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New Horizons for Patients New Horizons for Patients
with ST-Elevation Myocardial with ST-Elevation Myocardial
InfarctionInfarction
Gregg W. Stone MDGregg W. Stone MD
Columbia University Medical Center Columbia University Medical Center Cardiovascular Research FoundationCardiovascular Research Foundation
Potential Conflicts of InterestPotential Conflicts of Interest
Speaker’s name: Gregg W. Stone, MDSpeaker’s name: Gregg W. Stone, MD
I have the following potential conflicts of interest to report:I have the following potential conflicts of interest to report:
ConsultingConsulting
Employment in industryEmployment in industry
Stockholder of a healthcare companyStockholder of a healthcare company
Owner of a healthcare companyOwner of a healthcare company
Grant/Research Support: The Medicines Company and Grant/Research Support: The Medicines Company and Boston ScientificBoston Scientific
I do not have any potential conflict of interestI do not have any potential conflict of interest
Major bleedingMajor bleeding (with or without (with or without blood product transfusions) blood product transfusions)
has emerged as a has emerged as a powerful powerful independent predictor of early independent predictor of early and late mortality and late mortality in pts with in pts with NSTEMI, STEMI and in those NSTEMI, STEMI and in those
undergoing PCIundergoing PCI
Major bleedingMajor bleeding (with or without (with or without blood product transfusions) blood product transfusions)
has emerged as a has emerged as a powerful powerful independent predictor of early independent predictor of early and late mortality and late mortality in pts with in pts with NSTEMI, STEMI and in those NSTEMI, STEMI and in those
undergoing PCIundergoing PCI
FACT
Ndrepepa et al. JACC 2008;51:690–7
Time from Randomization in DaysTime from Randomization in Days
Cu
mu
lati
ve %
Mo
rta
lity
Cu
mu
lati
ve %
Mo
rta
lity
With MIWith MI 5.7%5.7%
Without major bleedWithout major bleed 2.0%2.0%
Impact of Major Bleed and MI Impact of Major Bleed and MI after Elective and Urgent PCIafter Elective and Urgent PCI
1-Year Mortality (N=6,012)1-Year Mortality (N=6,012)
Without MIWithout MI 1.9%1.9%
With major bleedWith major bleed 8.8%8.8%
Stone GW. J Inv Cardiol 2004;16(suppl G):12–17.Stone GW. J Inv Cardiol 2004;16(suppl G):12–17.
VariableVariable GroupsGroups O.R.O.R. (95% CI)(95% CI) p-valuep-value
Creatinine clear.Creatinine clear. <30 mL/min<30 mL/min 7.217.21 (2.53–20.51)(2.53–20.51)
<0.0001<0.000130–60 mL/min30–60 mL/min 3.343.34 (1.92–5.78)(1.92–5.78)
60–90 mL/min60–90 mL/min 1.571.57 (0.96–2.57)(0.96–2.57)
CHFCHF YesYes 4.38 4.38 (2.83–6.78)(2.83–6.78) <0.0001<0.0001
Major BleedingMajor Bleeding YesYes 3.263.26 (1.78–5.96)(1.78–5.96) 0.00010.0001
MI @30dayMI @30day YesYes 2.772.77 (1.62–4.75)(1.62–4.75) 0.00020.0002
Urg Revasc @30dUrg Revasc @30d YesYes 2.772.77 (1.15–6.71)(1.15–6.71) .024.024
Hx anginaHx angina YesYes 2.182.18 (1.25–3.81)(1.25–3.81) 0.0060.006
Prior MIPrior MI YesYes 1.811.81 (1.09–3.03)(1.09–3.03) 0.0230.023
DiabetesDiabetes YesYes 1.641.64 (1.10–2.44)(1.10–2.44) 0.0150.015
Predictors of 1-year MortalityPredictors of 1-year Mortality after Elective and Urgent PCIafter Elective and Urgent PCI
Stone GW. J Inv Cardiol 2004;16(suppl G):12–17.Stone GW. J Inv Cardiol 2004;16(suppl G):12–17.
