Harvey D White1, Andrew Tonkin2, John Simes3, Ralph Stewart4, Kristy Mann3, Peter Thompson5, David Colquhoun6, Malcolm West6, Paul Nestel7, David Sullivan8, Anthony C Keech3, David Hunt9, Stefan Blankenberg10. 1. Green Lane Cardiovascular Service, Auckland City Hospital and Auckland University, Auckland, New Zealand. Electronic address: harveyw@adhb.govt.nz. 2. Monash University, Melbourne, Australia. 3. NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia. 4. Green Lane Cardiovascular Service, Auckland City Hospital and Auckland University, Auckland, New Zealand. 5. University of Western Australia, Perth, Australia. 6. University of Queensland, Brisbane, Australia. 7. Baker IDI Heart & Diabetes Institute, Melbourne, Australia. 8. Royal Prince Alfred Hospital, Camperdown, Australia. 9. Department of Cardiology, Royal Melbourne Hospital and University of Melbourne, Melbourne, Australia. 10. University Heart Centre Hamburg, Hamburg, Germany.
Abstract
OBJECTIVES: This study sought to assess whether baseline and change in contemporary sensitive troponinI (TnI) levels predicts coronary heart disease (CHD) death and myocardial infarction (MI), and to determine the effects of pravastatin on TnI levels. BACKGROUND: The role of troponins in predicting long-term outcomes in patients with stable CHD is not clearly defined. METHODS: The LIPID (Long-Term Intervention With Pravastatin in Ischaemic Disease) study randomized patients with cholesterol levels of 155 to 271 mg/dl 3 to 36 months after MI or unstable angina toplacebo or pravastatin 40 mg per day. TnI levels were measured at baseline and after 1 year in 7,863 patients. Median follow-up was 6 years. Change in TnI was defined as moving up or down 1 tertile or ≥50% change. RESULTS: Baseline TnI tertiles were <0.006 ng/ml, 0.006 to <0.018 ng/ml, and ≥0.018 ng/ml. TnI levels were related to CHD death and MI after adjustment for 23 risk factors and treatment (≥0.018 ng/ml vs. <0.006 ng/ml hazard ratio [HR]: 1.64; 95% CI: 1.41 to 1.90; p < 0.001). TnI levels increased in 23.0%, were unchanged in 51.3%, and decreased in 25.7% of patients. Pravastatin decreased TnI levels by 0.003 ng/ml versus placebo (p = 0.002). In landmark analyses, increases in TnI levels were associated with increased numbers of CHD death and MI (HR: 1.31; 95% CI: 1.06 to 1.62) and decreases with decreased risk (HR: 0.90; 95% CI: 0.74 to 1.09; overall p = 0.01). Data were similar with 50% change criteria. Net reclassification improvement by adding TnI to the baseline model for CHD death and MI was 4.8% (p = 0.01). CONCLUSIONS: Baseline TnI levels and change at 1 year are independent predictors of CHD death and MI. TnI levels are strong predictors of risk, and change modifies risk.
RCT Entities:
OBJECTIVES: This study sought to assess whether baseline and change in contemporary sensitive troponin I (TnI) levels predicts coronary heart disease (CHD) death and myocardial infarction (MI), and to determine the effects of pravastatin on TnI levels. BACKGROUND: The role of troponins in predicting long-term outcomes in patients with stable CHD is not clearly defined. METHODS: The LIPID (Long-Term Intervention With Pravastatin in Ischaemic Disease) study randomized patients with cholesterol levels of 155 to 271 mg/dl 3 to 36 months after MI or unstable angina to placebo or pravastatin 40 mg per day. TnI levels were measured at baseline and after 1 year in 7,863 patients. Median follow-up was 6 years. Change in TnI was defined as moving up or down 1 tertile or ≥50% change. RESULTS: Baseline TnI tertiles were <0.006 ng/ml, 0.006 to <0.018 ng/ml, and ≥0.018 ng/ml. TnI levels were related to CHD death and MI after adjustment for 23 risk factors and treatment (≥0.018 ng/ml vs. <0.006 ng/ml hazard ratio [HR]: 1.64; 95% CI: 1.41 to 1.90; p < 0.001). TnI levels increased in 23.0%, were unchanged in 51.3%, and decreased in 25.7% of patients. Pravastatin decreased TnI levels by 0.003 ng/ml versus placebo (p = 0.002). In landmark analyses, increases in TnI levels were associated with increased numbers of CHD death and MI (HR: 1.31; 95% CI: 1.06 to 1.62) and decreases with decreased risk (HR: 0.90; 95% CI: 0.74 to 1.09; overall p = 0.01). Data were similar with 50% change criteria. Net reclassification improvement by adding TnI to the baseline model for CHD death and MI was 4.8% (p = 0.01). CONCLUSIONS: Baseline TnI levels and change at 1 year are independent predictors of CHD death and MI. TnI levels are strong predictors of risk, and change modifies risk.
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