Bleeding in the Elderly: Risk Factors and Impact on Clinical Outcomes After an Acute Coronary Syndrome, a Sub-study of the Randomized ANTARCTIC Trial

ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Sorbonne University, 47-83 bld de l'Hôpital, 75013, Paris, France. ACTION Study Group, Cardiology Department, Nîmes University Hospital, Montpellier University, Nîmes, France. ACTION Study Group, Cardiology Department, INSERM UMR1062, INRA UMR1260, Centre Hospitalier Universitaire La Timone, Aix-Marseille University, Marseille, France. Cardiology Department, Centre Hospitalier Universitaire de Montpellier, Montpellier University, Montpellier, France. Cardiology Department, Centre Hospitalier Universitaire Lariboisière (AP-HP), INSERM UMRS 942, Paris, France. Cardiology Department, Centre Hospitalier Universitaire de Tours, Tours, France. Cardiology Department, Hôpital Francois Mitterrand, Pau, France. Cardiology Department, Hôpital Ambroise Paré, Boulogne-Billancourt, France. Cardiology Department, Centre Hospitalier Universitaire Rangueil, Université Paul Sabatier Toulouse 3, Toulouse, France. Cardiology Department, Centre Hospitalier Universitaire Gabriel Montpied, Clermont-Ferrand, France. ACTION Study Group, Epidemiology and Clinic Research Unit, Lariboisiere University Hospital, Paris, France. ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Sorbonne University, 47-83 bld de l'Hôpital, 75013, Paris, France. gilles.montalescot@aphp.fr.

American journal of cardiovascular drugs : drugs, devices, and other interventions. 2021
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Abstract
BACKGROUND Elderly patients are at high-risk of bleeding, but are under-represented in clinical trials. OBJECTIVES The aims were to determine the incidence and the predictive factors of bleeding and to assess the impact of bleeding on further ischemic outcomes in elderly patients after acute coronary syndrome (ACS) treated with percutaneous coronary intervention. METHODS From the 877 patients aged ≥ 75 years included in the ANTARCTIC randomized trial, data on Bleeding Academic Research Consortium (BARC) bleeding complications and major adverse cardiovascular events (MACE), defined as the composite of cardiovascular death, myocardial infarction, and stroke, were collected over 1 year. RESULTS Clinically relevant bleeding events (BARC types 2, 3, or 5) were observed in 20.6% of patients (n = 181) at 1 year, of which, one third occurred in the first month. Anemia (adjusted hazard ratio [adj.HR] 3.98, 95% confidence interval [CI] 1.41-11.22; p = 0.009), severe chronic renal failure (adj.HR 1.83, 95% CI 1.12-2.98; p = 0.015), and femoral access (adj.HR 2.54, 95% CI 1.71-3.77; p < 0.001) were independently associated with clinically relevant bleeding events, while age > 85 years (adj.HR 2.22, 95% CI 1.14-4.30; p = 0.018) was independently associated with major bleeding events (BARC types 3 or 5). Patients with a clinically relevant bleeding event had a higher rate of MACE at 1 year (adj.HR 2.04, 95% CI 1.24-3.38; p = 0.005), with a particularly strong effect on stroke (adj.HR 5.55, 95% CI 2.04-15.06; p < 0.001). CONCLUSIONS Clinically relevant bleeding events were observed in one out of five elderly patients undergoing stenting for an ACS and were strongly associated with further stroke occurrence. Rather than the antiplatelet therapy, comorbidities and an age > 85 years predicted bleeding outcomes in this elderly population. CLINICAL TRIAL REGISTRATION Clinicaltrials.gov identifier: NCT01538446. https://www.clinicaltrials.gov .
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Language : eng
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