Paolo Zocca1, Marlies M Kok1, Kenneth Tandjung1, Peter W Danse2, Gillian A J Jessurun3, Raymond W M Hautvast4, K Gert van Houwelingen1, Martin G Stoel1, Alexander R Schramm3, R Melvyn Tjon Joe Gin2, Frits H A F de Man1, Marc Hartmann1, J Hans W Louwerenburg1, Gerard C M Linssen5, Marije M Löwik1, Carine J M Doggen6, Clemens von Birgelen7. 1. Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands. 2. Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands. 3. Department of Cardiology, Treant Zorggroep, Location Scheper, Emmen, the Netherlands. 4. Department of Cardiology, Medical Center Alkmaar, Alkmaar, the Netherlands. 5. Department of Cardiology, Ziekenhuisgroep Twente, Almelo and Hengelo, the Netherlands. 6. Department of Health Technology and Services Research, MIRA - Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, the Netherlands. 7. Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands; Department of Health Technology and Services Research, MIRA - Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, the Netherlands. Electronic address: c.vonbirgelen@mst.nl.
Abstract
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.
RCT Entities:
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 platinumchromium-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.
Authors: Rosaly A Buiten; Eline H Ploumen; Paolo Zocca; Carine J M Doggen; Liefke C van der Heijden; Marlies M Kok; Peter W Danse; Carl E Schotborgh; Martijn Scholte; Frits H A F de Man; Gerard C M Linssen; Clemens von Birgelen Journal: JAMA Cardiol Date: 2019-07-01 Impact factor: 14.676
Authors: Jacopo Burrello; Guglielmo Gallone; Alessio Burrello; Daniele Jahier Pagliari; Eline H Ploumen; Mario Iannaccone; Leonardo De Luca; Paolo Zocca; Giuseppe Patti; Enrico Cerrato; Wojciech Wojakowski; Giuseppe Venuti; Ovidio De Filippo; Alessio Mattesini; Nicola Ryan; Gérard Helft; Saverio Muscoli; Jing Kan; Imad Sheiban; Radoslaw Parma; Daniela Trabattoni; Massimo Giammaria; Alessandra Truffa; Francesco Piroli; Yoichi Imori; Bernardo Cortese; Pierluigi Omedè; Federico Conrotto; Shao-Liang Chen; Javier Escaned; Rosaly A Buiten; Clemens Von Birgelen; Paolo Mulatero; Gaetano Maria De Ferrari; Silvia Monticone; Fabrizio D'Ascenzo Journal: J Pers Med Date: 2022-06-17
Authors: Laura S M Kerkmeijer; Jaya Chandrasekhar; Deborah N Kalkman; Pier Woudstra; Ian B A Menown; Harry Suryapranata; Peter den Heijer; Andrés Iñiguez; Arnoud W J van 't Hof; Andrejs Erglis; Karin E Arkenbout; Philippe Muller; Karel T Koch; Jan G Tijssen; Marcel A M Beijk; Robbert J de Winter Journal: Catheter Cardiovasc Interv Date: 2020-10-08 Impact factor: 2.692
Authors: Paolo Zocca; Marlies M Kok; Liefke C van der Heijden; Peter W Danse; Carl E Schotborgh; Martijn Scholte; Marc Hartmann; Gerard C M Linssen; Carine J M Doggen; Clemens von Birgelen Journal: Cardiovasc Drugs Ther Date: 2018-12 Impact factor: 3.727
Authors: Endrin Koni; Wojciech Wanha; Jakub Ratajczak; Zhongheng Zhang; Przemysław Podhajski; Rita L. Musci; Giuseppe M. Sangiorgi; Maciej Kaźmierski; Antonio Buffon; Jacek Kubica; Wojciech Wojakowski; Eliano P. Navarese Journal: J Clin Med Date: 2021-03-19 Impact factor: 4.241