Sergio Leonardi1, Felice Gragnano2, Greta Carrara3, Giuseppe Gargiulo4, Enrico Frigoli5, Pascal Vranckx6, Dario Di Maio7, Vanessa Spedicato8, Emanuele Monda7, Luigi Fimiani9, Vincenzo Fioretti4, Fabrizio Esposito4, Marisa Avvedimento4, Fabio Magliulo4, Attilio Leone4, Salvatore Chianese4, Michele Franzese4, Martina Scalise4, Alessandra Schiavo7, Paolo Mazzone9, Giovanni Esposito4, Giuseppe Andò9, Paolo Calabrò7, Stephan Windecker8, Marco Valgimigli10. 1. University of Pavia and Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy. 2. Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland; Division of Cardiology, Department of Translational Medicine, University of Campania "Luigi Vanvitelli," Caserta, Italy. 3. Advice Pharma Group, Milan, Italy. 4. Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy. 5. Clinical Trials Unit, University of Bern, Bern, Switzerland. 6. Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium. 7. Division of Cardiology, Department of Translational Medicine, University of Campania "Luigi Vanvitelli," Caserta, Italy. 8. Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. 9. Unit of Cardiology, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy. 10. Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland; Cardiocentro Ticino, Lugano, Switzerland. Electronic address: marco.valgimigli@cardiocentro.org.
Abstract
BACKGROUND: Contemporary definitions of bleeding endpoints are restricted mostly to clinically overt events. Whether hemoglobin drop per se, with or without overt bleeding, adversely affects the prognosis of patients with acute coronary syndrome (ACS) remains unclear. OBJECTIVES: The aim of this study was to examine in the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial the incidence, predictors, and prognostic implications of in-hospital hemoglobin drop in patients with ACS managed invasively stratified by the presence of in-hospital bleeding. METHODS: Patients were categorized by the presence and amount of in-hospital hemoglobin drop on the basis of baseline and nadir hemoglobin values and further stratified by the occurrence of adjudicated in-hospital bleeding. Hemoglobin drop was defined as minimal (<3 g/dl), minor (≥3 and <5 g/dl), or major (≥5 g/dl). Using multivariate Cox regression, we modeled the association between hemoglobin drop and mortality in patients with and without overt bleeding. RESULTS: Among 7,781 patients alive 24 h after randomization with available hemoglobin data, 6,504 patients (83.6%) had hemoglobin drop, of whom 5,756 (88.5%) did not have overt bleeding and 748 (11.5%) had overt bleeding. Among patients without overt bleeding, minor (hazard ratio [HR]: 2.37; 95% confidence interval [CI]: 1.32 to 4.24; p = 0.004) and major (HR: 2.58; 95% CI: 0.98 to 6.78; p = 0.054) hemoglobin drop were independently associated with higher 1-year mortality. Among patients with overt bleeding, the association of minor and major hemoglobin drop with 1-year mortality was directionally similar but had wider CIs (minor: HR: 3.53 [95% CI: 1.06 to 11.79]; major: HR: 13.32 [95% CI: 3.01 to 58.98]). CONCLUSIONS: Among patients with ACS managed invasively, in-hospital hemoglobin drop ≥3 g/dl, even in the absence of overt bleeding, is common and is independently associated with increased risk for 1-year mortality. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox; NCT01433627).
BACKGROUND: Contemporary definitions of bleeding endpoints are restricted mostly to clinically overt events. Whether hemoglobin drop per se, with or without overt bleeding, adversely affects the prognosis of patients with acute coronary syndrome (ACS) remains unclear. OBJECTIVES: The aim of this study was to examine in the MATRIX (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial the incidence, predictors, and prognostic implications of in-hospital hemoglobin drop in patients with ACS managed invasively stratified by the presence of in-hospital bleeding. METHODS:Patients were categorized by the presence and amount of in-hospital hemoglobin drop on the basis of baseline and nadir hemoglobin values and further stratified by the occurrence of adjudicated in-hospital bleeding. Hemoglobin drop was defined as minimal (<3 g/dl), minor (≥3 and <5 g/dl), or major (≥5 g/dl). Using multivariate Cox regression, we modeled the association between hemoglobin drop and mortality in patients with and without overt bleeding. RESULTS: Among 7,781 patients alive 24 h after randomization with available hemoglobin data, 6,504 patients (83.6%) had hemoglobin drop, of whom 5,756 (88.5%) did not have overt bleeding and 748 (11.5%) had overt bleeding. Among patients without overt bleeding, minor (hazard ratio [HR]: 2.37; 95% confidence interval [CI]: 1.32 to 4.24; p = 0.004) and major (HR: 2.58; 95% CI: 0.98 to 6.78; p = 0.054) hemoglobin drop were independently associated with higher 1-year mortality. Among patients with overt bleeding, the association of minor and major hemoglobin drop with 1-year mortality was directionally similar but had wider CIs (minor: HR: 3.53 [95% CI: 1.06 to 11.79]; major: HR: 13.32 [95% CI: 3.01 to 58.98]). CONCLUSIONS: Among patients with ACS managed invasively, in-hospital hemoglobin drop ≥3 g/dl, even in the absence of overt bleeding, is common and is independently associated with increased risk for 1-year mortality. (Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox; NCT01433627).
Authors: Marcelo Harada Ribeiro; Carlos M Campos; Lucio Padilla; Antonio Carlos B da Silva; João Eduardo T de Paula; Marco Alcantara; Ricardo Santiago; Franklin Hanna; Franciele R da Silva; Karlyse C Belli; Lorenzo Azzalini; Pedro P de Oliveira; Gustavo N Araujo; Vincenzo Sucato; Kambis Mashayekhi; Alfredo R Galassi; Alexandre Abizaid; Alexandre Quadros Journal: J Am Heart Assoc Date: 2022-06-03 Impact factor: 6.106