translating advances in nstemi and stemi into real world institutional practice
DESCRIPTION
Translating Advances in NSTEMI and STEMI into Real World Institutional Practice. Harold L. Dauerman, MD Director, Cardiovascular Catheterization Laboratories Professor of Medicine University of Vermont Fletcher Allen Health Care. The Science and Medicine of ACS. - PowerPoint PPT PresentationTRANSCRIPT
Translating Advances in NSTEMI and STEMI into Real World
Institutional Practice
Translating Advances in NSTEMI and STEMI into Real World
Institutional Practice
Harold L. Dauerman, MDDirector, Cardiovascular Catheterization
LaboratoriesProfessor of MedicineUniversity of Vermont
Fletcher Allen Health Care
Harold L. Dauerman, MDDirector, Cardiovascular Catheterization
LaboratoriesProfessor of MedicineUniversity of Vermont
Fletcher Allen Health Care
The Science and Medicine of ACSThe Science and Medicine of ACS
Potential conflicts of interestPotential conflicts of interest
Speaker’s name: Harold L. Dauerman, MD
I have the following potential conflicts of interest to report:
Consulting: The Medicines Company, Abbott Vascular
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
Speaker’s name: Harold L. Dauerman, MD
I have the following potential conflicts of interest to report:
Consulting: The Medicines Company, Abbott Vascular
Employment in industry
Stockholder of a healthcare company
Owner of a healthcare company
Other(s)
I do not have any potential conflict of interest
University of Vermont Post-PCI Bleeding and Vascular Complication Rates
University of Vermont Post-PCI Bleeding and Vascular Complication Rates
NNE Rate: 2.0% in 2006
Any Transfusion, RPH or Repair = Bleeding ComplicationAny Transfusion, RPH or Repair = Bleeding Complication Any Transfusion, RPH or Repair = Bleeding ComplicationAny Transfusion, RPH or Repair = Bleeding Complication
Introduction ofIntroduction of Bivalirudin to Cath LabBivalirudin to Cath Lab
Introduction ofIntroduction of Bivalirudin to Cath LabBivalirudin to Cath Lab
Introduction of Introduction of Upstream BivalirudinUpstream Bivalirudin
Introduction of Introduction of Upstream BivalirudinUpstream Bivalirudin
0
0.5
1
1.5
2
2.5
3
3.5
4
2001 2002 2003 2004 2005 2006 2007
Ble
edin
g C
ompl
icat
ion,
%
Incorporation of Bivalirudin in Cath Lab for NSTEMI in 2003—A Cautious Beginning
Incorporation of Bivalirudin in Cath Lab for NSTEMI in 2003—A Cautious Beginning
82%18%
Drug Eluting Bare Metal
82%18%
Drug Eluting Bare Metal
42%
25% 33%
Bivalirudin
GP IIb/IIIa Inhibitor
UFH alone
Bivalirudin
GP IIb/IIIa Inhibitor
UFH alone
P < 0.001 for temporal trendP < 0.001 for temporal trend
Arterial injury and/or arterial injury related bleeding N= 36,631 Patients Undergoing PCI, NNE RegistryArterial injury and/or arterial injury related bleeding N= 36,631 Patients Undergoing PCI, NNE Registry
Signs of Hope Since 2004Signs of Hope Since 2004
Dauerman, Applegate and Cohen, JACC 2007
3.2
2.51
2.111.96
3.37
0
0.5
1
1.5
2
2.5
3
3.5
4
2002 2003 2004 2005 2006
Maj
or V
ascu
lar
Com
plic
atio
ns,
%*
How We Introduced Upstream and Downstream Bivalirudin: The UVMC Time Line
How We Introduced Upstream and Downstream Bivalirudin: The UVMC Time Line
2003: Put bivalirudin on the cath lab shelf as an option for NSTEMI
2007: Educational programs for fellows, floor staff and attendings
We did not remove GPI option
We did NOT involve community hospitals in this decision. They can do whatever they want as long as they transfer and don’t overdose patients.
