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The DELIVER Trial

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.

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The DELIVER Trial

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  1. 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 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 Paclitaxel Coated Bare Stent ACC 2003 Late Breaking Trials

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