Why the study?
Does centralised CEC adjudication of bleeding events compared to site-reporting impact the identification of events and their association with mortality in STEMI patients undergoing primary PCI?
Does centralised CEC adjudication of bleeding events compared to site-reporting impact the identification of events and their association with mortality in STEMI patients undergoing primary PCI?
Centralised adjudication of bleeding events identifies more events than site reporting, and both CEC-confirmed and non-CEC-confirmed bleeding events are independently predictive of long-term mortality in STEMI patients.
Bleeding events may warrant intensified post-PCI surveillance in STEMI; leaves open whether CEC adjudication adds prognostic value beyond site reports.
AIMS: Bleeding is a major safety outcome in cardiovascular trials. The present study assessed the impact of the adjudication process of bleeding events on three-year outcomes in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial. METHODS AND RESULTS: HORIZONS-AMI enrolled 3,602 patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. An independent CEC reviewed 445 potential bleeding events identified from three sources: 339 site-reported (SR), 35 CEC-identified, and 71 database (DB)-triggered events based on programmatic identification of a decline in haemoglobin of ≥3 g/dL or in haematocrit by ≥9%; of those, 383/445 (86.1%) met the protocol definition of major bleeding. By multivariable analysis, CEC-confirmed bleeding was an independent predictor of cardiovascular death (hazard ratio [HR] 2.84, 95% confidence interval [CI]: 1.81-4.45, p<0.0001) and all-cause death (HR 2.70, 95% CI: 1.92-3.79, p<0.0001) at three years. Non-CEC-confirmed bleeding was also a predictor of cardiovascular death (HR 3.45, 95% CI: 1.47-8.11, p=0.005) and all-cause death (HR 2.41, 95% CI: 1.11-5.23, p=0.03) at three years. CONCLUSIONS: In the HORIZONS-AMI trial, adjudication of bleeding via a centralised CEC process resulted in identification of a larger number of events than were SR. All CEC-confirmed bleeding events were independently predictive of three-year cardiovascular and all-cause mortality. The association of non-CEC-confirmed bleeding with mortality merits further investigation.
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Kosmidou et al. (2018) studied this question.
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