2008: A standardized STEMI bivalirudin approach
For upstream AMI utilization, bivalirudin ordered from pharmacy
In collaboration with ED (EDICT for ACS Strategy)
2003: Put bivalirudin on the cath lab shelf as an option for NSTEMI
2007: Educational programs for fellows, floor staff and attendings
We did not remove GPI option
We did NOT involve community hospitals in this decision. They can do whatever they want as long as they transfer and don’t overdose patients.
2008: A standardized STEMI bivalirudin approach
For upstream AMI utilization, bivalirudin ordered from pharmacy
In collaboration with ED (EDICT for ACS Strategy)
NSTEMI Transfers, Upstream
Strategies, andResults of Clinical Trials
NSTEMI Transfers, Upstream
Strategies, andResults of Clinical Trials
Non ST-Elevation Myocardial InfarctionNon ST-Elevation Myocardial Infarction
What We Really Do With Transfers? September 24, 2007 email from me
What We Really Do With Transfers? September 24, 2007 email from me
To: Sullivan, Claudia A.Cc: Ades, Philip A.Subject: Transfer of John XXXXX, DOB 11/08/25
81M with NSTEMI/old LBBB, Tn 3.0 Pain free, but with NSVT. ASA/clopidogrel 300 po/enoxaparin. From Adirondack Medical Center.
Class I transfer. Change to bivalirudin on arrival. DNR—reverse POLST (wants a cath, but no CABG). Echo today, cath tomorrow (or today if unstable).
Thanks,Harry
To: Sullivan, Claudia A.Cc: Ades, Philip A.Subject: Transfer of John XXXXX, DOB 11/08/25
81M with NSTEMI/old LBBB, Tn 3.0 Pain free, but with NSVT. ASA/clopidogrel 300 po/enoxaparin. From Adirondack Medical Center.
Class I transfer. Change to bivalirudin on arrival. DNR—reverse POLST (wants a cath, but no CABG). Echo today, cath tomorrow (or today if unstable).
Thanks,Harry
Protocol Major/Minor Bleed by SWITCH and Randomized Therapy
Protocol Major/Minor Bleed by SWITCH and Randomized Therapy
*P=NS for all 3-way comparisons versus bivalirudin alone; †P<.05 vs prior treatment with UFH or enoxaparin; ‡naïve=no prior AT therapy in preceding 48 hours.
Pro
toco
l maj
or/m
inor
ble
edP
roto
col m
ajor
/min
or b
leed
NaïveNaïve→→BivalirudinBivalirudin‡‡
(n=2,345)(n=2,345)
LMWH→LMWH→Bivalirudin Bivalirudin
(n=258)(n=258)
UFH→UFH→BivalirudinBivalirudin
(n=287)(n=287)
LMWH→UFH LMWH→UFH + GP IIb/IIIa+ GP IIb/IIIa
(n=313)(n=313)
Naïve→ UFH + Naïve→ UFH +
GP IIb/IIIaGP IIb/IIIa‡ ‡
(n=2,325)(n=2,325)
UFH→UFH UFH→UFH + GP IIb/IIIa + GP IIb/IIIa
(n=349)(n=349)
*
†
Gibson CM et al. Am J Cardiol. 2007;99:1687-1690.
15.6% 15.3%16.7%
28.6%
33.8% 34.8%
0%
5%
10%
15%
20%
25%
30%
35%
Transfer to Cardiology FloorTransfer to Cardiology Floor
► Enoxaparin held—wait 8 hours from community hospital last dose.
► Then, start upstream bivalirudin
► Patient pain free—1st case next A.M
► DES, no eptifibatide, closure device, 150 mg clopidogrel
► Ambulate at 6 hours► D/C following 0900 A.M.
► Enoxaparin held—wait 8 hours from community hospital last dose.
