Coronary Stenting With Absorbable Metal Stents - PROGRESS-1

Description:

The goal of the trial was to evaluate the safety of the absorbable metal stent among patients with a single de novo lesion in a native coronary artery.

Study Design

Patients Enrolled: 63
Mean Follow Up: Four months
Mean Patient Age: Mean age 61.3 years
Female: 30

Patient Populations:

Single de novo lesion in a native coronary artery, lesion length ≤13 mm, vessel diameter between 3.0 mm and 3.5 mm, and diameter stenosis 50% to 99%.

Drug/Procedures Used:

Consecutive patients (n=63) from nine centers with a single de novo coronary lesion in a native artery who gave consent were enrolled in the study. Patients in the trial were treated with the Absorbable Metal Stent. Lesions were pre-dilated before stenting. Patients underwent repeat angiography at four months, as well as intravascular ultrasound (IVUS).

Principal Findings:

Among the patients enrolled in the study, 82% had stable angina, 10% unstable angina, and 17% were diabetics. Target lesion was in the left anterior descending in 35%, left circumflex in 29%, and right coronary artery in 37%. Lesion success was 100%. An average of 1.1 stents were used per patient.

During the four month follow-up, there were no deaths, myocardial infarction (MI), or in-stent thrombosis. Ischemic-driven target lesion revascularization was performed in 23.8%, and any TLR was performed in 38.1%. There were no cases of stent thrombosis. Late lumen loss from baseline to 4 months was 1.09 mm. Percent diameter stenosis was 62% pre-PCI, 12% immediately post-PCI, and 48% at 4 month follow-up. Likewise, MLD was 1.05 mm, 2.46 mm, and 1.37 mm.

Interpretation:

Among patients with a single de novo lesion in a native coronary artery, use of an absorbable metal stent was safe, with no deaths or MIs and a moderate rate of ischemic driven TLR by four months, although longer follow-up is warranted, as well as a randomized evaluation with a control arm.

The present trial is a first-in-man study of an absorbable stent. The ischemic-driven revascularization rates were moderate compared to drug-eluting stent trials. Additionally, absolute percent diameter stenosis was relatively high at 4 months at 48%. A larger randomized trial is needed to fully evaluate the efficacy of this absorbable stent.

References:

Erbel R, Di Mario C, Bartunek J, et al. Temporary scaffolding of coronary arteries with bioabsorbable magnesium stents: a prospective, non-randomised multicentre trial. Lancet. 2007 Jun 2;369(9576):1869-75.

Presented by Dr. R. Erbel at the March 2006 i2 Summit Annual Scientific Session, Atlanta, GA.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Stable Ischemic Heart Disease, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease, Chronic Angina

Keywords: Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Angina, Stable, Metals, Thrombosis, Drug-Eluting Stents, Human Rights, Constriction, Pathologic, Diabetes Mellitus


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