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Prof. Robbert J. De Winter
Mr Robert Anthony Henderson,
By Robert Anthony Henderson, FESC (Nottingham, United Kingdom)View Discussant report
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List of Authors: RA. Henderson 1, C. Jarvis 2, T. Clayton 2, S. Pocock 2, KAA. Fox 3
(1) Nottingham University Hospitals NHS Trust, Trent Cardiac Centre, Nottingham, United Kingdom (2) London School of Hygiene and Tropical Medicine, London, United Kingdom(3) University of Edinburgh, Edinburgh, United Kingdom
BackgroundRandomised trials in patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS) demonstrate that a routine early invasive strategy reduces rates of refractory angina and death or myocardial infarction over 5 years, particularly in patients at increased baseline ischaemic risk. In the RITA-3 trial the early invasive strategy was also associated with lower 5 year mortality. In this report we extend follow-up of the RITA-3 patients to 10 years and assess the impact of baseline risk on long term mortality.MethodsFrom Nov 1997 to Oct 2001 1810 patients with NSTE-ACS were randomised within 48h of an index episode of cardiac pain to routine early invasive or selective invasive strategies. Patients assigned to the routine invasive strategy underwent coronary arteriography within 72h with subsequent management guided by the arteriographic findings. Patients assigned to the selective invasive strategy only underwent coronary arteriography for recurrent or persistent myocardial ischaemia. Vital status was determined for all patients from national mortality data (Office of National Statistics) and the certified cause of death was classified as cardiovascular or non-cardiovascular by an investigator blinded to treatment assignment. All analyses were done by intention to treat. Kaplan-Meier estimates of 10 year all-cause and cardiovascular mortality were compared with log rank test. Logistic regression was used for multivariable analysis. Patients were stratified into tertiles of risk with roughly equal numbers of deaths in each risk group using baseline variables and a modified post-discharge GRACE score. 10 year mortality was compared between the strategies in each risk tertile.ResultsBaseline characteristics were well matched between the randomised groups. At 10 years there were 225 deaths (25.1%) in the routine invasive group versus 232 deaths (25.4%) in the selective invasive group, p=0.94. Cardiovascular mortality was also similar between the two groups (135 deaths [15.1%] versus 147 deaths [16.1%], p=0.65). Baseline variables independently associated with total mortality included age, gender, use of loop diuretic (as a surrogate for heart failure), heart rate, current smoking, diabetes, previous myocardial infarction, and ST-segment deviation. A predictive model based on these variables showed good discrimination (c-statistic 0.809). The figure shows cumulative 10 year mortality by assigned strategy for the low (solid lines), intermediate (broken lines) and high risk (solid lines) tertiles. There is a large spread of observed risk, ranging from 13.4% in the low risk tertile to 58.0% in the high risk tertile. In the high risk tertile (14% of the total randomised cohort) any advantage of the routine early invasive strategy attenuated beyond 5 years (absolute risk difference at 10 years 0.3% [odds ratio 0.98, 95%CI 0.60-1.62]) and overall there was no evidence for an interaction (p=0.79).ConclusionIn RITA-3 10 year mortality was associated with several baseline variables and varied widely across tertiles of predicted risk. The mortality advantage of a routine early invasive strategy seen at 5 years appears to be confined to patients at high risk and attenuates during follow-up to 10 years. Based on these findings, further analyses of contemporary intervention strategies in patients with NSTE-ACS are warranted. An updated individual patient data meta-analysis of the FRISC, ICTUS and RITA trials is planned.
By Robbert J De Winter, FESC (Amsterdam, Netherlands)See Presenter abstract
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Clinical Trial Update Hot Line: Infarction, interventions and outcome
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