Author + information
- Received November 6, 2011
- Revision received January 11, 2012
- Accepted January 17, 2012
- Published online April 10, 2012.
- Clemens von Birgelen, MD, PhD⁎,†,⁎ (, )
- Mounir W.Z. Basalus, MD⁎,
- Kenneth Tandjung, MD⁎,
- K. Gert van Houwelingen, MD⁎,
- Martin G. Stoel, MD⁎,
- J.(Hans) W. Louwerenburg, MD⁎,
- Gerard C.M. Linssen, MD, PhD‡,
- Salah A.M. Saïd, MD, PhD§,
- Miep A.W.J. Kleijne, MD∥,
- Hanim Sen, MD⁎,
- Marije M. Löwik, PhD⁎,
- Job van der Palen, PhD¶,#,
- Patrick M.J. Verhorst, MD, PhD⁎ and
- Frits H.A.F. de Man, MD, PhD⁎
- ↵⁎Reprint requests and correspondence:
Prof. Clemens von Birgelen, Thoraxcentrum Twente, Department of Cardiology, MST, Haaksbergerstraat 55, 7513ER Enschede, the Netherlands
Objectives The aim of this study was to compare the safety and efficacy of Resolute zotarolimus-eluting stents (ZES) (Medtronic Cardiovascular, Santa Rosa, California) with Xience V everolimus-eluting stents (EES) (Abbott Vascular Devices, Santa Clara, California) at 1-year follow-up.
Background Only 1 randomized trial previously compared these stents.
Methods This investigator-initiated, patient-blinded, randomized noninferiority study had limited exclusion criteria (acute ST-segment elevation myocardial infarctions not eligible). Patients (n = 1,391; 81.4% of eligible population) were randomly assigned to ZES (n = 697) or EES (n = 694). Liberal use of stent post-dilation was encouraged. Cardiac biomarkers were systematically assessed. The primary endpoint was target vessel failure (TVF), a composite of cardiac death, myocardial infarction not clearly attributable to non-target vessels, and clinically indicated target-vessel revascularization. An external independent research organization performed clinical event adjudication (100% follow-up data available). Analysis was by intention-to-treat.
Results Acute coronary syndromes were present in 52% and “off-label” feature in 77% of patients. Of the lesions, 70% were type B2/C; the post-dilation rate was very high (82%). In ZES and EES, TVF occurred in 8.2% and 8.1%, respectively (absolute risk-difference 0.1%; 95% confidence interval: −2.8% to 3.0%, pnoninferiority = 0.001). There was no significant between-group difference in TVF components. The definite-or-probable stent thrombosis rates were relatively low and similar for ZES and EES (0.9% and 1.2%, respectively, p = 0.59). Definite stent thrombosis rates were also low (0.58% and 0%, respectively, p = 0.12). In EES, probable stent thrombosis beyond day 8 was observed only in patients not adhering to dual antiplatelet therapy.
Conclusions Resolute ZES were noninferior to Xience V EES in treating “real-world” patients with a vast majority of complex lesions and “off-label” indications for drug-eluting stents, which were implanted with liberal use of post-dilation. (The Real-World Endeavor Resolute Versus XIENCE V Drug-Eluting SteNt Study: Head-to-head Comparison of Clinical Outcome After Implantation of Second Generation Drug-eluting Stents in a Real World Scenario; NCT01066650)
- coronary artery disease
- drug-eluting stent
- percutaneous coronary intervention
- randomized controlled trial
This was an investigator-initiated study supported by equal unrestricted grants from Abbott Vascular and Medtronic. Dr. von Birgelen is consultant to and has received lecture fees or travel expenses from Abbott, Medtronic, and Boston Scientific; and has received a speaker's honorarium from MSD. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. von Birgelen and Basalus contributed equally to this work.
- Received November 6, 2011.
- Revision received January 11, 2012.
- Accepted January 17, 2012.
- American College of Cardiology Foundation