0.0
0.5
1.0
1.5
2.0
2.5
3.0
0 60 120 180 240 300 360
Heparin+GPllb/llla N=3008 Bivalirudin N=2994
1-year Mortality1-year MortalityAll 6,012 Patients (ITT)All 6,012 Patients (ITT)
P value = 0.16P value = 0.16
Cu
mu
lati
ve D
eat
hs
Cu
mu
lati
ve D
eat
hs
DaysDays
2.5%2.5%
1.9%1.9%
Lincoff AM et al. JAMA 2004;292:696–703Lincoff AM et al. JAMA 2004;292:696–703
Mo
rtal
ity
(%)
Days from Randomization
0 30 60 90 120 150 180 210 240 270 300 330 360 3900
5
15
30
10
25
20
1 yearEstimate
Major Bleed only (without MI) (N=551) 12.5%28.9%Both MI and Major Bleed (N=94)
3.4%No MI or Major Bleed (N=12,557)MI only (without Major Bleed) (N=611) 8.6%
Impact of MI and Major Bleeding (non-CABG) in the First 30 Days on Risk of Death Over 1 Year
Stone GW. ACC 2007
Cox model adjusted for baseline predictors, with MI and major bleeding (non-CABG) as time-updated covariates
Cox model adjusted for baseline predictors, with MI and major bleeding (non-CABG) as time-updated covariates
Influence of Major Bleeding and MI in the First 30 Days on the Risk of Death within 30
Days
Myocardial infarction 5.25 (3.72-7.43) <0.0001
Major bleeding without or before transfusion 3.04 (1.66-5.55) <0.0001
Major bleeding after transfusion 5.45 (3.54-8.38) <0.0001
HR ± 95% CI P-valueHR (95% CI)
Stone GW. ACC 2008
Of 13,819 enrolled pts, 704 (5.1%) had a MI, 644 (4.7%) had a major bleed (non CABG), and 206 (1.5%) died within 30 days
Attributabledeaths
42.0*
38.2**
*20.4% of all deaths**18.5% of all deaths
Attributable deaths = N deathsAttributable deaths = N deathsamong pts with the time updatedamong pts with the time updatedevent (attribute) X (adj. HR – 1)/adj. HRevent (attribute) X (adj. HR – 1)/adj. HR
Attributable deaths = N deathsAttributable deaths = N deathsamong pts with the time updatedamong pts with the time updatedevent (attribute) X (adj. HR – 1)/adj. HRevent (attribute) X (adj. HR – 1)/adj. HR Mehran RM et al. Submitted
Influence of Major Bleeding and MI in the First 30 Days on Risk of Death Over 1 Year
Cox model adjusted for baseline predictors, with MI and major bleeding (non-CABG) as time-updated covariates
Cox model adjusted for baseline predictors, with MI and major bleeding (non-CABG) as time-updated covariates
Of 13,819 enrolled pts, 524 (3.8%) died within 1 year
Myocardial infarction 2.51 (1.95-3.25) <0.0001
Major bleeding without or before transfusion 2.00 (1.30-3.06) <0.0001
Major bleeding after transfusion 3.93 (2.95-5.24) <0.0001
HR ± 95% CI P-valueHR (95% CI)Attributable
deaths
51.5*
66.5**
*9.8% of all deaths**12.7% of all deaths
ACUITY: Early and Late MortalityLandmark analysis
ACUITY: Early and Late MortalityLandmark analysis
0 30 60 90 120 150 180 210 240 270 300 330 360 3900
3
4
2
1
UFH/Enoxaparin + IIb/IIIaBivalirudin + IIb/IIIa
Bivalirudin alone
30 dayEstimate
P(log rank)
1.4%0.531.6%0.391.6%
—
EstimateP
(log rank)
3.1%0.542.7%0.212.3%
30d - 1 year
—
Mo
rtal
ity
(%)
Days from Randomization
Stone GW. JAMA 2007;298:2497-506
HHarmonizing armonizing OOutcomes with utcomes with RRevascularevascularizizatiationon and and SStents in AMItents in AMI
≥≥3400* pts with STEMI with symptom onset ≤12 hours3400* pts with STEMI with symptom onset ≤12 hours
Emergent angiography, followed by triage to…Emergent angiography, followed by triage to…
Primary PCIPrimary PCICABGCABG –– Medical RxMedical Rx––
UFH + GP IIb/IIIa inhibitorUFH + GP IIb/IIIa inhibitor(abciximab or eptifibatide)(abciximab or eptifibatide)
Bivalirudin monotherapyBivalirudin monotherapy(± provisional GP IIb/IIIa)(± provisional GP IIb/IIIa)
Aspirin, thienopyridineAspirin, thienopyridine R 1:1
3000 pts eligible for stent randomization3000 pts eligible for stent randomization R 1:3
Bare metal stentBare metal stent TAXUS paclitaxel-eluting stentTAXUS paclitaxel-eluting stent
*To rand 3000 stent pts*To rand 3000 stent pts
Clinical FU at 30 days, 6 months,1 year, and then yearly through 5 years
Clinical FU at 30 days, 6 months,1 year, and then yearly through 5 years
HHarmonizing armonizing OOutcomes with utcomes with RRevascularevascularizizatiationon and and SStents in AMItents in AMI
UFH +GP IIb/IIIaN=1802
BivalirudinMonotherapy
N=1800
R 1:1
RandomizedRandomized
30 day FU*30 day FU*
* Range ±7 days* Range ±7 days
ITT populationITT population
N=1778(98.7%)
N=1777(98.7%)
N=1802 N=1800
• • • • • • Withdrew • • •Withdrew • • •
• • • • • • Lost to FU • • •Lost to FU • • •99
15151010
1313
3602 pts with STEMI3602 pts with STEMI
Stone GW et al. In press.Stone GW et al. In press.