► Then, start upstream bivalirudin
► Patient pain free—1st case next A.M
► DES, no eptifibatide, closure device, 150 mg clopidogrel
► Ambulate at 6 hours► D/C following 0900 A.M.
Not Thienopyridine ExposedNot Thienopyridine Exposed
If Patient is not Clopidogrel Exposed, Do We Use Bivalirudin? Definitions?
If Patient is not Clopidogrel Exposed, Do We Use Bivalirudin? Definitions?
RR [95%CI]RR [95%CI]
0.81 (0.68-0.96)0.81 (0.68-0.96)
RR [95%CI] RR [95%CI]
0.96 (0.77-1.20)0.96 (0.77-1.20)
RR [95%CI] RR [95%CI]
0.50 (0.37-0.67)0.50 (0.37-0.67)
RR [95%CI] RR [95%CI]
1.07 (0.83-1.39)1.07 (0.83-1.39)
RR [95%CI] RR [95%CI]
1.37 (1.00-1.88)1.37 (1.00-1.88)
RR [95%CI] RR [95%CI]
0.61 (0.39-0.97)0.61 (0.39-0.97)
Stone GW, McLaurin BT. NEJM. 2006 Nov 23;355(21):2203-16 Stone GW, McLaurin BT. NEJM. 2006 Nov 23;355(21):2203-16
Thienopyridine ExposedThienopyridine Exposed
13.8%
8.4%7.2%
8.1%
11.1%
3.6%
Net clinicaloutcomes
Ischemiccomposite
Major bleeding
UFH/Enoxaparin + IIb/IIIa (N=1722)
Bivalirudin Alone (N=1789)
11.8%
7.5%
5.7%
3.5%
12.7%
10.3%
Net clinicaloutcomes
Ischemiccomposite
Major bleeding
UFH/Enoxaparin + IIb/IIIa (N=811)
Bivalirudin Alone (N=804)
Risk ratio (RR) ±95% CI for the triple ischemic endpoint(death, MI, unplanned revascularization)
Risk ratio (RR) ±95% CI for the triple ischemic endpoint(death, MI, unplanned revascularization)
Bivalirudin alone betterBivalirudin alone better Heparin + GPIIb/IIIa better Heparin + GPIIb/IIIa better
Peri-PCI Clopidogrel N=1044, RR 1.26 [95% CI 0.82,1.92]
Peri-PCI Clopidogrel N=1044, RR 1.26 [95% CI 0.82,1.92]
Post-PCI Clopidgrel(> 30 minutes After PCI)
N=519 RR 1.48 [95% CI 0.89, 2.47]
Post-PCI Clopidgrel(> 30 minutes After PCI)
N=519 RR 1.48 [95% CI 0.89, 2.47]
Pre-PCI clopidogrel N=3429, RR 0.92 [95% CI 0.74,1.15]
Pre-PCI clopidogrel N=3429, RR 0.92 [95% CI 0.74,1.15]
No Clopidogrel N=88 RR 2.62 [95% CI 0.89, 7.72]
No Clopidogrel N=88 RR 2.62 [95% CI 0.89, 7.72]
pinteraction = 0.35pinteraction = 0.35
00 11 22 33 44 55 66 77 88
Timing of Clopidogrel Administration and 30-Day Risk of Ischemic Outcomes
Timing of Clopidogrel Administration and 30-Day Risk of Ischemic Outcomes
S. Steinhubl TCT 2007S. Steinhubl TCT 2007
Does Periprocedural Infarct Increase With Upstream and Downstream Bivalirudin? No!Does Periprocedural Infarct Increase With
Upstream and Downstream Bivalirudin? No!
