Michela Faggioni1, Usman Baber2, Jaya Chandrasekhar2, Samantha Sartori2, Bimmer E Claessen2, Sunil V Rao3, Birgit Vogel2, Mark B Effron4, Kanhaiya Poddar5, Serdar Farhan2, Annapoorna Kini2, William Weintraub6, Catalin Toma7, Sabato Sorrentino2, Sandra Weiss6, Clayton Snyder2, Joseph B Muhlestein8, Samir Kapadia5, Stuart Keller9, Craig Strauss10, Melissa Aquino2, Brian Baker11, Anthony Defranco12, Stuart Pocock13, Timothy Henry14, Roxana Mehran15. 1. Icahn School of Medicine at Mount Sinai, New York, NY, United States of America; James J Peters Veterans Affairs Medical Center, Bronx, NY, United States of America. 2. Icahn School of Medicine at Mount Sinai, New York, NY, United States of America. 3. The Duke Clinical Research Institute, Durham, NC, United States of America. 4. John Ochsner Heart and Vascular Institute, Ochsner Medical Center, New Orleans, LA, United States of America; Eli Lilly and Company, Indianapolis, IN, United States of America. 5. Cleveland Clinic, Cleveland, OH, United States of America. 6. Christiana Care Health System, Newark, DE, United States of America. 7. University of Pittsburgh Medical Center, Pittsburgh, PA, United States of America. 8. Intermountain Heart Institute, Salt-Lake city, UT, United States of America. 9. Eli Lilly and Company, Indianapolis, IN, United States of America. 10. Minneapolis Heart Institute, Minneapolis, MN, United States of America. 11. Daiichi-Sankyo, Inc., Basking Ridge, NJ, United States of America. 12. Aurora Cardiovascular Services, Milwaukee, WI, United States of America. 13. London School of Hygiene and Tropical Medicine, London, United Kingdom. 14. Cedars-Sinai Heart Institute, Los Angeles, CA, United States of America. 15. Icahn School of Medicine at Mount Sinai, New York, NY, United States of America. Electronic address: roxana.mehran@mountsinai.org.
Abstract
BACKGROUND: Clinical trial data studies suggest superiority of prasugrel over clopidogrel in patients with diabetes. However, the use, safety and efficacy profile of prasugrel in unselected diabetic patients presenting with acute coronary syndromes (ACS) remain unclear. METHODS: PROMETHEUS was a prospective multicenter observational study of 19,919 ACS PCI patients enrolled between 2010 and 2013. The primary endpoint was 90-day major adverse cardiovascular events (MACE), comprising all-cause death, myocardial infarction, stroke or unplanned revascularization. The safety endpoint was bleeding requiring hospitalization. RESULTS: We identified 7580 (38%) subjects with and 12,329 (62%) without diabetes. Diabetic patients were older and had significantly higher rates of cardiovascular risk factors. However, they were less likely to receive prasugrel (18.2% vs. 21.7%). Use of prasugrel did not increase with the severity of clinical presentation in diabetics, whereas, among non-diabetics, prescription of prasugrel was higher in NSTEMI and STEMI compared to unstable angina. The 90-day and 1-year adjusted risk of MACE was greater in diabetics (at 1 year: 22.7% vs. 16.5%; HR 1.22 [1.14-1.33], p < 0.001). At 1 year, the risk of bleeding was also higher in diabetics (4.9% vs. 4.1%, HR 1.19 [1.01-1.39], p = 0.035). After multivariable adjustment, use of prasugrel was associated with a lower risk of death in diabetic patients both at 90 days and 1 year. CONCLUSIONS: Use of prasugrel in diabetic patients with PCI-treated ACS was lower than in non-diabetics despite their high-risk profile and the severity of their clinical presentation. In diabetics, prasugrel was associated with a lower adjusted risk of 90-day death compared with clopidogrel.
BACKGROUND: Clinical trial data studies suggest superiority of prasugrel over clopidogrel in patients with diabetes. However, the use, safety and efficacy profile of prasugrel in unselected diabeticpatients presenting with acute coronary syndromes (ACS) remain unclear. METHODS: PROMETHEUS was a prospective multicenter observational study of 19,919 ACS PCI patients enrolled between 2010 and 2013. The primary endpoint was 90-day major adverse cardiovascular events (MACE), comprising all-cause death, myocardial infarction, stroke or unplanned revascularization. The safety endpoint was bleeding requiring hospitalization. RESULTS: We identified 7580 (38%) subjects with and 12,329 (62%) without diabetes. Diabeticpatients were older and had significantly higher rates of cardiovascular risk factors. However, they were less likely to receive prasugrel (18.2% vs. 21.7%). Use of prasugrel did not increase with the severity of clinical presentation in diabetics, whereas, among non-diabetics, prescription of prasugrel was higher in NSTEMI and STEMI compared to unstable angina. The 90-day and 1-year adjusted risk of MACE was greater in diabetics (at 1 year: 22.7% vs. 16.5%; HR 1.22 [1.14-1.33], p < 0.001). At 1 year, the risk of bleeding was also higher in diabetics (4.9% vs. 4.1%, HR 1.19 [1.01-1.39], p = 0.035). After multivariable adjustment, use of prasugrel was associated with a lower risk of death in diabeticpatients both at 90 days and 1 year. CONCLUSIONS: Use of prasugrel in diabeticpatients with PCI-treated ACS was lower than in non-diabetics despite their high-risk profile and the severity of their clinical presentation. In diabetics, prasugrel was associated with a lower adjusted risk of 90-day death compared with clopidogrel.
Authors: Juan Miguel Ruiz-Nodar; María Asunción Esteve-Pastor; Jose Miguel Rivera-Caravaca; Miriam Sandín; Teresa Lozano; Nuria Vicente-Ibarra; Esteban Orenes-Piñero; Manuel Jesús Macías; Vicente Pernías; Luna Carrillo; Elena Candela; Andrea Veliz; Antonio Tello-Montoliu; Juan Gabriel Martínez Martínez; Francisco Marín Journal: Br J Clin Pharmacol Date: 2020-02-03 Impact factor: 4.335