Wertigkeit und Einsatz von bioresorbierbaren Koronarstents

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1 Wertigkeit und Einsatz von bioresorbierbaren Koronarstents Prof. Dr. med. Christoph A. Nienaber Universität Rostock Universitäres Herzzentrum

2 New Indications for stents: LM New Generations of stents (DES) Transient bioabsorbable scaffolds (BVS) - Polylactite - Magnesium

3 Gruentzig s 3rd PTCA LMCD a problem for PCI?

4 34 Years After Gruentzig Safer complex PCI - Advanced PCI technology - DES (3rd generation) - Preloaded dual ATT - TA testing - Prasugrel

5 MAIN-COMPARE (DES vs. CABG) Propensity Score matching 396 patients PCI-Stent (DES) 396 patients CABG EP: Death Death, MI stroke TVR Seung et al, NEJM 2008

6 True story Max, made a decisison based on this evidence and went for CABG. Max is a 79 yo man with well controlled HTN, hypercholesterolemia, afib, and diet controlled-dm knowing about the comparative effectiveness of PCI and CABG by key subgroups would help his decision making

7 Impact of SYNTAX Score

8 RCI: PRECOMBAT (DES vs. CABG) MACE (Cumulative Incidence) Cumulative Incidence of Death from any cause, MI or stroke Park et al, NEJM 2011

9 RCT: PRECOMBAT (DES vs. CABG) MACE (Cumulative Incidence) Cumulative Incidence of 1 EP: Major adverse cardiac and cerebrovascular event including TVR Park et al, NEJM 2011

10 story ends. Based on the best available evidence, Max chose CABG. He chose to have it at a high-volume academic center by a highly experienced surgeon. His surgery was complicated by a stroke and prolonged ICU stay. He was discharged to a skilled nursing facility and died 3 months after his bypass.

11 UPLM PCI to Improve Survival (SIHD) Risk of PCI Complication Low Likelihood Long-of Good term Outcome Hi CABG Mortality Risk Hi COR IIa For SIHD when low risk of PCI complications and high likelihood of good long-term outcome (e.g., SYNTAX score of 22, ostial or trunk left main CAD), and a signficantly increased CABG risk (e.g., STS-predicted risk of operative mortality 5%) IIb For SIHD when low to intermediate risk of PCI complications and intermediate to high likelihood of good long-term outcome (e.g., SYNTAX score of <33, bifurcation left main CAD) and increased CABG risk (e.g., moderate-severe COPD, disability from prior stroke, prior cardiac surgery, STS-predicted operative mortality >2%) LOE B B Hi Low Low III: Harm For SIHD in patients (versus performing CABG) with unfavorable anatomy for PCI and who are good candidates for CABG B 2011 AHA/ACC Guidelines

12 New Indications for stents: LM New Generations of stents (DES) Transient bioabsorbable scaffolds (BVS) - Polylactite - Magnesium

13 Correlates of Late DES thrombosis Heterogeneity of neo-intimal healing with DES Finn AV, et al. Circulation 2007; 115:

14 No more old DES

15 BMS vs Cypher/Taxus vs Endeavor/Res Xience V/Prime Restenosis Stent thrombosis EHJ 2011

16 BMS vs Cypher/Taxus vs Endeavor/Res Xience V/Prime Restenosis Stent thrombosis EHJ 2011

17 BMS vs Cypher/Taxus vs Endeavor/Res Xience V/Prime Risk of death Real world population: - ZES, EES better - Lower ST rate - Lower restenosis rate - Lower mortality - Better healing EHJ 2011

18 Drug-Eluting Stents versus CABG Repeat Revascularization Meta-Analysis EES vs PES Kalesan, Jüni Updated 08/ Year SYNTAX Serruys PW et al. NEJM 2009 EES vs CABG? Trials EES PES RR (95% CI) SPIRIT II SPIRIT III 4/223 22/669 5/77 18/ (0.08, 1.00) 0.61 (0.33, 1.12) PES SPIRIT IV COMPARE 61/ /897 55/ / (0.39, 0.79) 0.38 (0.21, 0.68) EES 6.9 Overall (I-squared = 0.0%, p = 0.491) 0.51 (0.39, 0.66) NOTE: Weights are from random effects analysis Risk ratio Favors EES Favors PES HR=0.51, 95% CI HR=2.3, 95% CI

19 Less is more! Lancet 2011

20 Durable Polymer SES vs. biodegradable polymer BES LEADERS 4 years F/U RCT on 1707 pts (2472 ls) - Reduced risk of MACE - reduced ST rate - Improved LT outcome - Advantage between 1and 4 year of F/U Lancet 2011

