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M. Valgimigli University of Ferrara Italy MultiStrategy Study design MultiStrategy Study design.

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Presentation on theme: "M. Valgimigli University of Ferrara Italy MultiStrategy Study design MultiStrategy Study design."— Presentation transcript:

1 M. Valgimigli University of Ferrara Italy MultiStrategy Study design MultiStrategy Study design

2 Background Primary angioplasty is the current preferred therapeutic option for patients with ST- segment elevation myocardial infarction (STEMI). Routine coronary stent implantation in patients with STEMI decreases the need for target vessel revascularization (TVR). Grines CL, et al. N Engl J Med 1999; 341: 1949 Stone G, et al. N Engl J Med 2002; 346: 957

3 STEMI: Stent and Mortality

4 STEMI: Stent and Reintervention 30 days 6 months

5 What about external validity? In some of these trials randomization occurred after angiography before PCI In some of these studies randomization occurred after balloon angioplasty In none of these studies patients were recruited without prior knowledge of coronary anatomy Mostly excluded patients: Shock Shock Diffusely diseased or small coronary vessel Diffusely diseased or small coronary vessel Large thrombus burden Large thrombus burden Severe coronary calcification or tortuosity Severe coronary calcification or tortuosity Bifurcated lesions Bifurcated lesions Ideal or good stent candidates

6 Participants: All Patients with STEMI randomly assigned to stenting or balloon Angioplasty. No exclusion criteria were applied. Death or Reinfarction TVR (%) RR 0.98 (95%CI: ) N=1683 Heart 2005;91:641– Stent Balloon

7 Lessons from the BMS Era BMS in the setting of STEMI is far from being the perfect solution for restenosis and TVR may remain high New devices are needed which have to be tested in unselected (no angiographic selection bias) patient population

8 GP IIb/IIIa inhibitors The word to the …Guidelines Primary PCI: Class IIA indication Class IIA indication Class IIA indication with Stent Class IIA indication with Stent Class I indication without Stent Class I indication without Stent Class IIB for tirofiban and eptifibatide Class IIB for tirofiban and eptifibatide AbciximabAbciximab

9 STEMI UFH - ASA Clopidogrel Tirofiban SHDB Abciximab stand. regimen Cypher BMS CCU Cath-Lab Valgimigli et al. Cardiovasc Drugs Ther 04; 18: Study design Inclusion Criteria: STEMI all comers: shock, elderly included Exclusion Criteria: Contraindications to Gp IIb/IIIa Inclusion Criteria: STEMI all comers: shock, elderly included Exclusion Criteria: Contraindications to Gp IIb/IIIa

10 175 Randomized SHDB Tirofiban (n=87) Abciximab (n=88) 3 No PCI 1:1 219 Assessed for Eligibility 44 Excluded 34 Not Meeting Inclusion Criteria 10 Refused to Participate 3 POBA 74 SES7 BMS 84 PTCA Clinical Follow-up Angiographic Follow-up Pts not eligible Refused to participate 4 POBA 77 BMS2 SES 83 PTCA 5 No PCI Study Profile Valgimigli et al. JAMA 2005; 293: % 88% 77% 75%

11 30-Day Outcome n=175 P=0.33 P>0.99P=0.62 P=>0.99 % Abciximab+BMS Tirofiban+SES Valgimigli et al. JAMA 2005; 293:

12 Death/MI at 8 Months JAMA 2005; 293: p=0.4 HR 0.71 [95% CI: ]

13 Death/MI/TVR at 8 Months HR 0.53 [95% CI: ] p=0.043 JAMA 2005; 293:

14 8-Month Outcome n=175 P=0.043 P=0.8P=0.6 P=0.01 P>0.99 P=0.004 P=0.005 MACEDeathMITVRCVA1° EndPointBR % Abciximab+BMS Tirofiban+SES 50% 19% Valgimigli et al. JAMA 2005; 293:

15 STEMI All Comers Patients Aspirin + Clopidogrel + UFH Intent-to-stent Intent-to-stent N ~ 730 TirofibanTirofibanAbciximabAbciximab SESSESBMSBMS MULTI-STRATEGY Trial Design SESSESBMSBMS Università degli Studi di Ferrara - Cattedra di Cardiologia 1:1 Valgimigli M. et al Am Heart J Jul;154(1):39-45.

