title: Influence of balloon pressure during stent placement in native coronary arteries on early and late angiographic and clinical outcome: A randomized evaluation of high-pressure inflation.
abstract: BACKGROUND
  High-pressure dilatation is considered a better stent placement strategy, but this has not yet been proved by appropriately designed studies. The objective of this randomized trial was to assess the role of high-pressure dilatation in the early and late outcome of patients undergoing coronary stent placement.
  
  
  RESULTS
  Consecutive patients with coronary stent placement were randomly assigned to high- (15 to 20 atm, 468 patients) or low- (8 to 13 atm, 466 patients) balloon-pressure dilatation. The primary end point of the study was the event-free survival at 1 year. Secondary end points were the incidence of stent thrombosis at 30 days and angiographic restenosis (>/=50% diameter stenosis) at 6 months. The incidence of stent thrombosis was 1.7% in the high-pressure and 1.9% in the low-pressure group (relative risk 0.89; 95% CI 0.30 to 2.56). During the first 30 days, although there was no significant difference in the incidence of Q-wave myocardial infarction, the incidence of non-Q-wave infarction was 6.4% in the high-pressure and 3.4% in the low-pressure group (relative risk 1. 87; 95% CI 1.02 to 3.42). The restenosis rate was 30.4% in the high-pressure and 31.4% in the low-pressure group (relative risk 0. 97; 95% CI 0.75 to 1.26). Event-free survival at 1 year was not significantly different between the groups, with 78.8% in high-pressure patients and 75.5% in patients assigned to low-pressure dilatation (hazard ratio 0.85; 95% CI 0.65 to 1.11).
  
  
  CONCLUSIONS
  The systematic use of high-balloon-pressure inflation (15 to 20 atm) during coronary stent placement is not associated with any significant influence on the 1-year outcome of patients undergoing this intervention.
authors.affiliation: 1. Medizinische Klinik rechts der Isar der Technischen Universität, Munich, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Dirschinger
authors.forename: A
authors.initials: A
authors.lastname: Kastrati
authors.forename: F J
authors.initials: FJ
authors.lastname: Neumann
authors.forename: P
authors.initials: P
authors.lastname: Boekstegers
authors.forename: S
authors.initials: S
authors.lastname: Elezi
authors.forename: J
authors.initials: J
authors.lastname: Mehilli
authors.forename: H
authors.initials: H
authors.lastname: Schühlen
authors.forename: J
authors.initials: J
authors.lastname: Pache
authors.forename: E
authors.initials: E
authors.lastname: Alt
authors.forename: R
authors.initials: R
authors.lastname: Blasini
authors.forename: G
authors.initials: G
authors.lastname: Steinbeck
authors.forename: A
authors.initials: A
authors.lastname: Schömig
mesh_terms: D000368:Aged; D002404:Catheterization / Q000379:methods*; D015986:Confounding Factors, Epidemiologic; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011312:Pressure; D012008:Recurrence; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome