SESAMI: Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction
". . . the SESAMI results are encouraging and provide further proof of the safety of sirolimus-eluting stents in STEMI patients. Such findings are likely to add to the growing list of available indications for drug-eluting stents."
Presenter: Maurizio Menichelli, MD (San Camillo Hospital, Rome, Italy)
Background
Primary percutaneous coronary intervention (PCI) in the acute phase of myocardial infarction (MI) is the treatment of choice in patients presenting in the early hours of an ST-segment MI (STEMI). Lesions in these patients are considered to be at especially high risk for restenosis. Until now, bare-metal stents have been the treatment of choice for these lesions.
The Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI) trial was designed to assess the impact of the sirolimus-eluting stent on restenosis rates in STEMI patients undergoing primary PCI.
Study Design
SESAMI was an open label, 1:1 study that randomized patients to either sirolimus-eluting or bare-metal stent placement. Patients with left main lesions, graft lesions, or those who were in shock were excluded from the trial.
Primary Endpoint: Angiographic restenosis at 1 year
Secondary Endpoints
1-year rates of:
A total of 423 patients with acute MI were treated during the study period, of which 320 were evenly randomized to a study arm (n = 160 for each arm); 103 patients were excluded from the trial. Baseline clinical and procedural characteristics of randomized patients are shown in the Table.
Table. SESAMI: Baseline Clinical and Procedural Characteristics
LAD = left anterior descending artery; MI = myocardial infarction; PCI = percutaneous coronary intervention; S/P = status-post; TIMI = Thrombolysis in Myocardial Infarction
In-hospital outcomes were similar between the 2 groups (Figure 1). At 1-year angiographic follow-up, restenosis rates were significantly higher in patients treated with bare-metal stents (Figure 2). Overall, the use of a sirolimus-eluting stent was associated with a 56% reduction in binary restenosis and a 64% reduction in clinically driven restenosis relative to control.
Figure 1. SESAMI: In-hospital outcomes.
MI = myocardial infarction; SES = sirolimus-eluting stent
Figure 2. SESAMI: Angiographic 1-year follow-up.
RR = risk reduction; SES = sirolimus-eluting stent
Similarly, all other endpoints (TLR, TVR, MACE, and TVF) were significantly lower in patients treated with the sirolimus-eluting stent (Figure 3). Acute and subacute stent thrombosis rates were low in both the sirolimus and control groups (acute, 0.6% vs 0.6%; subacute, 3.1% vs 3.7%). Of interest, by multivariate logistic regression analysis, female sex and bare-metal stents were predictors of binary restenosis at 1 year (OR 5.3 and 3.8, respectively).
Figure 3. SESAMI: Clinical outcomes at 1-year follow-up.
MACE = major adverse cardiac events; RR = risk reduction; SES = sirolimus-eluting stent; TLR = target lesion revascularization; TVF = target vessel failure; TVR = target vessel revascularization Conclusion
The use of sirolimus-eluting stents in acute STEMI patients undergoing primary PCI is safe and is associated with significantly lower rates of restenosis when compared with bare-metal stents.
Viewpoint
Although SESAMI is a small, single-center study involving a limited number of patients, its results confirm those from larger trials recently presented at the American College of Cardiology meeting. Unfortunately, due to time constraints of the late-breaking trial session at the EuroPCR meeting, only succinct data were presented, leaving crucial information regarding the way these trials were performed outstanding. This significantly limits our ability to interpret these results on a general scale.
Nevertheless, the SESAMI results are encouraging and provide further proof of the safety of sirolimus-eluting stents in STEMI patients. Such findings are likely to add to the growing list of available indications for drug-eluting stents.
". . . the SESAMI results are encouraging and provide further proof of the safety of sirolimus-eluting stents in STEMI patients. Such findings are likely to add to the growing list of available indications for drug-eluting stents."
Presenter: Maurizio Menichelli, MD (San Camillo Hospital, Rome, Italy)
Background
Primary percutaneous coronary intervention (PCI) in the acute phase of myocardial infarction (MI) is the treatment of choice in patients presenting in the early hours of an ST-segment MI (STEMI). Lesions in these patients are considered to be at especially high risk for restenosis. Until now, bare-metal stents have been the treatment of choice for these lesions.
