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Sci Rep. 2016 Sep 14;6:33054. doi: 10.1038/srep33054.

Six Versus Twelve Months Clopidogrel Therapy After Drug-Eluting Stenting in Patients With Acute Coronary Syndrome: An ISAR-SAFE Study Subgroup Analysis.

Author information

1
Deutsches Herzzentrum München, Technische Universität, Munich, Germany.
2
Universitätsklinikum Goettingen, Goettingen, Germany.
3
St. Antonius Hospital, Nieuwegein, Netherlands.
4
Universitäts-Herzzentrum Freiburg - Bad Krozingen, Bad Krozingen, Germany.
5
Shenyang Northern Hosp, Shenyang, China.
6
University Hospital Leuven, Leuven, Belgium.
7
Herzzentrum der Segeberger Kliniken Gruppe, Bad Segeberg, Germany.
8
Helios Klinik Wuppertal, Wuppertal, Germany.
9
Aarhus University Hospital, Aarhus, Denmark.
10
Krankenhaus Landshut-Achdorf, Landshut, Germany.
11
Universitätsklinikum Ulm, Ulm, Germany.
12
1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany.
13
Universitätsklinikum Regensburg, Regensburg, Germany.
14
DZHK, Partner Site Munich Heart Alliance, Munich, Germany.
15
Munich University Clinic, Ludwig-Maximilians University, Munich, Germany.

Abstract

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.

PMID:
27624287
PMCID:
PMC5021963
DOI:
10.1038/srep33054
[Indexed for MEDLINE]
Free PMC Article

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