Author + information
- Nikolaus Sarafoff, MD∗ (, )
- Robert A. Byrne, MB, BCH, PhD,
- Julinda Mehilli, MD,
- Dirk Sibbing, MD,
- Steen D. Kristensen, MD,
- Karl-Ludwig Laugwitz, MD,
- Michael Maeng, MD and
- Adnan Kastrati, MD
- ↵∗Klinikum der Universität München, Ludwig-Maximilians Universität, Medizinische Klinik und Poliklinik I, Marchioninistrasse 15, Munich 81377, Germany
We thank Dr. Nairooz and colleagues for the comments regarding the results of our ISAR TRIPLE trial (Duration of Triple Therapy in Patients Requiring Oral Anticoagulation After Drug Eluting Stent Implantation) (1) and are happy to provide our answers to his 3 questions:
1. Only 5% of the patients (n = 30) in the ISAR TRIPLE trial were loaded with 300-mg clopidogrel, and they were evenly distributed in the 2 study arms. Interestingly, all patients who developed myocardial infarction had a loading dose of 600-mg clopidogrel.
2. The lack of treatment effect regarding the primary combined endpoint was consistent in the pre-specified subgroup analysis according to renal function and this, as well as the prevalence of reduced renal function, was already shown in Online Figure 2. Dr. Nairooz and colleagues are concerned that patients with chronic kidney disease may have experienced higher bleeding rates; however, there was also no association with renal function and the occurrence of the secondary endpoint Thrombolysis In Myocardial Infarction major bleeding (p for interaction = 0.89) or any bleeding according to Bleeding Academic Research Consortium (p for interaction = 0.70).
3. A longer follow-up period for the evaluation of treatment effect would have been inappropriate because the protocol did not define differences in antiplatelet therapy after 6 months in the 2 study arms. Thus, ischemic complications occurring after this time point may not be attributed to duration of clopidogrel therapy.
Please note: Dr. Sarafoff has received fees for lectures or traveling from Lilly/Daiichi-Sankyo, Boehringer Ingelheim, AstraZeneca, Bayer Healthcare, Boston Scientific, Biotronik, and Medtronic. Dr. Byrne has received lecture fees from B. Braun and Biotronik; and has received fees for lectures, advisory board service, or traveling from Abbott Vascular and Medtronic. Dr. Mehilli has received fees for lectures and advisory board service from Abbot Vascular, Terumo, and Lilly/Daiichi-Sankyo. Dr. Sibbing has received speaker fees and honoraria for consulting from Eli Lilly, Daiichi-Sankyo, Bayer Vital, AstraZeneca, Verum Diagnostica, and Roche Diagnostics; and has received research grants from Roche Diagnostics. Dr. Kristensen has received lecture fees from AstraZeneca, Eli Lilly, Sanofi, and The Medicines Company. Dr. Kastrati has received payments for lectures or event adjudication activity from Abbott, AstraZeneca, Biosensors, Biotronik, Daiichi-Sankyo, MSD, and The Medicines Company; and holds patents related to stent technology. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- 2015 American College of Cardiology Foundation