title: Safety of direct stenting with the Endeavor stent: results of the Endeavor II continued access registry.
abstract: OBJECTIVE
  The safety and efficacy of direct stenting with the Endeavor stent is unknown. The acute and 9 month outcome after direct stenting vs. predilatation was tested in a multicentre, prospective, single-arm study.
  
  
  RESULTS
  300 patients were treated with the Endeavor stent for a single, previously untreated coronary artery stenosis (vessel diameter 2.25 to 3.75 mm; lesion length 14 to 27 mm). Predilatation was at discretion of the operator for lesions < 20 mm in length but mandatory for lesions > 20 mm. Angiographic follow-up at 8 months was prespecified for the first 150 consecutive patients. Out of 296 patients, 126 (42.6%) underwent direct stenting and 170 (57.4%) predilatation. Patients in the direct stenting group were younger (62.9 years vs 65.3 years, P=0.04) and lesions were predictably more proximally located and shorter (14.29 mm vs 18.16 mm, P<0.0001), with larger pre-procedural minimum lumen diameter. Success rate was 92.9% with direct stenting vs. 95.3% with predilatation (P=0.45). At 8 months, late loss was not significantly different between groups. The rate of MACE at 9 months was 10.6% with direct stenting vs. 10.2% with predilatation (P=1.00). There were no occurrences of stent thrombosis in either group.
  
  
  CONCLUSIONS
  Direct stenting with the Endeavor stent as deemed feasible by the operator, was safe and effective, and comparable to the results of implantation following predilatation.
authors.affiliation: Universitätsklinikum Benjamin Franklin, Berlin, Germany.
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Schultheiss
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Kuck
authors.forename: Maarten J
authors.initials: MJ
authors.lastname: Suttorp
authors.forename: Hans
authors.initials: H
authors.lastname: Heuer
authors.forename: Hans
authors.initials: H
authors.lastname: Bonnier
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.forename: Richard E
authors.initials: RE
authors.lastname: Kuntz
authors.forename: Jean
authors.initials: J
authors.lastname: Fajadet
authors.forename: William
authors.initials: W
authors.lastname: Wijns