TY - JOUR
T1 - Six Versus Twelve Months Clopidogrel Therapy after Drug-Eluting Stenting in Patients with Acute Coronary Syndrome
T2 - An ISAR-SAFE Study Subgroup Analysis
AU - Lohaus, Raphaela
AU - Michel, Jonathan
AU - Mayer, Katharina
AU - Lahmann, Anna Lena
AU - Byrne, Robert A.
AU - Wolk, Annabelle
AU - Ten Berg, Jurrien M.
AU - Neumann, Franz Josef
AU - Han, Yaling
AU - Adriaenssens, Tom
AU - Tölg, Ralph
AU - Seyfarth, Melchior
AU - Maeng, Michael
AU - Zrenner, Bernhard
AU - Jacobshagen, Claudius
AU - Wöhrle, Jochen
AU - Kufner, Sebastian
AU - Morath, Tanja
AU - Ibrahim, Tareq
AU - Bernlochner, Isabell
AU - Fischer, Marcus
AU - Schunkert, Heribert
AU - Laugwitz, Karl Ludwig
AU - Mehilli, Julinda
AU - Kastrati, Adnan
AU - Schulz-Schüpke, Stefanie
N1 - Publisher Copyright:
© The Author(s) 2016.
PY - 2016/9/14
Y1 - 2016/9/14
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/84987748133
U2 - 10.1038/srep33054
DO - 10.1038/srep33054
M3 - Article
C2 - 27624287
AN - SCOPUS:84987748133
SN - 2045-2322
VL - 6
JO - Scientific Reports
JF - Scientific Reports
M1 - 33054
ER -