ACS PCI OutcomesACS PCI Outcomes20052005
Bival 61%Bival 61%N=373N=373
20072007Bival 91%Bival 91%
N=361N=361P valueP value
Any Transfusion (%)Any Transfusion (%) 2.02.0 1.01.0 NSNS
Death (%)Death (%) 3.03.0 1.01.0 0.080.08
Urgent revascularization (%)Urgent revascularization (%) 2.02.0 1.01.0 NSNS
MI, 50% CK-MB Rise (%)MI, 50% CK-MB Rise (%) 4.04.0 1.01.0 0.020.02
Mechanical Complication (%)Mechanical Complication (%) 8.08.0 6.06.0 NSNS
Clopidogrel preload in approx 60% of PCI patientsCK-MB on all patients the day after PCI (University of Vermont data)
Submitted, TCT 2008Submitted, TCT 2008
STEMI Switching, Clopidogrel and
Stent Thrombosis
STEMI Switching, Clopidogrel and
Stent Thrombosis
ST-Elevation Myocardial Infarction ST-Elevation Myocardial Infarction
Primary PCI for STEMI N= 7,629
Bivalirudin and GPIIbIIIa PCIN=177 (55%)
No Bivalirudin PCI N= 7,309
ClopidogrelN=171 (97%)
GP IIbIIIa Inhibitor useN=6,873 (94%)
Prior to PCI N=37 (21%)
Not Prior to PCI N= 140 (79%)
Prior to PCI N=2,489 (36%)
Not Prior to PCI N= 4,384 (64%)
Abciximab N=64 (36%)Eptifibatide N=93 (52%)Tirofiban N=1 (1%)Unkown N=19 (11%)
Abciximab N=2,283 (33%)Eptifibatide N=3,551 (52%)Tirofiban N=154 (2%)Unknown N= 885 (13%)
AbciximabN=8 (22%)EptifibatideN=27 (73%)TirofibanN=1 (3%)Unknown N=1 (2%)
AbciximabN=622 (25%)EptifibatideN=1621 (65%)TirofibanN=99 (4%)Unknown N=147 (6%)
AbciximabN=56 (40%)EptifibatideN=66 (47%)TirofibanN=0 (0%)Unknown N=18 (13%)
AbciximabN=1661 (38%)EptifibatideN=1930 (44%)TirofibanN=55 (1%)Unknown N=738 (17%)
Bivalirudin Alone N=143 (45%)
ClopidogrelPrior to PCI N=41 (24%)
ClopidogrelN=137 (96%)
Prior to PCI N=31 (23%)
ClopidogrelN=6878 (94%)
Clopidogrel Prior to PCI
N=1466 (21%)
Bivalirudin PCIN=320 (4%)
Dauerman and French, Coronary Artery Disease, 2006
The Standard of Care for STEMI PCI in 2005:The Standard of Care for STEMI PCI in 2005:National Registry of Myocardial Infarction-5National Registry of Myocardial Infarction-5
Implementation of HORIZONS AMI PCI Pharmacologic Aspects of Management
Implementation of HORIZONS AMI PCI Pharmacologic Aspects of Management
Unfractionated heparin 60 U/kg IV*; subsequent boluses titrated by nomogram to ACT 200-250
secs; terminated at procedure end unless prolonged antithrombin needed
Bivalirudin at the REPLACE-2 Dosing (NOT ACUITY) Bolus 0.75 mg/kg IV**, infusion 1.75 mg/kg/h, not titrated to ACT;
terminated at procedure end unless prolonged antithrombin needed (0.25 mg/kg/hr infusion)
Glycoprotein IIb/IIIa inhibitors Routine use in UFH arm; recommended only for giant thrombus or
refractory no reflow in bivalirudin arm Abciximab or double bolus eptifibatide as per investigator discretion –
dosing per FDA label, renal adjusted; continued for 12 (abciximab) or 12-18 (eptifibatide)
Unfractionated heparin 60 U/kg IV*; subsequent boluses titrated by nomogram to ACT 200-250
secs; terminated at procedure end unless prolonged antithrombin needed
