The DELIVER Trial
A Multi-Center, Randomized Study of the Paclitaxel-Eluting Stent in the
Treatment of Patients with De Novo
Coronary Artery Lesions
Presented at ACC 2003 Late Breaking Clinical Trials
DELIVER: Study Design
1,043 patients with de novo lesions in native coronary arteries <25 mm in length and 2.5 to 4.0 mm in diameter, randomized to:
RX ACHIEVE? Stent Coated with Paclitaxel (n=522)
MULTI-LINK RX PENTA? stent
(n=519)
ASA for 1 year
Clopidogrel for 3 months
+
+
Target Vessel Failure (TVF) (Death / MI / TLR)
8 Month Angiographic study
ACC 2003 Late Breaking Trials
ASA for 1 year
Clopidogrel for 3 months
DELIVER: 8 Month In-stent Angiographic Results
(mm)
(%)
p = 0.149
ACC 2003 Late Breaking Trials
p = 0.003
Bare
Stent
Paclitaxel
Coated
Bare
Stent
Paclitaxel
Coated
Late Loss
Binary Restenosis
Bare
Stent
Paclitaxel
Coated
p=0.079
TVF*
Death
MI
DELIVER: 9 Month Clinical Event Results
* TVF = Death/MI/TLR
Bare
Stent
Paclitaxel
Coated
p=NS
Bare
Stent
Paclitaxel
Coated
p=NS
DELIVER: Conclusions
Treatment of de novo lesions with a paclitaxel-eluting stent was not associated with a reduction in target vessel failure at 9 months binary restenosis
Late loss on 8 month angiographic follow-up was reduced in paclitaxel-eluting stent arm but no difference in binary restenosis
TAXUS II trial showed a reduction in death, MI or TVR with a paclitaxel-coated stent; however, TAXUS II used polymeric paclitaxel-eluting stent but DELIVER used non-polymeric
ACC 2003 Late Breaking Trials