Author + information
- Received September 28, 2015
- Revision received December 14, 2015
- Accepted January 1, 2016
- Published online April 25, 2016.
- Sebastian Kufner, MDa,
- Jonas Sorgesa,
- Julinda Mehilli, MDb,c,
- Salvatore Cassese, MD, PhDa,
- Janika Repp, MDa,
- Jens Wiebe, MDa,
- Raphaela Lohaus, MDa,
- Annalena Lahmann, MDa,
- Tobias Rheude, MDa,
- Tareq Ibrahim, MDd,
- Steffen Massberg, MDb,c,
- Karl L. Laugwitz, MDc,d,
- Adnan Kastrati, MDa,c,
- Robert A. Byrne, MB, BCh, PhDa,∗ (, )
- ISAR-TEST-5 Investigators
- aDeutsches Herzzentrum München, Technische Universität München, Munich, Germany
- bDepartment of Cardiology, Ludwig-Maximilians-Universität, Munich, Germany
- cDZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany
- dI. Medizinische Klinik, Klinikum Rechts der Isar, Technische Universität München, Munich, Germany
- ↵∗Reprint requests and correspondence:
Dr. Robert A. Byrne, Deutsches Herzzentrum München, Lazarettstrasse, 36, Munich, Germany.
Objectives The aim of this study was to evaluate the late clinical performance of a polymer-free sirolimus- and probucol-eluting stent compared with a new-generation durable polymer-based zotarolimus-eluting stent.
Background It was previously shown that polymer-free sirolimus- and probucol-eluting stents were noninferior to zotarolimus-eluting stents at 12 months. However, long-term follow-up of these devices is critical to evaluate late comparative efficacy.
Methods In a clinical trial with minimal exclusion criteria, 3,002 patients were randomly assigned to treatment with polymer-free sirolimus- and probucol-eluting stents versus zotarolimus-eluting stents. The primary endpoint was the combined incidence of cardiac death, target vessel–related myocardial infarction, or target lesion revascularization.
Results At 5 years, there was no difference in the incidence of the primary endpoint between sirolimus- and probucol-eluting stents and zotarolimus-eluting stents (23.8% vs. 24.2%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.84 to 1.15; p = 0.80). The rates of the individual components of the primary endpoint were also comparable in both groups. The incidence of definite or probable stent thrombosis was low in both groups (1.3% vs. 1.6%, respectively; hazard ratio: 0.86; 95% confidence interval: 0.46 to 1.62; p = 0.64). The rates of any death, myocardial infarction, and revascularization were similar in both groups. Results were consistent across pre-specified subgroups of age, sex, diabetes, and vessel size.
Conclusions Long-term outcomes of patients treated with polymer-free sirolimus- and probucol-eluting stents compared with a new-generation durable polymer-based zotarolimus-eluting stent were similar. Rates of stent thrombosis were low and comparable in both treatment groups, with few events beyond 12 months. (Efficacy Study of Rapamycin- vs. Zotarolimus-Eluting Stents to Reduce Coronary Restenosis [ISAR-TEST-5]; NCT00598533)
Funding for this study was provided in part by the Bavarian Research Foundation (BFS-ISAR Aktenzeichen AZ: 504/02 and BFS-DES Aktenzeichen AZ: 668/05) and by the European Union FP7 (PRESTIGE 260309). Dr. Kastrati has patent applications related to drug-eluting stent coatings. Dr. Byrne has received lecture fees from B. Braun Melsungen AG, Biotronik, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 28, 2015.
- Revision received December 14, 2015.
- Accepted January 1, 2016.
- 2016 American College of Cardiology Foundation