Bivalirudin at the REPLACE-2 Dosing (NOT ACUITY) Bolus 0.75 mg/kg IV**, infusion 1.75 mg/kg/h, not titrated to ACT;
terminated at procedure end unless prolonged antithrombin needed (0.25 mg/kg/hr infusion)
Glycoprotein IIb/IIIa inhibitors Routine use in UFH arm; recommended only for giant thrombus or
refractory no reflow in bivalirudin arm Abciximab or double bolus eptifibatide as per investigator discretion –
dosing per FDA label, renal adjusted; continued for 12 (abciximab) or 12-18 (eptifibatide)
* If pre randomization UFH administered, ACT is checked first* If pre randomization UFH administered, ACT is checked first** If pre randomization UFH administered, started 30’ after last bolus** If pre randomization UFH administered, started 30’ after last bolus
Primary PCI for STEMI: Community Hospital AlgorithmPrimary PCI for STEMI: Community Hospital AlgorithmASA, Clopidogrel and UFH and then Switch to Bivalirudin at UVMASA, Clopidogrel and UFH and then Switch to Bivalirudin at UVM
Time from ED Presentation at NWMC to Open Artery at FAHC: 88 Minutes
Time from ED Presentation at NWMC to Open Artery at FAHC: 88 Minutes
27 miles, on interstate highway27 miles, on interstate highway
UFH + GP UFH + GP
IIb/IIIaIIb/IIIa(N=1802)(N=1802)
BivalirudinBivalirudin(N=1800)(N=1800)
UFH pre randomizationUFH pre randomization 65.6%65.6% 65.6%65.6%
Antithrombin in CCLAntithrombin in CCL
UFHUFH 98.9%98.9% 4.1%4.1%
BivalirudinBivalirudin 0.4%0.4% 96.9%96.9%
Peak ACTPeak ACT 264 [228, 320]264 [228, 320] 357 [300, 402]357 [300, 402]
GP IIb/IIIa in CCLGP IIb/IIIa in CCL 94.5%*94.5%* 7.2%*7.2%*
Bail-out per protocol**Bail-out per protocol** -- 4.4%4.4%
AbciximabAbciximab 49.9%49.9% 4.0%4.0%
EptifibatideEptifibatide 44.4%44.4% 3.1%3.1%
TirofibanTirofiban 0.2%0.2% 0.1%0.1%
Do I Have to Load Bivalirudin in the ED or Can I Start in the Cath Lab? The HORIZONS AMI Switching Perspective
Do I Have to Load Bivalirudin in the ED or Can I Start in the Cath Lab? The HORIZONS AMI Switching Perspective
*97.7% and 7.5% during PCI. ** For giant thrombus or refractory no reflow after *97.7% and 7.5% during PCI. ** For giant thrombus or refractory no reflow after PCI. CCL = cardiac catheterization laboratoryPCI. CCL = cardiac catheterization laboratory
G Stone TCT 2007G Stone TCT 2007
Bivalirudin Improves Mortality in STEMI Bivalirudin Improves Mortality in STEMI
Dea
th (
%)
Dea
th (
%)
Dea
th (
%)
Dea
th (
%)
Time in DaysTime in DaysTime in DaysTime in Days
3.1%3.1%
2.1%2.1%
HR [95%CI] =0.66 [0.44, 1.00]
P=0.048
HR [95%CI] =0.66 [0.44, 1.00]
P=0.048
Heparin + GPIIb/IIIa inhibitor (n=1802)Heparin + GPIIb/IIIa inhibitor (n=1802)
Bivalirudin monotherapy (n=1800)Bivalirudin monotherapy (n=1800)
G Stone TCT 2007G Stone TCT 2007
The UVM STEMI Order SheetOne Pathway for Primary PCI and ED Collaboration
The UVM STEMI Order SheetOne Pathway for Primary PCI and ED Collaboration
TESTS AND MEDICATIONSEKG: EKG for diagnosis performed within 10 minutes of ED arrival. No further EKG required.
