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( SESAMI Trial) Maurizio Menichelli Presenter Disclosure Information Nothing to Disclose

Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction. ( SESAMI Trial) Maurizio Menichelli Presenter Disclosure Information Nothing to Disclose. Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial). PAMI :20,3%.

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( SESAMI Trial) Maurizio Menichelli Presenter Disclosure Information Nothing to Disclose

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  1. Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction ( SESAMI Trial) Maurizio MenichelliPresenter Disclosure Information Nothing to Disclose

  2. Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial) PAMI :20,3% Registry :28% Cadillac:23,4 % • Background and study rationale • Primary PCI :high restenosis rate • Drug eluting stent : one digit restenosis rate • Sirolimus eluting stent in myocardial infarction >> Costs, Rehospit, << QALYS

  3. Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial) • Study objective: • Improvement of the results of primary angioplasty by introducing a drug-eluting stent through restenosis rate reduction • Primary endpoint • One year angiographic restenosis • Secondary endpoints • One year TLR, TVR, MACE, TVF

  4. Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial) Power 90% • Statistical Analysis • Primary endpoint : Binary Restenosis • Sample Size and Power Calculation • Two-sided test for differences in independent binomial proportions at the 2.5 percent level of significance • Expected Restenosis • Bare-metal stent : 27% • SES : 7%

  5. Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial) 423patientswithacutemyocardialinfarction Primary or Rescue Angioplasty February 9th 2003 320 randomized to SESAMI Trial 103 patients Left Main, Grafts, Shock , No consent 160 SES 160 Bare-metal stent Excluded from Trial 86 pts , 12 months angiographic control 80 pts , 12 months angiographic control

  6. Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial) • Population Sirolimus Control P Value • Age(ys) 61,7 61,4 0,35 • Male sex ( % of patients) 81,6 81,2 0,36 • Diabetes mellitus ( % of patients) 17,5 23,7 0,13 • Hypertension ( % of patients) 53,3 59,1 0,20 • Current cigarette use (% of patients) 56,9 48,5 0,10 • Prior myocardial infarction (% of patients) 5,7 12,8 0,04 • Prior PTCA (% of patients) 9,1 10,2 0,38 • Primary coronary bypass (% of patients) 0,3 0,3 0,75 • Killip ≥ 2 (n.of patients) 8 9 0,38 • ST-segment elevation (% of patients) 99 99 0,5 • Primary PTCA (% of patients) 82,5 82,3 0,53 • Rescue PTCA (% of patients) 17,5 17,7 0,53 • Infarct-related vessel (% of patients) • Left anterior descending artery 46,6 52,5 0,29 • Left circumflex artery 13,3 12,7 0,54 • Right coronary artery 40,1 34,8 0,46 • Abciximab Emergency Room (% of patients) 14,6 21,5 0,25 • Abciximab Cath-Lab (% of patients) 61,4 52,4 0,32 • TIMI RISK SCORE (mean) 3,7 3,1 0,10

  7. Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial) • Results (320 Pts)Sirolimus Control P • Acute Procedural Success ( % of patients) 98,2 98,8 0,47 • TIMI III Pre_Procedural ( % of patients) • Primary Angioplasty 17,2 19,3 0,58 • TIMI III Post-Procedural ( % of patients) • Primary Angioplasty 93,8 96,2 0,35 • Stent length (mm) 20,8 18,2 0,02 • Stent size (mm) 3,02 3,14 0,01 • In Hospital Oucome • Death 0,6 2,5 0,21 • Death + MI 3,1 3,7 0,45

  8. Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial) RRR:64% * RRR:56% * *= P <0,05

  9. Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial) RRR:62% * RRR:59% * RRR:53% * RRR:61% * *= P <0,05

  10. Multivariate Predictors of Binary Restenosis at One Year Multiple Logistic RegressionCoefficient Standard Error OR P Value Female Sex 1,668 0,50 5,301 0,001 Treatment (Bare metal vs SES) 1,379 0,477 3,970 0,004 Number of Stents 0,960 0,357 2,613 0,007 Patient treated with SES Female Sex 1,739 0,804 5,689 0,030 TIMI post III -1,913 0,904 0,148 0,034

  11. SESAMI Trial

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