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

• Published in: European heart journal 2009-07, Vol.30 (13), p.1590-1597
• Main Authors: Lüscher, Thomas Felix, Pieper, Michael, Tendera, Michael, Vrolix, Mathy, Rutsch, Wolfgang, van den Branden, Frank, Gil, Robert, Bischoff, Karl-Otto, Haude, Michael, Fischer, Dieter, Meinertz, Thomas, Münzel, Thomas
• Format: Article
• Language: English
• Subjects: Acetylcholine; Adult; Aged; Angiography; Angioplasty, Balloon, Coronary; Biological and medical sciences; Blood Pressure - drug effects; Calcium Channel Blockers - adverse effects; Calcium Channel Blockers - therapeutic use; Cardiology. Vascular system; Cardiovascular system; Clinical Research; Combined Modality Therapy; Coronary Artery Disease - drug therapy; Coronary Artery Disease - pathology; Coronary Artery Disease - physiopathology; Coronary Artery Disease - therapy; Coronary heart disease; Coronary Vessels - drug effects; Coronary Vessels - physiopathology; Disease Progression; Double-Blind Method; Endothelium; Endothelium, Vascular - drug effects; Endothelium, Vascular - physiopathology; Female; Heart; Humans; Investigative techniques, diagnostic techniques (general aspects); IVUS; Lipids - blood; Male; Medical sciences; Middle Aged; Nifedipine - adverse effects; Nifedipine - therapeutic use; Plaque; Radiodiagnosis. Nmr imagery. Nmr spectrometry; Vasodilator Agents; Vasomotor System - drug effects; Vasomotor System - physiopathology
• ISSN: 0195-668X; 1522-9645
• DOI: 10.1093/eurheartj/ehp151

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.