21 Durable Polymer SES vs. biodegradable polymer BES LEADERS 4: - Landmark analysis - Events associated a ST occured between 1 and 4 years - Better long-term prognosis with biodegradable polymer Lancet 2011

22 Metaanalysis of RCT of biodegradable vs durable polymer Biodegradable PM - Less late ST - Less TLR - Better safety profile Lancet 2011

23 Next step: Polymer-free DES BioFreedom Selectively micro-structured surface holds drug in abluminal surface structures Hypothesis: Polymer-free drug release via porous-eluting stents may reduce late events caused by polymer stent coatings. Potential advantage Proprietary Highly Lipophilic Limus drug Avoid long term late adverse effects that might be attributable to the polymer Improved surface integrity since there is no polymer to be sheared or peeled away from the stent struts Possible shorter need of dual antiplatelet therapy

24 Case Example BioFreedom SD OCT Evaluation at 1 Year FU Grube E., oral presentation, TCT 2010

25 New Indications for stents: LM New Generations of stents (DES) Transient bioabsorbable scaffolds (BVS) - Polylactite - Magnesium

26 Good to be gone? EHJ (2012) 33, Serruys et al

27 Technological evolution EHJ (2012) 33, Serruys et al

28 Glagov Effect and ISR EHJ (2012) 33, Serruys et al

29 Plaque regression and lumen enlargement with BVS EHJ (2012) 33, Serruys et al

30 Tissue changes after BVS EHJ (2012) 33, Serruys et al

31 Vessel architecture after Stent EHJ (2012) 33, Serruys et al

32 Vessel architecture with BVS Vascular reconstruction to normal anatomy EHJ (2012) 33, Serruys et al

33 Bioabsorbable poly-l-lactite BVS 33

34 Porcine Coronary Safety Study: Representative Photomicrographs (2x) 2 years 3 years 4 years 2 years 3 years 4 years 34

35 Clinical experience: Next Generation BVS Stent 35

36 Klinisches Studienprogramm BVS Generation 1.0 Generation 1.1 FIM ABSORB (Kohorte A) 30 Patienten mit einfachen Läsionen Probleme mit den mechanischen Stent-eigenschaften (Lagerung bei -20 C) Schlechte Deliverability ABSORB (Kohorte B) 100 Patienten mit komplexeren Läsionen B1 Recoro nach 6 Monaten, B2 Recoro nach 12 Monaten Lagerung bei Raumtemperatur Deliverability soll ähnlich Xience V sein Source: Presentation Ormiston, ACC.09; Ormiston et al., Lancet 2009;373:

37 Clinical Trial Programs - BVS (Abbott) Source: Presentation Serruys, PCR 2010

38 Clinical Study Design Cohort A Single, de-novo lesion 3.0 mm n = 30 BVS Device Sponsor: Abbott Vascular Prospective, open label PI: John Ormiston, MD Patrick Serruys, MD, PhD DSMB: J. Tijssen PhD, T. Lefèvre MD, P. Urban MD CEC: C. Hanet MD, D. McClean MD, V. Umans MD Angiographic and IVUS corelab: Cardialysis (Rotterdam, NL) 3.0 x 12mm device (3.0 x 18mm device available after enrolment start and used in 2 patients) 6 sites EU, NZ Rotterdam, NL, Patrick Serruys Krakow, PL, Dariusz Dudek Auckland, NZ, John Ormiston Aarhus, DN, Leif Thuesen Aalst, BE, Bernard de Bruyne St Denis, F, Bernard Chevalier Post-procedure clopidogrel for 6 months, aspirin for 5 years

39 ABSORB (Cohort A): Vasomotor Function Testing at 2 Years ABSORB Cohort A at 2 years Acetylcholine (Vasodilator) Methergine (Vasoconstrictor) Vasodilation Vasoconstriction The reappearance of vasomotion in the proximal, distal, as well as treated segments in response to methergine or acetylcholine suggests that vessel vasoreactivity has been restored and that a physiological response to vasoactive stimuli might occur anew Serruys PW, et al. Lancet 2009; 373:

40 ABSORB (Cohort A): Clinical Results Intent to treat 6 Months 30 Patients 12 Months 29 Patients** 24 Months 28 Patients** 36 Months Hierarchical 28 Patients* * Ischemia Driven MACE 1 (3.3%)* 1 (3.4%)* 1 (3.6%)* 1 (3.6%)* Cardiac Death 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) MI 1 (3.3%)* 1 (3.4%)* 1 (3.6%)* 1 (3.6%)* Q-Wave MI 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Non Q-Wave MI 1 (3.3%)* 1 (3.4%)* 1 (3.6%)* 1 (3.6%)* Ischemia Driven TLR 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) by PCI 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) by CABG 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) No new MACE between 6 and 36 months Serruys, PW., AHA 2009

