Atherectomy and Multilink stenting Improves Gain in Outcome trial - AMIGO

Apr 04, 2002
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Date Presented:
01/01/2002
Date Updated:
04/04/2002
Original Posted Date:
04/04/2002

Description:

Randomized trial to compare outcomes of patients undergoing coronary stenting with or without partial blockage removal by directional atherectomy.

Study Design

Study Design:

Patients Enrolled: 753
Mean Follow Up: 8 months

Primary Endpoints:

Restenosis rates

Drug/Procedures Used:

A total of 753 patients from six European centers were randomized in the Atherectomy and Multilink stenting Improves Gain and Outcome (AMIGO) trial. Of these, 381 underwent directional atherectomy (DCA) plus stenting and 372 had stenting alone. Patients in each group were similar with the average lesion length being 14.6 mm in the DCA/stent group and 14.3 mm in the stent-only group.

Principal Findings:

At 8 months, there was no significant overall difference in binary restenosis rates (24.1% in DCA/stent group vs. 19.66% in the stent only group, p=NS). However, in centers reporting higher rates of optimal DCA, angiographic results showed that DCA could improve stenting efficacy. Restenosis rates for example, were 21.8% for the stent only patients, 31.8% for those having suboptimal DCA, but only 16.2% for those achieving optimal DCA. Overall, only 21.5% of lesions treated achieved optimal DCA in this trial. In addition, restenosis rates among bifurcated lesions were 9.8% for DCA/stent and 20.9% for stent only treatment.

Interpretation:

Overall, binary restenosis rates were not improved at 8 months among those patients treated with DCA prior to stenting. Non-randomized substudy data did show that a more aggressive approach of debulking known as "optimal DCA" tended to be associated with reduced rates of restenosis. While provocative, the "optimal DCA" approach preceding stenting would require confirmation in a randomized trial.

Keywords: Coronary Artery Disease, Atherectomy, Stents


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