ABSORB Trial
ABSORB
Presented at the American College of
Cardiology Annual Scientific Session
March, 2007
Presented by Dr. Patrick W. Serruys
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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.
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ACC 2007
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.
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ACC 2007
ABSORB Trial: Baseline Characteristics
Characteristic
Everolimus eluting
stent platform
(n=30)
Mean minimum lumen
diameter (MLD) (mm)
Percent stenosis (%)
Lesion length (mm)
1.10
59
8.66
LAD Lesion location (%)
50
Type B1 lesions (%)
65
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ACC 2007
ABSORB Trial: Post-procedure Data
Characteristic
Everolimus eluting
stent platform
(n=26)
Mean MLD (mm)
Stenosis (%)
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2.33
16
ACC 2007
ABSORB Trial: Six Month Follow-up
Characteristics
Characteristic
Everolimus eluting
stent platform (n=26)
In-stent late loss (mm)
0.44
Mean MLD (mm)
1.88
Stenosis (%)
27
Volume Obstruction (%)
5.54
Neointimal volume (mm3)
4.26
Incomplete apposition at
6 mos. (% of patients)
Late incomplete
apposition (% of patients)
23.1
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26.9
ACC 2007
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.
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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.
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ACC 2007
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.
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ACC 2007