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STATINS PRE-PCI: A Prospective, Randomized Trial of Statins Prior to Stent Implantation in Patients with
Stable Angina
Josef VESELKA
CardioVascular Center
University Hospital Motol
Prague, Czech Republic
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Disclosure Statement
I, Josef Veselka DO NOT have a financialinterest/arrangement or affiliation with
oneor more organizations that could be
perceived as a real or apparent conflict of
interest in the context of the subject of this
presentation.
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Background
• Periprocedural non-Q MI (PMI) is a frequent and prognostically important complication of PCI.
• The available randomized studies suggest that statins prevent PMI1-4.
1-2/ Briguori C. et al. EHJ 2004, JACC 20093/ DiSciascio G. et al. JACC 20094/ Pasceri V. et al., Circulation 2004
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Mechanisms of Plaque Stabilization
• Thicken fibrous cap
• Remove lipids
• Reduce thrombosis
• Reduction of inflammation
• Improvement of endothelial function
• Increase of NO bioavailability
Danesh RD, Kanwar YS. FASEB J 2004;18:805-15.
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Pilot, non-randomized study
Pre-procedural statin therapy reduces risk and extent of cardiac biomarker release
following PCI.
400 consecutive pts. with SAP treated by PCI.
Statin group: 218 pts.(81% pts. simvastatin 20 mg)
No statin group: 182 pts.
Veselka J. et al. Heart Vessels 2006
12% vs 20%p = 0.04 OR 1.84 95% CI 1.1 to 3.2
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Purpose
• The purpose of this randomized study was to investigate, in stable angina pectoris patients undergoing elective PCI, the effect of two-day atorvastatin (80 mg) therapy on the incidence of PMI.
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Design393 patients with SAP
Statin – YES193 pts.
Statin – NO200 pts.
RANDOMIZATION 1:1
100 pts.Atorvastatin 80 mg
2 day therapy, then PCI
100 pts.Immediate PCI
193 pts. Registry
Immediate PCI
TnI and CK-MB mass 16-24 hours after PCI
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Sample size
The sample size was based on previous studies1, 2 to demonstrate a reduction in the primary end point from 18% in the Control group to 5% in the Atorvastatin group (two-sided chi square test, α = 0.05, power = 0.83)
1/ Pasceri V. et al., Circulation 20042/ Veselka J. et al. Heart Vessels 2006
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Inclusion / exclusion criteria
• Inclusion:– patients with stable angina pectoris or a
pathological exercise test – de-novo lesion 50 - 99% of luminal diameter
• Exclusion:– major diseases other than angina pectoris– acute coronary syndromes in the last two
weeks
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End-point
• The primary end point of this study was the incidence of PMI based on post-interventional release of Troponin I (TnI) and creatine kinase-MB mass (CK-MB mass).
• TnI and CK-MB mass values were considered abnormal if they were elevated at least 3 times ULN.
• Blood samples for TnI (CK-MB mass) measurements were taken immediately prior to PCI and 16-24 hours thereafter.
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Patient characteristics at randomization
Atorvastatin group100 pts.
Control group100 pts.
p value
Age(range)
68 ± 11(44-91)
64 ± 10(46-89)
0.006
Gender (male) 54% 79% < 0.001
Angina pectoris, class (CCS)
2 ± 0.9 1.9 ± 0.8 0.28
History of myocardial infarction
23% 27% 0.51
Current smokers 16% 23% 0.21
Hypertension 77% 65% 0.06
Diabetes 26% 25% 0.87
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Patient characteristics at randomization
Atorvastatin group100 pts.
Control group100 pts.
P value
Hypercholesterolemia > 5 mmol/l
40% 33% 0.30
Total plasma cholesterol (mmol/l)
4.8 ± 1 4.6 ± 1.3 0.35
LDL-cholesterol (mmol/l) 3 ± 0.8 3 ± 1 0.93
HDL-cholesterol (mmol/l) 1.1 ± 0.3 1.0 ± 0.3 0.37
Hypertriglyceridemia > 2 mmol/l
23% 14% 0.10
Plasma triglyceride (mmol/l)
1.7 ± 0.9 1.5 ± 0.7 0.26
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Medication at randomization
Atorvastatin group100 pts.
Control group100 pts.
P value
Beta-blockers 63% 63% 1
Calcium channel blockers
25% 15% 0.08
ACE inhibitors 43% 41% 0.77
Clopidogrel 27% 16% 0.06
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Angiographic and interventional characteristics
Atorvastatin group
100 pts.
Control group100 pts.
Lesion located in LAD, RCA, LCx, SVG, LMCA
54/27/21/1/1% 53/18/29/0/0%
One/two/three vessel disease 55/27/18% 63/23/14%
Type of lesion A/B1/B2/C lesions 15/29/38/18% 10/35/40/15%
Pre-PCI stenosis 82 ± 8% 84 ± 10%
Post-PCI stenosis 3 ± 10% 3 ± 12%
Intracoronary thrombosis 1% 2%
Number of treated lesions (mean)
1.2 ± 0.1 1.1 ± 0.1
Stents per patient (n) 1.12 1.12
Complete revascularization (%) 74 82
Mean fluoroscopic time (min) 6.9 ± 4 6.7 ± 5
Angiographic success 99% 97%
Q-wave MI within 24 hours (n) 0 0
All differences were not significant
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Results
Atorvastatin group
100 pts.
Control group
100 pts.
Registry193 pts.
p value
After PCI (ng/ml)(interquartile range)TnI > 3x ULN
0.100(0.096-0.385)
17%
0.100(0.060-0.262)16%
0.100(0.100-0.270)
12%
NS
NS
Incidence of PMI based on TnI release
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Results
Atorvastatin group
100 pts.
Control group
100 pts.
Registry193 pts. p value
After PCI (ng/ml),(interquartile range)CK-MB mass > 3x ULN
1.46(0.83-2.52)
10%
1.40(0.90-2.54)
12%
1.33(0.73-2.40)
10%
NS
NS
Incidence of PMI based on CK-MB mass release
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Predictors of PMI based on TnI release
(multivariate analysis)Variable Odds ratio (95% CI) P value
Age 1.026-1.159 0.006
Atorvastatin pre-treatment 0.365-3.488 0.834
Clopidogrel pre-treatment 0.525-7.191 0.320
Diabetes mellitus 0.055-1.134 0.072
Total cholesterol 0.956-2.837 0.072
Beta-blockers 0.175-1.793 0.329
Degree of stenosis 0.966-1.090 0.392
Length of stents 0.957-1.083 0.569
Complex lesion 0.038-1.491 0.126
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Conclusion
The results of this study demonstrate that in stable patients undergoing PCI, pretreatment with atorvastatin (80 mg) for 48 hours preceding PCI is not associated with a different incidence of PMI.
A large, international, statistically robust, randomized trial addressing the dose, duration, and type of statin is necessary to settle the issue of routine administration (reload) of statins prior to acute or elective PCI.
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Acknowledgement
Co- authors: D. Zemánek, MD, P. Hájek, MD, M. Malý, MD, PhD, R. Adlová, MD, L. Martinkovičová, MD, D. Tesař, MD, PhD.
Statisticians: E. Hansvenclová, M. Malý
Staff of the Dept. of Cardiology, University Hospital Motol, Prague, CZ