03:15 pm

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0315 pm 0330 pm Lecture Bioresorbable
vascular scaffolding (BVS) in clinical practice
what can we expect after CE Mark?
Raul Moreno University Hospital La Paz Madrid,
Spain
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Bioresorbable vascular scaffolding (BVS)
START randomized study (n452) Long-term follow-up
Mechanical support is needed to avoid negative
remodeling and vessel shrinkage, that occur
during the first 6 mo.
JACC 1999341498-1506.
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Bioresorbable vascular scaffolding (BVS)
Long-term safety problems of coronary stents
Two Patients with Extremely Late (8 and 12 Years)
Bare-Metal Stent Thrombosis The Risk Never
Completely Disappears!
J Invasive Cardiol 200820E329-330.
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Bioresorbable vascular scaffolding (BVS)
The problem of VLST is more evident with DES
J Am Coll Cardiol 2008521134-1140.
Am J Med 20061191056-1061.
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Bioresorbable vascular scaffolding (BVS)
Is there a need for bioabsorbable
stents? Potential advantages of bioasborbable
stents

• Risk of stent thrombosis never completely
  dissapears.
• Need for indefinite anti-platelet therapy.
• Potential limitation for future CABG.
• Stent fracture.
• Prevent late stent malapposition allow
  positive remodeling.
• Stent in thrombus containing lesions.
• Side branch compromise in bifurcations.
• Bifurcations Long-term safety issues of 2-stent
  techniques.
• Aorto-ostial lesions.
• Concerns about endothelial function.
• PCI in children.
• IRM MSC imaging.

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Bioresorbable vascular scaffolding (BVS)
Previous bioabsorbable stents
Net gain 1
Late loss (mm)
BMS
BA
PES
SES EES
Acute gain (mm)
Lancet 20073691869 PCR 2011
TCT 2009 TCT 2010
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Bioresorbable vascular scaffolding (BVS)
Polylactic acid
L-LA
Polymer a large molecule (macromolecule)
composed of repeating structural units.
D-LA
Meso L,D-LA
Racemic D,L-LA
J Exp Biol 20052084561
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Bioresorbable vascular scaffolding (BVS)
REVA
Late loss (mm)
Mg
Net gain 1
BMS
DREAMS
BA
PES
SES EES
Acute gain (mm)
Circulation 2000102399 TCT 2009 TCT 2010
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Bioresorbable vascular scaffolding (BVS)
Lessons

• Acute gain should be optimal (radial strength).
• Absorption should not be too quick.
• Neo-intimal hyperplasia occurs release
  anti-proliferative drugs.

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Bioresorbable vascular scaffolding (BVS)
ABSORB (Cohort A)
(30 patients treated with 3x12 or 3x18 mm BVS)

• Clinical FU (4 yr) 1 NQMI, 2 non-cardiac
  deaths, no ST.
• OCT resorption begins at 6 mo, almost complete
  at 2 yr.

Eurointervention 2005158-65 Lancet
2008371899-907
NCT00300131
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Bioresorbable vascular scaffolding (BVS)
Second generation BVS

• Same composition, dose of everolimus
  resorption time.
• Same strut thickness (150 µm).
• Modified platform designed with a reduced
  maximal circular unsupported scaffold area
  (MCUSA) and a different manufacturing process of
  the polymer.
• More uniform strut distribution.
• Similar profile to a 1st-generation DES

BVS 1.1 Cypher Select
Profile 1.40 1.23
Strut thickness (µm) 158 (150 6-8 polymer) 164 (140 24 polymer)
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Bioresorbable vascular scaffolding (BVS)
ABSORB (Cohort B)
n 101 (3x18 mm stents)
Current data up to 1 year no deaths, no QMI, no
stent thrombosis
BVS
EES
BMS
BVS 1.1
0.44
0.10
0.87
Late loss (mm)
0.19
-11.2
-0.3
-2.0
? Stent area ()
-2.0
-16.6
-7.2
-29.4
? Lumen area ()
-5.4
0.30
0.50
1.98
NIH area (mm2)
0.08
EES and BMS provided by SPIRIT-I
TCT 2010 NCT00856856 PCR 2011
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Bioresorbable vascular scaffolding (BVS)
Mg
Late loss (mm)
Net gain 1
BMS
Tamai (PLLA)
DREAMS
BA
PES
SES EES
Acute gain (mm)
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Bioresorbable vascular scaffolding (BVS)
ONGOING FUTURE TRIALS ABSORB Extend
1,000 patients, 100 centers. Single arm. No
angio. follow-up (clinical end-points).
ABSORB Randomized study 500 patients.
RCT vs Xience. Angio follow-up.
Preliminary data
No episodes of stent thrombosis
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Bioresorbable vascular scaffolding (BVS)
Abbott Receives CE Mark Approval for World's
First Drug Eluting Bioresorbable Vascular
Scaffold for Treatment of Coronary Artery Disease
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Bioresorbable vascular scaffolding (BVS)
CONCLUSIONS

• Fully bioabsorbable stents (BVS) are already
  here !
• Absorption and vessel wall integration are real
  phenomena.
• We do not have to worry about acute recoil.
• Neo-intimal hyperplasia inhibited by everolimus.
• Vessel shrinkage (late recoil) solutioned with
  BVS 1.1.
• No early, late or very late ST observed in
  ABSORB AB (n131) or the interim data of
  ABSORB-EXTEND.
• Concerns about acute gain (immediate result) in
  some subsets. Thus, lesions not included in
  ABSORB may be considered off-label (studies
  with complex lesions needed).