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Maeng, Michael, MD, PhD; Tilsted, Hans-Henrik, MD; Jensen, Lisette Okkels, MD, DMSci; Kaltoft, Anne, MD, PhD; Kelbæk, Henning, MD, DMSci; Abildgaard, Ulrik, MD, DMSci; Villadsen, Anton B., MD; Krusell, Lars Romer, MD; Ravkilde, Jan, MD, DMSci; Hansen, Knud Nørregaard, MD; Christiansen, Evald Høj, MD, PhD; Aarøe, Jens, MD; Jensen, Jan Skov, MD, DMSci; Kristensen, Steen Dalby, MD, DMSci; Bøtker, Hans Erik, MD, DMSci; Madsen, Morten, MSc; Thayssen, Per, MD, DMSci; Sørensen, Henrik Toft, MD, DMSci; Thuesen, Leif, MD, DMSci; Lassen, Jens Flensted, MD, PhD
JACC. Cardiovascular interventions, 08/2012, Volume: 5, Issue: 8Journal Article
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 )
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