1. Maintenance of Long-Term Clinical Benefit with
Sirolimus-Eluting Stents in Patients with ST-Segment
Elevation Myocardial Infarction: Three-year results
of the SESAMI Trial
Musto C, Fiorilli R, De Felice F, Nazzaro MS, Cifarelli A, Violini R
Interventional Cardiology Department, San Camillo Hospital, Rome

2. Presenter Disclosure Information Name: Carmine Musto
Maintenance of Long-Term Clinical Benefit with
Sirolimus-Eluting Stents in Patients with ST-Segment
Elevation Myocardial Infarction: Three-year results
of the SESAMI Trial
Presenter Disclosure Information
Name: Carmine Musto
Nothing to Disclose

3. INTRODUCTION
Primary PCI has become the treatment of choice in patients presenting with STEMI
The incidence of BMS re-stenosis in the STEMI patients remains high leading to rehospitalization and increased costs
DES implantation reduces neo-intimal proliferation with better short- and long-term clinical and angiographic results compared to BMS

4. DES in AMI: 1-year TVR %
p= p< p< p= p<0.01 20
13.1
13.4
13.2
7.8 7
5.3
5.6 5
5.1

5. DES in AMI:1-year stent thrombosis
Kastrati A et al. Eur Heart J 2007;28:

6. INTRODUCTION The use of DES in AMI remains controversial
Randomized data on safety and clinical benefit of DES have usually been limited to ≤ 2 years
Data from registries have provided mixed results with respect to the long-term safety of DES in the setting of AMI
Long-term follow-up data from randomized trials on the use of DES in AMI are mandatory

7. AIM
To define whether the favourable effect on clinical outcome, observed in the SESAMI trial (Sirolimus Eluting-Stent in Acute Myocardial Infarction) persisted at 3 years’ follow-up

8. SESAMI TRIAL PROTOCOL 423 Elegible patients with STEMI
Patients excluded: 103
LM disease: 3
Graft disease: 15
Cardiogenic shock: 32
No consent: 19
Primary or Rescue Angioplasty
Randomized Patients:320
Allocated to SES: 160
Allocated to BMS: 160
86 pts, 12 months
angiographic f-u
80 pts, 12 months
angiographic f-u
Menichelli M et al. J Am Coll Cardiol 2007;49:

9. METHODS Inclusion criteria: Exclusion criteria: > 18 years
Symptoms of acute MI for ≥ 30 min but ≤ 12 h
≥ 1 mm ST-segment elevation in at least 2 contiguous leads or LBBB
Exclusion criteria:
Cardiogenic shock
History of bleeding diathesis, leukopenia, thrombocytopenia, severe renal or hepatic dysfunction
Non-cardiac disorder associated with a life expectancy of <1 year
LM or graft disease
Involved in another study or unable to give informed consent

10. METHODS Study end-points Primary end-point Secondary end-points
3-year MACE
3-year TLR
3-year TVR
3-year TVF
MACE: composite of cardiac and non-cardiac death, Q-wave and non-Q-wave MI, TLR
TLR: repeated PCI or CABG of the target lesion driven by symptoms of ischemia, positive stress test due to the target vessel or in-stent restenosis >70%
TVR: repeated revascularization within the treated vessel
TVF: combination of TVR, recurrent MI or target vessel-related death

11. RESULTS Baseline characteristics of SES and BMS groups
N. patients
Age, years (mean, range) (54-70) (52-72)
Male gender, n. (%) (80) (80)
Diabetes mellitus, n. (%) (17.5) (23.7)
Hypertension, n. (%) (54.3) (58.7)
Hyperlipidemia, n. (%) (62.5) (65%)
Smoker, n. (%) (56.8) (51.7)
Prior myocardial infarction, n. (%) (5.6) (12.5)
Prior PCI, n. (%) (9.4) (10.6%)
Time from symptom onset to PCI (h)
(mean, range) (3-7) (3-6)
Rescue PCI, n. (%) (17.5) (18.2)
TIMI risk score (mean)
*DAT (days±SD) † ± ± NS
SES BMS p
* Dual anti-platelet therapy

12. RESULTS Procedural characteristics of SES and BMS groups
SES group BMS group p
Abciximab therapy (%) (77.5) (74%) NS
Infarct-related vessel (%):
LAD Cx
RCA
TIMI III pre-procedural (%)
TIMI III post-procedural (%)
Stent length (mm±SD) ± ±
Stent diameter (mm±SD) ± ±

13. 1-year angiographic follow-up
p< p<0.05 %
21.3
17.2
9.3
5.6
Menichelli M et al. J Am Coll Cardiol 2007;49:

14. CLINICAL OUTCOME: 1-year follow-up%
p<0.005
p<0.02
p<0.015
p<0.007
18.7
16.8
13.1
11.2
8.7
6.8 5
4.3
Menichelli M et al. J Am Coll Cardiol 2007;49:

15. CLINICAL OUTCOME: 3-year follow-up% 21
20.5 16
12.7
13.5
11.5
p=NS
8.3 7 5
3.2
Complete SES group F-U: 98%
Complete BMS group F-U: 97.5%

16. Actuarial rate of survival free from MACE
1.00
87%
p<0.05
79%
0.75
MACE-free survival (%)
0.50
0.25
0.00 6 12 18 24 30 36
Months
BMS
SES

17. Actuarial rate of survival free from TLR
1.00
93%
p<0.05
86.5%
0.75
TLR-free survival (%)
0.50
0.25
0.00 6 12 18 24 30 36
Months
BMS
SES 17

18. Actuarial rate of survival free from TVF
1.00
89.5%
p<0.05
79.5%
0.75
TVF Free Survival (%)
0.50
0.25
0.00 6 12 18 24 30 36
Months
BMS
SES 18

19. Stent Thrombosis
p=NS
p=NS
1.9 %
1.3
0.8
0.7

20. Clinical events during 12 to 36 months’ follow-up
SES group BMS group p
N. patients
Death, n. (%) (95% C.I.) (1.4) (0.1-4) (0.8) ( ) NS
Re-infarction, n. (%) (95% C.I.) (0.7) (0.01-3) (0.8) ( ) NS
Stent thrombosis n. (%) (95% C.I.):
Definite (0.7) (0.01-3) (0.8) ( ) NS
Probable/possible NS
MACE, n. (%) (95% C.I.) (4.8) (1.9-9) (3.9) ( ) NS
TLR, n. (%) (95% C.I.) (2.7) ( ) (2.3) ( ) NS
TVR, n. (%) (95% C.I.) (4.1) ( ) (5.5) (2.2-11) NS
TVF, n. (%) (95% C.I.) (4.8) ( ) (6.3) (2.7-12) NS
Death/ re-MI, n. (%) (95% C.I.) (2) ( ) (1.5) ( ) NS

21. LIMITS Small, single center study designed to compare the
efficacy of the SES vs BMS in the STEMI setting
Not powered to demonstrate significant differences in terms of
death, re-MI or ST

22. Conclusions The SESAMI trial demonstrated that:
The cumulative incidence of MACE, TLR, TVR and TVF remains lower
in the SES group compared to the BMS group at 3-year clinical follow-up
The better results in the SES group are due primarily to the different rate
of TLR
No significant differences in terms of death, re-MI or ST were found with
1-year dual anti-platelet therapy
No increased risk of adverse events was found following withdrawal of
dual anti-platelet therapy