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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- Acute coronary syndrome
- angioplasty offsite
- aortic valve disease
- BBC ONE trial
- cardiac catheterisation
- cardiomyopathy dilated
- clinical trials
- congenital heart disease
- coronary syndromes
- ESC/ACC universal definition
- interventional cardiology
- ischaemic heart disease
- myocardial ischaemia and infarction (IHD)
- non-coronary intervention
- percutaneous valve therapy
- periprocedural myocardial infarction
- platelet and angioplasty
- quality of care and outcomes
- valvular disease
Competing interests Research Grant (Boston Scientific) Hildick-Smith. Advisory Board (Boston Scientific) Hildick-Smith, Thomas, Curzen, MacCarthy, Baumbach, Stables.
Provenance and peer review Not commissioned; internally peer reviewed.
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