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DELIVER - DELIVER
Description:
The goal of the DELIVER trial was to evaluate the safety and efficacy of the paclitaxel-coated RX ACHIEVE™ Drug-Eluting Coronary Stent System (CSS) with the metallic MULTI-LINK RX PENTA™ CSS in patients with de novo coronary lesions.
Study Design
Study Design:
Patients Enrolled: 1,043
Mean Follow Up: 270 days
Mean Patient Age: Mean 62 years
Female: 29
Patient Populations:
De novo target lesion >2.5, and <4.0 mm in diameter and <25 mm in length; and stenosis of 50-100% in target lesion.
Exclusions:
Left main disease, calcification, angulation, ejection fraction <30%, and prior or planned percutaneous coronary intervention within 180 days.
Primary Endpoints:
TVF at 270 days, defined as death, MI, or target lesion revascularization.
Secondary Endpoints:
In-stent angiographic binary restenosis at 240 days.
Drug/Procedures Used:
Patients were randomized to paclitaxel-coated (3.0 µg/mm2) RX ACHIEVE™ Drug-Eluting CSS (coated stent, n=522) or the metallic MULTI-LINK RX PENTA™ CSS (bare stent, n=519).
Concomitant Medications:
Aspirin 325 mg for one year; clopidogrel (300 mg loading dose + 75 mg/d for three months). Glycoprotein IIb/IIIa inhibitors were used in 64% of patients in each arm.
Principal Findings:
Target vessel failure (TVF) at 270 days did not differ significantly between the coated and bare stent arms (11.9% vs. 14.5%, p=0.12), nor did 240-day in-stent angiographic binary restenosis (14.9% vs. 20.6%, p=0.076). There was no difference in mortality (1.0% vs. 1.0%, p=NS) or myocardial infarction (MI; 1.0% vs. 1.2%, p=NS). In-stent late loss at 240 days was smaller in the coated stent arm compared with the bare stent arm (0.81 mm vs. 0.98 mm, p=0.003). There was no difference in subacute (0.2% for each arm, p=1.0) or late thrombosis (0.2% for each arm, p=1.0).
Interpretation:
Among patients with de novo coronary artery lesions, treatment with the paclitaxel-coated RX ACHIEVE™ Drug-Eluting CSS was not associated with a significant reduction in TVF or angiographic binary restenosis compared with the metallic MULTI-LINK RX PENTA™ CSS.
Other drug-eluting stent trials using sirolimus-coated stents such as SIRIUS and RAVEL have shown a significant reduction in TVF, primarily driven by a reduction in target vessel revascularization (TVR), with no difference in death or MI. Additionally, the TAXUS II trial showed a reduction in death, MI, or TVR with a paclitaxel-coated stent. However, in the TAXUS II trial, paclitaxel was eluted via a polymer, but not via a polymer in DELIVER, which may in part explain the differences in the results between TAXUS II and DELIVER.
References:
Lansky AJ, et al. Non–Polymer-Based Paclitaxel-Coated Coronary Stents for the Treatment of Patients With De Novo Coronary Lesions. Circulation. 2004;109:1948-1954.
Presented at Late-Breaking Trials, ACC 2003.
Keywords: Paclitaxel, Coronary Artery Disease, Myocardial Infarction, Thrombosis, Drug-Eluting Stents, Constriction, Pathologic, Sirolimus, Stents
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