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Impact of bleeding assessment and adjudication methodology on event rates and clinical trial outcomes: insights from the HORIZONS-AMI trial
- Source :
- EuroIntervention. 14:e580-e587
- Publication Year :
- 2018
- Publisher :
- Europa Digital & Publishing, 2018.
-
Abstract
- 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
- Subjects :
- medicine.medical_specialty
medicine.medical_treatment
Myocardial Infarction
Hemorrhage
030204 cardiovascular system & hematology
Revascularization
Electrocardiography
03 medical and health sciences
Percutaneous Coronary Intervention
0302 clinical medicine
Internal medicine
medicine
Humans
Prospective Studies
030212 general & internal medicine
Myocardial infarction
Prospective cohort study
medicine.diagnostic_test
business.industry
Hazard ratio
Percutaneous coronary intervention
medicine.disease
Confidence interval
Clinical trial
Treatment Outcome
cardiovascular system
Stents
Cardiology and Cardiovascular Medicine
business
Subjects
Details
- ISSN :
- 19696213
- Volume :
- 14
- Database :
- OpenAIRE
- Journal :
- EuroIntervention
- Accession number :
- edsair.doi.dedup.....66e49c956d8567af2bc32eb6d7f6d700
- Full Text :
- https://doi.org/10.4244/eij-d-18-00131