Randomized comparison of direct and provisional stenting in de novo coronary artery lesions: the RADICAL study.

BACKGROUND: Although preliminary reports have demonstrated excellent primary success and improved economics with direct stenting, a clinically relevant reduction of restenosis rate has not been documented yet. AIMS: Aims of the study were the comparison of restenosis rate (primary endpoint), procedural success, fluoroscopy time, amount of contrast dye and clinical outcome (secondary endpoints). METHODS AND RESULTS: Between January and December 1999, 250 patients were randomly assigned either to direct stent implantation without predilatation (DS; 125 patients) or provisional stenting (PB; 125 patients) and followed for 7.9+/-2.7 (6-9) months. Angiographic follow-up was available in 92.0% of patients. Procedural success rate was 92.8% in DS and 100% in PB (n.s.), while radiation exposure was lower (4.7+/-4.3 versus 5.1+/-1.8 min; p<0.0001) with DS. Conversely, the amount of contrast dye (131+/-62 versus 139+/-36 ml; n.s.) was not different between DS and PB. Direct stenting leads to a 25.0% reduction in binary restenosis rate (15.7% in DS versus 20.9% in PB), indicating an advantageous trend, missing however the level of statistical significance. Similarly, there was a trend to fewer major cardiac events with DS (DS 16.8%, PB 21.6%). CONCLUSIONS: We conclude that direct stenting is at least as safe and efficacious as balloon dilatation followed by provisional stent implantation, but failed to reduce restenosis rate or improve outcome within 6 months. Larger prospective randomized trials are required to assess the potential of direct stenting to reduce restenosis rate and improve clinical outcome in subgroups of patients.

Immediate and late effects of coronary angiography on soluble endothelial cell markers and P-selectin in patients with and without coronary artery disease.

Endothelial cell injury and platelet activation are considered primary events in the pathogenesis of coronary artery disease (CAD) and are marked by plasma concentrations of von Willebrand factor (vWF) and soluble thrombomodulin, and by soluble P-selectin, respectively. Because both endothelial cells and platelets interact with contrast media, we aimed to detect immediate and 24-h changes in these markers following coronary angiography in patients with and without CAD. Sixteen patients with angiographically proven CAD and 14 patients without significant coronary stenosis were investigated. Blood samples were obtained from an antecubital vein before and 24 h after cardiac catheterization, and from the coronary sinus before and immediately after angiography. Concentrations of the markers were determined using enzyme-linked immunosorbent assays. In the coronary sinus samples, the only significant finding was an increase in levels of soluble P-selectin in the patients with CAD (P < 0.038). In the post-catheterization peripheral blood samples, concentrations of soluble P-selectin (P = 0.004), vWF (P = 0.0007) and soluble thrombomodulin (P = 0.0013) were all increased in patients with CAD. In contrast, patients without CAD demonstrated increased levels of vWF only (P = 0.0015) in peripheral blood samples obtained 24 h after angiography. We conclude that both immediate and 24-h changes take place in endothelial cells and platelet markers in response to cardiac catheterization, and that these changes are different in patients with angiographically proven CAD and in patients free of disease. These differences may reflect alterations in endothelial cell or platelet reactivity in patients with CAD.