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Relationship between renal function and outcomes in high-risk patients with non-ST-segment elevation acute coronary
Sarah A Spinler1, Kenneth W Mahaffey, Dianne Gallup
1Department of Pharmacy Practice and Pharmacy Administration, Philadelphia College of Pharmacy, University of the Sciences in Philadelphia, Philadelphia, PA, USA. s.spinle@usp.edu
Insights
Patients with chronic kidney disease (CKD) face higher risks of death, heart attack, and bleeding when treated for acute coronary syndromes (ACS). Renal function impacts outcomes similarly for different antithrombotic therapies.
Area of Science:
- Cardiology
- Nephrology
- Pharmacology
Background:
- Chronic kidney disease (CKD) is a significant risk factor for adverse outcomes in patients with acute coronary syndromes (ACS).
- Antithrombotic therapy in ACS patients with CKD is associated with increased risks of coronary heart disease and bleeding.
- The SYNERGY trial investigated high-risk NSTE ACS patients, providing data to assess renal function's impact.
Purpose of the Study:
- To evaluate the effect of renal function on the efficacy and outcomes of antithrombotic therapy in patients with NSTE ACS.
- To determine if creatinine clearance (CrCl) influences the risk of death, myocardial infarction (MI), or bleeding events.
- To analyze outcomes across different strata of renal function.
Main Methods:
- Creatinine clearance (CrCl) was analyzed as a continuous variable.
- Multivariable logistic regression models were used to assess 30-day death or MI, major bleeding (TIMI and GUSTO criteria), and transfusion rates.
- Analyses were performed on the overall study population, patients undergoing coronary angiography, and those undergoing percutaneous coronary intervention (PCI).
Main Results:
- Of 9838 patients, 70.6% had CrCl ≥60 mL/min, 27.8% had CrCl 30-59 mL/min, and 1.6% had CrCl <30 mL/min.
- No significant interaction was found between randomized treatment and CrCl, indicating similar effects of enoxaparin and unfractionated heparin across renal function levels.
- Adjusted analyses revealed CrCl as an independent predictor for 30-day death or MI (OR 1.06), TIMI major bleeding (OR 1.06), GUSTO severe bleeding (OR 1.10), and transfusion (OR 1.07).
Conclusions:
- Patients with CKD exhibited higher rates of 30-day death or MI and bleeding compared to those without CKD, irrespective of the antithrombin therapy received.
- A trend of increased bleeding events was observed as CrCl decreased in both treatment groups.
- The study highlights the increased risk associated with reduced renal function but could not determine if dose reduction would mitigate bleeding risk.
Background:
Chronic kidney disease (CKD) is a risk factor for coronary heart disease and bleeding with antithrombotic therapy in patients with acute coronary syndromes (ACS). We evaluated the effect of renal function on efficacy and outcomes in high-risk patients with NSTE ACS in the SYNERGY trial.
Methods:
Creatinine clearance (CrCl) at the time of randomization was analyzed as a continuous variable added to multivariable logistic regression models for 30-day death or MI, non-CABG-associated TIMI major bleeding, GUSTO severe bleeding, and transfusion in the overall study population, patients undergoing coronary angiography, and patients undergoing PCI.
Results:
Of 9838 patients with a CrCl value, 70.6% (N=6950) had CrCl≥60 mL/min, 27.8% (N=2732) had CrCl 30-59 mL/min, and 1.6% (N=156) had CrCl<30 mL/min. No randomized treatment by CrCl interaction test was found to be statistically significant, suggesting renal insufficiency affected enoxaparin and unfractionated heparin outcomes similarly. After adjustment, CrCl was an independent predictor of 30-day death or MI (OR 1.06, 95% CI 1.03-1.09), TIMI major bleeding (OR 1.06, 95% CI 1.02-1.10), GUSTO severe bleeding (OR 1.10, 95% CI 1.03-1.17), and transfusion (OR 1.07, 95% CI 1.04-1.11).
Conclusions:
Patients with CKD had higher rates of 30-day death or MI and bleeding than those without CKD, regardless of randomized antithrombin therapy. While this analysis suggests that there is a rise in bleeding events as CrCl falls for patients in either treatment group, it is unknown whether a reduction in dose would decrease bleeding risk.
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