Bioresorbable stents for all or for few? Franz-Josef Neumann

Bioresorbable stents for all or for few? Franz-Josef Neumann

Personal: None Institutional: Conflict of Interest Speaker honoraria, consultancy fees and research grants from Lilly, Daiichi Sankyo, Sanofi-Aventis, Bayer, Boehringer, The Medicines Company, Bristol, Novartis, Roche, Boston Scientific, Cordis, Biotronik, Medtronic, Edwards

Bioresorbable poly-l-lactide (PLLA) stent Drug/polymer matrix 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 Polymer backbone PLLA backbone Highly crystalline Provides device integrity Processed for increased radial strength Abbott Vascular, data on file

ABSORB: Complete Absorption of Stent Material BL 2Y Baseline OCT OCT at 2 years Serruys PW. et al., TCT 2008

ABSORB cohort A: Late Loss Mean late loss: 0.44 + 0.35 mm Ormiston JA et al., Lancet 2008

ABSORB: Restoration of vasomotor function Serruys PW et al., Lancet 2009

ABSORB Cohort B: Late lumen loss at 2 years Target vessel failure 1 year: 6.9% 2 years: 11% 3 years: 13% Ormiston JA et al., Circ Cardiovasc Interv 2012

- ABSORB II - 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 Serruys PW et al., Lancet 2016

ABSORB II: Randomisation Study Population N = 501 Absorb BVS n = 335 Xience Stent n = 166 Serruys PW et al., Lancet 2016

ABSORB II 1-Year Results Serruys PW et al., Lancet 2016

No proven benefit of bioresorbable scaffolds 1-year incidence (%) 5 4 3 2 P = 0.06 4.5% P = 0.15 4.8% 2.4% 1 0 P = 0.11 1.2% 0% 0% Cardiac Death Infarction Re-intervention P = 0.55 0.9% 0% Stent thrombosis Metallic stent Bioresorbable scaffold Serruys PW et al., Lancet 2015

Lower cumulative angina rates with bioresorbable scaffolds Rate (%) 40 30 20 P = 0.04 30% 22% Metallic stent Bioresorbable scaffold 10 0 1 year Serruys PW et al., Lancet 2015

ABSORB III: Randomisation Study Population N = 2008 Absorb BVS n = 1322 Xience Stent n = 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 1-year incidence (%) 10 P = 0.29 P = 0.28 P = 0.18 P = 0.13 8 6 6.9% 4 5.6% 5.0% 2 0 0.1% 0.6% Cardiac Death Infarction 3.7% Ischemia-driven reintervention 0.7% 1.5% Stent thrombosis Ellis SG et al., N Engl J Med 2015 Metallic stent Bioresorbable scaffold

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 - Superiority Late 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 P superiority < 0.01 Serruys PW et al., Lancet 2016

Lower cumulative angina rates with bioresorbable scaffolds? Rate (%) 40 30 P = 0.04 30% Metallic stent Bioresorbable scaffold 20 10 22% Not reported 0 1 year 3 years Serruys PW et al., Lancet 2016

Seattle angina questionaire No benefit of scaffold with respect to angina relief Bioresorbable scaffold Xience stent % angina free Serruys PW et al., Lancet 2016

- ABSORB II - Device-oriented outcome: Scaffold inferior to stent Absorb scaffold Xience stent Serruys PW et al., Lancet 2016

- ABSORB II - Device-oriented outcome: Scaffold inferior to stent Proportion with event at 3 years (%) 10 P = 0.40 P = 0.006 P = 0.036 P = 0.031 8 6 7 6 4 2 0 1 2 1 2 Cardiac Target vessel Clinically death MI indicated TLR - Device-oriented clincal outcome - 3 0 Definite/probable stent thrombosis Serruys PW et al., Lancet 2016 Absorb scaffold Xience stent

Updated meta-analysis: More target lesion failures with scaffold Ha FJ et al., J Am Coll Cardiol Intv 2017

Updated meta-analysis: More target lesion problems with scaffold Odds ratio Cardiac death Target vessel myocardial infarction Target lesion revascularisation 0 1 2 3 BVS better DES better 4 5 6 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

Haude M et al., presented at TCT 2016 Bioresorbable Mg - Stent

Haude M et al., Lancet 2015, Eur Heart J 2016 BIOSOLVE II

Haude M et al., Lancet 2016, Eur Heart J 2016 BIOSOLVE II

Bioresorbable Scaffolds - Summary - The development of bioresorbable scaffolds continues. Further clinical studies are needed. Bioresorbable scaffolds are not ready for clinical use outside studies.

Bioresorbable stents for all or for few? For none (except clinical studies)