title: Comparison of the efficacy of direct coronary stenting with sirolimus-eluting stents versus stenting with predilation by intravascular ultrasound imaging (from the DIRECT trial).
abstract: A direct coronary stenting technique using drug-eluting stents may decrease drug-eluting stent efficacy due to possible damage to the surface coating of the stent. The DIRECT is a multicenter, prospective, nonrandomized trial designed to evaluate the direct stenting strategy for the sirolimus-eluting Bx-Velocity stent compared with the historical control (SIRIUS trial, stenting with predilation). Volumetric and cross-sectional intravascular ultrasound analyses at 8-month follow-up were performed in 115 patients (DIRECT n= 64, control n = 51). Patient and lesion characteristics were comparable between groups. The DIRECT group achieved an equivalent uniform expansion index, defined as minimum stent area/maximum stent area x 100, compared with the control group (65.9 +/- 11.7 vs 63.1 +/- 12.7, p = NS). At 8-month follow-up, vessel, stent, lumen, and neointimal volume index (volume in cubic millimeters/length in millimeters) and percent neointimal volume were similar between the DIRECT and control groups (vessel volume index 13.9 +/- 4.40 vs 15.0 +/- 3.83; stent volume index 6.83 +/- 2.02 vs 6.94 +/- 2.04; lumen volume index 6.71 +/- 2.04 vs 6.81 +/- 2.07; neointimal volume index 0.14 +/- 0.24 vs 0.16 +/- 0.23; percent neointimal volume 3.73 +/- 6.97 vs 3.14 +/- 5.32, p = NS for all). In addition, in-stent neointimal hyperplasia distribution was significantly smaller near the distal stent edge (0.22 vs 0.098 mm(3)/mm, p = 0.01 for an average neointimal volume index within 3 mm from the distal stent edge). In conclusion, direct coronary stenting with the sirolimus-eluting Bx-Velocity stent is equally effective in terms of uniform stent expansion and long-term quantitative intravascular ultrasound results compared with conventional stenting using predilation. This strategy appears to be associated with less neointimal hyperplasia near the distal stent edge.
authors.affiliation: Center for Research in Cardiovascular Intervention, Stanford University, Stanford, California, USA.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Hirohata
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Morino
authors.forename: Junya
authors.initials: J
authors.lastname: Ako
authors.forename: Ryota
authors.initials: R
authors.lastname: Sakurai
authors.forename: Maurice
authors.initials: M
authors.lastname: Buchbinder
authors.forename: Ronald P
authors.initials: RP
authors.lastname: Caputo
authors.forename: Steven P
authors.initials: SP
authors.lastname: Karas
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Mishkel
authors.forename: Michael R
authors.initials: MR
authors.lastname: Mooney
authors.forename: Charles D
authors.initials: CD
authors.lastname: O'shaughnessy
authors.forename: Albert E
authors.initials: AE
authors.lastname: Raizner
authors.forename: Robert L
authors.initials: RL
authors.lastname: Wilensky
authors.forename: David O
authors.initials: DO
authors.lastname: Williams
authors.forename: Shing-Chiu
authors.initials: SC
authors.lastname: Wong
authors.forename: Paul G
authors.initials: PG
authors.lastname: Yock
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Honda
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Fitzgerald
mesh_terms: D023921:Coronary Stenosis / Q000628:therapy*; D003331:Coronary Vessels / Q000473:pathology*; D004106:Dilatation / Q000379:methods*; D005260:Female; D006801:Humans; D006965:Hyperplasia; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage*; D015607:Stents; D018084:Ultrasonography, Interventional
chemical_list: D020123:Sirolimus