Long-term (>3 Years) outcome and predictors of clinical events after insertion of sirolimus-eluting stent in one or more native coronary arteries (from the Israeli arm of the e-Cypher registry).
The aim of this study was to evaluate long-term (3.4 years) outcomes and predictors of clinical events in patients treated with sirolimus-eluting stents in the Israeli arm of the e-Cypher registry. From July 2002 to October 2003, 488 patients from 8 medical centers in Israel were enrolled in the e-Cypher registry. Nineteen patients with interventions in venous grafts were excluded from the final analysis. Long-term follow-up was completed for 98% of the remaining patients. There were 29 cases (6.3%) of death (3.9% cardiac and 2.4% noncardiac deaths). According to the broad academic research consortium definition of stent thrombosis, there were 19 cases (4%) of stent thrombosis (incidence density 0.9 cases/100 patient-years). There were 46 cases (9.9%) of target lesion revascularization and 76 cases (16.3%) of major adverse cardiac events (combination of death, myocardial infarction, and target lesion revascularization). Independent predictors of stent thrombosis were renal failure (hazard ratio 9.6, 95% confidence interval 1.9 to 47), stent length (hazard ratio 1.1, 95% confidence interval 1 to 1.2), and the off-label use of sirolimus-eluting stents (hazard ratio 5.3, 95% confidence interval 1.2 to 24). In conclusion, during >3 years of follow-up, stent thrombosis, major adverse cardiac events, and target lesion revascularization continued at constant rates over time. Clinical parameters such as renal failure and procedural parameters such as off-label use and stent length were independent predictors of stent thrombosis.
Planer
David
D
Hadassah-Hebrew University Medical Centre, Jerusalem, Israel. davidpl@ekmd.huji.ac.il <davidpl@ekmd.huji.ac.il>
Beyar
Rafael
R
Almagor
Yaron
Y
Banai
Shmuel
S
Guetta
Victor
V
Miller
Hilton
H
Kornowski
Ran
R
Brandes
Simcha
S
Krakover
Ricardo
R
Solomon
Mivi
M
Lotan
Chaim
C
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D001026:Coronary Artery Bypass; D003324:Coronary Artery Disease / Q000628:therapy*; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D007557:Israel; D008297:Male; D008875:Middle Aged; D012042:Registries; D020123:Sirolimus / Q000008:administration & dosage*; D016019:Survival Analysis; D013927:Thrombosis / Q000209:etiology*; D013997:Time Factors; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; D020123:Sirolimus