American Heart Association Scientific Sessions – November 5, 2007
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Transcript of American Heart Association Scientific Sessions – November 5, 2007
Bleeding in Patients Undergoing Percutaneous Coronary
Interventions: A Risk Model From 302,152 Patients in the
NCDR.
Sameer K. Mehta MD, Andrew D. Frutkin MD, Sunil V. Rao MD, Fang–Shu Ou MS, Eric D.
Peterson MD, MPH, John A. Spertus MD, MPH, Steven P. Marso MD, on behalf of the NCDR
The Mid America Heart Institute and Duke Clinical Research Institute.
American Heart Association Scientific Sessions – November 5, 2007American Heart Association Scientific Sessions – November 5, 2007
Presenter Disclosure Information
Sameer K. Mehta MD et al.Bleeding in Patients Undergoing Percutaneous
CoronaryInterventions: A Predictive Model From 302,152
Patients in the NCDR.
No authors report any disclosures or conflicts of interest.
Bleeding and PCI
• The incidence of major bleeding in patients undergoing PCI is as high as 5%.
• Bleeding events have been associated with an increased incidence of adverse outcomes, including death, MI, and stroke.
• A tool that helps physicians assess the risk of bleeding in PCI patients may allow physicians to individualize antithrombotic and antiplatelet therapy while mitigating the risk of bleeding.
Goodman et al. Circulation 2003.
Eikelboom et al. Circulation 2007.
Rao et al. American Journal of Cardiology 2005.
Aims
• To determine the risk factors of bleeding in a large, contemporary, real-world cohort of patients undergoing PCI.
• To develop a risk model for bleeding. • To test the validity of this risk model in
clinically important subgroups.
Methods
• Version 3.04 of NCDR Cath-PCI Registry• Contains data from PCI procedures performed
from Jan. 1, 2004 to March 31, 2006 at over 600 U.S. hospitals.
• Exclusions:- Non-index PCI- Patients who died same day as PCI - Patients with missing bleeding data- Centers that did not report any bleeding events
Methods (2)
• Final study population:– 302,152 patients – 302,152 PCI procedures– 440 U.S. hospitals
• Determined predictors of bleeding with generalized estimating equation models.– Models adjusted for age, sex, weight, GFR, PCI status,
presence of ACS, cardiogenic shock, intra-aortic balloon pump treatment, history of MI, diabetes, cerebrovascular disease, peripheral vascular disease, hypertension, COPD, prior PCI, NYHA class, prior valve surgery, Caucasian, prior CHF, smoker, family history of CAD, EF, dyslipidemia, prior CABG, and CHF.
Methods (3)
• Risk model training set.– 241,512 patients (80% of total)
• Risk model validation set– 60,640 patients (20% of total)
• Variable selection via backward selection and clinical judgment
• Goodness of fit determined by calibration plot• Discrimination assessed by c-statistic • Risk model tested in various clinically meaningful
subgroups
NCDR Bleeding Definitions
Primary Endpoint: Bleeding from any source
• Percutaneous entry site: – during hospitalization; – transfusion and/or cause a drop in hemoglobin >3.0 g/dl; – hematoma
• >10cm for femoral access, • >2cm for radial access, • or >5cm for brachial access.
• Retroperitoneal:– transfusion and/or cause a drop in hemoglobin >3.0 g/dl.
NCDR Bleeding Definitions (2)
• GI:– transfusion and/or cause a drop in hemoglobin >3.0 g/dl.
• GU:– transfusion and/or cause a drop in hemoglobin >3.0 g/dl.
• Other/Unknown:– During hospitalization– transfusion and/or cause a drop in hemoglobin >3.0 g/dl.
Select Baseline CharacteristicsAge (years, median) 64
Female (%) 34
Caucasian (%) 87
Weight <50 kg (%) 1.5
GFR <30 (%) 10
Hypertension (%) 25
ACS (%) 66
Cardiogenic Shock (%) 2.0
IABP (%) 2.2
2b/3a Use (%) 48
Direct Thrombin Inhibitor (%) 32
Results
Incidence of Bleeding in Training Set
2.5%
Risk Factors for Bleeding- Adjusted Analysis
Variable OR 95% CI Square
Female 1.74 1.64-1.85
319.3
Age (per 10 yrs) 1.36 1.31-1.42
223.6
GFR (per 10 ml/min decrease)
1.11 1.10-1.13
210.2
Prior PCI 0.69 0.64-0.73
128.9
Cardiogenic Shock 1.87 1.66-2.10
104.7
Emergent/Salvage PCIUrgent PCI
2.221.46
1.98-2.491.34-1.57
81.7
COPD 1.31 1.23-1.39
70.6
All p values <0.001
Risk Factors for Bleeding- Adjusted Analysis
Variable OR 95% CI Square
NYHA Class 3NYHA Class 4
1.141.42
1.05-1.241.30-1.56
41.4
Non-STEMI/ Unstable AnginaSTEMI
1.131.49
1.04-1.221.32-1.69
35.9
Prior Valve Surgery 1.61 1.34-1.94 24.8
CVD 1.16 1.09-1.24 19.1
Intra-aortic balloon pump
1.95 1.41-2.70 16.1
PVD 1.15 1.07-1.23 13.6
HTN 1.12 1.05-1.19 12.5
Weight (per 5 kg decrease)
1.02 1.01-1.03 11.9
Overall Model
N= 60,640
C Statistic =0.73
Pre
dict
ed B
leed
ing
(%)
Observed Bleeding (%)
Subgroup Analyses
N= 9,130
C Statistic =0.70
N= 30,872
C Statistic =0.72
Pre
dict
ed B
leed
ing
(%)
Observed Bleeding (%)
Elective PCI Patients
N= 29,733
C Statistic =0.67
Pre
dict
ed B
leed
ing
(%)
Observed Bleeding (%)
Antithrombotic Therapy
N=24,969
C Statistic =0.73
N= 22,666
C Statistic =0.72
Pre
dict
ed B
leed
ing
(%)
Observed Bleeding (%)
Unfractionated HeparinUnfractionated Heparin
plus IIb/IIIa
Antithrombotic Therapy
N= 19,316
C Statistic =0.73
N= 10,108
C Statistic =0.68
Pre
dict
ed B
leed
ing
(%)
Observed Bleeding (%)
Low Molecular Weight Heparin Direct Thrombin Inhibitors
Conclusions
• Identified risk factors for bleeding in PCI patients
• Developed a risk model that predicted the risk of bleeding in patients undergoing PCI
• Model performed well in various clinically important subgroups
Limitations
• Bleeding definitions differ between NCDR and TIMI/ GUSTO
• Low reported incidence of bleeding events
Future Directions
• Risk Score for Bleeding.• Implementation of predictive model/ risk
score into randomized studies of patients undergoing PCI.