title: Randomized comparison of direct stenting with predilatation followed by stenting on vessel trauma and restenosis.
abstract: BACKGROUND
  Direct stenting may reduce trauma to the vessel wall, thereby having a positive impact on acute and long-term results. This study evaluated acute vessel trauma and acute and follow-up angiographic and intravascular ultrasound (IVUS) results after direct stenting in comparison to conventional stenting.
  
  
  METHODS
  Two hundred forty-nine patients were randomly assigned to direct stenting (n = 124) or stenting after predilatation (n = 125) and were followed up by angiography at 6 +/- 2 months. Intracoronary serum endothelin (ET-1) levels were determined distal to the lesion before and after coronary intervention to define vessel trauma, and IVUS was performed before and after intervention and at follow-up to determine induced changes in vessel morphology and intimal hyperplasia in a subgroup of 40 patients.
  
  
  RESULTS
  Feasibility of direct stenting was 91%, with 9% requiring crossover to predilatation. There were no differences between the 2 groups in immediate clinical, angiographic, and intravascular ultrasound results. Intracoronary ET-1 levels increased significantly after intervention, without differences between the 2 groups (increase in ET-1 level, 0.79 +/- 1.06 vs 0.96 +/- 1.22 fmol/L, P =.206). At 6-month follow-up, angiographic late loss (0.76 +/- 0.86 vs 0.69 +/- 1.09 mm, P =.788) and restenosis rate (21% vs 20%, P = 1.000) were similar for direct stenting versus conventional stenting, respectively. IVUS demonstrated comparable intimal hyperplasia areas for direct versus conventional stenting (2.0 +/- 1.5 mm(2) vs 2.2 +/- 1.6 mm(2), respectively, P =.243).
  
  
  CONCLUSIONS
  Direct stenting is highly feasible and results in similar vessel trauma and change in vessel morphology and acute lumen dimensions compared with stenting after predilatation. Similar acute angiographic and IVUS results persist at 6-month follow-up.
authors.affiliation: Medical Clinic I, University Hospital RWTH, Aachen, Germany. rhoffmann@ukaachen.de
authors.forename: Rainer
authors.initials: R
authors.lastname: Hoffmann
authors.forename: Mefaret
authors.initials: M
authors.lastname: Takimoglu-Boerekci
authors.forename: Roswitha
authors.initials: R
authors.lastname: Langenberg
authors.forename: Christian
authors.initials: C
authors.lastname: Knackstedt
authors.forename: Andreas
authors.initials: A
authors.lastname: Franke
authors.forename: Peter W
authors.initials: PW
authors.lastname: Radke
authors.forename: Peter
authors.initials: P
authors.lastname: Hanrath
mesh_terms: D000368:Aged; D000787:Angina Pectoris / Q000209:etiology / Q000628:therapy; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000150:complications / Q000628:therapy*; D003331:Coronary Vessels / Q000000981:diagnostic imaging; D016232:Endothelins / Q000097:blood; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000209:etiology / Q000628:therapy; D015607:Stents; D018084:Ultrasonography, Interventional
chemical_list: D016232:Endothelins