A randomized comparison of direct stenting versus stenting with predilatation in native coronary artery disease: results from the multicentric Crosscut study

J Invasive Cardiol. 2003 Jan;15(1):1-5.

Abstract

Stenting without predilatation has become possible due to the availability of a new generation of flexible, low-profile, securely crimped, balloon-expandable stents. This study compared the feasibility, efficacy and cost-effectiveness of direct stenting (DS) to the standard predilatation technique (PS) using the premounted Crossflex LC stent (Cordis Corporation, Miami Lakes, Florida). The study is a randomized prospective multicenter evaluation including 271 patients (140 patients in the DS group and 131 patients in the PS group) with 1 or 2 de novo or restenotic lesions located in native coronary arteries. Procedural success was 98.9% and 98.7% in the DS and PS groups, respectively (p = NS); crossover to PS was required in 22/166 lesions (13.2%) enrolled in the DS group because of inability to cross the target lesion without predilatation. Nonsignificant reductions in procedural time (-10.5%), fluoroscopy time (-4.7%) and amount of contrast (-3.8%) were observed in the DS group in comparison to the PS group. The number of balloons used (-76.6%) and the global cost of the procedure (-18.8%) were significantly lower in the DS group (p < 0.01 for both comparisons). After 6 months, no differences were observed in the restenosis rate between the two groups (22.0% for DS group versus 18.1% for PS group; p = NS) and in the incidence of major adverse clinical events (5.0% for DS group versus 3.0% for PS group; p = NS). Direct stenting is safe and feasible for the treatment of lesions in native coronary arteries and obtains a significant reduction in procedural cost, mainly due to the lower number of balloons used. Clinical and angiographic results at 6 months are comparable to those obtained after a conventional predilatation-stenting strategy.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Catheterization
  • Coronary Angiography
  • Coronary Artery Disease / diagnostic imaging
  • Coronary Artery Disease / therapy*
  • Cost-Benefit Analysis
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Safety
  • Stents*
  • Time Factors