Anthony J Dalby1, Shmuel Gottlieb2, Derek D Cyr3, Erik Magnus Ohman4, Darren K McGuire5, Witold Ruzyllo6, Deepak L Bhatt7, Stephen D Wiviott7, Kenneth J Winters8, Keith A A Fox9, Paul W Armstrong10, Harvey D White11, Dorairaj Prabhakaran12, Matthew T Roe13. 1. Milpark Hospital, Johannesburg, South Africa. 2. Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel. 3. Duke Clinical Research Institute, Durham, NC, USA. 4. Duke Clinical Research Institute, Durham, NC, USA; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA. 5. Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX, USA. 6. Department of Coronary Artery Disease, Institute of Cardiology, Warsaw, Poland. 7. Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA. 8. Eli Lilly and Company, Indianapolis, IN, USA. 9. Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, Scotland, United Kingdom. 10. Canadian VIGOUR Centre and Division of Cardiology, Department of Medicine, University of Alberta, Edmonton, Alberta, Canada. 11. Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. 12. Centre for Chronic Disease Control and Public Health Foundation of India, New Delhi, India. 13. Duke Clinical Research Institute, Durham, NC, USA; Division of Cardiology, Department of Medicine, Duke University School of Medicine, Durham, NC, USA. Electronic address: matthew.roe@duke.edu.
Abstract
OBJECTIVE:Patients with diabetes mellitus (DM) presenting with acute coronary syndrome (ACS) and undergoingpercutaneous coronary intervention (PCI) derived enhanced benefit with dual antiplatelet therapy (DAPT) with prasugrel vs. clopidogrel. The risk profile and treatment response to DAPT for medically managed ACS patients with DM remains uncertain. METHODS: The TRILOGY ACS trial compared aspirin + prasugrel vs. aspirin + clopidogrel for up to 30months in non-ST-segment elevation (NSTE) ACS patients managed medically without revascularization. We compared treatment-related outcomes among 3539 patients with DM vs. 5767 patients without DM. The primary endpoint was a composite of cardiovascular death, myocardial infarction, or stroke. RESULTS: Patients with vs. without DM were younger, more commonly female, heavier, and more often had revascularization prior to the index ACS event. The frequency of the primary endpoint through 30months was higher among patients with vs. without DM (24.8% vs. 16.3%), with a higher risk for those patients with DM treated with insulin vs. those treated without insulin (35.3% vs. 19.9%). There was no significant difference in the frequency of the primary endpoint by treatment with prasugrel vs. clopiodgrel in those with or without DM (Pint=0.82) and with or without insulin treatment among those with DM (Pint=0.304). CONCLUSIONS: Among NSTE ACS patients managed medically without revascularization, patients with DM had a higher risk of ischemic events that was amplified among those treated with insulin. There was no differential treatment effect with a more potent DAPT regimen of aspirin + prasugrel vs. aspirin + clopidogrel.
RCT Entities:
OBJECTIVE:Patients with diabetes mellitus (DM) presenting with acute coronary syndrome (ACS) and undergoing percutaneous coronary intervention (PCI) derived enhanced benefit with dual antiplatelet therapy (DAPT) with prasugrel vs. clopidogrel. The risk profile and treatment response to DAPT for medically managed ACS patients with DM remains uncertain. METHODS: The TRILOGY ACS trial compared aspirin + prasugrel vs. aspirin + clopidogrel for up to 30months in non-ST-segment elevation (NSTE) ACS patients managed medically without revascularization. We compared treatment-related outcomes among 3539 patients with DM vs. 5767 patients without DM. The primary endpoint was a composite of cardiovascular death, myocardial infarction, or stroke. RESULTS:Patients with vs. without DM were younger, more commonly female, heavier, and more often had revascularization prior to the index ACS event. The frequency of the primary endpoint through 30months was higher among patients with vs. without DM (24.8% vs. 16.3%), with a higher risk for those patients with DM treated with insulin vs. those treated without insulin (35.3% vs. 19.9%). There was no significant difference in the frequency of the primary endpoint by treatment with prasugrel vs. clopiodgrel in those with or without DM (Pint=0.82) and with or without insulin treatment among those with DM (Pint=0.304). CONCLUSIONS: Among NSTE ACS patients managed medically without revascularization, patients with DM had a higher risk of ischemic events that was amplified among those treated with insulin. There was no differential treatment effect with a more potent DAPT regimen of aspirin + prasugrel vs. aspirin + clopidogrel.