Six Versus Twelve Months Clopidogrel Therapy After Drug-Eluting Stenting in Patients With Acute Coronary Syndrome: An ISAR-SAFE Study Subgroup Analysis.
In patients presenting with acute coronary syndrome (ACS) the optimal duration of dual-antiplatelet therapy after drug-eluting stent (DES) implantation remains unclear. At 6 months after intervention, patients receiving clopidogrel were randomly assigned to either a further 6-month period of placebo or clopidogrel. The primary composite endpoint was death, myocardial infarction, stent thrombosis, stroke, or major bleeding 9 months after randomization. The ISAR-SAFE trial was terminated early due to low event rates and slow recruitment. 1601/4000 (40.0%) patients presented with ACS and were randomized to 6 (n = 794) or 12 months (n = 807) clopidogrel. The primary endpoint occurred in 14 patients (1.8%) receiving 6 months of clopidogrel and 17 patients (2.2%) receiving 12 months; hazard ratio (HR) 0.83, 95% confidence interval (CI) 0.41-1.68, P = 0.60. There were 2 (0.3%) cases of stent thrombosis in each group; HR 1.00, 95% CI 0.14-7.09, P = >0.99. Major bleeding occurred in 3 patients (0.4%) receiving 6 months clopidogrel and 5 (0.6%) receiving 12 months; HR 0.60, 95% CI 0.15-2.49, P = 0.49. There was no significant difference in net clinical outcomes after DES implantation in ACS patients treated with 6 versus 12 months clopidogrel. Ischaemic and bleeding events were low beyond 6-months.
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Raphaela
R
Lohaus
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Jonathan
J
Michel
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Katharina
K
Mayer
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Anna Lena
AL
Lahmann
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Robert A
RA
Byrne
Universitätsklinikum Goettingen, Goettingen, Germany.
Annabelle
A
Wolk
St. Antonius Hospital, Nieuwegein, Netherlands.
Jurrien M
JM
Ten Berg
Universitäts-Herzzentrum Freiburg - Bad Krozingen, Bad Krozingen, Germany.
Franz-Josef
FJ
Neumann
Shenyang Northern Hosp, Shenyang, China.
Yaling
Y
Han
University Hospital Leuven, Leuven, Belgium.
Tom
T
Adriaenssens
Herzzentrum der Segeberger Kliniken Gruppe, Bad Segeberg, Germany.
Ralph
R
Tölg
Helios Klinik Wuppertal, Wuppertal, Germany.
Melchior
M
Seyfarth
Aarhus University Hospital, Aarhus, Denmark.
Michael
M
Maeng
Krankenhaus Landshut-Achdorf, Landshut, Germany.
Bernhard
B
Zrenner
Universitätsklinikum Goettingen, Goettingen, Germany.
Claudius
C
Jacobshagen
Universitätsklinikum Ulm, Ulm, Germany.
Jochen
J
Wöhrle
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Sebastian
S
Kufner
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
Tanja
T
Morath
1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany.
Tareq
T
Ibrahim
1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany.
Isabell
I
Bernlochner
Universitätsklinikum Regensburg, Regensburg, Germany.
Marcus
M
Fischer
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.|DZHK, Partner Site Munich Heart Alliance, Munich, Germany.
Heribert
H
Schunkert
1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany.|DZHK, Partner Site Munich Heart Alliance, Munich, Germany.
Karl-Ludwig
KL
Laugwitz
DZHK, Partner Site Munich Heart Alliance, Munich, Germany.|Munich University Clinic, Ludwig-Maximilians University, Munich, Germany.
Julinda
J
Mehilli
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.|DZHK, Partner Site Munich Heart Alliance, Munich, Germany.
Adnan
A
Kastrati
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.|DZHK, Partner Site Munich Heart Alliance, Munich, Germany.
Stefanie
S
Schulz-Schüpke
D054058:Acute Coronary Syndrome / Q000401:mortality* / Q000628:therapy*; D000368:Aged; D000077144:Clopidogrel; D054855:Drug-Eluting Stents; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D006801:Humans; D008875:Middle Aged; D013988:Ticlopidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D013997:Time Factors
D000077144:Clopidogrel; D013988:Ticlopidine