A Randomized Comparison of Genous Stent Versus Chromium-Cobalt Stent for Treatment of ST-Elevation Myocardial Infarction - GENIUS-STEMI — Presented at ACC.09/i2

Mar 28, 2009
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Date Presented:
01/01/2009
Date Updated:
03/28/2009
Original Posted Date:
03/28/2009
References

Description:

The goal of the trial was to evaluate treatment with the endothelial progenitor cell capture stent compared with a cobalt chromium stent in patients with ST-elevation myocardial infarction (STEMI).

Hypothesis:

The endothelial progenitor cell capture stent will be more effective in preventing major adverse cardiac events.

Study Design

Study Design:

Patients Enrolled: 100
Mean Follow Up: 6 months
Mean Patient Age: 57 years
Female: 21%

Patient Populations:

  • Patients with STEMI

Primary Endpoints:

  • MACE defined as cardiovascular death, MI, or TLR at 6 months

Secondary Endpoints:

  • Stent thrombosis
  • Late lumen loss

Drug/Procedures Used:

Patients with STEMI were randomized to the endothelial progenitor cell capture stent (n = 50) versus a cobalt chromium stent (n = 50).

Concomitant Medications:

All patients were treated with dual antiplatelet therapy for 30 days.

Principal Findings:

Overall, 100 patients were randomized. Baseline and procedural characteristics were well matched between the groups. The mean age was 57 years, 21% were women, and 29% had diabetes. The time from onset of symptoms until PCI was 230 minutes versus 203 minutes, use of thromboaspiration was 17% versus 25%, and use of a glycoprotein IIb/IIIa inhibitor was 32% versus 22%, respectively. There were no procedural complications in either group.

At 6 months, the incidence of major adverse cardiac events (MACE) was 24% with the endothelial progenitor cell capture stent versus 10% with the cobalt chromium stent (p = 0.03). Target lesion revascularization (TLR) was 14% versus 4% (p = 0.04), cardiovascular death was 4% versus 4% (p = NS), MI was 6% versus 2% (p = NS), and stent thrombosis was 6% versus 0% (p = NS), respectively for endothelial progenitor cell capture stent versus cobalt chromium stent.

At 6 months, late lumen loss was 0.89 mm versus 0.79 mm (p = NS), respectively for endothelial progenitor cell capture stent versus cobalt chromium stent.

Interpretation:

Among patients with STEMI, the use of the endothelial progenitor cell capture stent was inferior to the cobalt chromium stent. This was due to a high incidence of MACE, TLR, and stent thrombosis at 6 months. There was also slightly more late lumen loss with the endothelial cell capture stent.

The results of this trial indicate strong safety concerns for this experimental device. To date, the benefit of endothelial cell capture technology to prevent restenosis and stent thrombosis remains unproven.

References:

A Randomized Comparison of Genous Stent Versus Chromium-Cobalt Stent for Treatment of ST-Elevation Myocardial Infarction: A 6-Month Clinical, Angiographic, and IVUS Follow-up: GENIUS-STEMI trial. Presented by Dr. Pavel Cervinka at ACC.09/i2, Orlando, FL, March 2009.

Keywords: Myocardial Infarction, Coronary Restenosis, Cobalt, Thrombosis, Chromium, Angioplasty, Balloon, Coronary, Endothelial Cells, Diabetes Mellitus, Stents


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