incidence, impact and preventative strategies for non-access site bleeding in the pci patient
DESCRIPTION
Incidence, impact and preventative strategies for non-access site bleeding in the PCI patient. Martial Hamon. MD. FESC University Hospital. Caen. France. PTRANSCRIPT
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Incidence, impact and preventative strategies for non-access site bleeding
in the PCI patient
Martial Hamon. MD. FESCUniversity Hospital. Caen. France
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Vasc
ular
Com
plic
atio
ns (%
)
0123456789
Group 1 Group 2 Group 31994-95 1996-99 2000-05
P<0.001For trend
Doyle BJ et al. JACC Intervention 2008;1:202-209.
Changing Incidence from the earliest (8.4%)to the contemporary time period (3.5%)
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Doyle BJ et al. JACC Intervention 2008;1:202-209.
Major Femoral BleedingComplications After PCI
Impacton Survival
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Jolly S et al. Am Heart J 2009
Meta-analysis of 18 Randomized Trials
Radial vs Femoral AccessImpact on Major Bleeding
RADIAL VS FEMORAL
Favours RADIAL Favours FEMORALMajor Bleeding: 0.54% vs 2.32%
(5 had no bleeding events) 4.458 patients
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Death,MI or StrokeMeta-analysis of Randomized Trials
Radial vs Femoral AccessImpact on Ischemic Outcomes
Jolly S et al. Am Heart J 2009
RADIAL VS FEMORAL
Favours RADIAL Favours FEMORALTrend for reduction in composite
of death.MI. stroke(2.5% vs 3.8%. P = .06)
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Endpoint Measures at Day 30 Radial vs. Femoral
11.1%10.5% 0.95 (0.77-1.17) 0.62
0 1 2
Risk ratio±95% CIEndpoint
Net clinical outcome
Ischemic composite
Major bleeding
Radial better Femoral better
Radial(n=798)
Femoral(n=11.988)
OR (95% CI)adjusted p-value
7.4%8.1% 1.10 (0.86-1.40) 0.45
4.8%3.0% 0.63 (0.42-0.95) 0.02
ACUITY
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ACUITY: Femoral vs. Radial AccessMajor or Minor Organ Bleeding
Hamon M. Rasmussen LH. Manoukian SV. et al. EuroIntervention 2009.
0
5
10
Femoral Radial
Heparin+GPI Bivalirudin
Major or minor organ bleeding were reduced to a similar extent in patients treated with bivalirudin alone compared to heparin plus a GPI and were
present with both femoral access (4.1% vs 7.4% respectively. p<0.0001) and radial access (4.9% vs 7.2% respectively. p=0.26).
7.4% 4.1% 7.2% 4.9%
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0.67 1.2
3.7
5.9
3.1 3.7
0
1
2
3
4
5
6
7
ACUITY 30 Days
TRITON 3 Days
EARLY ACS 120 hours
SYNERGY 30 Days
OASIS 5 9 days
ABOARD 30 Days
Early Non-CABG Major Bleeding in ACS Trials in PCI-Treated Patients
88% FemoralAccess
84% RadialAccess
Percent Protocol Major Bleed
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Bleeding definitions
Variation in definitions
Intracranial hemorrhage
Retroperitoneal hemorrhage
Bleeding with 5g/dL fall in hemoglobin
Bleeding with 3g/dL fall in hemoglobin
4g/dL fall in hemoglobin without site
Blood transfusion 3 units
TIMI Major
TIMI Minor
Gross hematuria or hematemesis
Lincoff et al. JAMA 2003
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Beyond Access Site Bleeding:
Incidence, Sources, and Impact of Antithrombotic Therapy in
the PCI Patient A Combined Analysis of 17,393 Patients REPLACE-2, ACUITY and HORIZONS-AMI
Freek W.A. Verheugt, Steven R. Steinhubl, Martial Hamon, Harald Darius, Ph. Gabriel Steg, Marco Valgimigli, Steven
P. Marso, Sunil V. Rao, Anthony H. Gershlick.
Onze Lieve Vrouwe Gasthuis, Amsterdam
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Bleeding Definitions - 30-day Endpoint
1. Protocol Major (different between REPLACE-2 and ACUITY, HORIZONS)
2. TIMI Major
3. TIMI Minor
4. TIMI Major + Minor
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Purpose1. To identify the incidence and source of
bleeding events unrelated to access site among over 17,300 patients undergoing a PCI for a wide variety of clinical diagnoses.
2. Evaluate the impact of antithrombotic therapy (bivalirudin versus heparin + GPIIb/IIIa antagonist) on the occurrence of bleeding unrelated to the access site.
