Author + information
- Received April 12, 2012
- Accepted April 27, 2012
- Published online August 1, 2012.
- Michael Maeng, MD, PhD⁎,⁎ (, )
- Hans-Henrik Tilsted, MD†,
- Lisette Okkels Jensen, MD, DMSci‡,
- Anne Kaltoft, MD, PhD⁎,
- Henning Kelbæk, MD, DMSci§,
- Ulrik Abildgaard, MD, DMSci∥,
- Anton B. Villadsen, MD†,
- Lars Romer Krusell, MD⁎,
- Jan Ravkilde, MD, DMSci†,
- Knud Nørregaard Hansen, MD‡,
- Evald Høj Christiansen, MD, PhD⁎,
- Jens Aarøe, MD†,
- Jan Skov Jensen, MD, DMSci∥,
- Steen Dalby Kristensen, MD, DMSci⁎,
- Hans Erik Bøtker, MD, DMSci⁎,
- Morten Madsen, MSc¶,
- Per Thayssen, MD, DMSci‡,
- Henrik Toft Sørensen, MD, DMSci¶,
- Leif Thuesen, MD, DMSci⁎ and
- Jens Flensted Lassen, MD, PhD⁎
- ↵⁎Reprint requests and correspondence:
Dr. Michael Maeng, Department of Cardiology, Aarhus University Hospital, Skejby, Brendstrupgaardsvej 100, Aarhus N, Denmark
Objectives This study sought to examine the 3-year clinical outcomes in patients treated with the Endeavor (Medtronic, Santa Rosa, California) zotarolimus-eluting stent (ZES) or the Cypher (Cordis, Johnson & Johnson, Warren, New Jersey) sirolimus-eluting stent (SES) in routine clinical practice.
Background The long-term clinical outcome in patients treated with ZES in comparison with SES is unclear.
Methods The authors randomized 2,332 patients to ZES (n = 1,162) or SES (n = 1,170) implantation. Endpoints included major adverse cardiac events (MACE), a composite of cardiac death, myocardial infarction, or target vessel revascularization; the individual endpoints of MACE; and definite stent thrombosis.
Results At 3-year follow-up, the MACE rate was higher in patients treated with ZES than in patients treated with SES (148 [12.9%] vs. 116 [10.1%]; hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 1.04 to 1.69; p = 0.022). Target vessel revascularization was more frequent in the ZES group compared with the SES group (103 [9.1%] vs. 76 [6.7%]; HR: 1.40, 95% CI: 1.04 to 1.89; p = 0.025), whereas the occurrence of myocardial infarction (3.8% vs. 3.3%) and cardiac death (2.8% vs. 2.8%) did not differ significantly. Although the rate of definite stent thrombosis was similar at 3-year follow-up (1.1% vs. 1.4%), very late (12 to 36 months) definite stent thrombosis occurred in 0 (0%) patients in the ZES group versus 12 (1.1%) patients in the SES group (p = 0.0005).
Conclusions Although the 3-year MACE rate is higher in patients treated with ZES versus SES, our data highlight a late safety problem concerning definite stent thrombosis with the use of SES. This finding underscores the importance of long-term follow-up in head-to-head comparisons of drug-eluting stents. (Randomized Clinical Comparison of the Endeavor and the Cypher Coronary Stents in Non-selected Angina Pectoris Patients [SORT OUT III]; NCT00660478)
The study was supported by unrestricted research grants from Cordis and Medtronic. Both companies had no influence on the study design, data collection, data analysis, data interpretation; they did not have access to the clinical trial database, and they did not have the opportunity to review or comment on the manuscript. Dr. Maeng has received travel grants from Cordis, Medtronic, Boston Scientific, Abbott, and St. Jude Medical. Dr. Ravkilde has received unrestricted grants from Medtronic, Johnson & Johnson Cordis, Abbott, Terumo, and Boston Scientific; and is on the advisory board of Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received April 12, 2012.
- Accepted April 27, 2012.
- American College of Cardiology Foundation