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Presented at ACC 2003 Late Breaking Clinical Trials

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1 Presented at ACC 2003 Late Breaking Clinical Trials
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

2 DELIVER: Study Design + + MULTI-LINK RX PENTA™ stent
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: MULTI-LINK RX PENTA™ stent (n=519) RX ACHIEVE™ Stent Coated with Paclitaxel (n=522) + + ASA for 1 year Clopidogrel for 3 months ASA for 1 year Clopidogrel for 3 months 8 Month Angiographic study Target Vessel Failure (TVF) (Death / MI / TLR) ACC 2003 Late Breaking Trials

3 DELIVER: 8 Month In-stent Angiographic Results
Late Loss Binary Restenosis p = 0.003 p = 0.149 (mm) (%) Bare Stent Paclitaxel Coated Bare Stent Paclitaxel Coated ACC 2003 Late Breaking Trials

4 DELIVER: 9 Month Clinical Event Results
TVF* Death MI p=0.079 p=NS p=NS Paclitaxel Coated Bare Stent Paclitaxel Coated Bare Stent Paclitaxel Coated Bare Stent * TVF = Death/MI/TLR

5 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


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