LABORATORY:7. CBC,lytes, BUN, CR, PT, PTT, Lipids, LFT’s, CK, CK-MB and TnI sent immediately on arrival: STAT8. Other labs: MEDICATIONS: Weight: __kg Estimated / Actual (Circle one) Check patient not allergic to aspirin9. Aspirin Non- Enteric Coated 325 mg PO Daily 10. Clopidogrel 600 mg PO x one11. Bivalirudin bolus 0.75 mg/kg IV, then infusion 1.75 mg/kg/hr (STAT from Pharmacy)12. Saline Lock with routine flushes every 8 hours
OPTIONAL:13. Nitroglycerin infusion: 400 mcg/ml infusion at _______ mcg/kg/min IV Titrate to chest pain, keep systolic BP >90. 14. Lopressor 5 mg IVP x 1 if HR > 80 and SBP > 140
TESTS AND MEDICATIONSEKG: EKG for diagnosis performed within 10 minutes of ED arrival. No further EKG required.
LABORATORY:7. CBC,lytes, BUN, CR, PT, PTT, Lipids, LFT’s, CK, CK-MB and TnI sent immediately on arrival: STAT8. Other labs: MEDICATIONS: Weight: __kg Estimated / Actual (Circle one) Check patient not allergic to aspirin9. Aspirin Non- Enteric Coated 325 mg PO Daily 10. Clopidogrel 600 mg PO x one11. Bivalirudin bolus 0.75 mg/kg IV, then infusion 1.75 mg/kg/hr (STAT from Pharmacy)12. Saline Lock with routine flushes every 8 hours
OPTIONAL:13. Nitroglycerin infusion: 400 mcg/ml infusion at _______ mcg/kg/min IV Titrate to chest pain, keep systolic BP >90. 14. Lopressor 5 mg IVP x 1 if HR > 80 and SBP > 140
The Bivalirudin Strategy for STEMI PCIThe Bivalirudin Strategy for STEMI PCI
ASA, clopidogrel 600 po x 1, bivalirudin and stent
What About The Stent Thrombosis Risk? What About The Stent Thrombosis Risk?
*Protocol definition of stent thrombosis, CEC adjudicated*Protocol definition of stent thrombosis, CEC adjudicated*Protocol definition of stent thrombosis, CEC adjudicated*Protocol definition of stent thrombosis, CEC adjudicated
UFH + GP IIb/IIIaUFH + GP IIb/IIIa(N=1553)(N=1553)
BivalirudinBivalirudin(N=1571)(N=1571)
PPValueValue
ARC definite or ARC definite or probable*probable*
1.9%1.9% 2.5%2.5% 0.330.33
DefiniteDefinite 1.4%1.4% 2.2%2.2% 0.110.11
ProbableProbable 0.5%0.5% 0.3%0.3% 0.260.26
Acute Acute (≤24 hrs)(≤24 hrs)
0.3%0.3% 1.3%1.3% 0.00090.0009
Subacute Subacute (>24 hrs – 30d)(>24 hrs – 30d)
1.7%1.7% 1.2%1.2% 0.300.30
G Stone TCT 2007G Stone TCT 2007
Sianos, G. et al. J Am Coll Cardiol 2007;50:573-583
Risk Stratification For STEMI Stent ThrombosisRisk Stratification For STEMI Stent ThrombosisThe Importance of Thrombus BurdenThe Importance of Thrombus Burden
Large thrombus burden (LTB), defined as thrombus burden > 2 vessel diameters: Approx 25% of STEMI
Large thrombus burden (LTB), defined as thrombus burden > 2 vessel diameters: Approx 25% of STEMI
Sianos, G. et al. J Am Coll Cardiol 2007;50:573-583
Drug Eluting Stent Thrombosis and Large Thrombus Drug Eluting Stent Thrombosis and Large Thrombus Burden: Modifying Strategy In Highest Risk PatientsBurden: Modifying Strategy In Highest Risk Patients
Large Thrombus Burden> 5 fold Increased Risk of
30 Day Stent Thrombosis
Large Thrombus Burden> 5 fold Increased Risk of
30 Day Stent Thrombosis
ThrombectomyProlonged BivalirudinGPI
ThrombectomyProlonged BivalirudinGPI
