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Trapidil in Stent - TRAPIST
Description:
Trapidil for reducing 6-month in-stent neointimal hyperplasia.
Hypothesis:
To evaluate the efficacy of trapidil in reducing in-stent neointimal hyperplasia.
Study Design
Study Design:
Patients Screened: Not given
Patients Enrolled: 312
Mean Follow Up: 7 months
Patient Populations:
De novo lesion in native vessel
Native vessel suitable to receive a stent
Single lesion treatment.
Exclusions:
Lesion length greater than 40mm
Left main lesion
Primary Endpoints:
In-stent neointimal volume at 6-months measured by IVUS.
Drug/Procedures Used:
Trapidil 200 mg PO t.i.d. vs. placebo
Concomitant Medications:
Wallstent
Principal Findings:
The 6 month IVUS analysis showed the expected stent volume increase, since self-expanding stents dilate by 10-15% over time. The in-stent neointimal volume was 109 cu mm in the trapidil group, slightly higher than the value for the placebo group. The degree of in-stent restenosis was 37% in the trapidil group and 36% in the placebo group.
At the seven-month follow-up, 78% of the patients in the trapidil group and 79% of the patients in the placebo group were event free. The MLD of the trapidil group was not significantly different at follow-up. Restenosis rate and loss index were not significantly different for the trapidil group.
At seven months, there were no significant differences detected in the frequency of anginal complaints or silent ischemia (41 patients in the trapidil group vs. 35 patients in the placebo group).
Interpretation:
The TRAPIST investigators concluded that in the population treated with a cell-expandable stent for de novo lesions, no difference was seen in clinical angiography and IVUS outcome between placebo and trapidil treatment.
References:
1. Presented at XXth Congress of the European Society of Cardiology, Vienna, 1998.
Keywords: Follow-Up Studies, Research Personnel, Trapidil, Hyperplasia, Vasodilator Agents, Stents
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