16 MULTI-STRATEGY 1. Whether tirofiban administered at high bolus dose is non inferior to abciximab on the degree of cumulative ST-segment resolution, expressed as the proportion of patients reaching ≥ 50% recovery, at 90’ after the mechanical intervention. 1. Whether tirofiban administered at high bolus dose is non inferior to abciximab on the degree of cumulative ST-segment resolution, expressed as the proportion of patients reaching ≥ 50% recovery, at 90’ after the mechanical intervention. 2. Whether SES implantation –based on the intention-to- treat principle– is superior to BMS on the incidence of major adverse cardiovascular events (MACE) within 8 months, defined as the composite of death, nonfatal myocardial infarction and clinically-driven target vessel revascularization (TVR). 2. Whether SES implantation –based on the intention-to- treat principle– is superior to BMS on the incidence of major adverse cardiovascular events (MACE) within 8 months, defined as the composite of death, nonfatal myocardial infarction and clinically-driven target vessel revascularization (TVR). Primary objectives Università degli Studi di Ferrara - Cattedra di Cardiologia Valgimigli M. et al Am Heart J Jul;154(1):39-45.

17 The effect of tirofiban infusion or SES implantation on the MACE either singularly considered or as a composite and on the incidence of stent thrombosis. The effect of tirofiban infusion or SES implantation on the MACE either singularly considered or as a composite and on the incidence of stent thrombosis. The effect of tirofiban on the rate of TIMI 3 flow before and after intervention and on partial (≥50%) or complete (≥70%) cumulative ST segment resolution or in the single lead with greatest ST changes. The effect of tirofiban on the rate of TIMI 3 flow before and after intervention and on partial (≥50%) or complete (≥70%) cumulative ST segment resolution or in the single lead with greatest ST changes. The effect of SES implantation on the rate of major cardiovascular events either singularly considered or as a composite after thienopyridines discontinuation The effect of SES implantation on the rate of major cardiovascular events either singularly considered or as a composite after thienopyridines discontinuation The cost-effectiveness profile in STEMI of SES implantation or tirofiban infusion The cost-effectiveness profile in STEMI of SES implantation or tirofiban infusion The effect of tirofiban on the rate of bleeding and thrombocytopenia The effect of tirofiban on the rate of bleeding and thrombocytopenia MULTI-STRATEGY Major Secondary objectives

18 MULTI-STRATEGY 16 Participating centers MULTI-STRATEGY 16 Participating centers Università degli Studi di Ferrara - Cattedra di Cardiologia Ferrara, M.Valgimigli Valle Oppio, GF Percoco Arezzo. L. Bolognese Verona, M. Anselmi Bergamo, N. De Cesare Mirano, GP Pasquetto Pavia, E. Bramucci Ancona, R. Piva Torino, I. Sheiban Torino, S. Colangelo Roma, F. Prati Roma, R. Violini Italy Argentina Spain Buenos Aires, A. Rodriguez Otamendi Hospital Madrid, R. Moreno Huelva, José Díaz Valgimigli M. et al Am Heart J Jul;154(1):39-45.

19 STEMI All Comers Patients Aspirin + Clopidogrel + UFH Intent-to-stent Intent-to-stent N ~ 730 TirofibanTirofibanAbciximabAbciximab SESSESBMSBMS MULTI-STRATEGY Trial Design SESSESBMSBMS Università degli Studi di Ferrara - Cattedra di Cardiologia 1:1 ACC 2008 Valgimigli M. et al Am Heart J Jul;154(1):39-45.


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