Diff = Diff = 0.0% [-1.6, 1.5] RR = 0.99RR = 0.99 [0.76, 1.30]
PPsupsup = 0.95 = 0.95
Primary Outcome Measures (ITT)
Diff = Diff = -3.3% [-5.0, -1.6] RR = RR = 0.60 [0.46, 0.77]
PPNINI ≤ 0.0001 ≤ 0.0001
PPsupsup ≤ 0.0001 ≤ 0.0001
Diff = Diff = -2.9% [-4.9, -0.8]RR = RR = 0.76 [0.63, 0.92]
PPNINI ≤ 0.0001 ≤ 0.0001
PPsupsup = 0.005 = 0.005
1 endpoint 1 endpoint
*Not related to CABG*Not related to CABG**MACE = All cause death, reinfarction, ischemic TVR or stroke**MACE = All cause death, reinfarction, ischemic TVR or stroke
30 Day Bleeding Endpoints*30 Day Bleeding Endpoints*UFH + GP IIb/IIIaUFH + GP IIb/IIIa
(N=1802)(N=1802)BivalirudinBivalirudin(N=1800)(N=1800) P ValueP Value
Protocol Major, non CABG**Protocol Major, non CABG** 8.3%8.3% 4.9%4.9% <0.0001<0.0001
Protocol Major, AllProtocol Major, All 10.8%10.8% 6.8%6.8% <0.0001<0.0001
Protocol MinorProtocol Minor 15.4%15.4% 8.6%8.6% <0.0001<0.0001
Blood transfusionBlood transfusion 3.5%3.5% 2.1%2.1% 0.0090.009
TIMI MajorTIMI Major 5.0%5.0% 3.1%3.1% 0.0020.002
TIMI MinorTIMI Minor 4.6%4.6% 2.8%2.8% 0.0060.006
TIMI Major or MinorTIMI Major or Minor 9.6%9.6% 5.9%5.9% <0.0001<0.0001
GUSTO LT*** or SevereGUSTO LT*** or Severe 0.6%0.6% 0.4%0.4% 0.490.49
GUSTO ModerateGUSTO Moderate 5.0%5.0% 3.1%3.1% 0.0020.002
GUSTO LT or Sev or ModGUSTO LT or Sev or Mod 5.6%5.6% 3.5%3.5% 0.0020.002
*CEC adjudicated, except protocol minor; *CEC adjudicated, except protocol minor; **Primary endpoint; ***Life threatening**Primary endpoint; ***Life threatening
Thrombocytopenia
P = 0.02P = 0.02
P = 0.04P = 0.04
P = 0.002P = 0.002
<100,000 cells/mm3 <20,000 cells/mm3<50,000 cells/mm3
Stone GW et al. In press.Stone GW et al. In press.
