Schulz-Schuepke, Stefanie and Byrne, Robert A. 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 Mudra, Harald and von Hodenberg, Eberhard and Woehrle, Jochen and Angiolillo, Dominick J. and von Merzljak, Barbara and Rifatov, Nonglag and Kufner, Sebastian and Morath, Tanja and Feuchtenberger, Antonia and Ibrahim, Tareq and Janssen, Paul W. A. and Valina, Christian and Li, Yi and Desmet, Walter and Abdel-Wahab, Mohamed and Tiroch, Klaus and Hengstenberg, Christian and Bernlochner, Isabell and Fischer, Marcus and Schunkert, Heribert and Laugwitz, Karl-Ludwig and Schoemig, Albert and Mehilli, Julinda and Kastrati, Adnan (2015) ISAR-SAFE: a randomized, double-blind, placebo-controlled trial of 6 vs. 12 months of clopidogrel therapy after drug-eluting stenting. EUROPEAN HEART JOURNAL, 36 (20). pp. 1252-1263. ISSN 0195-668X, 1522-9645
Full text not available from this repository. (Request a copy)Abstract
Background In patients receiving aspirin, the optimal duration of clopidogrel therapy after drug-eluting stent (DES) implantation remains unclear. Methods This multicentre, randomized, double-blind, placebo-controlled trial tested the hypothesis that in patients undergoing DES implantation, 6 months of clopidogrel is non-inferior to 12 months in terms of clinical outcomes. At 6 months after DES implantation, patients on clopidogrel were randomly assigned to either a 6-month period of placebo or an additional 6-month period of clopidogrel. The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, and thrombolysis in myocardial infarction major bleeding at 9 months after randomization. Results Owing to slow recruitment and low event rates, the trial was stopped prematurely after enrolment of 4005 of 6000 planned patients. Of 4000 patients included in the final analysis, 1997 received 6 months of clopidogrel and 2003 received 12 months. The primary endpoint occurred in 29 patients (1.5%) assigned to 6 months of clopidogrel and 32 patients (1.6%) assigned to 12 months, observed difference -0.1%, upper limit of one-sided 95% confidence interval (CI) 0.5%, limit of non-inferiority 2%, P-for (noninferiority) <0.001. Stent thrombosis was observed in five patients (0.3%) assigned to 6 months of clopidogrel and three patients (0.2%) assigned to 12 months; hazard ratio (HR) 1.66, 95% CI: 0.40-6.96, P = 0.49. Thrombolysis in myocardial infarction major bleeding was observed in 4 patients (0.2%) assigned to 6 months clopidogrel and 5 patients (0.3%) assigned to 12 months; HR 0.80, 95% CI: 0.21-2.98, P = 0.74. Conclusions In the present trial, characterized by low event rates, we did not observe a significant difference in net clinical outcome between 6 and 12 months of clopidogrel therapy after DES implantation. However, the results of the trial must be considered in view of its premature termination and lower than expected event rates.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | DUAL-ANTIPLATELET THERAPY; PERCUTANEOUS CORONARY INTERVENTIONS; CLINICAL-TRIALS; IMPLANTATION; EFFICACY; THROMBOSIS; DURATION; DISCONTINUATION; GUIDELINES; RISK; Clopidogrel; Double-blind; Dual antiplatelet therapy; Drug-eluting stent; Randomized trial; Stent thrombosis |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin II |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 18 Jul 2019 08:20 |
| Last Modified: | 18 Jul 2019 08:20 |
| URI: | https://pred.uni-regensburg.de/id/eprint/5484 |
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