Bioresorbable stents for all or for few? · BIOSOLVE II Haude M et al., Lancet 2015, Eur Heart J...
Transcript of Bioresorbable stents for all or for few? · BIOSOLVE II Haude M et al., Lancet 2015, Eur Heart J...
Franz-Josef Neumann
Bioresorbable stents – for all or for few?
Personal: None
Institutional:
Speaker honoraria, consultancy fees andresearch grants from
Lilly, Daiichi Sankyo, Sanofi-Aventis, Bayer, Boehringer, The Medicines Company, Bristol, Novartis, Roche, Boston
Scientific, Cordis, Biotronik, Medtronic, Edwards
Conflict of Interest
Bioresorbable poly-L-lactide (PLLA) stent
Everolimus/poly-D,L-lactide matrix coating
• Thin coating layer
• Amorphous (non-crystalline)
• 1:1 ratio of Everolimus/PDLLA matrix
• Conformal Coating, 2-4 m thick
• Controlled drug release
PLLA backbone
• Highly crystalline
• Provides device integrity
• Processed for increased radial strength
Polymer backbone
Drug/polymer matrix
Abbott Vascular, data on file
BL 2Y
ABSORB:
Complete Absorption of Stent Material
Baseline OCT OCT at 2 years
Serruys PW. et al., TCT 2008
Ormiston JA et al., Lancet 2008
ABSORB cohort A: Late Loss
Mean late loss:
0.44 + 0.35 mm
ABSORB: Restoration of vasomotor function
Serruys PW et al., Lancet 2009
ABSORB Cohort B: Late lumen loss at 2 years
Ormiston JA et al., Circ Cardiovasc Interv 2012
Target vessel failure
1 year: 6.9%2 years: 11%3 years: 13%
Hypothesis:
BVS superior to XIENCE with respect to vasomotion at 3 years
BVS non-inferior to XIENCE with respect to late lumen loss at 3 years
- ABSORB II -
Serruys PW et al., Lancet 2016
ABSORB II: Randomisation
Study PopulationN = 501
Absorb BVSn = 335
Xience Stentn = 166
Serruys PW et al., Lancet 2016
ABSORB II
1-Year Results
Serruys PW et al., Lancet 2016
No proven benefit of bioresorbable scaffolds
5
2
3
1
00% 0%
P = 0.11 1.2%
4.5%
P = 0.06
4
InfarctionCardiac Death
2.4%
4.8%
Re-intervention
P = 0.15
Metallic stent Bioresorbable scaffold
1-year incidence (%)
0.9%0%
Stent thrombosis
P = 0.55
Serruys PW et al., Lancet 2015
Lower cumulative angina rates with bioresorbable scaffolds
Metallic stent
Bioresorbable scaffold
20
30
10
0
30%
22%
P = 0.04 40
1 year
Rate (%)
Serruys PW et al., Lancet 2015
ABSORB III: Randomisation
Study PopulationN = 2008
Absorb BVSn = 1322
Xience Stentn = 686
Ellis SG PW et al., N Engl J Med 2015
ABSORB III:Numerical increase in target lesion failure with scaffold
Ellis SG et al., N Engl J Med 2015
ABSORB III:Numerically higher risk with bioresorbable scaffolds
10
4
6
2
00.1%
0.6%
P = 0.29
5.6%
6.9%
P = 0.28 8
InfarctionCardiac Death
5.0%
3.7%
Ischemia-driven
reintervention
P = 0.18
Metallic stent Bioresorbable scaffold
1-year incidence (%)
1.5%0.7%
Stent thrombosis
P = 0.13
Ellis SG et al., N Engl J Med 2015
Meta-analysis:Higher in-device late lumen loss with scaffold
Cassese S & Byrne RA et al., Lancet 2016
Meta-analysis:Higher risk of stent thrombosis with scaffold
Cassese S & Byrne RA et al., Lancet 2016
ABSORB II
3-Year Results:Primary endpoints
Serruys PW et al., Lancet 2016
ABSORB II: Primary endpoint
Co-primary endpoint:
Vasomotion in response to nitrate at 3 years - SuperiorityLate lumen loss at 3 years – Non inferiority
Non-inferiority margin for late loss: 0・14 mm
Serruys PW et al., Lancet 2016
- ABSORB II -Vasomotion: Scaffold non-superior to stent
Serruys PW et al., Lancet 2016
- ABSORB II -Late lumen loss: Scaffold inferior to stent
Serruys PW et al., Lancet 2016
Psuperiority < 0.01
Lower cumulative angina rates with bioresorbable scaffolds?
Metallic stent
Bioresorbable scaffold
20
30
10
0
30%
22%
P = 0.04 40
1 year
Rate (%)
Serruys PW et al., Lancet 2016
3 years
Not
reported
No benefit of scaffold with respect to angina relief
Xience stent
Bioresorbable scaffold
Serruys PW et al., Lancet 2016
Seatt
le a
ngin
aquestionaire
% angina free
- ABSORB II -Device-oriented outcome: Scaffold inferior to stent
Serruys PW et al., Lancet 2016
Absorb scaffold
Xience stent
- ABSORB II -Device-oriented outcome: Scaffold inferior to stent
Serruys PW et al., Lancet 2016 Absorb scaffold Xience stent
0
4
6
10
1
8
2
Cardiacdeath
2
7
1
Target vesselMI
P = 0.40 P = 0.006
6
2
Clinicallyindicated TLR
30
Definite/probablestent thrombosis
P = 0.036 P = 0.031
Proportion with event at 3 years (%)
- Device-oriented clincal outcome -
Updated meta-analysis:More target lesion failures with scaffold
Ha FJ et al., J Am Coll Cardiol Intv 2017
Odds ratio
Cardiac death
Target vesselmyocardial infarction
Target lesionrevascularisation
0 1 2 3
DES betterBVS better
4 5 6
Updated meta-analysis:More target lesion problems with scaffold
Ha FJ et al., J Am Coll Cardiol Intv 2017
Updated meta-analysis:Higher risk of stent thrombosis with scaffold
Ha FJ et al., J Am Coll Cardiol Intv 2017
Bioresorbable Mg - Stent
Haude M et al., presented at TCT 2016
BIOSOLVE II
Haude M et al., Lancet 2015, Eur Heart J 2016
BIOSOLVE II
Haude M et al., Lancet 2016, Eur Heart J 2016
Bioresorbable Scaffolds- Summary -
• The development of bioresorbable scaffoldscontinues.
• Further clinical studies are needed.
• Bioresorbable scaffolds are not ready forclinical use outside studies.
For none
(except clinical studies)
Bioresorbable stents – for all or for few?