30 Day MACE Components*30 Day MACE Components*
UFH + GP IIb/IIIaUFH + GP IIb/IIIa(N=1802)(N=1802)
BivalirudinBivalirudin(N=1800)(N=1800) P ValueP Value
DeathDeath 3.1%3.1% 2.1%2.1% 0.0470.047
- Cardiac- Cardiac 2.9%2.9% 1.8%1.8% 0.0280.028
- Non cardiac- Non cardiac 0.2%0.2% 0.3%0.3% 0.750.75
ReinfarctionReinfarction 1.8%1.8% 1.8%1.8% 0.900.90
- Q-wave- Q-wave 1.2%1.2% 1.4%1.4% 0.660.66
- Non Q-wave- Non Q-wave 0.7%0.7% 0.4%0.4% 0.370.37
Ischemic TVRIschemic TVR 1.9%1.9% 2.6%2.6% 0.180.18
- Ischemic TLR- Ischemic TLR 1.8%1.8% 2.5%2.5% 0.130.13
- Ischemic remote TVR- Ischemic remote TVR 0.3%0.3% 0.3%0.3% 1.01.0
StrokeStroke 0.6%0.6% 0.7%0.7% 0.680.68
*CEC adjudicated*CEC adjudicatedStone GW et al. In press.Stone GW et al. In press.
30 Day Mortality30 Day Mortality
Number at riskNumber at risk
BivalirudinBivalirudin 1800 1800 17581758 17511751 17461746 17421742 17291729 16661666
Heparin + GPIIb/IIIaHeparin + GPIIb/IIIa 1802 1802 17641764 17481748 17361736 17281728 17071707 16301630
Dea
th (
%)
Dea
th (
%)
Time in DaysTime in Days
3.1%
2.1%
HR [95%CI] =0.66 [0.44, 1.00]
P=0.048
Heparin + GPIIb/IIIa inhibitor (n=1802)Bivalirudin monotherapy (n=1800)
Stone GW et al. In press.Stone GW et al. In press.
30 Day Mortality: 30 Day Mortality: Cardiac and Non CardiacCardiac and Non Cardiac
Number at riskNumber at risk
BivalirudinBivalirudin 1800 1800 17581758 17511751 17461746 17421742 17291729 16661666
Heparin + GPIIb/IIIaHeparin + GPIIb/IIIa 1802 1802 17641764 17481748 17361736 17281728 17071707 16301630
Dea
th (
%)
Dea
th (
%)
Time in DaysTime in Days
2.9%
1.8%
Heparin + GPIIb/IIIa inhibitor (n=1802)Bivalirudin monotherapy (n=1800)
0.3%0.2%
Cardiac
Non cardiac
HR [95%CI] =0.62 [0.40, 0.96]
P=0.029
Stone GW et al. In press.Stone GW et al. In press.
30 Day Stent Thrombosis (N=3,124)30 Day Stent Thrombosis (N=3,124)
UFH + UFH + GP IIb/IIIaGP IIb/IIIa(N=1553)(N=1553)
BivalirudinBivalirudin(N=1571)(N=1571)
PPValueValue
ARC 30d definite or probable stent thrombosis* 1.9%1.9% 2.5%2.5% 0.300.30
- definite 1.4%1.4% 2.2%2.2% 0.090.09
- probable 0.5%0.5% 0.3%0.3% 0.240.24
- acute (≤24 hrs) 0.3%0.3% 1.3%1.3% 0.00070.0007
- subacute (>24 hrs – 30d) 1.7%1.7% 1.2%1.2% 0.280.28
*Protocol definition of stent thrombosis, CEC adjudicated*Protocol definition of stent thrombosis, CEC adjudicated
Number at riskNumber at risk
Bivalirudin Bivalirudin 16781678 16471647 16401640 16351635 16321632 16201620 1563 1563
Heparin + GPIIb/IIIa Heparin + GPIIb/IIIa 16621662 16311631 16151615 16041604 15981598 15831583 1512 1512
Dea
th (
%)
Dea
th (
%)
Time in daysTime in days
1.8%
Heparin + GPIIb/IIIa inhibitor (n=1662)Bivalirudin monotherapy (n=1678)
0.2%0.1%
Cardiac
Non cardiac
30 Day Mortality: 30 Day Mortality: PCI CohortPCI Cohort
0
1
2
3
4
5
0 5 10 15 20 25 30
2.8%
HR [95%CI] =0.63 [0.40, 0.99]
P=0.049
Stone GW et al. In press.Stone GW et al. In press.
