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Anticoagulation and Antiplatelets in Coronary Angioplasty
Patients with High Hemorrhagic Risk- Indications and evidence for a tailored
treatment
Alexandra Lansky, MD
Yale University School of Medicine
University College of London
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• Antiplatelet drugs
• Cox-1 inhibitors
• P2Y12 inhibitors
• Glycoprotein Inhibitors
• Oral Anticoagulants
• Vit K Antagonists
• Factor Xa inhibitors
• Antithrombins
• Indirect thrombin Inhibitors (Heparin, LMWH)
• Direct Thrombin Inhibitors (Bivalirudin)
Anticoagulation and Antiplatelets in
Coronary Angioplasty
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High Hemorrhagic Risk
Clinical Senarios to Discuss
The Patient requiring anticoagulation
The Patient who bleeds
The Patient who needs surgery
What Stent?
What Drug?
How Long?
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Impact of BARC type 3-5 Bleeding
on 1 Year Mortality
Prognosis of Bleeding after Stent
Implantation
P<0.001
Ndrepepa G et al. Circulation 2012
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High Hemorrhagic Risk
Clinical Senarios to Discuss
Procedural anticoagulation Consideration
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Bivalirudin vs Heparin + GPI in ACS
STEMI
AHA/ACC 2012 GPG
In Patients with STEMI Bivalirudin is the preferred
IV anticoagulant agent
NSTEMI
AHA/ACC 2012 GPG
In Patients with NSTEMI Bivalirudin OR Heparin
* GPI with high risk features not adequately treated with
P2Y12 (Class I a); adequately pretreated (Class IIb)
B
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EUROMAX BRIGHT HEAT PPCI
N Center 65 82 1
N patients 2,198 2,194 1,812
- Bivalirudin 1,089 735 905
- Heparin 460 729 907
- Heparin + GPI 649 730 --
- Heparin bolus 60 IU/kg 100 IU/kg 70 IU/kg
- Bival Infusion 4.5 hrs 4.0 hrs No
- GPI Bail out 7.9% vs 25% 4.4% vs 5.6% 13.5% vs 15.5%
- New P2Y12 59% 0 89%
- Radial 47% 79% 81%
Current Controversies
Bivalirudin vs Heparin in STEMI
Recent Studies (6,200 pts)
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Sabatine M. The Lancet 2014
Metananalysis:Bivalirudin vs Heparin
MACE
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Sabatine M. The Lancet 2014
Metananalysis:Bivalirudin vs Heparin
Ischemic Events
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GPI mainly in Heparin Arm
Provisional GPI in both Arm
Planned GPI in both Arm
Metananalysis:Bivalirudin vs Heparin
Bleeding and GPI Utilization
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Increasing Bleeding According to
GPI Utilization L
og
od
ds
ra
tio
Favors
Heparin
Favors
Bivalirudin P:0.02
Presented at TCT September 2014
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ESC 2014 Guidelines
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High Hemorrhagic Risk
Clinical Senarios to Discuss
The Patient requiring anticoagulation
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Incidence of Bleeding in Relation to Antithrombotic Therapy
Sørensen R et al. Lancet 2009;374:1967-74
40,812 patients with MI between 2005-2008
Yearl
y i
ncid
en
ce (
%)
Single
Therapy
Dual
Therapy
Triple
Therapy
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0.0
0.0
20
.04
0.0
60
.08
0.1
0
0.0 0.5 1.0 1.5
OAC
Clopidogrel+ASA
ACTIVE W: OAC vs ASA+ Clopidogrel
6706 Pts with Afib at risk of Stroke C
um
ula
tive H
aza
rd R
ate
s
Years
3.93 %/year
5.64 %/year RR = 1.45
P = 0.0002
Lancet 2006 Jun 10;367(9526):1903-12.