41 ABSORB (Cohort A): Thrombosis through 3 Years Per protocol and per ARC definition 0 3 Years Acute (< 1 day) 0 (0.0%) N = 30 Sub-Acute (1 30 days) 0 (0.0%) N = 30 Late (> 30 days 1 year) 0 (0.0%) N = 29 Very Late (> 1 year) 0 (0.0%) N = 29 No stent thrombosis up to 3 years Serruys, PW., AHA 2009

42 ABSORB (Cohort B): Temporal Lumen Dimensional Changes Post-PCI 6 Months 2 Years n = 33 n = 33 n = 33 ABSORB Cohort B1 Serial Analysis* Scaffold Lumen Area Area 6.36 mm 6.53 mm mm 2 1.7% Lumen Area 7.2% 1 Late Loss = 0.19 mm Late Loss = 0.27 mm Post-PCI 12 Months 3 Years n = 56 n = 56 n = 56 ABSORB Cohort B2 Paired Analysis** Lumen Area 6.29 mm mm mm 2 Lumen Area 7.2% 2 Late Loss = 0.27 mm Late Loss = 0.29 mm 1. Patient-level serial analysis 2. Calculated from overall mean values *Serruys PW, ABSORB Cohort B 2-year results; TCT 2011 **Serruys PW, ABSORB Cohort B 3-year results; ACC 2013

43 ABSORB (Cohort B): Groups 1&2 Clinical Results - Intent to treat 30 Days 6 Months 1 Year 2 Years 3 Years Non-Hierarchical n = 101 n = 101 n = 101 n = 100* n = 100* Cardiac Death % Myocardial Infarction % (n) 2.0 (2) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3) Q-wave MI Non Q-wave MI 2.0 (2) 3.0 (3) 3.0 (3) 3.0 (3) 3.0 (3) Ischemia driven TLR % (n) (2) 4.0 (4) 6.0 (6) 7.0 (7) CABG PCI (2) 4.0 (4) 6.0 (6) 7.0 (7) Hierarchical MACE % (n) 2.0 (2) 5.0 (5) 6.9 (7) 9.0 (9) 10.0 (10) Hierarchical TVF % (n) 2.0 (2) 5.0 (5) 6.9 (7) 11.0 (11) 13.0 (13) No scaffold thrombosis by ARC or protocol out to 3 years only 3 additional TLR events between 1 and 3 years *One patient missed the 2 year FUP MACE: Cardiac death, MI, ischemia-driven TLR TVF: Cardiac death, MI, ischemia-driven TLR, ischemia-driven TVR Serruys PW, ABSORB Cohort B 3-year results; ACC 2013

44 ABSORB EXTEND: Non-Randomized, Single-Arm, Continued Access Trial ~1,000 patients Up to 100 global sites (non-us) Clinical Follow-Up Clinical Follow-up (months) MSCT follow up (n=100) OCT follow up (n=50) Study Objective Continued Access trial. FPI: Jan 11, 2011 Endpoints Treatment Typical PCI clinical endpoints Up to 2 de novo lesions in different epicardial vessels Planned overlapping allowed in lesions >22 and 28 mm Device Sizes Scaffold diameters: 2.5, 3.0, 3.5 mm Scaffold lengths: 12*, 18, 28 mm * Sizes to be introduced into the trial once available.

45 ABSORB EXTEND: Clinical Results - Intent to treat; Interim Snapshot Non-Hierarchical 6 Months* n = Months* n = 450 Cardiac Death % (n) Myocardial Infarction % (n) Q-wave MI Non Q-wave MI Ischemia Driven TLR % (n) PCI CABG Hierarchical MACE % (n) Scaffold Thrombosis (ARC Def/Prob) % (n) 0.2 (1)** 2.7 (12) 0.7 (3) 2.0 (9) 0.4 (2) 0.4 (2) 0.0 (0) 2.9 (13) 0.2 (1)** 2.9 (13) 0.9 (4) 2.0 (9) 1.8 (8) 1.6 (7) 0.2 (1) 4.2 (19) 0.7 (3) 0.9 (4) *Reflects an interim snapshot with only cleaned data as of the cut-off date of 03 December 2012 **No Absorb BVS was implanted in the target lesion MACE: cardiac death, MI, ischemia-driven TLR Chevalier B, ABSORB EXTEND 12-month outcomes in the first 450 patient enrolled, Rotterdam EuroPCR Focus on BVS 2013

