statins pre-pci: a prospective, randomized trial of statins prior to stent implantation in patients...
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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
veselka.josef@seznam.cz
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.
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
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.
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
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.
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
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
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
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.
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
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
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
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
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
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
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
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.
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
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