BVS

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ABSORB
ABSORB Trial
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.

ACC 2007
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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 gt 8mm
stenosis gt 50 and lt 100 with TIMI flow gt
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 gt 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
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ABSORB Trial Baseline Characteristics
Characteristic Everolimus eluting stent platform (n30)
Mean minimum lumen diameter (MLD) (mm) 1.10
Percent stenosis () 59
Lesion length (mm) 8.66
LAD Lesion location () 50
Type B1 lesions () 65
ACC 2007
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ABSORB Trial Post-procedure Data
Characteristic Everolimus eluting stent platform (n26)
Mean MLD (mm) 2.33
Stenosis () 16
ACC 2007
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ABSORB Trial Six Month Follow-up Characteristics
Characteristic Everolimus eluting stent platform (n26)
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) 23.1
Late incomplete apposition ( of patients) 26.9
ACC 2007
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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
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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.

ACC 2007
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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