Author + information
- Received October 13, 2017
- Revision received November 15, 2017
- Accepted November 21, 2017
- Published online March 5, 2018.
- Paolo Zocca, MDa,
- Marlies M. Kok, MDa,
- Kenneth Tandjung, MD, PhDa,
- Peter W. Danse, MD, PhDb,
- Gillian A.J. Jessurun, MD, PhDc,
- Raymond W.M. Hautvast, MD, PhDd,
- K. Gert van Houwelingen, MDa,
- Martin G. Stoel, MD, PhDa,
- Alexander R. Schramm, MDc,
- R. Melvyn Tjon Joe Gin, MDb,
- Frits H.A.F. de Man, MD, PhDa,
- Marc Hartmann, MD, PhDa,
- J. (Hans) W. Louwerenburg, MDa,
- Gerard C.M. Linssen, MD, PhDe,
- Marije M. Löwik, PhDa,
- Carine J.M. Doggen, PhDf and
- Clemens von Birgelen, MD, PhDa,f,∗ ()
- aDepartment of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands
- bDepartment of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands
- cDepartment of Cardiology, Treant Zorggroep, Location Scheper, Emmen, the Netherlands
- dDepartment of Cardiology, Medical Center Alkmaar, Alkmaar, the Netherlands
- eDepartment of Cardiology, Ziekenhuisgroep Twente, Almelo and Hengelo, the Netherlands
- fDepartment of Health Technology and Services Research, MIRA – Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, the Netherlands
- ↵∗Address for correspondence:
Dr. Clemens von Birgelen, Thoraxcentrum Twente, Medisch Spectrum Twente, Koningsplein 1, 7512 KZ Enschede, the Netherlands.
Objectives The study sought to evaluate for the first time the 5-year outcomes after treating an all-comers population with newer-generation cobalt chromium-based Resolute Integrity zotarolimus-eluting stents (ZES) (Medtronic, Santa Rosa, California) versus platinum chromium-based PROMUS Element everolimus eluting stents (EES) (Boston Scientific, Natick, Massachusetts).
Background The DUTCH PEERS (TWENTE II) (DUrable polymer-based sTent CHallenge of Promus ElemEnt versus ReSolute integrity: TWENTE II) trial is a randomized, multicenter, single-blinded, investigator-initiated all-comers trial that found at its main analysis similar 1-year safety and efficacy for both drug-eluting stents. It is the first randomized trial ever to investigate the Resolute Integrity ZES and the first trial to compare both devices.
Methods In total, 1,811 patients were 1:1 randomized to ZES versus EES. We performed a pre-specified assessment of the 5-year clinical outcomes in terms of safety and efficacy. The main endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel–related myocardial infarction, or target vessel revascularization. Secondary endpoints included the individual components of TVF, and stent thrombosis. The study was independently monitored, and adverse clinical events were independently adjudicated.
Results Five-year clinical follow-up data was available in 1,798 (99.3%) patients. The ZES and EES groups showed favorable outcomes, with similar 5-year incidence of TVF (13.2% vs. 14.2%; plog-rank = 0.62) and its individual components: cardiac death (4.5% vs. 4.9%; plog-rank = 0.69), target vessel–related myocardial infarction (3.1% vs. 2.6%; plog-rank = 0.47), and target vessel revascularization (7.6% vs. 8.6%; plog-rank = 0.46). The 5-year incidence of definite or probable stent thrombosis was similar (1.5% vs. 1.3%; plog-rank = 0.83).
Conclusions At 5-year follow-up, the Resolute Integrity ZES and PROMUS Element EES showed similar and sustained results in terms of safety and efficacy for treating a broad population of all-comers.
- long-term outcome
- newer-generation drug-eluting stent(s)
- percutaneous coronary intervention
- PROMUS Element everolimus-eluting stent(s)
- Resolute Integrity zotarolimus-eluting stent(s)
This investigator-initiated study was equally supported by Boston Scientific and Medtronic. Dr. von Birgelen has reported that the research department of Thoraxcentrum Twente has received institutional research grants provided by AstraZeneca, Biotronik, Boston Scientific, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 13, 2017.
- Revision received November 15, 2017.
- Accepted November 21, 2017.
- 2018 The Authors
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