title: Intracoronary stenting and angiographic results: Restenosis after direct stenting versus stenting with predilation in patients with symptomatic coronary artery disease (ISAR-DIRECT trial).
abstract: The objective of this randomized study was to assess whether direct stenting leads to less restenosis than does conventional stenting (CS) with predilation in clinical practice. We included 910 patients who were randomly assigned to undergo either direct stenting (DS; n = 456) or CS (n = 454). No significant difference was observed in the incidence of angiographic restenosis (primary endpoint): 23.6% for DS and 21.0% for CS (P = 0.41; relative risk = 1.1; 95% CI = 0.8-1.5). The incidence of target vessel revascularization was 17.3% among DS and 14.8% among CS patients (P = 0.29; relative risk = 1.2; 95% CI = 0.8-1.6). The combined incidence of death or myocardial infarction at one year was 9.0% in the DS group and 7.0% in the CS group (P = 0.28). In conclusion, direct stenting is not associated with any reduction of thrombotic and restenotic complications as compared to the conventional stenting.
authors.affiliation: Deutsches Herzzentrum, Munich, Germany. mehilli@dhm.mhn.de
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.forename: Josef
authors.initials: J
authors.lastname: Dirschinger
authors.forename: Lena
authors.initials: L
authors.lastname: Etzel
authors.forename: Hildegard
authors.initials: H
authors.lastname: Bollwein
authors.forename: Jürgen
authors.initials: J
authors.lastname: Pache
authors.forename: Helmut
authors.initials: H
authors.lastname: Schühlen
authors.forename: Nicolas
authors.initials: N
authors.lastname: Von Beckerath
authors.forename: Melchior
authors.initials: M
authors.lastname: Seyfarth
authors.forename: Claus
authors.initials: C
authors.lastname: Schmitt
authors.forename: Albert
authors.initials: A
authors.lastname: Schömig
mesh_terms: D000368:Aged; D002404:Catheterization; D016009:Chi-Square Distribution; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000517:prevention & control*; D023903:Coronary Restenosis / Q000453:epidemiology*; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D009203:Myocardial Infarction / Q000601:surgery*; D015607:Stents; D016896:Treatment Outcome