Short- and long-term outcomes of Wiktor stent implantation at low versus high pressures

A prospective, randomized, multicenter trial was conducted to evaluate whet her high-pressure postdilation of the Wiktor stent provides short- and long -term benefits compared with the conventional low-pressure implantation tec hnique. From June 1995 through May 1996, 181 patients were randomly assigne d to either low-pressure (6 to 12 arm, group A, n = 94) Wiktor stent placem ent or to high-pressure postdilation (greater than or equal to 13 arm, grou p B, n = 87) after stent deployment. All patients were followed up clinical ly for 7 +/- 3 months, with an angiographic follow-up in 154 patients (85%) . After stent implantation, neither minimal lumen diameter (MLD) nor percen t diameter stenosis (%DS) differed significantly between the 2 groups (MLD, 2.8 +/- 0.5 vs 2.9 +/- 0.5 mm; %DS, 17 +/- 8% vs 16 +/- 9% for groups A an d B, respectively). However, a trend toward a larger mean lumen diameter wi thin the stent was observed in group B (3.3 +/- 0.6 vs 3.5 +/- 0.5 mm for g roups A and B, respectively; difference between means 0.14 mm, 95% confiden ce interval -0.01 to 0.29, p = 0.08). Angiographic follow-up revealed simil ar MLD and %DS in bath treatment groups (MLD, 2.1 +/- 0.7 vs 2.2 +/- 0.8 mm ; %DS, 31 +/- 17% vs 30 +/- 24% for groups A and B, respectively, p = NS). Acute stent thrombosis occurred in 2 patients (1%) (1 patient in each group ), and subacute thrombosis in 1 patient (0.6%) in group A. There was 1 deat h in group A, and target lesion restenosis (greater than or equal to 50% DS ) was observed in 15% of patients with no differences between the groups. I n conclusion, this study demonstrated favorable short- and long-term result s of Wiktor stent implantation. Despite a trend toward additional initial l umen gain by high-pressure postdilation, this did not translate into a meas urable improvement in long-term outcome. (C) 1999 by Excerpta Medica, Inc.