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For the above reasons, cardiac death should remain the primary endpoint for coronary revascularization trials and meta-analyses. The rising competing risk from non-cardiac mortality suggests that revascularization trials will be increasingly difficult to power statistically for treatment effects on total mortality and meta-analyses will similarly be challenged. 5 Long-term follow-up of ISCHEMIA will provide additional information on all-cause death rates by strategy arm but will be impacted by increasing non-cardiac deaths, which made up ∼30% of all-cause deaths at 5 years. All-cause mortality was non-significantly higher in the invasive arm 9.0% vs. Cardiovascular death rate at 5 years was non-significantly lower in the invasive strategy. 1 are consistent with the ISCHEMIA trial, which randomized 5179 patients with stable coronary disease and moderate or severe ischaemia to an invasive strategy or a conservative strategy. The meta-analysis results by Navarese et al. Because cardiac mortality is the most specific endpoint to detect intervention effects and is not swamped by non-cardiac causes of death, many trials that form the basis of EBM have not used total mortality as the primary endpoint ( Table 1). 2 In parallel, with longer follow-up, all-cause mortality will tend towards the null regardless of treatment.
For example, in COURAGE that compared elective PCI with optimal medical therapy, at 4.6 years follow-up, cardiac deaths made up only 26.7% of total deaths. Contemporary trials show that longer follow-up results in decreasing cardiac death rates and increasing non-cardiac death rates. The longer the follow-up the more likely non-cardiac deaths will occur diluting the impact of a randomized treatment on total mortality even if there is an effect on cardiac mortality.
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Treatments of ischaemic events during trial follow-up such as myocardial infarction have dramatically improved due to reduced reperfusion times and use of evidence-based medicine (EBM) leading to low cardiovascular mortality in both randomized groups and consequently reducing statistical power. from cancer or chronic diseases, should not be counted in the primary endpoint for several reasons. In revascularization trials, deaths not possibly affected by revascularization, e.g. However, for precise treatment effect estimates, primary endpoints should be more specific than total mortality. Total mortality has been advocated to be the best endpoint in clinical trials as it embraces both benefits and harms of treatments. prespecified cardiac mortality as primary and total mortality as secondary endpoint of their analysis. These findings raise the issue of what should be the primary endpoint in revascularization trials and meta-analyses. medical therapy trials in stable coronary disease showed a 21% risk reduction in cardiac mortality over 5.7 years but no effect on total mortality. medical therapy alone in stable coronary syndromes’, by E.P. Navarese et al., doi:10.1093/eurheartj/ehab460 and the discussion pieces ‘Cardiac mortality, adequate power, and objective inclusion of the entire evidence are key to accurately define the long-term effect of revascularisation vs. Dayan et al., doi:10.1093/eurheartj/ehab443 ‘When a meta-analysis equals a single large-scale trial with meaningful follow-up’, by E.P. Navarese et al., doi:10.1093/eurheartj/ehab246 ‘In the pool: dilution or drowning?’, by V.
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This commentary refers to ‘Cardiac mortality in patients randomised to elective coronary revascularisation plus medical therapy or medical therapy alone: a systematic review and meta-analysis’, by E.P.