LTB vs. STB, p<0.001LTB vs. STB, p<0.001
Total PopulationTotal Population
STBSTB
LTBLTB
2.7%2.7%3.2%3.2%
5.8%5.8%
8.2%8.2%
1.1%1.1% 1.4%1.4%2.1%2.1% 3.2%3.2%
0.5%0.5% 0.7%0.7% 0.7%0.7%1.3%1.3%
0 1 3 6 9 12 15 18 21 240 1 3 6 9 12 15 18 21 24
15
12
9
6
3
0
15
12
9
6
3
0
Months of follow-upMonths of follow-up
Cum
ulat
ive
IRA
-ST
Rat
e (%
)C
umul
ativ
e IR
A-S
T R
ate
(%)
ACUITYACUITYHeparinHeparin + IIb/IIIa+ IIb/IIIa(N=222)(N=222)
Bivalirudin Bivalirudin + + IIb/IIIaIIb/IIIa
(N=241)(N=241)
Bivalirudin Bivalirudin
alonealone(N=249)(N=249)
P valueP value3-way3-way
Any thrombotic Any thrombotic complication post complication post
PCIPCI8.6%8.6% 3.7%3.7% 5.6%5.6% 0.090.09
Final TIMI flow 3Final TIMI flow 3 90.5%90.5% 93.7%93.7% 90.7%90.7% 0.370.37
Final blush grade 3Final blush grade 3 81.5%81.5% 79.0%79.0% 79.5%79.5% 0.780.78
ACUITY and Large Thrombus DataThe Rationale for Selective Adjunctive GPI
ACUITY and Large Thrombus DataThe Rationale for Selective Adjunctive GPI
* New or ↑ thrombus, abrupt closure, no reflow, or distal embolization * New or ↑ thrombus, abrupt closure, no reflow, or distal embolization
G. Stone AHA 2006G. Stone AHA 2006
Projecting What Happens if You Use GPI in 25% of Your Bivalirudin STEMI Patients
Projecting What Happens if You Use GPI in 25% of Your Bivalirudin STEMI Patients
Assumes Bival + GPI bleeding rate of 6.8%Assumes Bival + GPI bleeding rate of 6.8%
P < 0.001
Still P < 0.001Still P < 0.001
HORIZONS 7%HORIZONS 7% UVM Implemented HORIZONS—25%UVM Implemented HORIZONS—25%
4.9 5.2
8.3 8.3
0
1
2
3
4
5
6
7
8
9
Maj
or B
leed
ing,
%
Bival +UFH + GPI
Incorporation of HORIZONS AMI and Large Thrombus Data—STEMI Algorithm
Incorporation of HORIZONS AMI and Large Thrombus Data—STEMI Algorithm
► ED STEMI—25% of PatientsED STEMI—25% of Patients► ASA/clopidogrel 600 mg po ASA/clopidogrel 600 mg po
load and bivalirudinload and bivalirudin► Bolus and infusion of Bolus and infusion of
eptifibatide after wiring eptifibatide after wiring vessel shows Large vessel shows Large Thrombus BurdenThrombus Burden
► Angiojet and Bare Metal Angiojet and Bare Metal StentStent
► 150 mg clopidogrel and 18 150 mg clopidogrel and 18 hours of eptifibatidehours of eptifibatide
► No ambulation until No ambulation until eptifibatide off (18 hours)eptifibatide off (18 hours)
► D/C on Day 3 postD/C on Day 3 post MI
STEMI:STEMI:Within 24 Hours CPWithin 24 Hours CP
UFH (60 U/Kg)UFH (60 U/Kg)Beta Blockers only if HTNBeta Blockers only if HTN
UFH or Bivalirudin:UFH or Bivalirudin:GPI Optional: Avoid if High Bleed RiskGPI Optional: Avoid if High Bleed Risk
B Blockers ONLY if HTNB Blockers ONLY if HTN
PCI Capability or < 60 minute Transfer Time
No PCI Capability and > 60 minute Transfer Time
Primary PCI with Stenting:Primary PCI with Stenting:GPI/Thrombectomy if Large ThrombusGPI/Thrombectomy if Large Thrombus
or as Bailout; Otherwise, Bivalirudin Aloneor as Bailout; Otherwise, Bivalirudin Alone
90 minutesTo Open
Artery Lytic Lytic ContraindicatedContraindicated
Emergent Transfer
TNK and UFHTNK and UFH
Transfer Transfer from from Community ERCommunity ER
To PCI SiteTo PCI Site
