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

Transcription

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

2 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

3 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

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

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

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

7 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

8 - 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

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

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

11 No proven benefit of bioresorbable scaffolds 1-year incidence (%) P = % P = % 2.4% 1 0 P = % 0% 0% Cardiac Death Infarction Re-intervention P = % 0% Stent thrombosis Metallic stent Bioresorbable scaffold Serruys PW et al., Lancet 2015

12 Lower cumulative angina rates with bioresorbable scaffolds Rate (%) P = % 22% Metallic stent Bioresorbable scaffold year Serruys PW et al., Lancet 2015

13 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

14 ABSORB III: Numerical increase in target lesion failure with scaffold Ellis SG et al., N Engl J Med 2015

15 ABSORB III: Numerically higher risk with bioresorbable scaffolds 1-year incidence (%) 10 P = 0.29 P = 0.28 P = 0.18 P = % 4 5.6% 5.0% % 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

16 Meta-analysis: Higher in-device late lumen loss with scaffold Cassese S & Byrne RA et al., Lancet 2016

17 Meta-analysis: Higher risk of stent thrombosis with scaffold Cassese S & Byrne RA et al., Lancet 2016

18 ABSORB II 3-Year Results: Primary endpoints Serruys PW et al., Lancet 2016

19 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

20 - ABSORB II - Vasomotion: Scaffold non-superior to stent Serruys PW et al., Lancet 2016

21 - ABSORB II - Late lumen loss: Scaffold inferior to stent P superiority < 0.01 Serruys PW et al., Lancet 2016

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

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

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

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

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

27 Updated meta-analysis: More target lesion problems with scaffold Odds ratio Cardiac death Target vessel myocardial infarction Target lesion revascularisation BVS better DES better Ha FJ et al., J Am Coll Cardiol Intv 2017

28 Updated meta-analysis: Higher risk of stent thrombosis with scaffold Ha FJ et al., J Am Coll Cardiol Intv 2017

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

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

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

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

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