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Maintenance of Long-Term Clinical Benefit with

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

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Maintenance of Long-Term Clinical Benefit with

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  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. 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=0.006 p<0.001 p< 0.015 p= 0.23 p<0.01 20 13.1 13.4 13.2 7.8 7 5.3 5.1 5.6 5

  5. DES in AMI:1-year stent thrombosis Kastrati A et al. Eur Heart J 2007;28:2706-13

  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. 423 Elegible patients with STEMI Randomized Patients:320 SESAMI TRIAL PROTOCOL • Patients excluded: 103 • LM disease: 3 • Graft disease: 15 • Cardiogenic shock: 32 • No consent: 19 Primary or Rescue Angioplasty 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;49:1924-30

  9. METHODS Inclusion 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 TLR 3-year TVR 3-year TVF 3-year MACE 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 160 160 Age, years (mean, range) 63 (54-70) 62 (52-72) 0.81 Male gender, n. (%) 128 (80) 128 (80) Diabetes mellitus, n. (%) 28 (17.5) 37 (23.7) 0.13 Hypertension, n. (%) 87 (54.3) 98 (58.7) 0.20 Hyperlipidemia, n. (%) 123 (62.5) 105 (65%) 0.12 Smoker, n. (%) 91 (56.8) 83 (51.7) 0.1 Prior myocardial infarction, n. (%) 9 (5.6) 20 (12.5) 0.047 Prior PCI, n. (%) 15 (9.4) 17 (10.6%) 0.38 Time from symptom onset to PCI (h) (mean, range) 4 (3-7) 4 (3-6) 0.64 Rescue PCI, n. (%) 28 (17.5) 29 (18.2) 0.54 TIMI risk score (mean) 3.7 3.1 0.10 *DAT (days±SD) † 375±12 369±35 NS SES BMS p * Dual anti-platelet therapy

  12. RESULTS Procedural characteristics of SES and BMS groups Abciximab therapy (%) 124 (77.5) 118 (74%) NS Infarct-related vessel (%): LAD 46.6 52.5 0.29 Cx 13.3 12.7 0.54 RCA 40.1 34.8 0.46 TIMI III pre-procedural (%) 17.2 19.3 0.58 TIMI III post-procedural (%) 93.8 96.2 0.35 Stent length (mm±SD) 19.4±4.8 16.9±4.1 0.001 Stent diameter (mm±SD) 3.02±0.28 3.14±0.034 0.001 SES group BMS group p

  13. 1-year angiographic follow-up p<0.05 p<0.05 % 21.3 17.2 9.3 5.6 Menichelli M et al. J Am Coll Cardiol 2007;49:1924-30

  14. CLINICAL OUTCOME: 1-year follow-up % p<0.005 p<0.02 p<0.007 p<0.015 18.7 16.8 13.1 11.2 8.7 6.8 5 4.3 Menichelli M et al. J Am Coll Cardiol 2007;49:1924-30

  15. CLINICAL OUTCOME: 3-year follow-up p<0.027 p<0.028 p<0.034 p<0.048 % 21 20.5 16 13.5 12.7 11.5 p=NS 8.3 7 5 3.2 2.5 2.5 1.9 1.3 Complete SES group F-U: 98% Complete BMS group F-U: 97.5%

  16. BMS SES 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 0 6 12 18 24 30 36 Months

  17. BMS SES 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 0 6 12 18 24 30 36 Months

  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 0 6 12 18 24 30 36 Months BMS SES

  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 144 127 Death, n. (%) (95% C.I.) 2 (1.4) (0.1-4) 1 (0.8) (0.01-4.3) NS Re-infarction, n. (%) (95% C.I.) 1 (0.7) (0.01-3) 1 (0.8) (0.01-4.3) NS Stent thrombosis n. (%) (95% C.I.): Definite 1 (0.7) (0.01-3) 1 (0.8) (0.01-4.3) NS Probable/possible 0 0 NS MACE, n. (%) (95% C.I.) 7 (4.8) (1.9-9) 5 (3.9) (1.2-8.9) NS TLR, n. (%) (95% C.I.) 4 (2.7) (0.7-6.9) 3 (2.3) (0.4-6.7) NS TVR, n. (%) (95% C.I.) 6 (4.1) (1.5-8.8) 7 (5.5) (2.2-11) NS TVF, n. (%) (95% C.I.) 7 (4.8) (1.9-9.7) 8 (6.3) (2.7-12) NS Death/ re-MI, n. (%) (95% C.I.) 3 (2) (0.4-5.9) 2 (1.5) (0.1-5.5) 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

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