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?