Sirolimus Stent vs. Bare Stent in Acute Myocardial Sirolimus Stent vs. Bare Stent in Acute Myocardial Infarction TrialInfarction Trial

Sirolimus Stent vs. Bare Stent in Acute Myocardial Sirolimus Stent vs. Bare Stent in Acute Myocardial Infarction TrialInfarction Trial

Presented atPresented atThe EuroPCR meeting The EuroPCR meeting Paris, France May 2006Paris, France May 2006

Presented by Dr. Maurizio MenichelliPresented by Dr. Maurizio Menichelli

SESAMI TrialSESAMI TrialSESAMI TrialSESAMI Trial

www. Clinical trial results.org

SESAMI Trial: BackgroundSESAMI Trial: BackgroundSESAMI Trial: BackgroundSESAMI Trial: Background

• The goal of the trial was to evaluate primary/rescue The goal of the trial was to evaluate primary/rescue percutaneous coronary intervention (PCI) using a percutaneous coronary intervention (PCI) using a sirolimus-eluting stent compared with a bare metal sirolimus-eluting stent compared with a bare metal stent among patients with acute myocardial stent among patients with acute myocardial infarction.infarction.

• The goal of the trial was to evaluate primary/rescue The goal of the trial was to evaluate primary/rescue percutaneous coronary intervention (PCI) using a percutaneous coronary intervention (PCI) using a sirolimus-eluting stent compared with a bare metal sirolimus-eluting stent compared with a bare metal stent among patients with acute myocardial stent among patients with acute myocardial infarction.infarction.

Presented at EuroPCR May 2006Presented at EuroPCR May 2006

www. Clinical trial results.org

SESAMI Trial: Study DesignSESAMI Trial: Study DesignSESAMI Trial: Study DesignSESAMI Trial: Study Design

Primary Endpoint: Angiographic binary restenosis at one year Primary Endpoint: Angiographic binary restenosis at one year Secondary Endpoint: One year target lesion revascularization (TLR), target Secondary Endpoint: One year target lesion revascularization (TLR), target

vessel revascularization (TVR), target lesion vessel failure (TVF) and major vessel revascularization (TVR), target lesion vessel failure (TVF) and major adverse cardiac events (MACE)adverse cardiac events (MACE)

Primary Endpoint: Angiographic binary restenosis at one year Primary Endpoint: Angiographic binary restenosis at one year Secondary Endpoint: One year target lesion revascularization (TLR), target Secondary Endpoint: One year target lesion revascularization (TLR), target

vessel revascularization (TVR), target lesion vessel failure (TVF) and major vessel revascularization (TVR), target lesion vessel failure (TVF) and major adverse cardiac events (MACE)adverse cardiac events (MACE)

Primary or rescue angioplasty with sirolimus-eluting stent

n=160

Primary or rescue angioplasty with sirolimus-eluting stent

n=160

Primary or rescue angioplasty with bare metal stent

n=160

Primary or rescue angioplasty with bare metal stent

n=160

320 patients with acute myocardial infarction to be treated with primary or rescue angioplasty without left main disease, saphenous vein grafts, and cardiogenic shock.

Randomized.19% female, mean age 61 years, follow-up 1 year

320 patients with acute myocardial infarction to be treated with primary or rescue angioplasty without left main disease, saphenous vein grafts, and cardiogenic shock.

Randomized.19% female, mean age 61 years, follow-up 1 year

One year angiographic follow up

n=166

One year angiographic follow up

n=166

Presented at EuroPCR May 2006Presented at EuroPCR May 2006

www. Clinical trial results.org

SESAMI Trial: Baseline CharacteristicsSESAMI Trial: Baseline CharacteristicsSESAMI Trial: Baseline CharacteristicsSESAMI Trial: Baseline Characteristics

•Baseline characteristics were balanced between Baseline characteristics were balanced between groups, with primary PCI performed in 82% of groups, with primary PCI performed in 82% of patients and rescue PCI in 18% of patients. patients and rescue PCI in 18% of patients.

•In approximately half of the patients, the infarct–In approximately half of the patients, the infarct–related artery was the left anterior descending artery.related artery was the left anterior descending artery.

•In the majority of patients, Abciximab was used in In the majority of patients, Abciximab was used in either the emergency room or the cath lab. either the emergency room or the cath lab.

•Post-procedural TIMI grade 3 flow was present in Post-procedural TIMI grade 3 flow was present in 95% of patients.95% of patients.

Presented at EuroPCR May 2006Presented at EuroPCR May 2006

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SESAMI Trial: Primary EndpointSESAMI Trial: Primary EndpointSESAMI Trial: Primary EndpointSESAMI Trial: Primary Endpoint

• The primary endpoint of The primary endpoint of one year binary one year binary restenosis on restenosis on angiography occurred angiography occurred less often in the less often in the sirolimus-eluting stent sirolimus-eluting stent group vs. the bare group vs. the bare metal stent group (9.3% metal stent group (9.3% vs. 21.3%, relative risk vs. 21.3%, relative risk reduction [RRR] 56%, reduction [RRR] 56%, p<0.05).p<0.05).