Predictors of 30 Day MortalityPredictors of 30 Day Mortality32 Candidate Baseline Variables*32 Candidate Baseline Variables*
Demographic:Demographic: Age; sex; race; US vs. OUS; HTN, hyperlipidemia, Age; sex; race; US vs. OUS; HTN, hyperlipidemia, smoking, diabetes, diabetes on insulin, MI, PCI, CABG, CAD, smoking, diabetes, diabetes on insulin, MI, PCI, CABG, CAD, angina, CHF, major cardiac rhythm/rate disturbances, PVDangina, CHF, major cardiac rhythm/rate disturbances, PVD
Medication use at home previous 5 days:Medication use at home previous 5 days: aspirin, beta blocker, aspirin, beta blocker, thienopyridines, calcium channel blocker, ACE/ARB, diureticthienopyridines, calcium channel blocker, ACE/ARB, diuretic
Time from symptom onset to hospital ERTime from symptom onset to hospital ER
Physical exam:Physical exam: BMI; KILLIP classBMI; KILLIP class
Baseline labsBaseline labs: : Estimated CrCl, anemia, platelet count Estimated CrCl, anemia, platelet count
Medications in hospital prior to angiography:Medications in hospital prior to angiography: Randomized Randomized treatment (bivalirudin vs. heparin + GPI; pre-procedure heparin; treatment (bivalirudin vs. heparin + GPI; pre-procedure heparin; clopidogrel loadclopidogrel load
* Angiographic variables not yet available;* Angiographic variables not yet available; - treatment related variables not used- treatment related variables not used
Time-updated covariate adjusted Cox model relating Time-updated covariate adjusted Cox model relating single 30-day adverse events to 30-day mortalitysingle 30-day adverse events to 30-day mortality
Ischemic EventsIschemic Events HR (95% CI)HR (95% CI) PP deaths* deaths* C-statC-stat
ReinfarctionReinfarction 11.09 [5.44,22.59] <0.001<0.001 9.1 [8.2,9.6] 0.830.83
Ischemic TVRIschemic TVR 6.91 [3.36,14.18] <0.001<0.001 7.7 [6.3,8.4] 0.830.83
Stent thrombosis, definite**Stent thrombosis, definite**
- any- any 10.71 [3.93,29.18] <0.001<0.001 4.5 [3.7,4.8] 0.830.83
- acute (<24 hours)- acute (<24 hours) 5.88 [0.78,44.30] 0.090.09 0.8 [-0.3,1] 0.820.82
StrokeStroke 5.44 [1.67,17.69] 0.0050.005 2.4 [1.2,2.8] 0.820.82
AttributableAttributable
* Of 93 total deaths; ** in 3,124 successfully stented pts* Of 93 total deaths; ** in 3,124 successfully stented pts***Only 2 pts with acute stent thrombosis died within 30 ***Only 2 pts with acute stent thrombosis died within 30 days, 1 in each randomized groupdays, 1 in each randomized group
Time-updated covariate adjusted Cox model relating Time-updated covariate adjusted Cox model relating single 30-day adverse events to 30-day mortalitysingle 30-day adverse events to 30-day mortality
Bleeding EventsBleeding Events HR (95% CI)HR (95% CI) PP deaths* deaths* C-statC-stat
Major bleed Major bleed (non-CABG)(non-CABG) 4.43 [2.67, 7.33] <0.001<0.001 20.1 [16.3,22.5] 0.850.85
Major bleed (all)Major bleed (all) 5.92 [3.73, 9.41] <0.001<0.001 29.1 [25.6,31.3] 0.860.86
TransfusionTransfusion 3.88 [2.09, 7.20] <0.001<0.001 11.9 [8.4,13.8] 0.830.83
Thrombocytopenia**Thrombocytopenia**
- <100,000 cells/mm- <100,000 cells/mm33 3.89 [2.22, 6.84] <0.001<0.001 11.1 [8.2,12.8] 0.780.78
- <50,000 cells/mm- <50,000 cells/mm33 6.44 [2.93,14.18] <0.001<0.001 5.9 [4.6,6.5] 0.780.78
- <20,000 cells/mm- <20,000 cells/mm33 4.98 [1.20,20.66] 0.030.03 1.6 [0.3,1.9] 0.770.77
AttributableAttributable
* Of 93 total deaths; ** * Of 93 total deaths; ** 88 deaths in 3550 patientsAttributable deaths = N deaths among pts with the time Attributable deaths = N deaths among pts with the time updated event (attribute) X (adj. HR – 1)/adj. HRupdated event (attribute) X (adj. HR – 1)/adj. HR
HR [95% CI] P-valueRisk Factor
Time-updated covariate adjusted Cox model Time-updated covariate adjusted Cox model relating 30-day events to 30-day mortalityrelating 30-day events to 30-day mortality
- Complete model with MACE components and major bleeding -- Complete model with MACE components and major bleeding -
Hazard Ratio [95% CI]Hazard Ratio [95% CI]
0.01 0.1 1 10 100
C-statistic = 0.87. C-statistic = 0.87.
