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Presenters’ Disclosure Information:Relationships Related to this Presentation
Research Grants and/or Consultant fees:Research Grants and/or Consultant fees:
Mahaffey: Mahaffey: Aventis, AstraZeneca, Berlex, Lilly, Daiichi, Aventis, AstraZeneca, Berlex, Lilly, Daiichi,
Millennium, Merck, Schering-Plough, The Millennium, Merck, Schering-Plough, The Medicines CompanyMedicines Company
Ferguson: Ferguson: Aventis, AstraZeneca, Bristol Myers Squibb, Aventis, AstraZeneca, Bristol Myers Squibb,
Guidant, Merck, Sanofi, Schering-Plough, Guidant, Merck, Sanofi, Schering-Plough, The Medicines CompanyThe Medicines Company
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Kenneth W. Mahaffey, M.D.
James J. Ferguson, M.D.
On behalf of the SYNERGY Investigators
The SYNERGY Trial
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Superior
Yield of the
New strategy of
Enoxaparin,
Revascularization &
GlYcoprotein IIb/IIIa Inhibitors
The SYNERGY Trial
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Key Prior Trials
ESSENCE / TIMI 11b:ESSENCE / TIMI 11b: Superiority of enoxaparin vs UFH Superiority of enoxaparin vs UFH
in conservative management in conservative management strategystrategy
NICE Registries:NICE Registries: Comparable safety and efficacy to Comparable safety and efficacy to
historical controls in PCIhistorical controls in PCI
ACUTE 2 / INTERACT / AtoZACUTE 2 / INTERACT / AtoZ Contemporary trials in higher risk Contemporary trials in higher risk
patientspatients
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Key Questions
What is the role of enoxaparin in high-What is the role of enoxaparin in high-risk NSTEMI ACS patients managed with risk NSTEMI ACS patients managed with an early invasive treatment strategy ?an early invasive treatment strategy ?
Can we safely bring patients on Can we safely bring patients on enoxaparin rapidly forward to the enoxaparin rapidly forward to the catheterization laboratory ?catheterization laboratory ?
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Study DesignAt least 2 of 3 required:At least 2 of 3 required:
• Age Age 60 60
• ST ST (transient) or (transient) or • (+) CK-MB or Troponin(+) CK-MB or Troponin
Enoxaparin IV Heparin
Primary endpoint: Death or MI at 30 days
High-RiskHigh-RiskACS PatientsACS Patients
RandomizeRandomize(n = 10,000)(n = 10,000)
Early invasive strategyOther therapy per AHA/ACC Guidelines
(ASA, -blocker, ACE, clopidogrel, GP IIb/IIIa)
60 U/kg 60 U/kg 12 U/kg/hr 12 U/kg/hr (aPTT 50-70 sec)(aPTT 50-70 sec)1 mg/kg SC Q12H1 mg/kg SC Q12H
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Statistical Assumptions
InferiorityInferiority
NoninferiorityNoninferiority
SuperioritySuperiority
0.60.6 11 1.21.2
Hazard Ratio (95% CI)
Enoxaparin Better UFH Better
Control group 15% death/MIControl group 15% death/MI
17% reduction primary endpoint17% reduction primary endpoint
Type I error of 5% (2-sided)Type I error of 5% (2-sided)
90% power 90% power
Sample size ~10,000 patientsSample size ~10,000 patients
Sample size:
8000 10,000 pts
For crossover and interim event rate
Sample size:
8000 10,000 pts
For crossover and interim event rate
1.1
zone of noninferiority
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Europe: 5163
Australia: 253Australia: 253
New Zealand: 160New Zealand: 160
Brazil: 289Brazil: 289
Argentina: 192Argentina: 192
Canada: 1616Canada: 1616
USA: 5702USA: 5702
BelgiumBelgium 355355
GermanyGermany 456456
ItalyItaly 7272
PolandPoland 381381
SpainSpain 412412
TurkeyTurkey 139139
12 Countries. 467 Sites. 10,027 Patients.
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Inclusion Criteria
AgeAge
(+) ECG(+) ECG
(+) Biomarkers(+) Biomarkers
20%20%
16%16%
20%20%
44%44%
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Enoxaparin UFH(n = 4993) (n = 4985)
Median age (years) 68 68
Female sex (%) 34 34
Hypertension (%) 68 68
Diabetes (%) 29 30
Hypercholesterolemia (%) 58 59
Family history of CAD (%) 46 45
Myocardial infarction (%) 29 28
CHF (%) 9 9
Stroke (%) 5 5
PVD (%) 10 10
CABG (%) 16 17
PCI (%) 21 19
Baseline Characteristics
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Concomitant Medications
Enoxaparin UFH(n = 4993) (n = 4985)
Aspirin (%) 95 95
Beta blocker (%) 86 86
Ace inhibitor (%) 64 62
Statin (%) 69 70
Clopidogrel (%) 62 63
GP IIb-IIIa inhibitor (%) 56 58
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Pre-randomization Therapy
Enoxaparin UFH All Patients(n = 4993) (n = 4985) (n = 9978)
Received pre-randomization (%):
No antithrombinNo antithrombin 2424 25 25 2424
UFH onlyUFH only 2929 30 30 2929
Enoxaparin onlyEnoxaparin only 4242 42 42 4343
UFH and enoxaparinUFH and enoxaparin 3 3 3 3 3 3
No antithrombinNo antithrombin 2424 25 25 2424
UFH onlyUFH only 2929 30 30 2929
Enoxaparin onlyEnoxaparin only 4242 42 42 4343
UFH and enoxaparinUFH and enoxaparin 3 3 3 3 3 3
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Enoxaparin UFH(n = 4993) (n = 4985)
Cath during baseline hosp (%) 92 92
Time to cath* 22 21 (hours) (6, 44) (6, 43)
Percutaneous intervention 46 47
Time to PCI* 23 22 (hours) (6, 49) (6, 48)
CABG (%) 19 18
Time to CABG* 91 89 (hours) (44, 167) (45, 166)
Days hospitalized* 5 4 (3, 8) (3, 8)
In-hospital Procedures
*Median (25th ,75th)
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Kenneth W. Mahaffey, M.D.
James J. Ferguson, M.D.
On behalf of the SYNERGY Investigators
The SYNERGY Trial
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Primary Results (30 Days)
Enoxaparin UFH Unadjusted(n = 4993) (n = 4985) P-value
Death and MI (%) 14.0 14.5 0.396
Death (%) 3.2 3.1 0.705
MI (%) 11.7 12.7 0.135
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Death and MI at 30 Days
30-Day Death/MI30-Day Death/MI
0.80.8 11 1.21.2
Hazard Ratio (95% CI)
Enoxaparin
Better
UFH
Better0 5 10 15 20 25 30
0.8
0.85
0.9
0.95
1.0
Free
dom
from
Dea
th /
MI
Days from Randomization
UFHUFHEnoxaparinEnoxaparin
HR 0.96 (0.87-1.06)HR 0.96 (0.87-1.06)
1.11.1
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In-hospital Cardiac Events
Enoxaparin UFH(n = 4993) (n = 4985)
CHF (%) 8.0 7.9
Cardiogenic shock (%) 2.0 2.3
Cardiac arrest (%) 2.0 2.2
Ventricular tachycardia/fib (%) 4.8 4.9
Atrial fib / flutter (%) 8.6 7.7
2nd or 3rd degree heart block (%) 1.0 1.1
Acute mitral regurgitation (%) 0.3 0.3
Pulmonary edema (%) 0.2 0.2
Deep vein thrombosis (%) 0.2 0.2
Ventricular septal defect (%) 0.1 < 0.1
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Bleeding Events
Enoxaparin UFH(n = 4993) (n = 4985) P-value
GUSTO severe 2.9 2.4 0.106
