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Update : November 14, 2008

	Left main coronary disease

	Ostial disease

	Bifurcation

	Graft vessel disease

	Diffuse coronary disease

	Chronic total occlusion (CTO)

	Restenosis

	Multivessel disease

	Drug eluting stent

	Vulnerable plaque

TCT 2003

Untitled Document

FUTURE-I and II
: Dual Trials Promote Effectiveness of Everolimus-Eluting Stent

An everolimus-eluting coronary stent showed efficacy in reducing neointimal proliferation at six months with no subacute thrombosis or late malapposition, according to results from two trials presented yesterday.
Eberhard Grube, MD, Heart Center of Siegburg, Germany, reported that the everolimus-eluting stent proved safe and effective in the FUTURE-I and FUTURE-II trials. ‘There was sustained safety with no new MACE [major adverse coronary events], no aneurysms and no late malapposition seen in either arm”, Dr. Grube said. “There is sustained efficacy with minimal lumen areas and lumen volume index sustained up to 12 months, and no in-stent binary restenosis up to 12 months.”

FUTURE-I

In the FUTURE-I trial, 25 patients received the everolimus stent. Eleven patients were in the control group. At six-month follow-up, there was a 7.7% MACE rate in both groups. Dr. Grube said that one MACE in the stent group was due to underlying chronic obstructive pulmonary disease and, therefore, unrelated to the stent. Dr. Grube presented new 12-month follow-up data on the FUTURE-I patient group yesterday. No additional MACEs were reported between six and 12 months in either the stent or control group. Twelve-month angiographic information was available for eight patients, although additional data are being collected. In that small patient group, however, there was no binary restenosis with, a late loss of 0.29 mm, a minimal luminal diameter of 2.70 mm and a percentage diameter stenosis of 9.14%.

FUTURE-II

The FUTURE-II trial was a prospective, randomized, multicenter study. The trial enrolled 64 patients in two groups: one received the everolimus stent (21 patients) and the other, a bare metal stent (43 patients). The average lesion length in both groups was approximately 11.0 mm. Dr. Grube presented six-month follow-up results from the FUTURE-II trial yesterday. There was one MACE in the stent group that required target lesion revascularization due to proximal edge restenosis. There were seven adverse coronary events in the control group, including six target lesion revascularization. In-stent angiography at six months showed a minimal luminal diameter of 2.74 mm in the everolimus stent group vs. 2.02 mm in the bare metal stent group (P<.0001). There was also a statistically significant difference in percent age diameter stenosis (2.94% vs. 30.35%, P<.0001) and late loss (0.12 mm vs. 0.85 mm, P<.0001) favoring the everolimus stent group. In-segment angiography at six months showed a mean luminal diameter of 2.19 mm in the everolimus stent group vs. 1.75 mm in the bare metal stent group (P=.003). There was also a statistically significant difference in percentage diameter stenosis (22.3% vs. 40.26%, p=.0006) and late loss (0.17 mm vs. 0.54 mm, p<.002) favoring the everolimus stent group.
In August, Guidant submitted six-month results from the FUTURE-I trial to the European regulatory authorities in its application for the CE mark.