Author + information
- Received January 16, 2019
- Revision received April 17, 2019
- Accepted April 26, 2019
- Published online September 2, 2019.
- Christian Zanchin, MDa,
- Yasushi Ueki, MDa,
- Thomas Zanchin, MDa,
- Jonas Häner, MDa,
- Tatsuhiko Otsuka, MDa,
- Stefan Stortecky, MDa,
- Konstantinos C. Koskinas, MD, MSca,
- George C.M. Siontis, MD, PhDa,
- Fabien Praz, MDa,
- Aris Moschovitis, MDa,
- Lukas Hunziker, MDa,
- Marco Valgimigli, MD, PhDa,
- Thomas Pilgrim, MDa,
- Dik Heg, PhDb,
- Stephan Windecker, MDa and
- Lorenz Räber, MD, PhDa,∗ ()
- aSwiss Cardiovascular Center Bern, Department of Cardiology, Bern University Hospital, Bern, Switzerland
- bClinical Trials Unit, University of Bern, Bern, Switzerland
- ↵∗Address for correspondence:
Prof. Lorenz Räber, Department of Cardiology, Bern University Hospital, Freiburgstrasse, 3010 Bern, Switzerland.
Objectives The aim of this study was to compare the efficacy and safety of a thin-strut, biodegradable-polymer everolimus-eluting stent (BP-EES) (Synergy, Boston Scientific, Marlborough, Massachusetts) and a thin-strut, durable-polymer everolimus-eluting stent (DP-EES) (XIENCE, Abbott Vascular, Abbott Park, Illinois) in an all-comers population.
Background BP-EES have been shown to be noninferior to DP-EES in randomized trials in patients at low to moderate risk.
Methods Among 7,042 consecutive patients who underwent percutaneous coronary intervention between December 2012 and December 2016, 3,870 patients were exclusively treated with BP-EES (n = 1,343) or with DP-EES (n = 2,527). After propensity score matching, the final study population consisted of 1,041 matched patients. The primary endpoint was the device-oriented composite endpoint (cardiac death, target vessel myocardial infarction, and target lesion revascularization) at 12 months.
Results The device-oriented composite endpoint did not differ between the 2 groups (7.8% with BP-EES vs. 7.1% with DP-EES; hazard ratio: 1.12; 95% confidence interval: 0.81 to 1.53; p = 0.49). There were no differences in rates of cardiac death (3.0% vs. 3.0%; p = 1.00), target vessel myocardial infarction (3.6% vs. 3.1%; p = 0.53), and target lesion revascularization (3.0% vs. 2.5%; p = 0.41). The rate of acute stent thrombosis was significantly higher in the BP-EES group compared with the DP-EES group (1.2% vs. 0.3%; hazard ratio: 4.00; 95% confidence interval: 1.13 to 14.19; p = 0.032). At 12 months, the frequency of definite stent thrombosis did not differ (1.5% vs. 0.9%; hazard ratio: 1.67; 95% confidence interval: 0.73 to 3.82; p = 0.22).
Conclusions In this consecutively enrolled percutaneous coronary intervention population reflecting routine clinical practice, no difference in the device-oriented composite endpoint between BP-EES and DP-EES was observed throughout 12 months. There was a higher rate of acute stent thrombosis with the BP-EES, a difference that disappeared at 1 year. (CARDIOBASE Bern PCI Registry; NCT02241291)
Prof. Pilgrim has received research grants to the institution from Biotronik, Symetis/Boston Scientific, and Edwards Lifesciences; and has received speaking fees from Biotronik and Boston Scientific. Prof. Valgimigli has received research grants to the institution from Terumo, Medicure, Abbott, and AstraZeneca; and has received honoraria from Abbott, Chiesi, Bayer, Daiichi-Sankyo, Amgen, Terumo, AstraZeneca, Alvimedica, and Biosensors. Prof. Windecker has received research grants to the institution from Abbott, Amgen, Bayer, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, Terumo, and St. Jude Medical. Prof. Räber has received research grants to the institution from Abbott Vascular, Boston Scientific, HeartFlow, Sanofi, and Regeneron; and has received speaking honoraria from Abbott Vascular, Amgen, AstraZeneca, Biotronik, CSL Behring, Sanofi, and Regeneron. All other authors have reported that they have no relationships relevant to the content of this paper to disclose.
- Received January 16, 2019.
- Revision received April 17, 2019.
- Accepted April 26, 2019.
- 2019 American College of Cardiology Foundation
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.