of the current study was to investigate the prognostic impact of diabetes on clinical outcome among patients included in the Elderly-ACS 2 trial, a randomized, open-label, blinded endpoint study carried out at 32 centers in Italy. METHODS: Our population is represented by 1443 patients included in the Elderly-ACS 2 trial. Diabetes was defined as known history of diabetes at admission. The primary endpoint of this analysis was cardiovascular mortality, while secondary endpoints were all-cause death, recurrent myocardial infarction, Bleeding Academic Research Consortium type 2 or 3 bleeding, and rehospitalization for cardiovascular event or stent thrombosis within 12 months after index admission. RESULTS:Diabetes was present in 419 (29%) out of 1443 patients. Diabetic status was significantly associated with major cardiovascular risk factors and history of previous coronary disease, presentation with non-ST segment elevation myocardial infarction (P = 0.01) more extensive coronary disease (P = 0.02), more advanced Killip class at presentation (P = 0.003), use at admission of statins (P = 0.004) and diuretics at discharge (P < 0.001). Median follow-up was 367 days (interquartile range: 337-378 days). Diabetic status was associated with an absolute increase in the rate of cardiovascular mortality as compared with patients without diabetes [5.5 vs. 3.3%, hazard ratio (HR) 1.7 (0.99-2.8), P = 0.054], particularly among those treated with clopidogrel [HR (95% confidence interval (CI)) = 1.89 (0.93-3.87), P = 0.08]. However, this difference disappeared after correction for baseline differences [Adjusted HR (95% CI) 1.1(0.4-2.9), P = 0.86]. Similar findings were observed for other secondary endpoints, except for bleeding complications, significantly more frequent in diabeticpatients [HR (95% CI) 2.02 (1.14-3.6), P = 0.02; adjusted HR (95% CI) = 2.1 (1.01-4.3), P = 0.05]. No significant interaction was observed between type of dual antiplatelet therapy, diabetic status and outcome. CONCLUSION: Among elderly patients with acute coronary syndromes, diabetic status was associated with higher rates of comorbidities, more severe cardiovascular risk profile and major bleeding complications fully accounting for the absolute increase in mortality. In fact, diabetes mellitus did not emerge as an independent predictor of survival in advanced age.
Authors: Giuseppe De Luca; Matteo Nardin; Magdy Algowhary; Berat Uguz; Dinaldo C Oliveira; Vladimir Ganyukov; Zan Zimbakov; Miha Cercek; Lisette Okkels Jensen; Poay Huan Loh; Lucian Calmac; Gerard Roura Ferrer; Alexandre Quadros; Marek Milewski; Fortunato Scotto di Uccio; Clemens von Birgelen; Francesco Versaci; Jurrien Ten Berg; Gianni Casella; Aaron Wong Sung Lung; Petr Kala; José Luis Díez Gil; Xavier Carrillo; Maurits Dirksen; Victor M Becerra-Munoz; Michael Kang-Yin Lee; Dafsah Arifa Juzar; Rodrigo de Moura Joaquim; Roberto Paladino; Davor Milicic; Periklis Davlouros; Nikola Bakraceski; Filippo Zilio; Luca Donazzan; Adriaan Kraaijeveld; Gennaro Galasso; Arpad Lux; Lucia Marinucci; Vincenzo Guiducci; Maurizio Menichelli; Alessandra Scoccia; Aylin Hatice Yamac; Kadir Ugur Mert; Xacobe Flores Rios; Tomas Kovarnik; Michal Kidawa; Josè Moreu; Vincent Flavien; Enrico Fabris; Iñigo Lozano Martínez-Luengas; Marco Boccalatte; Francisco Bosa Ojeda; Carlos Arellano-Serrano; Gianluca Caiazzo; Giuseppe Cirrincione; Hsien-Li Kao; Juan Sanchis Forés; Luigi Vignali; Helder Pereira; Stephane Manzo; Santiago Ordoñez; Alev Arat Özkan; Bruno Scheller; Heidi Lehtola; Rui Teles; Christos Mantis; Ylitalo Antti; João António Brum Silveira; Rodrigo Zoni; Ivan Bessonov; Stefano Savonitto; George Kochiadakis; Dimitrios Alexopulos; Carlos E Uribe; John Kanakakis; Benjamin Faurie; Gabriele Gabrielli; Alejandro Gutierrez Barrios; Juan Pablo Bachini; Alex Rocha; Frankie Chor-Cheung Tam; Alfredo Rodriguez; Antonia Anna Lukito; Veauthyelau Saint-Joy; Gustavo Pessah; Andrea Tuccillo; Giuliana Cortese; Guido Parodi; Mohammed Abed Bouraghda; Elvin Kedhi; Pablo Lamelas; Harry Suryapranata; Monica Verdoia Journal: Diabet Epidemiol Manag Date: 2021-10-30
Authors: Nousjka P A Vranken; Saman Rasoul; Jasper J P Luijkx; Tobias F S Pustjens; Sonja Postma; Evelien J Kolkman; Elvin Kedhi; Sodiqur Rifqi; Michael K Y Lee; Henning Ebelt; Béla Merkely; Monica Verdoia; Wojtek Wojakowski; Arnoud A W J van 't Hof; Harry Suryapranata; Giuseppe De Luca Journal: Diabetes Metab Res Rev Date: 2022-04-22 Impact factor: 8.128