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The FINESSE Trial: Results of the Formal Low Molecular Weight Heparin Substudy Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events.

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Presentation on theme: "The FINESSE Trial: Results of the Formal Low Molecular Weight Heparin Substudy Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events."— Presentation transcript:

1 The FINESSE Trial: Results of the Formal Low Molecular Weight Heparin Substudy Facilitated INtervention with Enhanced Reperfusion Speed to Stop Events Gilles Montalescot, MD, PhD for the FINESSE Investigators TCT Washington, DC 2007

2 Study Organization Steering Committee –Stephen Ellis, PI –Eric Topol, Co-PI –Paul Armstrong –Amadeo Betriu –Bruce Brodie –Howard Herrmann –Gilles Montalescot –Franz Neumann –Elliot Barnathan –Mark Effron Clinical Events Committee –Cleveland Clinic ECG Core Lab –Mayo Clinic Executive Committee –Eric Topol, Chair –Howard Herrmann –Franz Neumann –Lawrence Deckelbaum –Mark Effron Safety Monitoring Committee –David Holmes, Chair –Robert Harrington –Merril Knudtson –Kerry Lee –Harvey White

3 Elective PCI: STEEPLE Drug Dose Monitoring n = 3,528 Primary objective: non-CABG bleeding at 48 hours ACT IV UFHIV enoxaparin 70 – 100 IU/kg 50 – 70 IU/kg 0.75 mg/kg0.50 mg/kg Stratified by GP IIb/IIIa inhibitor use PCI Montalescot G, et al. N Engl J Med. 2006;355: W/o GP IIb/IIIa inhibitor W/ GP IIb/IIIa inhibitor

4 Non-CABG-Related Bleeding: 1° Endpoint P = 0.01 P = P = P = % Montalescot G, et al. N Engl J Med. 2006;355:

5 Individual Ischaemic Endpoints at 30 Days Non-fatal MI DeathUTVR Enoxaparin 0.5 mg/kgEnoxaparin 0.75 mg/kg UFH P = all NS DaysDaysDays Montalescot G, et al. N Engl J Med. 2006;355:

6 Meta-Analysis, IV LMWH in PCI (n = 7,318, 13 Studies) LMWH better UFH better Major bleeding DeathMI Death or MI Composite efficacy 0123 P = Dumaine R, et al. Arch Int Med (in press).

7 LMWH in Primary PCI No randomized data (against UFH) Registry data ExTRACT-PCI data in STEMI FINESSE: largest experience in primary PCI

8 Objectives Primary –Evaluate the safety of enoxaparin 0.5mg/kg IV (+ 0.3mg/kg SC) vs. UFH 40U/kg (max 3000U) in Primary PCI with in lab abciximab –Compare the safety of LMWH to UFH in facilitated PCI with both abciximab and reteplase and with abciximab alone Secondary –Compare LMWH to UFH within similar treatment strategies with respect to efficacy

9 Objectives Primary PCI with in lab Abciximab R Abciximab Facilitated Primary PCI Reteplase/Abciximab Facilitated Primary PCI Heparin (40U/kg, 3000U max) “Main Study” Primary PCI with in lab Abciximab R Abciximab Facilitated Primary PCI Reteplase/Abciximab Facilitated Primary PCI With Enoxaparin (0.5 mg/kg IV, 0.3 mg/kg SC) “LMWH Substudy” Compare safety and efficacy between LMWH and UFH

10 Enrollment Into LMWH Substudy vs UFH By Country UK251 France153 Denmark130 Poland 101 Belgium 88 United States33 Sweden2 Switzerland1 Poland668 Czech Republic239 United States158 The Netherlands 118 Spain115 Italy93 UK73 Belgium58 Substudy (LMWH) Austria42 Bulgaria40 Germany32 Romania30 Argentina16 Israel5 South Africa5 Canada1 Main Study (UFH)x Total 759 Total 1693

11 Baseline Demographics/Medical History Primary PCIAbxRet/AbxPrimary PCIAbxRet/Abx with in FacFac with in FacFac Lab AbxPCIPCI Variable (n=560)(n=563)(n=570)(n=246)(n=255)(n = 258) Age (years, mean) Gender (% Female)26%27%25% 26%25%30% Race (% Caucasian)98%98%99%97%97%97% Smoker (past or current)64%64%64%67%75%67% HTN or Rx’ed HTN49%55%51%40%38%40% Anterior MI (%)47%48%47%44%52%51% Diabetes18%16%18%14%13%11% Prior MI11%11%13%9%8%11% Killip Class >110%11%10%10%10%6% Prior PCI4%4%8%4%8%5% Prior Stroke1%2%3%2%3%0.4% High Risk (Anterior MI, Age >70, Killip >I or HR >100)65%67%66%65%71%68% Main: UFH Substudy: LMWH

12 TIMI Major or Minor Bleeding (nonintracranial) through Discharge/Day7 p=0.109 p=0.088

13 TIMI Major Bleeding p=0.043 p=0.464 p=0.015p=NS

14 ICH All p=NS

15 Death or Complications of MI at 90days (1° EP of main study) All p=NS

16 Death at 90 days p=0.065p=0.061

17 Death or Re-MI Through Day 30 p=0.095p=0.096

18 Death, Re-MI, Urgent Revascularization Through Day 30 p=0.103p=0.160

19 Death, Re-MI, Urgent Revascularization, or Refractory Ischemia Through Day 30 p=0.016p=0.047

20 Adjusted Odds Ratios for Key Efficacy and Safety Endpoints LMWH vs UFH Logistic Regression Model adjusting for: Region, Sx onset to ECG; ECG to Balloon; Killip Class, Anterior MI, Prior MI, Age, Sex, HTN, Hub/Spoke, and randomized treatment EndpointOR95% CIp value TIMI Major or Minor Non-ICH bleeding TIMI Major Bleeding Death/Complications of MI to D90 (Primary)* Death to D Death or MI to D Death, MI, or Urg Revasc to D Death, MI, Urg Revasc or Refr. Ischemia to D *Hazard Ratio (Cox proportional hazard model)

21 Conclusions Compared with UFH and after adjustment for confounding variables, enoxaparin (0.5mg/kg IV + 0.3mg/kg SC) was associated with reductions of: –Major bleeding –Death –Death and complications of MI –All composite ischemic end-points Limitations of a non-randomized comparison  the ATOLL randomized study is underway

22 STEMI candidate for primary PCI ENOXAPARIN IV 0.5 mg.kg (with or without GPIIbIIIa Inh.) UFH IV IU if GP IIbIIIa IU if no GP IIbIIIa Dose adjusted to ACT Randomization N=850 Primary PCI and stenting Primary EP: Death, Complication of MI, Procedure Failure or non-CABG major Bleeding at 30 days Main secondary EP: Death, MI, refractory isch., Urg. Revasc. 6-month FU The ATOLL randomized study


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