Comparison of Efficacy and Safety of a Standard Versus a Loading
Dose of Clopidogrel for Acute Myocardial Infarction in Patients
>75 Years of Age (from the FAST-MI Registry)
Etienne Puymirat, MD
a,b,
*, Nadia Aïssaoui, MD
a,b
, Pierre Coste, MD
c
, Gilles Dentan, MD
d
,
Vincent Bataille, MSc
e
, Elodie Drouet, MSc
f
, Geneviève Mulak, PharmD
g
, Dider Carrié, MD, PhD
e
,
Didier Blanchard, MD
a,b
, Tabassome Simon, MD, PhD
f,h
, and Nicolas Danchin, MD, PhD
a,b
Data are lacking on the efficacy and safety of a loading dose (LD) of clopidogrel in elderly
patients with acute myocardial infarction (AMI). FAST-MI is a nationwide registry that
was carried out over a 1-month period in 2005 and included consecutive patients with AMI
admitted to intensive care units <48 hours from symptom onset in 223 participating
centers. We assessed the impact of a clopidogrel LD (>300 mg) compared to a conventional
dose (<300 mg) on bleeding, need for blood transfusion, and 30-day and 12-month
survivals in 791 elderly patients (>75 years old, mean age 81 4 years, 48% women, 35%
with ST-segment elevation MI) included in this registry. Fifty-nine percent (466 patients)
received a clopidogrel LD. Follow-up was >99% complete. Major bleeding and blood
transfusions were not significantly different in patients who received a clopidogrel LD
(3.2% vs 3.7%, p 0.72; 5.4% vs 6.2%, p 0.64, respectively). Early mortality was also not
significantly different (10.1 vs 10.8, p 0.76). Using multivariate analyses, clopidogrel LD
did not significantly affect major bleeding or transfusion (odds ratio 1.03, 95% confidence
interval 0.49 to 2.17, p 0.94) and 12-month mortality (hazard ratio 1.00, 95% confidence
interval 0.72 to 1.40, p 0.98). In conclusion, the present data showed that in elderly
patients admitted for AMI, use of a LD of clopidogrel compared to a conventional dose was
not associated with increased in-hospital bleeding, need for transfusion, or mortality.
Large-scale randomized trials are still needed to identify the optimal LD of clopidogrel for
elderly patients admitted for AMI. © 2011 Elsevier Inc. All rights reserved. (Am J Cardiol
2011;108:755–759)
The objective of this study was to assess the impact of
using a loading dose (LD) of clopidogrel (300 mg) com-
pared to a conventional dose (300 mg) on major bleeding,
need for transfusion, and 12-month survival in elderly pa-
tients (75 years of age) with acute myocardial infarction
(AMI) from the French Registry of Acute ST-Elevation or
Non–ST-elevation Myocardial Infarction (FAST-MI) of the
French Society of Cardiology.
1
Methods
Patients 75 years of age receiving a known dose of
clopidogrel 48 hours of admission and participating in the
FAST-MI were included. Methods of the FAST-MI have
been described in detail elsewhere.
1
Briefly, the primary
objectives were to evaluate practices for MI management in
“real-life” practice and to measure their impact on medium-
and long-term prognoses of patients admitted to intensive
care units (ICUs) for MI. This registry results from a pro-
spective multicenter (223 centers) study including 3,059
patients. Patients were recruited consecutively from ICU
departments over a period of 1 month (October 2005).
Participation in the study was offered to all French institu-
tions, university teaching hospitals, general and regional
hospitals, and private clinics with ICUs authorized to re-
ceive acute coronary syndrome (ACS) emergencies. In each
center, a physician was in charge of the registry and pro-
vided a full list of all patients admitted to the unit.
Inclusion criteria were (1) men or women 18 years old;
(2) patients admitted within 48 hours after symptom onset in
an ICU for an AMI characterized by increased troponin or
creatine kinase-MB associated with 1 of the following
elements: symptoms compatible with myocardial ischemia,
appearance of pathologic Q waves, or ST-T changes com-
patible with myocardial ischemia (ST-segment elevation or
depression, T-wave inversion); and (3) consent to take part
a
Division of Coronary Artery Disease and Intensive Cardiac Care,
Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pom-
pidou, Paris, France;
b
Faculty of Medicine, University Paris Descartes,
Paris, France;
c
Department of Cardiology, Hôpital Haut-Lévèque, Pessac,
France;
d
Department of Cardiology, Clinique de Fontaine, Dijon, France;
e
Department of Cardiology B, Department of Epidemiology, Institut Na-
tional de la Sante et de la recherche Medicale U558, Toulouse University
Hospital, Toulouse, France;
f
Assistance Publique des Hôpitaux de Paris,
URC-EST, St. Antoine Hospital, Paris, France;
g
Société Française de
Cardiologie, Paris, France;
h
UPMC-Paris, 06 University, Paris, France.
Manuscript received March 31, 2011; revised manuscript received and
accepted April 29, 2011.
FAST-MI is a registry of the French Society of Cardiology supported
by unrestricted grants from Pfizer (New York, New York) and Servier
(Neuilly, France). Additional support was obtained from a research grant
from the Caisse Nationale d’Assurance maladie (Paris, France).
*Corresponding author: Tel: 00-33-0-1-56-09-28-51; fax: 00-33-0-1-
56-09-25-71.
E-mail address: etiennepuymirat@yahoo.fr (E. Puymirat).
0002-9149/11/$ – see front matter © 2011 Elsevier Inc. All rights reserved. www.ajconline.org
doi:10.1016/j.amjcard.2011.04.028