Randomized trial of Sirolimus Stent vs Bare Stent

Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction ( SESAMI Trial) Maurizio Menichelli Presenter Disclosure Information Nothing to Disclose Maurizio Menichelli MD San Camillo Hospital, Rome

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 >> Costs, Rehospit, << QALYS Drug eluting stent : one digit restenosis rate Sirolimus eluting stent in myocardial infarction Maurizio Menichelli MD San Camillo Hospital, Rome

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 Maurizio Menichelli MD San Camillo Hospital, Rome

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% Maurizio Menichelli MD San Camillo Hospital, Rome

Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial) 423 patients with acute myocardial infarction February 9 th 2003 Primary or Rescue Angioplasty 320 randomized to SESAMI Trial 160 SES 86 pts , 12 months angiographic control 160 Bare-metal stent 103 patients Left Main, Grafts, Shock , No consent Excluded from Trial 80 pts , 12 months angiographic control Maurizio Menichelli MD San Camillo Hospital, Rome

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

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

Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial) RRR: 56% * RRR: 64% * *= P <0, 05 Maurizio Menichelli MD San Camillo Hospital, Rome

Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial) RRR: 62% * RRR: 61% * RRR: 59% * RRR: 53% * *= P <0, 05 Maurizio Menichelli MD San Camillo Hospital, Rome

Multivariate Predictors of Binary Restenosis at One Year Multiple Logistic Regression Coefficient Standard Error OR P Value Female Sex 1, 668 0, 50 5, 301 0, 001 (Bare metal vs SES) 1, 379 0, 477 3, 970 0, 004 Number of Stents 0, 960 0, 357 2, 613 0, 007 Treatment 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 Maurizio Menichelli MD San Camillo Hospital, Rome

SESAMI Trial Maurizio Menichelli MD San Camillo Hospital, Rome