1. Harvard Clinical Research Institute, Boston, US
A Pooled Analysis of Data Comparing Sirolimus-Eluting Stents with Bare-Metal Stents
Paris 5 Medical School René Descartes University, France Erasmus Medical Center, Rotterdam, Netherlands
Harvard Clinical Research Institute, Boston, US
N Engl J Med 2007;356:989-97
R3 맹치훈 / prof. 김수중

2. Background
Drug-eluting stent VS Bare-metal stent - previous randomized trial ; Superiority of “drug-elution” to “bare metal” - recent meta-analysis ; increased rate of death and MI with drug-eluting stent inserted patient
Cause ? impared reendothelialization - hypersensitivity reaction to the stent - stent thrombosis

3. Study Objective
Discordance between previous study and recent meta-analysis
Even slight increased rates of death and myocardial infarction
Inadequate statistical power of previous study
New safety analysis comparing sirolimus-eluting stent with BMS
FROM more reliable long-term pooled data of other randomized trial

4. Sirolimus-eluting stent Vs Bare-metal stent
Methods
Data pooling from FOUR previous conducted trials
Current analysis  data collection from above four studies
Sirolimus-eluting stent Vs Bare-metal stent
RAVEL
Comparison of Target-Vessel Failure death, myocardial infarction, target-vessel revascularization
SIRIUS
E-SIRIUS
C-SIRIUS

5. Methods
End points of Current data analysis ) Primary safety end point : death from any cause ) Secondary safety end point : death from cardiovascular cause : AMI, stent thrombosis, CVA, etc non-cardiovascular cause

6. Results Baseline Characteristics
Table Baseline Clinical and Angiographic Characteristics
Baseline Characteristics
Drug elution
Bare metal
Number
878
870
More Complex Lesion ↑ ↓
Association with Diabetes
Otherwise No Significant Difference Between Two Groups

7. No Superiority of Sirolimus Elution to Bare-metal Stent for All Data
Table 2 Incidences of Death, Myocardial Infarction, and Stent Thrombosis after 1440 Days of Follow-up
No Superiority of Sirolimus Elution to Bare-metal Stent for All Data

8. Figure Kaplan–Meier Survival Curves for Patients Who Received a Sirolimus-Eluting Stent and Those Who Received a Bare-Metal Stent
No significant difference Even slightly increased mortality in Sirolimus-elution group

9. Figure Kaplan–Meier Survival Curves for Patients with Diabetes (Panel A) and Those without Diabetes (Panel B)
DM+
DM-
Significantly Lower Survival rate in Sirolimus-elution group with DM
No significant Difference in patients without DM

10. Sirolimus-eluting Stent
Conclusion
Sirolimus-eluting Stent
Bare-metal Stent VS
NO SIGINIFICANCE in the rate of death, myocardial infarction, stent thrombosis between the two groups