Rapamycin- and Paclitaxel-Eluting Stents With Identical Biodegradable Polymeric Coating and Design - Rapamycin- and Paclitaxel-Eluting Stents With Identical Biodegradable Polymeric Coating and Design

Description:

Randomized trial comparing identical drug eluting stents coated with a biodegradable polymer eluding rapamycin or paclitaxel

Hypothesis:

On identical drug-eluting stent platform with a biodegradable polymer, rapamycin would be more efficient for the prevention of restenosis than paclitaxel

Study Design

Patients Enrolled: 91
Mean Follow Up: 9 months

Patient Populations:

De novo coronary lesion suitable for stent implantation

Exclusions:

Left main, acute myocardial infaction

Primary Endpoints:

In-stent late lumen loss

Secondary Endpoints:

Death, myocardial infarction, in-segment late loss, binary restenosis, target lesion revascularization

Drug/Procedures Used:

Patients were randomized to rapamycin or paclitaxel coated stent. The coronary stents had a biodegradable polymeric matrix that is completely degraded within weeks after stent placement. Stents were coated with rapamycin at a concentration of 2.0 mcg/mm2 stent surface or with paclitaxel at 0.25 mcg/mm2). Clinical follow-up at 9 months. Follow-up angiography at 6 months.

Principal Findings:

Baseline clinical and angiographic characteristics were well matched. At 30 days and 9 months,no death or stent thrombosis were noted. One non-ST segment myocardial infarction was reported.

At 6 month angiographic follow-up, late loss was larger with paclitaxel compared with rapamycin (0.94 mm vs. 0.34 mm; p<0.001). Angiographic (34.8% vs. 10.2%; p<0.0001) and clinical restenosis (TLR) rates were increased with the paclitaxel compared with the rapamycin stent (24.0% vs. 8.3%; p=0.03).

Interpretation:

Among patients with de novo coronary lesions, using a specific stent and biodegradeable polymer delivery system, rapamycin-eluting stents were associated with less late loss and need for repeat revascularization compared with paclitaxel-eluting stents. These findings cannot be extrapolated to other technologies involving differing stent platforms and polymers with differing release kinetics.

References:

Wessely R, Kastrati A, Mehilli J, Dibra A, Pache J, Schömig A. Randomized trial of rapamycin- and paclitaxel-eluting stents with identical biodegradable polymeric coating and design. Eur Heart J. 2007 Nov;28(22):2720-5.

Presented by Dr. Rainer Wessley at the March 2006 i2 Summit Annual Scientific Session, Atlanta, GA.

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

Keywords: Paclitaxel, Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Thrombosis, Drug-Eluting Stents, Polymers, Sirolimus, Kinetics, Stents


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