Lohaus, Raphaela and Michel, Jonathan and Mayer, Katharina and Lahmann, Anna Lena and Byrne, Robert A. and Wolk, Annabelle and ten Berg, Jurrien M. and Neumann, Franz-Josef and Han, Yaling and Adriaenssens, Tom and Toelg, Ralph and Seyfarth, Melchior and Maeng, Michael and Zrenner, Bernhard and Jacobshagen, Claudius and Woehrle, Jochen and Kufner, Sebastian and Morath, Tanja and Ibrahim, Tareq and Bernlochner, Isabell and Fischer, Marcus and Schunkert, Heribert and Laugwitz, Karl-Ludwig and Mehilli, Julinda and Kastrati, Adnan and Schulz-Schuepke, Stefanie (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: 33054. ISSN 2045-2322,
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | DUAL-ANTIPLATELET THERAPY; PLACEBO-CONTROLLED TRIAL; LONG-TERM DURATION; DOUBLE-BLIND; IMPLANTATION; METAANALYSIS; EFFICACY; INTERVENTION; MULTICENTER; TICAGRELOR; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 03 Apr 2019 12:02 |
| Last Modified: | 03 Apr 2019 12:02 |
| URI: | https://pred.uni-regensburg.de/id/eprint/3291 |
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