Prospective non-randomized multi-centre evaluation of the non-polymer based ACHIEVE Paclitaxel Eluting Coronary Stent System in treatment of lesions with high risk of revascularization due to restenosis: the DELIVER II study.
BACKGROUND
The ACHIEVE Paclitaxel Eluting Coronary Stent System (CSS) is a non-polymeric paclitaxel coated stent loaded with a dose density of 3.0 microg/mm2 stent surface area. DELIVER II set out to evaluate the use of this stent in the treatment of patients with coronary lesions with a higher risk of revascularization including chronic total or sub-total occlusion, small vessel, bifurcated, and long lesions, multivessel disease, and restenotic lesions.


METHODS
DELIVER II was a prospective, non-randomized, single-arm, multi-centre study. A total of 1531 patients with 1986 lesions were enrolled at 86 sites worldwide. The primary endpoint was target lesion revascularization (TLR) rate at six months follow-up. The lesion subsets were comprised of 28.5% restenotic lesions, 16.5% chronic total or subtotal occlusions, 29.0% bifurcation lesions, 37.4% small vessels and 16.6% long lesions.


RESULTS
The Target Lesion Revascularization (TLR) rate (intent-to-treat) at 180 days was 8.2% (156/1909). The MACE rate for the overall per-protocol population was 3.6% (47/1310) at 30 days, 13.0% (167/1287) at 180 days, and in a sub-set of 500 patients, 20.5% (84/409) at 365 days. Multivariable logistic regression analysis identified that the factors leading to higher risk of revascularization were left anterior descending artery lesions, restenotic lesions, the post-procedural minimum luminal diameter, total stent length and number of diseased vessels.


CONCLUSIONS
DELIVER II demonstrated comparatively low rates of TLR and MACE for the ACHIEVE Paclitaxel Eluting CSS in high risk patients. In addition, this registry helped to identify risk factors leading to an increased risk of revascularization in difficult-to-treat patient groups.
Grube
Eberhard
E
Heart Center Siegburg, Siegburg, Germany.
Gershlick
Anthony
A
Bartorelli
Antonio
A
Buellesfeld
Lutz
L
Blanchard
Didier
D
Macaya
Carlos
C
Büttner
Heinz J
HJ
Lim
Victor Y
VY
Boone
Els
E
Dorange
Cécile
C
Marco
Jean
J