- 作者：Michael Maeng ; Hans-Henrik Tilsted ; Lisette Okkels Jensen ; Anne Kaltoft ; Henning Kelb?k ; Ulrik Abildgaard ; Anton B. Villadsen ; Lars Romer Krusell ; Jan Ravkilde ; Knud N?rregaard Hansen ; Evald H?j Christiansen ; Jens Aar?e ; Jan Skov Jensen ; Steen Dalby Kristensen ; Hans Erik B?tker ; Morten Madsen ; Per Thayssen ; Henrik Toft S?rensen ; Leif Thuesen ; Jens Flensted Lassen ; et al.
- 关键词：coronary ; drug-eluting ; randomized clinical trial ; sirolimus ; stent ; zotarolimus
- 刊名：JACC: Cardiovascular Interventions
- 出版年：2012
- 出版时间：August, 2012
- 年：2012
- 卷：5
- 期：8
- 页码：812-818
- 全文大小：531 K
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]; )