SESAMI Menichelli

 ( SESAMI Trial)  Maurizio MenichelliPresenter Disclosure Information Nothing to Disclose: 

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

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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 Cadillac:23,4 % PAMI :20,3% Registry :28% Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial)

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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 Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial)

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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% Power 90% Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial)

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

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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 Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial)

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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 Randomized trial of Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI Trial)

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

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

Multivariate Predictors of Binary Restenosis at One Year: 

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 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

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SESAMI Trial