Stroke, Non-CNS Systemic Embolism, MI & Vascular Death
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Is OAC needed? Stroke Risk in Afib: CHADS-VASc Score > 2
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Predicting Bleeding after Stent Implantation
HAS-BLED Score > 2
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Management of Antithrombotic Therapy in Afib Patients
with ACS or Undergoing PCI: ESC
ESC WG Thrombosis Consensus Document: Lip G et al. Eur Heart J 2010;31:1311-18
Hemorrhagic
Risk Clinical Setting Stent Type Recommendation
Low
or
Intermediate
Elective BMS 1 month: ASA, Clop, OAC
Lifelong: OAC alone
Elective DES
3 months: ASA, Clop, OAC
3-12 months: Clop, OAC
Lifelong: OAC alone
ACS BMS/DES
6 months: ASA, Clop, OAC
6-12 months: OAC, ASA or Clop
Lifelong: OAC alone
High
Elective BMS 2-4 weeks: ASA, Clop, OAC
Lifelong: OAC alone
ACS BMS
4 weeks: ASA, Clop, OAC
1-12 months: OAC, ASA or Clop
Lifelong: OAC alone
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Consensus Document: Antithrombotic Therapy In Patients With Atrial Fibrillation Undergoing Coronary Stenting
A North-American Perspective
Faxon D et al. Thromb Haemost 2011; 106: 571–584
High risk ST and low bleeding risk
Low risk ST and low bleeding risk
Any risk ST and high bleeding risk
BMS - Triple Rx for at least 1 mo then OAC+ single
AP for 12 mo
DES - Triple Rx for at least 6 mo then OAC+ single
AP for 12 mo
After 12 mo OAC indefinitely
BMS - Triple Rx for at least 1 mo then OAC+ single
AP for 12 mo
DES - not recommended
BMS - Triple Rx for at least 6 mo then OAC+ single
AP for 12 mo
DES - Triple Rx for 12 mo
Atrial fibrillation and a coronary stent with moderate/high stroke risk (CHADS2>1)
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High Hemorrhagic Risk
Clinical Scenarios to Discuss
The Patient who bleeds
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A 67-year-old Woman Admitted with melanotic stool
Risk factors: hypertension, dyslipidemia, chronic atrial fibrillation, and smoking, prior TIA
No history of bleeding diathesis
HPI:
- 4 weeks ago was hospitalized for STEMI, was treated with primary PCI to Prox LAD using drug-eluting stent, LVEF 40%
- Meds at discharge: ASA 325 mg/d qd, coumadin 5.0 mg alter with 2.5 mg /day, Clopidogrel 75 mg/d qd, Carvedilol 12.5 mg bid, Lisinopril 40 mg qd, rosuvastatin 20 mg qd
CHADsVAS= 4
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Physical Findings
• BP 96/68 mm Hg;
• HR 110/min, irregular;
• RR 18/min, Sat – 96%
• Cardiac exam: normal S1, S2,
no murmurs or rubs
• Clear lungs
• Abdomen: soft, mild
tenderness in epigastrium,
normal bowel sounds
• Labs: Hgb – 9.2 g/dL (12.8
g/dL 1 months ago), Hct –
26%
Management
• 0.9% Sodium Chloride IV
• Blood type was defined
• Omeprazole IV was
started: 80 mg bolus
followed by 8 mg/hr
infusion
• Gastroenterologist was
called, and urgent
endoscopy was
performed
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Endoscopy: a bleeding duodenal ulcer with
adherent clot
• Endoscopic treatment: epinephrine injection plus thermocoagulation to the point of vessel obliteration
• Campylobacter pylori (+)
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Rockall Scoring System for Predicting Re-bleeding and Mortality Based on Endoscopic and Clinical Variables
Score
Age
<60 0
60-79 1
>79 2
Shock
None 0
tachycardia 1
Hypotension 2
Comorbidity
None 0
CAD, CHF, other major comorbidity 1
Renal failure, liver failure, malignancy 2
Diagnosis
Mallory Weiss tear or no lesion observed 0
All other diagnosis 1
Malignant lesion 2
Stigmas of recent hemorrhage
None or spot in ulcer base 0
Blood in the GI tract, clot, visible vessel in ulcer base
2
Rockhall TA et al: Lancet 1996:347: 1138-1140
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Rockall Scoring and Prognosis after Upper GIB
Score Re-bleeding % Mortality %
1 3% 0%
2 5% 0%
3 12% 2%
4 13% 4%
5 17% 8%
6 30% 15%
7 40% 20%
8 48% 39%
Rockhall TA et al: Lancet 1996:347: 1138-1140
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Post Endoscopy
Omeprazole infusion 8 mg/hr for 72 hrs, followed
by Omeprazole 20 mg qd
ASA discontinued, coumadin held
Clopidogrel 75 mg qd continued
Clarithromycin 500 mg bid and amoxicillin 1 g bid
for 2 weeks
No signs of continuing GIB for 2 weeks
Repeated EGDS: healing duodenal ulcer
coumadin restarted 2.5 mg/day
F/U: uneventful at 1 year
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High Hemorrhagic Risk
Clinical Scenarios to Discuss
The Patient who needs surgery
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Bleeding Risk in Various Surgeries
Bleeding Risk Clinical Severity Type of Surgery
Low • Transfusions
rare
• Peripheral: plastic/general, biopsies
• Minor orthopedic, ENT general
• Endoscopy
• Eye: anterior chamber
• Dental
Intermediate
• Transfusions may be frequent
• More re-op, LOS
• Visceral
• Cardiovascular surgery
• Major orthopedic, ENT
• Urologic reconstructive
High • Bleeding into a
closed space
• Intracranial
• Spinal
• Eye: posterior chamber
Adapted from Abualsaud and Eisenberg, JACC: CV Intv 2010
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Late Surgery Group
(Beyond 3 months)
Early Surgery Group
(3 months)
3/34 8.9%
2 Deaths 1 MI
1/159 0.6% 1 MI
SENS Registry
p<0.001
Patients treated with ZES Undergoing Surgery and Discontinuing DAPT within 1 Year
Kim JW et al, ACC 2009
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Patients undergoing PCI:
Treatment interruption
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Strategies for Upcoming Surgery
• If at all possible, delay surgery!
Ideally 6 weeks for BMS*
• Less only if necessary
Ideally 6 months to 1 yr for DES*
• Likely 3-6 months with 2nd gen DES
• If surgery is needed and bleeding risk
low, continue DAPT through surgery