First Use To Underscore Restenosis Reduction with Everolimus - FUTURE I

Description:

The goal of the trial was to evaluate the safety and efficacy of the everolimus-eluting stent (EES) coated with a bioabsorbable polymer compared with bare metal stents.

Hypothesis:

Treatment with the EES will be safe and efficacious compared with bare metal stents in patients with de novo lesions.

Study Design

Study Design:

Patients Enrolled: 42
Mean Follow Up: 12 months
Mean Patient Age: Mean age 65 years
Female: 13

Patient Populations:

De novo coronary lesions with a reference diameter of 2.75-4.0 mm and lesion length <18 mm

Primary Endpoints:

MACE, including death, coronary artery bypass graft to the target vessel, Q-wave and non-Q-wave myocardial infarction, and target lesion revascularization at 30 days

Secondary Endpoints:

Quantitative angiographic and IVUS analysis, and MACE and restenosis rate at six-month follow-up

Drug/Procedures Used:

Patients were randomized 2:1 to the EES (n=27) or bare metal stent (n=15). The EESs were coated with a bioabsorbable polymer. Everolimus is an active immunosuppressive and antiproliferative agent from the same macrocyclic lactone family as sirolimus, and has been used for preventing rejection in kidney and heart transplantation. Predilatation was mandatory. Multiple stent placement to treat the target lesion was allowed.

Concomitant Medications:

Aspirin (325 mg/day) and clopidogrel (300 mg loading dose immediately and 75 mg/day for six months)

Principal Findings:

The procedure was successful in all patients in both arms. There were no major adverse cardiac events (MACE) in either group at 30 days, and MACE rates were similar in the EES group versus the bare stent group at six months (7.7%, n=2 vs. 7.1%, n=1; p=NS). There were no additional MACE events through the 12-month follow-up. There was no early or late stent thrombosis in either group.

Minimum lumen diameter at six-month angiographic follow-up was larger in the EES group versus bare stent (2.97 mm vs 2.10 mm, p<0.0001), and late loss was smaller (0.11 mm vs. 0.85 mm, p<0.0001). Percent diameter stenosis was also smaller in the EES group at six-month angiography (2.6% vs. 27.8%, p=0.0009).

Minimum lumen area on intravascular ultrasound (IVUS) at six months was larger in the EES group versus the bare stent group (6.9 mm2 vs. 4.6 mm2; p<0.01). Percent neointimal volume was smaller in the EES group versus the bare stent group (2.9% vs. 22.4%, p<0.001).

Interpretation:

Among patients with a de novo coronary lesion, treatment with an EES coated with a bioabsorbable polymer was associated with similar MACE rates through one year compared with bare metal stents. Both angiographic and IVUS measures at six months showed less restenosis in the EES group.

The everolimus compound shares similar proliferative properties with sirolimus, but is absorbed more quickly into the arterial wall. The present study is the first, randomized trial of EES versus bare stents in humans. Given the small number of patients in the trial and the single center nature of the trial, larger multicenter randomized trials are warranted.

References:

Grube E, Sonoda S, Ikeno F, et al. Six- and Twelve-Month Results From First Human Experience Using Everolimus-Eluting Stents With Bioabsorbable Polymer. Circulation 2004;109:2168-71.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and SIHD, Heart Transplant, Chronic Angina

Keywords: Coronary Restenosis, Metals, Thrombosis, Polymers, Constriction, Pathologic, Sirolimus, Stents, Heart Transplantation


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