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

Lohaus R, Michel J, Mayer K, Lahmann AL, Byrne RA, Wolk A, Ten Berg JM, Neumann FJ, Han Y, Adriaenssens T, Toelg R, Seyfarth M, Maeng M, Zrenner B, Jacobshagen C, Woehrle J, Kufner S, Morath T, Ibrahim T, Bernlochner I, Fischer M, Schunkert H, Laugwitz KL, Mehilli J, Kastrati A, Schulz-Schuepke S (2016)

Publication Type: Journal article

Publication year: 2016

Journal

Scientific Reports Nature Publishing Group: Open Access Journals - Option B

Book Volume: 6

Article Number: 33054

DOI: 10.1038/srep33054

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.

Involved external institutions

Technische Universität München (TUM) DE Germany (DE) Universitätsklinikum Göttingen DE Germany (DE) St. Antonius Ziekenhuis NL Netherlands (NL) Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH DE Germany (DE) University Hospital Leuven (UZ) / Universitaire ziekenhuizen Leuven BE Belgium (BE) Segeberger Kliniken DE Germany (DE) HELIOS Kliniken DE Germany (DE) Aarhus University Hospital / Aarhus Universitetshospital DK Denmark (DK) Krankenhaus Landshut-Achdorf (LAKUMED) DE Germany (DE) Universitätsklinikum Ulm DE Germany (DE) Universitätsklinikum Regensburg DE Germany (DE) Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK e.V.) DE Germany (DE) Shenyang Northern Hospital CN China (CN)

How to cite

APA:

Lohaus, R., Michel, J., Mayer, K., Lahmann, A.L., Byrne, R.A., Wolk, A.,... Schulz-Schuepke, S. (2016). Six Versus Twelve Months Clopidogrel Therapy after Drug-Eluting Stenting in Patients with Acute Coronary Syndrome: An ISAR-SAFE Study Subgroup Analysis. Scientific Reports, 6. https://doi.org/10.1038/srep33054

MLA:

Lohaus, Raphaela, et al. "Six Versus Twelve Months Clopidogrel Therapy after Drug-Eluting Stenting in Patients with Acute Coronary Syndrome: An ISAR-SAFE Study Subgroup Analysis." Scientific Reports 6 (2016).

BibTeX: Download