• Likewise, clinically Likewise, clinically driven restenosis was driven restenosis was also lower in the also lower in the sirolimus-eluting stent sirolimus-eluting stent group (5.6% vs. 17.2%, group (5.6% vs. 17.2%, RRR 64%, p<0.05).RRR 64%, p<0.05).

One year binary restenosisOne year binary restenosisp<0.05p<0.05

9.3%

21.3%

0%

10%

20%

SirolimusStent

Bare metalstent

9.3%

21.3%

0%

10%

20%

SirolimusStent

Bare metalstent

Presented at EuroPCR May 2006Presented at EuroPCR May 2006

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www. Clinical trial results.org

SESAMI Trial: Secondary EndpointsSESAMI Trial: Secondary EndpointsSESAMI Trial: Secondary EndpointsSESAMI Trial: Secondary Endpoints

• Among the secondary Among the secondary endpoints, the endpoints, the sirolimus-eluting stent sirolimus-eluting stent group had lower rates group had lower rates of TLR (4.3% vs. of TLR (4.3% vs. 11.2%), TVR (5% vs. 11.2%), TVR (5% vs. 13.1%), MACE (6.8% 13.1%), MACE (6.8% vs. 16.8%) and TVF vs. 16.8%) and TVF 8.7% vs. 18.7).8.7% vs. 18.7).

• There was no There was no difference in acute difference in acute thrombosis (0.6%), or thrombosis (0.6%), or acute + subacute acute + subacute thrombosis (3.1% vs. thrombosis (3.1% vs. 3.7%).3.7%).

4.3%5.0%

6.8%

8.7%

11.2%

13.1%

16.8%

18.7%

0%

4%

8%

12%

16%

20%

TLR TVR MACE TVFSirolimus Stent Bare metal stent

4.3%5.0%

6.8%

8.7%

11.2%

13.1%

16.8%

18.7%

0%

4%

8%

12%

16%

20%

TLR TVR MACE TVFSirolimus Stent Bare metal stent

Secondary EndpointsSecondary Endpoints(all p<0.05)(all p<0.05)

Presented at EuroPCR May 2006Presented at EuroPCR May 2006

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ate

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SESAMI Trial: SummarySESAMI Trial: SummarySESAMI Trial: SummarySESAMI Trial: Summary

• Among patients with acute myocardial infarction undergoing primary Among patients with acute myocardial infarction undergoing primary or rescue PCI, use of sirolimus-eluting stent was associated with a or rescue PCI, use of sirolimus-eluting stent was associated with a reduction in binary restenosis at one year compared with use of a reduction in binary restenosis at one year compared with use of a bare metal stent. bare metal stent.

• Results of the present single center trial are similar to those seen in Results of the present single center trial are similar to those seen in the multi-center TYPHOON trial, which showed a reduction in target the multi-center TYPHOON trial, which showed a reduction in target vessel failure at one year with sirolimus-eluting stents compared with vessel failure at one year with sirolimus-eluting stents compared with bare metal stents in PCI for acute MI, driven primarily by a reduction bare metal stents in PCI for acute MI, driven primarily by a reduction in TLR. in TLR.

• The PASSION trial, however, did not demonstrate a reduction in TLR The PASSION trial, however, did not demonstrate a reduction in TLR with paclitaxel-eluting stents over bare metal stents among STEMI with paclitaxel-eluting stents over bare metal stents among STEMI patients. patients.

• A cost-effectiveness analysis from the present trial is underwayA cost-effectiveness analysis from the present trial is underway ..

• Among patients with acute myocardial infarction undergoing primary Among patients with acute myocardial infarction undergoing primary or rescue PCI, use of sirolimus-eluting stent was associated with a or rescue PCI, use of sirolimus-eluting stent was associated with a reduction in binary restenosis at one year compared with use of a reduction in binary restenosis at one year compared with use of a bare metal stent. bare metal stent.

• Results of the present single center trial are similar to those seen in Results of the present single center trial are similar to those seen in the multi-center TYPHOON trial, which showed a reduction in target the multi-center TYPHOON trial, which showed a reduction in target vessel failure at one year with sirolimus-eluting stents compared with vessel failure at one year with sirolimus-eluting stents compared with bare metal stents in PCI for acute MI, driven primarily by a reduction bare metal stents in PCI for acute MI, driven primarily by a reduction in TLR. in TLR.

• The PASSION trial, however, did not demonstrate a reduction in TLR The PASSION trial, however, did not demonstrate a reduction in TLR with paclitaxel-eluting stents over bare metal stents among STEMI with paclitaxel-eluting stents over bare metal stents among STEMI patients. patients.

• A cost-effectiveness analysis from the present trial is underwayA cost-effectiveness analysis from the present trial is underway ..Presented at EuroPCR May 2006Presented at EuroPCR May 2006