TIMI major - clinical: 9.1 7.6 0.008 CABG-related 6.8 5.9 0.081 Non-CABG-related 2.4 1.8 0.025 H/H drop - algorithm 15.2 12.5 0.001
Any RBC transfusion 17.0 16.0 0.155
ICH < 0.1 < 0.1 NS
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PCI Patients: Thrombotic Complications
Enoxaparin UFH(n = 2321) (n = 2364)
Any unsuccessful PCI 3.6 3.4
Any threatened abrupt closure 1.1 1.0
Any abrupt closure 1.3 1.7
Emergency CABG 0.3 0.3
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No prior
UFH
Enox
Both
Pre-randomization
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No prior
UFH
Enox
Both
Pre-randomization Randomization
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Hazard Ratio (95% CI)
Enox UFHBetter Better
0.60.6 11 22
Hazard Ratio (95% CI)
Enox UFHBetter Better
0.60.6 11 22
Prior Antithrombin Therapy: Efficacy and Safety
Enox UFH (%) (%)Enox UFH (%) (%)
30-DAY DEATH / MI
30-DAY DEATH / MI
BLEEDINGGUSTO Severe
TIMI Major
BLEEDINGGUSTO Severe
TIMI MajorEnox UFH (%) (%)Enox UFH (%) (%)
2.9 2.42.9 2.4Total(n = 9978)
14.0 14.514.0 14.59.1 7.69.1 7.6
3.1 1.83.1 1.8No Prior Rx(n = 2440)
12.6 14.812.6 14.89.7 6.99.7 6.9
3.1 2.23.1 2.2ConsistentTherapy(n = 6138)
13.3 15.913.3 15.99.3 7.99.3 7.9
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No prior
UFH
Enox
Both
Pre-randomization Randomization
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No prior
UFH
Enox
Both
Pre-randomization Randomization Crossover
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Crossovers: Relation to Bleeding
TIMI MajorGUSTO Severe
0
2
4
6
8
10
Total No Crossover Crossover
0
2
4
6
8
10
Total No Crossover Crossover
0
4
8
12
16
20
Total No Crossover Crossover
0
4
8
12
16
20
Total No Crossover Crossover
(n = 9978)(n = 9978) (n = 9180)(n = 9180) (n =798)(n =798) (n = 9978)(n = 9978) (n = 9180)(n = 9180) (n =798)(n =798)
Enoxaparin
UFH
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Crossovers: Relation to Outcome
Enoxaparin
UFH Consistent RxDeath / MI
Total PopulationDeath / MI
(n = 9978)(n = 9978) (n = 9180)(n = 9180) (n =798)(n =798) (n = 6130)(n = 6130) (n = 5637)(n = 5637) (n =493)(n =493)
0
5
10
15
20
25
Total No Crossover Crossover
0
5
10
15
20
25
Total No Crossover Crossover
0
5
10
15
20
25
Total No Crossover Crossover
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Enox UFHBetter Better
SYNERGYSYNERGY
AtoZAtoZ
ACUTE 2ACUTE 2
TIMI 11BTIMI 11B
INTERACTINTERACT
ESSENCEESSENCE
0.50.5 11 22Enox UFHBetter Better
SYNERGYSYNERGY
AtoZAtoZ
ACUTE 2ACUTE 2
TIMI 11BTIMI 11B
INTERACTINTERACT
ESSENCEESSENCE
0.50.5 11 22
Systematic Overview:30-Day Death/MI and In-hospital Transfusions
30-DAY DEATH / MI
30-DAY DEATH / MI
IN-HOSPITALTRANSFUSIONS
IN-HOSPITALTRANSFUSIONS Enox UFHEnox UFH
2.6% 3.3%2.6% 3.3%
0.7% 0.6%0.7% 0.6%
2.5% 4.3%2.5% 4.3%
1.0% 0.8%1.0% 0.8%
17.0% 16.0%17.0% 16.0%
0.8% 0.9%0.8% 0.9%ESSENCEESSENCE
INTERACTINTERACT
TIMI 11BTIMI 11B
ACUTE 2ACUTE 2
AtoZAtoZ
SYNERGYSYNERGY
Enox UFHEnox UFH
5.0% 9.0%5.0% 9.0%
7.4% 8.3%7.4% 8.3%
7.9% 8.1%7.9% 8.1%
7.4% 7.9%7.4% 7.9%
14.0% 14.5%14.0% 14.5%
6.2% 7.7%6.2% 7.7%
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Hazard Ratio (95% CI)
Enoxaparin Better UFH Better
TIMI Major (All Trials)TIMI Major (All Trials)
Transfusions (All Trials)Transfusions (All Trials)
30-Day Death/MI (All Trials)30-Day Death/MI (All Trials)
0.60.6 11 22
Systematic Overview:Death/MI and Bleeding
10.1% 11.0%10.1% 11.0%
Enox UFHEnox UFH
8.2% 7.8%8.2% 7.8%
4.8% 4.1%4.8% 4.1%
(n = 21,946)(n = 21,946)
(n = 22,104)(n = 22,104)
(n = 22,104)(n = 22,104)
AtoZ did not include CABG data.
