Safety of direct stenting with the Endeavor stent: results of the Endeavor II continued access registry.
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.
Schultheiss
Hans-Peter
HP
Universitätsklinikum Benjamin Franklin, Berlin, Germany.
Grube
Eberhard
E
Kuck
Karl-Heinz
KH
Suttorp
Maarten J
MJ
Heuer
Hans
H
Bonnier
Hans
H
Popma
Jeffrey J
JJ
Kuntz
Richard E
RE
Fajadet
Jean
J
Wijns
William
W