The Sirolimus Stent vs Bare Stent in Acute Myocardial Infarction (SESAMI) trial was designed to assess the impact of the sirolimus-eluting stent on restenosis rates in STEMI patients undergoing primary PCI.
Study Design
SESAMI was an open label, 1:1 study that randomized patients to either sirolimus-eluting or bare-metal stent placement. Patients with left main lesions, graft lesions, or those who were in shock were excluded from the trial.
Primary Endpoint: Angiographic restenosis at 1 year
Secondary Endpoints
1-year rates of:
Target lesion revascularization (TLR)
Target vessel revascularization (TVR)
Major adverse cardiac events (MACE)
Target vessel failure (TVF)
A total of 423 patients with acute MI were treated during the study period, of which 320 were evenly randomized to a study arm (n = 160 for each arm); 103 patients were excluded from the trial. Baseline clinical and procedural characteristics of randomized patients are shown in the Table.
Table. SESAMI: Baseline Clinical and Procedural Characteristics
| Sirolimus (n = 160) |
Control (n = 160) |
P | |
|---|---|---|---|
| Clinical Characteristics | |||
| Age (yrs) | 62 | 61 | .35 |
| Female (%) | 18 | 19 | .36 |
| Diabetes (%) | 18 | 24 | .13 |
| Hypertension (%) | 53 | 59 | .2 |
| Smokers (%) | 57 | 49 | .1 |
| S/P MI (%) | 6 | 13 | .04 |
| S/P PCI (%) | 9 | 10 | .38 |
| Killip class ≥ 2 (%) | 8 | 9 | .38 |
| Rescue PCI (%) | 18 | 18 | .53 |
| Infarct-related artery LAD (%) | 47 | 53 | .29 |
| Procedural Outcomes | |||
| Acute success (%) | 98.2 | 98.8 | .47 |
| TIMI 3 Preprocedural (%) | 17 | 19 | .58 |
| TIMI 3 Postprocedural (%) | 93.8 | 96.2 | .35 |
| Stent length (mm) | 20.8 | 18.2 | .02 |
| Stent size (mm) | 3.02 | 3.14 | .01 |
In-hospital outcomes were similar between the 2 groups (Figure 1). At 1-year angiographic follow-up, restenosis rates were significantly higher in patients treated with bare-metal stents (Figure 2). Overall, the use of a sirolimus-eluting stent was associated with a 56% reduction in binary restenosis and a 64% reduction in clinically driven restenosis relative to control.
MI = myocardial infarction; SES = sirolimus-eluting stent
RR = risk reduction; SES = sirolimus-eluting stent
Similarly, all other endpoints (TLR, TVR, MACE, and TVF) were significantly lower in patients treated with the sirolimus-eluting stent (Figure 3). Acute and subacute stent thrombosis rates were low in both the sirolimus and control groups (acute, 0.6% vs 0.6%; subacute, 3.1% vs 3.7%). Of interest, by multivariate logistic regression analysis, female sex and bare-metal stents were predictors of binary restenosis at 1 year (OR 5.3 and 3.8, respectively).
MACE = major adverse cardiac events; RR = risk reduction; SES = sirolimus-eluting stent; TLR = target lesion revascularization; TVF = target vessel failure; TVR = target vessel revascularization Conclusion
The use of sirolimus-eluting stents in acute STEMI patients undergoing primary PCI is safe and is associated with significantly lower rates of restenosis when compared with bare-metal stents.
Viewpoint
Although SESAMI is a small, single-center study involving a limited number of patients, its results confirm those from larger trials recently presented at the American College of Cardiology meeting. Unfortunately, due to time constraints of the late-breaking trial session at the EuroPCR meeting, only succinct data were presented, leaving crucial information regarding the way these trials were performed outstanding. This significantly limits our ability to interpret these results on a general scale.
Nevertheless, the SESAMI results are encouraging and provide further proof of the safety of sirolimus-eluting stents in STEMI patients. Such findings are likely to add to the growing list of available indications for drug-eluting stents.
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