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Hazard Ratio (95% CI)
Enoxaparin Better UFH Better
TIMI Major (All Trials)TIMI Major (All Trials)
Transfusions (All Trials)Transfusions (All Trials)
30-Day Death/MI (All Trials)30-Day Death/MI (All Trials)
0.60.6 11 22
Systematic Overview—No Pre-rando Therapy: Death/MI and Bleeding
8.1% 9.5%8.1% 9.5%
Enox UFHEnox UFH
5.6% 5.5%5.6% 5.5%
3.5% 2.7%3.5% 2.7%
(n = 9835)(n = 9835)
(n = 8627)(n = 8627)
(n = 8627)(n = 8627)
AtoZ did not include CABG data.
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Summary
High-risk population treated with an early invasive management strategy
High-risk population treated with an early invasive management strategy
The studyThe studyThe studyThe study
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Summary
Efficacy — not superior but at least as effective as UFH in the overall population
Efficacy — not superior but at least as effective as UFH in the overall population
The resultsThe resultsThe resultsThe results
met criteria for non-inferiority met criteria for non-inferiority
High-risk population treated with an early invasive management strategy
High-risk population treated with an early invasive management strategy
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Summary
Efficacy — not superior but at least as effective as UFH in the overall population
Efficacy — not superior but at least as effective as UFH in the overall population
Bleeding — more frequent with enoxaparin Bleeding — more frequent with enoxaparin
The resultsThe resultsThe resultsThe results
UFHUFH
EnoxaparinEnoxaparin
7.6 %7.6 %
9.1 %9.1 %
2.4 %2.4 %
2.9 %2.9 %
16.0 %16.0 %
17.0 %17.0 %
TIMI TIMI MajorMajor
GUSTO GUSTO SevereSevere TransfusionTransfusion
High-risk population treated with an early invasive management strategy
High-risk population treated with an early invasive management strategy
p = 0.007p = 0.007 p = 0.106p = 0.106 p = 0.155p = 0.155
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Summary
Prior antithrombotic therapy
Post-randomization management
Bleeding definitions
Age, renal function
Prior antithrombotic therapy
Post-randomization management
Bleeding definitions
Age, renal function
Issues to Issues to considerconsiderIssues to Issues to considerconsider
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Summary
An overview of all recent RCTs comparing enoxaparin and UFH shows a consistent effect across the management spectrum
An overview of all recent RCTs comparing enoxaparin and UFH shows a consistent effect across the management spectrum
The study in contextThe study in contextThe study in contextThe study in context
Prior antithrombotic therapy
Post-randomization management
Bleeding definitions
Age, renal function
Prior antithrombotic therapy
Post-randomization management
Bleeding definitions
Age, renal function
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Summary
Current role — enoxaparin is an effective
and safe alternative to UFH for the early
invasive management of high risk ACS
patients.
Current role — enoxaparin is an effective
and safe alternative to UFH for the early
invasive management of high risk ACS
patients.
The The messagemessage
The The messagemessage
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