Coronary Stenting With Absorbable Metal Stents - PROGRESS-1
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.
Patients Enrolled: 63
Mean Follow Up: Four months
Mean Patient Age: Mean age 61.3 years
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%.
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).
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.
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.
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.
Keywords: Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Angina, Stable, Metals, Thrombosis, Drug-Eluting Stents, Human Rights, Constriction, Pathologic, Diabetes Mellitus
< Back to Listings