Author + information
- Received December 22, 2014
- Accepted January 1, 2015
- Published online June 1, 2015.
- Hanim Sen, MD, PhD∗,
- Ming Kai Lam, MD∗,
- Marije M. Löwik, PhD∗,
- Peter W. Danse, MD, PhD†,
- Gillian A.J. Jessurun, MD, PhD‡,
- K. Gert van Houwelingen, MD∗,
- Rutger L. Anthonio, MD, PhD‡,
- R. Melvyn Tjon Joe Gin, MD†,
- Raymond W.M. Hautvast, MD, PhD§,
- J. (Hans) W. Louwerenburg, MD∗,
- Frits H.A.F. de Man, MD, PhD∗,
- Martin G. Stoel, MD, PhD∗,
- Liefke C. van der Heijden, MD∗,
- Gerard C.M. Linssen, MD, PhD‖,
- Maarten J. IJzerman, PhD¶,
- Kenneth Tandjung, MD, PhD∗,
- Carine J.M. Doggen, PhD¶ and
- Clemens von Birgelen, MD, PhD∗,†∗ ()
- ∗Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands
- †Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands
- ‡Department of Cardiology, Scheper Hospital, Emmen, the Netherlands
- §Department of Cardiology, Medical Center Alkmaar, Alkmaar, the Netherlands
- ‖Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, the Netherlands
- ¶Department of Health Technology and Services Research, University of Twente, Enschede, the Netherlands
- ↵∗Reprint requests and correspondence:
Prof. Clemens von Birgelen, Department of Cardiology, Thoraxcentrum Twente, Haaksbergerstraat 55, 7513ER Enschede, the Netherlands.
Objectives This study assessed clinical events and patient-reported chest pain 2 years after treatment of all-comers with Resolute Integrity zotarolimus-eluting stents (Medtronic Vascular, Santa Rosa, California) and Promus Element everolimus-eluting stents (Boston Scientific, Natick, Massachusetts).
Background For both drug-eluting stents (DES), no all-comer outcome data from >12 months of follow-up have been published. Although there is increasing interest in patient-reported chest pain following stenting, data with novel DES are scarce.
Methods The DUTCH PEERS multicenter trial (TWENTE II) (DUrable Polymer-Based STent CHallenge of Promus ElemEnt Versus ReSolute Integrity) Randomized Trial [TWENTE II]) randomized 1,811 all-comer patients to treatment with 1 type of DES. Monitoring and event adjudication were performed by independent contract research organizations.
Results The 2-year follow-up of 1,810 patients (99.9%) was available. The primary composite endpoint target vessel failure occurred in 8.6% and 7.8% of patients treated with zotarolimus- and everolimus-eluting stents, respectively (p = 0.55). Rates of components of target vessel failure were: cardiac death (2.4% vs. 1.9%, p = 0.42); target vessel–related myocardial infarction (2.4% vs. 1.8%, p = 0.33); clinically-indicated target vessel revascularization (4.6% vs. 4.9%, p = 0.83). At 1- and 2-year follow-up, >80% of patients were free from chest pain (no between-stent difference). In addition, >87% of patients were either free from chest pain or experienced pain only at maximal physical exertion, but not during normal daily activities. Patients with chest pain after 12 months at no more than moderate physical effort had a higher risk of target vessel revascularization during the following year (hazard ratio: 1.89 [95% confidence interval: 1.05 to 3.39], p = 0.03).
Conclusions During the second year of follow-up, the incidence of adverse clinical endpoints remained similar and low for both DES. The vast majority of patients were free from chest pain.
- percutaneous coronary intervention
- Promus Element platinum-chromium everolimus-eluting stent
- randomized clinical trial
- Resolute Integrity cobalt-chromium zotarolimus-eluting stent
This investigator-initiated study was equally supported by Boston Scientific and Medtronic. Dr. von Birgelen has been a consultant to and has received lecture fees or travel expenses from Abbott Vascular, Boston Scientific, and Medtronic; has served on the advisory boards of Boston Scientific and Medtronic; has received lecture fees from Boston Scientific, Medtronic, and Merck Sharp & Dohme; and his institution has received research grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. Dr. IJzerman is a consultant to PANAXEA b.v.; and he has received payments for lectures from Roche, Pfizer, and Sanofi. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 22, 2014.
- Accepted January 1, 2015.
- American College of Cardiology Foundation