If no CP and less than 50% If no CP and less than 50% ST Elevations, PCI at 12-24ST Elevations, PCI at 12-24
Hours with StentHours with Stent
If Reperfusion Fails,If Reperfusion Fails,Emergent PCI with stentEmergent PCI with stent
ASA/ClopidogrelASA/ClopidogrelStatinStatin
Groin ClosureGroin ClosureCardiac RehabCardiac Rehab
Lopressor 12.5 bidLopressor 12.5 bid
Transfer
Rescue PCI:
Class I Indication
The NSTEMI Paradigm
of 4-48 Hours
ASA 325 po
ClopidogrelClopidogrel600 po600 po
Clopidogrel Clopidogrel 300 po300 po
Continue bivalirudin for 2 hours after PCI
Conclusions Key Implementation Points
Conclusions Key Implementation Points
► Bivalirudin can be safely instituted across the spectrum of PCI patients, including those with NSTE-ACS and STEMI.
► Clopidogrel 600 mg po load may be done in ED or immediately after PCI.
► Community referring hospitals may use antithrombotic therapy of choice—then switch to bivalirudin on arrival to PCI institution.
► STEMI requires an algorithm for care and bivalirudin is the baseline strategy. But, bivalirudin may be instituted in the ED or the cath lab, depending upon local issues.
► Enhanced management of large thrombus burden should be considered especially during the most “vulnerable” 2 hours after PCI.
► Bivalirudin can be safely instituted across the spectrum of PCI patients, including those with NSTE-ACS and STEMI.
► Clopidogrel 600 mg po load may be done in ED or immediately after PCI.
► Community referring hospitals may use antithrombotic therapy of choice—then switch to bivalirudin on arrival to PCI institution.
► STEMI requires an algorithm for care and bivalirudin is the baseline strategy. But, bivalirudin may be instituted in the ED or the cath lab, depending upon local issues.
► Enhanced management of large thrombus burden should be considered especially during the most “vulnerable” 2 hours after PCI.
Questions for the PanelQuestions for the Panel
► Does a consistent, unified upstream strategy for anticoagulation across the STEMI and NSTE-ACS risk spectrum make sense? When does it? When doesn’t it?
► Given that bleeding appears to be a driver of MACE events, including mortality, in ACS and STEMI, and since switching to bivalirudin appears to decrease bleeding, should this switching strategy be promulgated in patients undergoing PCI?
► What are the best ways, from an institutional/process-of-care perspective, to establish a consistent antithrombotic strategy for this patient population?
► Other issues? We’ll answer your questions!
► Does a consistent, unified upstream strategy for anticoagulation across the STEMI and NSTE-ACS risk spectrum make sense? When does it? When doesn’t it?
► Given that bleeding appears to be a driver of MACE events, including mortality, in ACS and STEMI, and since switching to bivalirudin appears to decrease bleeding, should this switching strategy be promulgated in patients undergoing PCI?
► What are the best ways, from an institutional/process-of-care perspective, to establish a consistent antithrombotic strategy for this patient population?
► Other issues? We’ll answer your questions!