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European Heart Journal Advance Access published online on May 27, 2009
European Heart Journal, doi:10.1093/eurheartj/ehp151
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2009. For permissions please email: journals.permissions@oxfordjournals.org
The online version of this article has been published under an open access model. Users are entitled to use, reproduce, disseminate, or display the open access version of this article for non-commercial purposes provided that the original authorship is properly and fully attributed; the Journal, Learned Society and Oxford University Press are attributed as the original place of publication with correct citation details given; if an article is subsequently reproduced or disseminated not in its entirety but only in part or as a derivative work this must be clearly indicated. For commercial re-use, please contact journals.permissions@oxfordjournals.org

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{dagger}

Thomas Felix Lüscher1,*, Michael Pieper2, Michael Tendera3, Mathy Vrolix4, Wolfgang Rutsch5, Frank van den Branden6, Robert Gil7, Karl-Otto Bischoff8, Michael Haude9, Dieter Fischer10, Thomas Meinertz11 and Thomas Münzel11

1 Department of Cardiology, Universitätsspital, Ramistrassee 100, CH-8091 Zürich, Switzerland
2 Herz- und Neuro-Zentrum Bodensee, Kreuzlingen, Switzerland
3 Silesian School of Medicine, Katowice, Poland
4 Algemeen Ziekenhuis St Jan, Genk, Belgium
5 Klinikum Charité der Humboldt Universität, Berlin, Germany
6 A. Z. Middelheim, Antwerp, Belgium
7 Klinika Kardiologii Inwazyjnej, Warsaw, Poland
8 Kreiskrankenhaus Waldbröl, Waldbröl, Germany
9 Universitätsklinikum Essen, Essen, Germany
10 Medical School, Hanover, Germany
11 Universitätsklinikum Eppendorf, Hamburg, Germany

Received 17 July 2007; revised 16 March 2009; accepted 17 March 2009 * Corresponding author. Tel: +41 1 255 21 21, Fax: +41 1 255 42 51, Email: cardiotfl{at}gmx.ch

Aims: Endothelial dysfunction and plaque formation are features of atherosclerosis. Inhibition of L-type calcium channels or HMG-CoA pathway improves endothelial function and reduces plaque size. Thus, we investigated in stable coronary artery disease (CAD) the effects of a calcium antagonist on coronary endothelial function and plaque size.

Methods and results: In 454 patients undergoing PCI, acetylcholine (10–6 to 10–4 M) was infused in a coronary segment without significant CAD. Changes in coronary diameter were measured and an intravascular ultrasound examination (IVUS) was performed. On top of statin therapy, patients were randomized in a double-blind fashion to placebo or nifedipine GITS 30–60 mg/day and followed for 18–24 months.

Blood pressure was lower on nifedipine than on placebo by 5.8/2.1 mmHg (P < 0.001) as was total and LDL cholesterol (4.8 mg/dL; P = 0.495), while HDL was higher (3.6 mg/dL; P = 0.026). In the most constricting segment, nifedipine reduced vasoconstriction to acetylcholine (14.0% vs. placebo 7.7%; P < 0.0088). The percentage change in plaque volume with nifedipine and placebo, respectively, was 1.0 and 1.9%, ns.

Conclusion: The ENCORE II trial demonstrates in a multi-centre setting that calcium channel blockade with nifedipine for up to 2 years improves coronary endothelial function on top of statin treatment, but did not show an effect of nifedipine on plaque volume.

Key Words: Acetylcholine • Angiography • Endothelium • IVUS • Plaque

{dagger} This manuscript was assessed and accepted for publication by the previous Editorial Office based in Leuven.


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