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ABSORB Trial. ABSORB. Presented at the American College of Cardiology Annual Scientific Session March, 2007 Presented by Dr. Patrick W. Serruys. ABSORB: Background.

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  1. ABSORB Trial ABSORB Presented at the American College of Cardiology Annual Scientific Session March, 2007 Presented by Dr. Patrick W. Serruys

  2. ABSORB: Background • The goal of this trial was to evaluate the use of a bioabsorbable drug-eluting stent (DES) platform among patients undergoing elective percutaneous coronary intervention (PCI) for a de novo coronary lesion. • The bioabsorbable structure of the stent is made of polylactic acid, a biodegradable polyester derived from lactic acid. ACC 2007

  3. ABSORB: Study Design 30 patients undergoing elective PCI for a single, de novo coronary lesion in a native artery with diameter of 3.0mm and lesion length > 8mm; stenosis > 50% and < 100% with TIMI flow > 1 First-in-man. Non-randomized. Mean follow-up 6 months. 42% female Exclusion criteria: Lesion within or distal to an arterial or saphenous vein graft; bifurcation lesions ≥ 2 mm in diameter and ostial lesion > 40% stenosed or side branch requiring predilatation; total occlusion; visible thrombus; another lesion in the same target vessel; prior use of brachytherapy in any epicardial vessel. Everolimus Eluting Stent Platform 6 mos. and 2 yrs. follow-up • Angiography and intravascular ultrasound (IVUS) to determine mean minimum lumen diameter, percent stenosis, volume obstruction, neointimal volume, and incomplete apposition. ACC 2007

  4. ABSORB Trial: Baseline Characteristics ACC 2007

  5. ABSORB Trial: Post-procedure Data ACC 2007

  6. ABSORB Trial: Six Month Follow-up Characteristics ACC 2007

  7. ABSORB: Limitations • The data from this non-randomized registry study of 30 patients only show feasibility; no conclusions regarding safety and efficacy of the device can be made. • Large-scale, randomized trials that follow patients for several years would be required, particularly since the excess in late stent thrombosis observed with DES does not begin to emerge until after one year post-PCI. ACC 2007

  8. ABSORB: Limitations • In-stent late loss in this 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), but was much higher than the everolimus-eluting metal stent arm of the recently reported SPIRIT III trial. • This higher rate of late lumen loss and greater percent stenosis than in other DES studies may be due to shrinkage of the stent during the follow-up period. • Modifications to the stent platform are planned. ACC 2007

  9. ABSORB: Summary • Among patients undergoing elective PCI for a single de novo lesion, short term follow-up data in a very small number of patients have shown feasibility of use of bioabsorbable everolimus-eluting stents in this first-in-man, non-randomized registry. ACC 2007

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