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Analysis Population:All PCI patients (ITT) from:
REPLACE-2 N = 6,002ACUITY N = 7,789HORIZONS N = 3,602
Total N = 17,393*
* For primary antithrombotic comparisons the GPIIb/IIIa antagonist + bivalirudin arm (n=2609) of ACUITY was excluded, leaving a total of 14,784 patients.
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Patient Demographics – N=17,393Age (years)Age ≥ 75 years (%)Weight (kg)Female (%)Diabetes (%)Current Smoker (%)CrCl < 60Baseline Diagnosis
STEMINSTEMIUnstable AnginaStable AnginaOther
62.3 ± 11.416.0%
85.6 ± 17.825.7%25.1%32.3%17.0%
20.7%30.0%29.5%8.6%11.2%
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Sources of Bleeding1. Access Site Only
2. Both Access and Non-Access
3. Non-Access Site Only
4. No Identified Location
Location of bleeds were determined post hoc using investigator-identified location and without knowledge of randomized therapy.
• Intracranial• Intraocular• Gastrointestinal• Genitourinary• Pleural• Pulmonary• Head and Neck• Epistaxis• Hemoptysis• Hematemasis• Gingival• Other
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Sources and Incidence of TIMI Bleeding Among 17,393 PCI Patients 5.3% (n=925) of the study population experienced a TIMI
(Major + Minor) bleeding event.
Access-site only bleeds occurred in
357 (39.6%) of patients.
Bleeding events not
limited to the access site occurred in
568 (60.4%) of patients.
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Figure 2
Incidence and Location of Bleeding Events Excluding Access Site
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Adjusted Relative Risk of 1-Year Mortality Based on TIMI Bleeding Source Compared to
No BleedingP<0.0001 for all bleeding versus none
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Impact of Randomized Antithrombotic Therapy: All Bleeding Sources
RR=0.52P<0.0001
RR=0.55P<0.0001RR=0.55
P<0.0001
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Relative Risk P-Value
Access 0.45 <0.0001
All Non-Access 0.62 <0.0001
Both 0.31 <0.0001
Non-Access Only 0.70 0.08
No Location 0.75 0.02
Bivalirudin better Hep + GPI better
0 0.5 1 1.5 2
Figure 3
Impact of Randomized Antithrombotic Therapy on TIMI Major + Minor
Bleeding by Source
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Hep + GPI (%)
Bivalirudin (%)
Relative Risk
Intracranial 0.04 0.03 0.66
GI 0.64 0.28 0.44
GU 0.64 0.28 0.44
HEENT 0.33 0.22 0.66
Pulmonary 0.18 0.05 0.31
Other 0.30 0.15 0.49
No Location 1.87 1.40 0.75
All Non-Access 3.66 2.27 0.62
Hep + GPI betterBivalirudin better
Impact of Randomized Therapy on TIMI Bleeding by Location Exclusive of Access Site
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Conclusions1. Two-thirds of PCI patients with a TIMI bleed unrelated
to the access site.
2. Bleeding, irrespective of the source, significantly associated with increased mortality at 1 year.
3. Non-access-related bleeding associated with double the risk of mortality compared to access bleeding.
4. The use of bivalirudin during a PCI associated with ~40% reduction in non-access site bleeding compared with heparin + a GPIIb/IIIa antagonist.
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Risk Factors For Bleeding in ACS Patients
Patient related Procedural related Treatment related
Female genderOlderHypertensionObesityLow weightRenal failureLow platelet count. pre-existing aneamiaMedical history (GI disease)
Puncture site (femoral vs radial)Level of puncture (femoral)Larger arterial sheathProlonged sheath timeIABP placementConcomitant venous sheathNeed for repeat intervention
Over anticoagulationType of anticoagulation (antiXa. direct thrombin inhibtor or LMWH and UFH)GP IIb/IIIa inhibitorsThrombolytic
Reducing Bleeding Risk: Preventive Actions
Patient level Procedural level Treatment level
Patient information (coughing. heavy lifting to be avoided after femoral puncture)Nurse training for early recognition of retroperitoneal hemorrhage
Perfect puncture siteAngiographic control before closure device useAlternative: RADIAL AccessDifferent access sites for staged proceduresDecrease size of arterial sheath
ACT during procedures for anticoagulation monitorringDiscontinuation of antithrombin after uncomplicated PCINew Antithrombotic Agents (Bivalirudin. Fondaparinux)
Identification of Risk Factors For Bleedingin ACS Patients and Preventive actions
Hamon M. et al. EuroIntervention 2007
Identification
Prevention
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PCI in ACS: Choice of Access Site
1. Radial Access Feasible?
2. Consider Bleeding risk?
Radial AccessConsider bleeding risk
Femoral AccessAdjunctive therapy needed?
YES NO
3. Consider Ischemic Risk?
LOW
HIGH LOW
HIGH
Default radialoperators
Am J Cardiol 2009 Hamon et al.BivalirudinBivalirudin or GPI