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ENCORE II
Evaluation of Nifedipine on Coronary Endothelial function II
Author(s)
(a) Sütsch G, Büchi M, Zeiher AM, Meinertz T, Hugenholtz PG, Jenni R, Rafflenbeul W, Drexler H, Haussmann D, Noll G, Quitzau K, Lüscher TF
(b) Lüscher TF, Pieper M, Tendera M, Vrolix M, Rutsch W, van den Branden F, Gil R, Bischoff K-O, Haude M, Fischer D, Meinertz T, Münzel T
Title(s)
(a) Effects of calcium antagonism and HMG-coenzyme reductase inhibition on endothelial function and atherosclerosis: rationale and outline of the ENCORE trials
(b) A randomized placebo-controlled study on the effect of nifedipine on coronary endothelial function and plaque formation in patients with coronary artery disease: the ENCORE II study
Reference(s)
(a) Eur Heart J 1999;1 Suppl M:M27–32
(b) Eur Heart J 2009;30:1590–7
Disease
Coronary artery disease
Purpose
To investigate the effects of adding nifedipine to standard therapy including statin on coronary endothelial function and plaque formation in patients with stable coronary artery disease undergoing PCI
Study design
Randomised, double-blind, placebo-controlled
Follow-up
18–24 months
Patients
443 patients, aged ≥ 18 years, with ≤ 40% area stenosis in left coronary artery segment, no vasodilatation of index artery upon acetylcholine infusion, undergoing coronary angiography with or without PCI
Treatment regimen
Nifedipine GITS, 30–60 mg/day, or placebo
Results
226 patients (114 nifedipine, 112 placebo) were included in the intention-to-treat analysis. The mean change from baseline of the acetylcholine-induced change in mean luminal diameter at the highest dose of acetylcholine applied both at baseline and follow-up was 13.9 ± 16.5% in the nifedipine group and 7.7 ± 18.0% in the placebo group (difference of 6.3%, 95% CI 1.6–10.9; p = 0.0088). There was no significant difference between the nifedipine and placebo groups in the percentage change in plaque volume as assessed by intravascular ultrasound (5.0% vs 3.2%; p = 0.66)
Comments
The study was initially designed to compare cerivastatin alone vs cerivastatin plus nifedipine. After cerivastatin was withdrawn from the market in 2001, the study was modified to compare nifedipine vs placebo
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