Author + information
- Received December 20, 2016
- Revision received February 21, 2017
- Accepted February 23, 2017
- Published online June 19, 2017.
- Georgios J. Vlachojannis, MD, PhDa,
- Pieter C. Smits, MD, PhDa,∗ (, )
- Sjoerd H. Hofma, MD, PhDb,
- Mario Togni, MDc,
- Nicolás Vázquez, MDd,
- Mariano Valdés, MDe,
- Vassilis Voudris, MDf,
- Ton Slagboom, MDg,
- Jean-Jaques Goy, MDc,
- Peter den Heijer, MD, PhDh and
- Martin van der Ent, MD, PhDa
- aDepartment of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands
- bDepartment of Cardiology, Medisch Centrum Leeuwarden, Leeuwarden, the Netherlands
- cDepartment of Cardiology, Hôpital Cantonal de Fribourg, Fribourg, Switzerland
- dDepartment of Cardiology, Hospitalario Juan Canalejo, Coruña, Spain
- eDepartment of Cardiology, Hospital Clinico Virgen de la Arrixaca, Murcia, Spain
- fDepartment of Cardiology, Onassis Cardiac Surgery Centre, Athens, Greece
- gDepartment of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
- hDepartment of Cardiology, Amphia Ziekenhuis, Breda, the Netherlands
- ↵∗Address for correspondence:
Dr. Pieter C. Smits, Department of Cardiology, Maasstad Hospital, Maasstadweg 21, 3079 DZ Rotterdam, the Netherlands.
Objectives This analysis investigates the 5-year outcomes of the biodegradable polymer biolimus-eluting stent (BP-BES) and durable polymer everolimus-eluting stent (DP-EES) in an all-comers population undergoing percutaneous coronary intervention.
Background Recent 1- and 3-year results from randomized trials have indicated similar safety and efficacy outcomes of BP-BES and DP-EES. Whether benefits of the biodegradable polymer device arise over longer follow-up is unknown. Moreover, in-depth, prospective, long-term follow-up data on metallic drug-eluting stents with durable or biodegradable polymers are scarce.
Methods The COMPARE II trial (Abluminal Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent) was a prospective, randomized, multicenter, all-comers trial in which 2,707 patients were randomly allocated (2:1) to BP-BES or DP-EES. The pre-specified endpoint at 5 years was major adverse cardiac events, a composite of cardiac death, nonfatal myocardial infarction, or target vessel revascularization.
Results Five-year follow-up was available in 2,657 patients (98%). At 5 years, major adverse cardiac events occurred in 310 patients (17.3%) in the BP-BES group and 142 patients (15.6%) in the DP-EES group (p = 0.26). The rate of the combined safety endpoint all-cause death or myocardial infarction was 15.0% in the BP-BES group versus 14.8% in the DP-EES group (p = 0.90), whereas the efficacy measure target vessel revascularization was 10.6% versus 9.0% (p = 0.18), respectively. Interestingly, definite stent thrombosis rates did not differ between groups (1.5% for BP-BES vs. 0.9% for DP-EES; p = 0.17).
Conclusions The 5-year analysis comparing biodegradable polymer-coated BES and the durable polymer-coated EES confirms the initial early- and mid-term results regarding similar safety and efficacy outcomes in this all-comers percutaneous coronary intervention population.
- biodegradable polymer-coated stent(s)
- biolimus-eluting stent(s)
- everolimus-eluting stent(s)
The study was supported by a grant from Terumo Europe (Leuven, Belgium) and the Research Foundation of the Cardiology Department, Maasstad Hospital (Rotterdam, the Netherlands). Dr. Vlachojannis has been a consultant for and received lecture fees from Abbott Vascular. Dr. Smits has received lecture fees from Abbott Vascular; and institutional research grants from Abbott Vascular, Terumo, and St. Jude Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 20, 2016.
- Revision received February 21, 2017.
- Accepted February 23, 2017.
- 2017 American College of Cardiology Foundation