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

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

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

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

Methods End points of Current data analysis 1) Primary safety end point : death from any cause 2) Secondary safety end point : death from - cardiovascular cause : AMI, stent thrombosis, CVA, etc. - non-cardiovascular cause

Results Baseline Characteristics Table 1 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

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

Figure 1 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

Figure 3 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

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