TAXUS IV Angiographic Study - TAXUS IV Angiographic Study

Description:

The goal of the TAXUS IV angiographic study was to evaluate restenosis rates with use of the slow-rate release polymer-based paclitaxel-eluting stent compared with bare stent in patients with single de novo coronary lesions.

Hypothesis:

Treatment with the slow-rate release polymer-based paclitaxel-eluting stent is associated with a reduction in angiographic binary restenosis compared with bare stent.

Study Design

Study Design:

Patients Enrolled: 532
Mean Follow Up: 9 months

Patient Populations:

Single de novo lesion, 10-28 mm in length and 2.5-3.75 mm in diameter

Exclusions:

Prior or planned percutaneous coronary intervention in target vessel within nine months

Secondary Endpoints:

Binary restenosis, defined as ≥50% vessel reocclusion; late lumen loss; and aneurysm

Drug/Procedures Used:

Patients with a single, de novo lesion were randomized in a double-blind manner to either paclitaxel-eluting stent (n=662) or placebo (n=652). All patients were followed for one year, and a subset of patients were followed for nine-month angiographic follow-up (n=532; n=292 in the paclitaxel arm and n=267 in the bare stent arm).

Principal Findings:

Percent diameter stenosis in the analysis segment was lower in the paclitaxel arm compared with bare stent (39.8% vs. 26.3%, p<0.0001). Late lumen loss was smaller in the paclitaxel arm in both the in-segment (0.23 mm vs. 0.61 mm, p<0.0001) and in-stent (0.39 mm vs. 0.92 mm, p<0.0001). Binary restenosis was also lower in the paclitaxel arm in both the in-segment (7.9% vs. 26.6%, p<0.0001) and in-stent (5.5% vs. 24.4%, p<0.0001).

Similar benefit in binary restenosis occurred in the subgroup analysis, including insulin-dependent diabetics (7.7% vs. 42.9%, p=0.007), small diameter vessels ≤2.5 mm (10.2% vs. 38.5%, p<0.0001), and long lesions >20 mm (14.9% vs. 41.5%, p=0.004). There was no difference in the risk of aneurysm formation or late total occlusion.

Interpretation:

Among patients with single de novo coronary lesions, treatment with the slow-rate release polymer-based paclitaxel-eluting stent was associated with a reduction in angiographic binary restenosis and late loss at nine-month follow-up compared with bare stent. Outcomes were similar across all subgroups, notably diabetic patients.

Prior studies have shown similar benefit in reduced angiographic restenosis and late loss with sirolimus-eluting stents, including the RAVEL trial and the SIRIUS trial. The ongoing REALITY trial is comparing the two drug-eluting stents in a head-to-head trial.

References:

Stone GW, et al. A Polymer-Based, Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease. N Engl J Med 2004;350:221-31.

Presented at the 2003 Transcatheter Cardiovascular Therapeutics conference, by Stephen G. Ellis, MD

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease

Keywords: Paclitaxel, Coronary Artery Disease, Follow-Up Studies, Drug-Eluting Stents, Polymers, Constriction, Pathologic, Insulins, Sirolimus, Diabetes Mellitus


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