Key result
Using troponin instead of creatine kinase to diagnose periprocedural MI increased overall MI detection from 7.4% to 37.0% and raised the composite endpoint rate to 32% vs 48%.
Why the study?
Does the use of troponin instead of creatine kinase to diagnose periprocedural myocardial infarction affect the incidence of composite endpoints in patients with coronary bifurcation lesions undergoing simple versus complex stenting?
RCT (n=500)
randomly allocated
Does the use of troponin instead of creatine kinase to diagnose periprocedural myocardial infarction affect the incidence of composite endpoints in patients with coronary bifurcation lesions undergoing simple versus complex stenting?
The use of troponin instead of creatine kinase to diagnose periprocedural myocardial infarction leads to a fivefold increase in detection, suggesting that incorporating this definition into composite endpoints for interventional trials may no longer be justified.
Answers are grounded in this paper and cite their sources.
Troponin-based periprocedural MI definitions may inflate composite rates in bifurcation PCI trials; challenges their routine inclusion in interventional endpoints.
BACKGROUND: Periprocedural myocardial infarction (PMI; ESC/ACC type 4a) is diagnosed on the basis of elevation of cardiac enzymes more than three times the 99th centile upper reference limit. Recent guidelines recommend the use of troponin instead of creatine kinase (CK) to diagnose PMI, but this assay increases diagnostic sensitivity, while the clinical significance of small increases in troponin remains undetermined. We examined the effects of using the new definition on the incidence of a composite endpoint (previously defined by CK) in a contemporary clinical randomised trial-the British Bifurcation Coronary Study (BBC ONE). METHODS: The BBC ONE trial randomly allocated 500 patients with coronary bifurcation lesions to either a simple or complex stenting strategy. The composite primary endpoint (CPEP) included death, myocardial infarction (MI) (PMI plus subsequent MI) and target vessel failure, at 9 months. RESULTS: In BBC ONE the CPEP occurred in 8% versus 15.2% in the simple and complex groups, respectively (HR 2.02, 95% CI 1.17 to 3.47, p=0.009). This difference was largely driven by PMI, which occurred in nine (3.6%) versus 28 (11.2%) patients (HR 3.24, 95% CI 1.53 to 6.86, p=0.001). Using troponin, PMI would have occurred in 71 (28.4%) versus 114 (45.6%) patients, respectively (HR 1.61, 95% CI 1.27 to 2.05, p=0.001), and the CPEP in 32% versus 48% of patients (HR 1.50, 95% CI 1.2 to 1.87, p=0.001). Use of troponin increased MI detection fivefold, from 7.4% to 37.0% overall. CONCLUSIONS: Use of troponin would have led to a fivefold increase in diagnosis of PMI in the BBC ONE trial. Incorporation of PMI into a composite endpoint may no longer be justified in many interventional trials.
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Cockburn et al. (2012) conducted an RCT in coronary bifurcation lesions (n=500). Complex stenting strategy vs. Simple stenting strategy was evaluated on Composite primary endpoint of death, myocardial infarction, and target vessel failure at 9 months (HR 2.02, 95% CI 1.17 to 3.47, p=0.009). Using troponin instead of creatine kinase to diagnose periprocedural MI increased overall MI detection from 7.4% to 37.0% and raised the composite endpoint rate to 32% vs 48%.
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