A Bioabsorbable Everolimus-Eluting Coronary Stent System for Patients With Single De-Novo Coronary Artery Lesions - ABSORB: 6-month and 2-year results

Description:

The goal of the trial was to evaluate use of a bioabsorbable drug-eluting stent (DES) platform among patients undergoing elective percutaneous coronary intervention (PCI) for a de novo coronary lesion.

Hypothesis:

The use of the bioabsorbable everolimus-eluting stent would be feasible and safe at treating native coronary artery disease.

Study Design

Patients Enrolled: 30
Mean Follow Up: 6 months
Female: 42

Patient Populations:

Single, de novo target lesion in a native artery with diameter of 3.0 mm, lesion length <8-14 mm, stenosis 50%-100%, and TIMI flow of at least 1

Exclusions:

  • Lesion within or distal to an arterial or saphenous vein graft
  • Bifurcation lesions more than 2 mm in diameter
  • Ostial lesion more than 40% stenosed or side branch requiring predilatation
  • Total occlusion (TIMI flow 0) prior to wire passing
  • Visible thrombus
  • Another clinically significant lesion in the same target vessel
  • Prior use of brachytherapy in any epicardial vessel

Primary Endpoints:

Cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization

Secondary Endpoints:

In-stent late loss, MLD, percent stenosis, percent volume obstruction, and incomplete stent apposition

Drug/Procedures Used:

The study was a first-in-man, nonrandomized, open-label study of a bioabsorbable DES platform. The stent eluted everolimus and was designed to absorb over time. The bioabsorbable structure of the stent is made of polylactic acid. Patients will be followed for up to 5 years. Patients will undergo angiography and intravascular ultrasound (IVUS) follow-up at 180 days and 2 years.

Concomitant Medications:

Patients were required to receive at least 75 mg of aspirin daily for 5 years and 75 mg of clopidogrel daily for 6 months.

Principal Findings:

Of the 30 patients randomized, three were excluded due to need for bailout stenting and one due to device failure. At baseline, mean minimum lumen diameter (MLD) was 1.10 mm, percent stenosis was 59%, and lesion length was 8.66 mm. Half of the lesions treated were in the left anterior descending artery and 65% were type B1 lesions. Post-procedure mean MLD was 2.33 mm and stenosis was 16%.

At 6-month angiographic follow-up, in-stent late loss was 0.44 mm, MLD was 1.88 mm, and stenosis was 27%. Intrastent neointimal hyperplasia on IVUS showed 5.54% volume obstruction. Incomplete apposition at 6 months was present in 16% of patients (n = 4/25) and late acquired incomplete apposition was present in 28% of patients (n = 7/25).

At 12-month clinical follow-up, one patient had a non-Q-wave myocardial infarction (3.3%). There were no other major adverse clinical events (no cardiac death or ischemia-driven target lesion revascularization). There were no cases of stent thrombosis through 12 months.

At 2 years, there were no cardiac deaths, one non-Q-wave myocardial infarction, no ischemia-driven target lesion revascularization, and no stent thromboses. In-stent late loss was 0.48 mm, MLD was 1.76 mm, and stenosis was 27%.

Interpretation:

Among patients undergoing elective PCI for a single de novo coronary lesion, short- and longer-term follow-up data in a very small number of patients have shown feasibility of use of the bioabsorbable everolimus-eluting stent in this first-in-man, nonrandomized registry.

Bioabsorbable stents are an important development for future PCI devices. The data from the present nonrandomized registry study of 30 patients shows feasibility, as well as important data regarding safety and efficacy of the device. Large-scale, randomized trials that follow patients for several years will additionally be required, particularly since the excess in late stent thrombosis observed with first generation DES did not begin to emerge until after 1 year post-PCI. In-stent late loss in the present study appears to be comparable with other trials of DES such as TAXUS IV, in which the paclitaxel-eluting stent group had a mean in-stent late loss of 0.39 mm. The late lumen loss seen with this stent was mostly due to a reduction in stent area, along with some neointimal hyperplasia.

References:

Serruys PW, Ormiston JA, Onuma Y, et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet 2009;373:897-910.

Presented by Dr. Patrick W. Serruys at the i2 Summit/American College of Cardiology Annual Scientific Session, New Orleans, LA, March 2007.

Ormiston JA, Serruys PW, Regar E, et al. A Bioabsorbable Everolimus-Eluting Coronary Stent System for Patients With Single De-Novo Coronary Artery Lesions (ABSORB): A Prospective Open-Label Trial Topic: Interventional Cardiology. Lancet 2008;371:899-907.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Atherosclerotic Disease (CAD/PAD), Interventions and Coronary Artery Disease

Keywords: Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Drug-Eluting Stents, Sirolimus, Constriction, Pathologic, Hyperplasia, Percutaneous Coronary Intervention, Equipment Failure, Stents, Paclitaxel, Registries, Polymers, Thrombosis, Lactic Acid


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