Randomized Clinical Trial Investigators. Randomized Comparison of GR-II Stent and Palmaz-Schatz Stent for Elective Treatment of Coronary Stenosis - Comparison of GR-II Stent and Palmaz-Schatz Stent for Elective Treatment of Coronary Stenosis

Mar 07, 2002
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Date Presented:
01/01/2002
Date Published:
01/01/2002
Date Updated:
03/07/2002
Original Posted Date:
03/07/2002
References

Description:

Randomized Clinical Trial Investigators. Randomized Comparison of GR-II Stent and Palmaz-Schatz Stent for Elective Treatment of Coronary Stenosis.

Hypothesis:

To compare long-term clinical and angiographic outcomes in patients with de novo coronary artery stenosis treated with either the coil design Gianturco-Robin II (GR-II) stent or with the slotted tube design Palmaz-Shatz (PS) stent.

Study Design

Study Design:

Patients Enrolled: 755

Primary Endpoints:

The primary end point was target lesion revascularization (TLR) at 12 months follow-up.

Secondary Endpoints:

Secondary end points included procedure success, stent thrombosis and major adverse cardiac events (MACE) defined as a composite of death, MI and TLR at 30 days and 12 months.

Drug/Procedures Used:

A total of 755 patients were randomized to either GR-II (380 patients) or to PS (375 patients) stent implantation. The primary end point was target lesion revascularization (TLR) at 12 months follow-up. Secondary end points included procedure success, stent thrombosis and major adverse cardiac events (MACE) defined as a composite of death, MI and TLR at 30 days and 12 months.

Principal Findings:

At 30 days, the composite MACE rate was significantly higher in the GR-II group when compared to the PS group (4.2% vs. 1.3%, p < 0.01). This difference was due primarily to a significantly higher incidence in the GR-II group of subacute stent thrombosis (3.9% vs. 0.3%, p = 0.001) and 30-day TLR (3.9% vs. 0.5% p < 0.001). Complete data at 12 months were available for 97.1% of the GR-II patients and 97.6% of the PS patients. TLR rate was significantly higher in the GR-II group (27.4% vs. 15.3%, p < 0.001). There was a non-significant trend toward a higher MI rate in the GR-II group, while there was no difference in incidence of death (2.7% vs. 2.7%). Multivariate analysis identified a smaller final minimal luminal diameter, diabetes and the use of the GR-II stent as independent predictors of TLR. There was a trend toward higher TLR rates in patients with oversized and undersized GR-II stents when compared with appropriately sized stents.

Treatment with the GR-II stent results in worse 30-day and 12-month outcomes when compared with treatment with the PS stent.

Interpretation:

This randomized clinical trial confirms the results of prior animal studies that have shown substantial differences between slotted tube and coil stent designs. Thus, not all stents are the same, and a comparison of newer stents with an established gold standard appears to be a needed step before their widespread clinical use.

References:

1. Lansky AJ, Roubin GS, O'Shaughnessy CD, Moore PB, Dean LS, Raizner AE, Safian RD, Zidar JP, Kerr JL, Popma JJ, Mehran R, Kuntz RE, Leon MB. Randomized comparison of GR-II stent and Palmaz-Schatz stent for elective treatment of coronary stenoses. Circulation. 2000;102(12):1364-8.

Keywords: Coronary Artery Disease, Multivariate Analysis, Coronary Stenosis, Thrombosis, Diabetes Mellitus, Stents


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