Reinfarction 9.75[2.72,34.91]
<0.001
Major bleeding (non CABG) 4.66[2.84, 7.63]
<0.001
Ischemic TVR 1.11[0.29, 4.21]
0.88
Stroke 2.64[0.71, 9.75]
0.15
HR [95% CI] P-valueAttributable
DeathsRisk Factor
Time-updated covariate adjusted Cox model Time-updated covariate adjusted Cox model relating 30-day events to 30-day mortalityrelating 30-day events to 30-day mortality
- - CompleteComplete model with MACE components and major bleeding - model with MACE components and major bleeding -
Hazard Ratio [95% CI]Hazard Ratio [95% CI]
0.01 0.1 1 10 100
C-statistic = 0.87. C-statistic = 0.87. Attributable deaths = N deaths among pts Attributable deaths = N deaths among pts with the time updated event (attribute) X (adj. HR – 1)/adj. HRwith the time updated event (attribute) X (adj. HR – 1)/adj. HR
*9.7% of 93 total deaths*9.7% of 93 total deaths**21.9% of 93 total deaths**21.9% of 93 total deaths
Major bleeding(Non CABG)Incidence 238 (6.8%)26 deaths with event
4.66[2.84, 7.63]
<0.001 20.4**[16.8, 22.6]
ReinfarctionIncidence 69 (2.2%)10 deaths with event
9.75[2.72,34.91]
<0.001 9.0*[6.3, 9.7]
HR [95% CI] P-valueAttributable
DeathsRisk Factor
Time-updated covariate adjusted Cox model Time-updated covariate adjusted Cox model relating 30-day events to 30-day mortalityrelating 30-day events to 30-day mortality
- - CompleteComplete model in 3,124 pts with successfully implanted stents - model in 3,124 pts with successfully implanted stents -
Hazard Ratio [95% CI]Hazard Ratio [95% CI]
0.01 0.1 1 10 100
C-statistic = 0.87. C-statistic = 0.87. Attributable deaths = N deaths among pts Attributable deaths = N deaths among pts with the time updated event (attribute) X (adj. HR – 1)/adj. HRwith the time updated event (attribute) X (adj. HR – 1)/adj. HR
*8.3% of 54 total deaths*8.3% of 54 total deaths**28.0% of 54 total deaths**28.0% of 54 total deaths
Major bleeding(non CABG)Incidence 195 (6.2%)18 deaths with event
6.22[3.33, 11.60]
<0.001 15.1** 15.1** [12.6, 16.4][12.6, 16.4]
Stent thrombosis(definite)Incidence 57 (1.8%)5 deaths with event
10.62[3.96, 28.48]
<0.001 4.5* 4.5*
[3.7, 4.8][3.7, 4.8]
1. 1. Major bleeding is a powerful independent determinant Major bleeding is a powerful independent determinant of mortality in ACS, STEMI, and in pts undergoing PCI, of mortality in ACS, STEMI, and in pts undergoing PCI, at least as important as MI/reinfarction.at least as important as MI/reinfarction.
1. 1. Major bleeding is a powerful independent determinant Major bleeding is a powerful independent determinant of mortality in ACS, STEMI, and in pts undergoing PCI, of mortality in ACS, STEMI, and in pts undergoing PCI, at least as important as MI/reinfarction.at least as important as MI/reinfarction.
Conclusions
2. In high risk pts with STEMI undergoing primary PCI, treatment with bivalirudin compared to heparin + GPI results in a significant reduction in bleeding, thrombocytopenia and transfusions, with similar rates of reinfarction, stent thrombosis, iTVR and stroke.
3. This favorable balance of adverse events results in lower 30-day mortality in primary PCI pts treated with bivalirudin rather than heparin + GPI, representing a new standard of care for pts with STEMI.