European Cobalt stent with antiproliferative for restenosis trial - EUROSTAR

Mar 30, 2005
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Date Presented:
01/01/2005
Date Updated:
03/30/2005
Original Posted Date:
03/30/2005
References

Description:

The goal of the EUROSTAR trial was to evaluate treatment with the paclitaxel-eluting Cobal Chromium coronary stent in patients with de novo lesions.

Study Design

Study Design:

Patients Enrolled: 145
Mean Follow Up: 1 year for clinical follow-up; 6 months for angiographic and IVUS follow-up
Mean Patient Age: Mean age 64 years

Primary Endpoints:

Late lumen loss at 6 months

Secondary Endpoints:

Major adverse coronary events (MACE) at 30 days, 6 months and 1 year; binary restenosis at 6 month angiographic follow-up; target vessel revascularization

Drug/Procedures Used:

Patients were treated with the paclitaxel-eluting Cobalt Chromium coronary stent. Randomization was to either a stent eluting 10 µg of paclitaxel (n=145) or a stent eluting 10 µg of paclitaxel (n=127). The stent was designed to have wells that serve as a reservoir for the elution drug. The wells have the potential to be filled with multiple drugs with multiple targets, one drug which could elute toward the lumen and one drug which could elute toward the vessel wall. Patients underwent follow-up angiography at 6 months. A subset of patients also underwent IVUS at 6 months.

Principal Findings:

Only data for the 10µg paclitaxel-eluting Cobal Chromium coronary stent arm were reported to date; data for the 30µg formuation are pending. At 6 months, late lumen loss was 0.26 mm in the in-stent region, 0.06 mm in the proximal edge, and -0.04 mm in the distal edge. Binary restenosis occurred in 3.4% in the in-stent region, 0.7% in the proximal edge, and 0.2% in the distal edge. Through 6 months, target lesion revascularization occurred in 1.7% of patients. The overall MACE rate was 4.8%. By 12 months, TLR had occurred in 2.9% of patients and MACE in 7.6%. Stent thrombosis through 12 months was 0.7%, with none occurring from 6 to 12 months.

Interpretation:

Among patients undergoing percutaneous coronary intervention and treated with the paclitaxel-eluting Cobalt Chromium coronary stent, late lumen loss and overall MACE were within line with other drug eluting stent trials. However, data from the 30µg formulation arm for the present trial are not yet available and conclusions regarding efficacy comparing the 10µg and 30µg formulation are not possible. The potential for elution of multiple drugs or elution to multiple targets is promising, allowing for targeting of both the lumen and the vessel wall with different agents.

References:

Presented by Dr. Dr. Patrick W. Serruys at the EuroPCR meeting, Paris, France, May 2005.

Presented by Dr. Patrick W. Serruys at the 2005 Cardiovascular Research Therapeutics Sessions, Washington, DC.

Keywords: Paclitaxel, Coronary Artery Disease, Follow-Up Studies, Cobalt, Thrombosis, Drug-Eluting Stents, Chromium, Stents, Percutaneous Coronary Intervention


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