Usman Baber1, Jaya Chandrasekhar1, Samantha Sartori1, Melissa Aquino1, Annapoorna S Kini2, Samir Kapadia3, William Weintraub4, Joseph B Muhlestein5, Birgit Vogel1, Michela Faggioni1, Serdar Farhan1, Sandra Weiss4, Craig Strauss6, Catalin Toma7, Anthony DeFranco8, Brian A Baker9, Stuart Keller10, Mark B Effron11, Timothy D Henry12, Sunil Rao13, Stuart Pocock14, George Dangas2, Roxana Mehran15. 1. Division of Cardiology, Icahn School of Medicine at Mount Sinai, New York, New York. 2. Division of Cardiology, Mount Sinai Hospital, New York, New York. 3. Division of Cardiology, Cleveland Clinic, Cleveland, Ohio. 4. Division of Cardiology, Christiana Care Health System, Newark, Delaware. 5. Division of Cardiology, Intermountain Heart Institute, Salt Lake City, Utah. 6. Division of Cardiology, Minneapolis Heart Institute, Minneapolis, Minnesota. 7. Division of Cardiology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. 8. Division of Cardiology, Aurora Cardiovascular Services, Milwaukee, Wisconsin. 9. Daiichi Sankyo, Parsippany, New Jersey. 10. Eli Lilly and Company, Indianapolis, Indiana. 11. Eli Lilly and Company, Indianapolis, Indiana; Division of Cardiology, John Ochsner Heart and Vascular Center, Ochsner Medical Center, New Orleans, Louisiana. 12. Division of Cardiology, Cedars-Sinai Heart Institute, Los Angeles, California. 13. Division of Cardiology, Duke University, Durham, North Carolina. 14. London School of Hygiene and Tropical Medicine, London, United Kingdom. 15. Division of Cardiology, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: roxana.mehran@mountsinai.org.
Abstract
OBJECTIVES: This study sought to compare clinical outcomes in a contemporary acute coronary syndrome (ACS) percutaneous coronary intervention (PCI) cohort stratified by chronic kidney disease (CKD) status. BACKGROUND: Patients with CKD exhibit high risks for both thrombotic and bleeding events, thus complicating decision making regarding antiplatelet therapy in the setting of ACS. METHODS: The PROMETHEUS study was a multicenter observational study comparing outcomes with prasugrel versus clopidogrel in ACS PCI patients. Major adverse cardiac events (MACE) at 90 days and at 1 year were defined as a composite of death, myocardial infarction, stroke, or unplanned revascularization. Clinically significant bleeding was defined as bleeding requiring transfusion or hospitalization. Cox regression multivariable analysis was performed for adjusted associations between CKD status and clinical outcomes. Hazard ratios for prasugrel versus clopidogrel treatment were generated using propensity score stratification. RESULTS: The total cohort included 19,832 patients, 28.3% with and 71.7% without CKD. CKD patients were older with greater comorbidities including diabetes and multivessel disease. Prasugrel was less often prescribed to CKD versus non-CKD patients (11.0% vs. 24.0%, respectively; p < 0.001). At 1 year, CKD was associated with higher adjusted risk of MACE (1.27; 95% confidence interval: 1.18 to 1.37) and bleeding (1.46; 95% confidence interval: 1.24 to 1.73). Although unadjusted rates of 1-year MACE were lower with prasugrel versus clopidogrel in both CKD (18.3% vs. 26.5%; p < 0.001) and non-CKD (10.9% vs. 17.9%; p < 0.001) patients, associations were attenuated after propensity stratification. Similarly, unadjusted differences in 1-year bleeding with prasugrel versus clopidogrel (6.0% vs. 7.4%; p = 0.18 in CKD patients; 2.6% vs. 3.5%; p = 0.008 in non-CKD patients) were not significant after propensity score adjustment. CONCLUSIONS: Although risks for 1-year MACE were significantly higher in ACS PCI patients with versus without CKD, prasugrel use was 50% lower in patients with renal impairment. Irrespective of CKD status, outcomes associated with prasugrel use were not significant after propensity adjustment. These data highlight the need for randomized studies evaluating the optimal antiplatelet therapy in CKD patients with ACS.
OBJECTIVES: This study sought to compare clinical outcomes in a contemporary acute coronary syndrome (ACS) percutaneous coronary intervention (PCI) cohort stratified by chronic kidney disease (CKD) status. BACKGROUND:Patients with CKD exhibit high risks for both thrombotic and bleeding events, thus complicating decision making regarding antiplatelet therapy in the setting of ACS. METHODS: The PROMETHEUS study was a multicenter observational study comparing outcomes with prasugrel versus clopidogrel in ACS PCI patients. Major adverse cardiac events (MACE) at 90 days and at 1 year were defined as a composite of death, myocardial infarction, stroke, or unplanned revascularization. Clinically significant bleeding was defined as bleeding requiring transfusion or hospitalization. Cox regression multivariable analysis was performed for adjusted associations between CKD status and clinical outcomes. Hazard ratios for prasugrel versus clopidogrel treatment were generated using propensity score stratification. RESULTS: The total cohort included 19,832 patients, 28.3% with and 71.7% without CKD. CKD patients were older with greater comorbidities including diabetes and multivessel disease. Prasugrel was less often prescribed to CKD versus non-CKD patients (11.0% vs. 24.0%, respectively; p < 0.001). At 1 year, CKD was associated with higher adjusted risk of MACE (1.27; 95% confidence interval: 1.18 to 1.37) and bleeding (1.46; 95% confidence interval: 1.24 to 1.73). Although unadjusted rates of 1-year MACE were lower with prasugrel versus clopidogrel in both CKD (18.3% vs. 26.5%; p < 0.001) and non-CKD (10.9% vs. 17.9%; p < 0.001) patients, associations were attenuated after propensity stratification. Similarly, unadjusted differences in 1-year bleeding with prasugrel versus clopidogrel (6.0% vs. 7.4%; p = 0.18 in CKD patients; 2.6% vs. 3.5%; p = 0.008 in non-CKD patients) were not significant after propensity score adjustment. CONCLUSIONS: Although risks for 1-year MACE were significantly higher in ACS PCI patients with versus without CKD, prasugrel use was 50% lower in patients with renal impairment. Irrespective of CKD status, outcomes associated with prasugrel use were not significant after propensity adjustment. These data highlight the need for randomized studies evaluating the optimal antiplatelet therapy in CKD patients with ACS.
Authors: Constance C F M J Baaten; Jonas R Schröer; Jürgen Floege; Nikolaus Marx; Joachim Jankowski; Martin Berger; Heidi Noels Journal: Clin J Am Soc Nephrol Date: 2021-11-08 Impact factor: 8.237
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Authors: Francesco Franchi; Stefan K James; Tatevik Ghukasyan Lakic; Andrzej J Budaj; Jan H Cornel; Hugo A Katus; Matyas Keltai; Frederic Kontny; Basil S Lewis; Robert F Storey; Anders Himmelmann; Lars Wallentin; Dominick J Angiolillo Journal: J Am Heart Assoc Date: 2019-03-19 Impact factor: 5.501
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