46 ABSORB EXTEND: Overlap Subset Clinical Outcomes Overlap population results at parity to non-overlap 1-year MACE rate in overlap population is comparable to non-overlap population Farooq, EXTEND Overlap Subgroup, Rotterdam PCR Focus on BVS, 2013

47 ABSORB EXTEND: Small Side Branch Occlusion Magnitude of post-procedural CK-MB elevation Higher rate of MI in SBO patients, but enzyme elevation levels mostly within 1x ULN Occlusion of visible side branches: ABSORB EXTEND 6.0% vs. SPIRIT First and II trials 4.1% (p=0.09) No significant difference in the incidence of CK-MB elevation and peak level of cardiac troponin Murama T et al. J Am Coll Cardiol Intv 2013;6:247-57

48 ABSORB EXTEND: Diabetic Subgroup 12-Month Clinical Outcomes Non-Hierarchical Diabetic n = 119 Non-Diabetic n = 331 P-value Cardiac Death % Myocardial Infarction % Q-wave MI Non Q-wave MI Ischemia Driven TLR % PCI CABG Hierarchical MACE % Hierarchical TLF% * P-values are not from formal hypotheses testing and are displayed for exploratory purpose only *Day 108, no Absorb BVS was implanted in the target lesion MACE: cardiac death, MI, ischemia-driven TLR Van Geuns RJ. ABSORB EXTEND Diabetic Subset; Rotterdam EuroPCR Focus on BVS 2013

49 ABSORB EXTEND: Diabetic Subgroup Scaffold Thrombosis (ARC Defined Definite/Probable) Diabetic Non-Diabetic P-value <1 day (Acute) 1 30 days (Subacute) days (Late) Cumulative to 393 days N = 119 N = NA P-values are not from formal hypotheses testing and are displayed for exploratory purpose only Van Geuns RJ. ABSORB EXTEND Diabetic Subset; Rotterdam EuroPCR Focus on BVS 2013

50 Propensity Score Analysis at 1 Year Adjusted # Clinical Outcomes Clinical Outcomes Absorb (N=503) XIENCE V (N=635) P-value* Myocardial Infarction, MI (%) Ischemic-Driven Target Lesion Revascularization, ID-TLR (%) MACE (%) Target Vessel Failure, TVF (%) Definite/Probable Scaffold/Stent Thrombosis, ST (%) * P-value: Weighted Chi-square test for dichotomous variables Similar safety and effectiveness at 1 year, with numerically lower rates for ID-TLR and MACE Significantly lower TVF rate in ABSORB EXTEND Absorb BVS Cohort: Pooled from ABSORB EXTEND and ABSORB Cohort B trials XIENCE V Cohort: Pooled from XIENCE V arms of SPIRIT FIRST, II, and III trials. Study funded by Abbott Vascular # Analysis adjusted for patient baseline demographics, risk factors and lesion characteristics with Inverse Propensity Scores Weighted method

51 Site-Reported* Angina Outcomes at 1 Year Preliminary Observation Population Site-reported Angina Events Through 1 Year Absorb BVS (EXTEND) (N=322) Xience V (SPIRIT IV) (N=1999) Unadjusted P-value 16.5% 25.8% P-values are descriptive and displayed for exploratory purposes only Site-reported angina for the TAXUS arm (N=1005) in SPIRIT IV: 26.1% *From the Adverse Event forms of the ecrf Study funded by Abbott Vascular Non-randomized data, analysis is not propensity-adjusted. Populations for Absorb Extend include the following geographies: EMEA, Japan, Australia, New Zealand, Latin America, Canada. Spirit IV was conducted in US

52 ABSORB II RCT Clinical Follow-Up 501 patients (Randomized 2:1 Absorb vs. XIENCE PRIME) Up to 40 European sites 30 days 6 months 12 months 24 months 36 months QOL follow-up Angio, OCT, IVUS, IVUS-VH follow-up MSCT follow-up (Absorb arm only*) Study Objective Co-primary Endpoints Treatment Device Sizes Compare safety, efficacy and performance of BVS vs. XIENCE PRIME FPI 28-Nov-2011 Vasomotion assessed by change in angiographic MLD between pre- and post-nitrate at 2 years (superiority) MLD at 2 years post nitrate minus angiographic MLD post procedure post nitrate (non-inferiority, reflex to superiority) Up to 2 de novo lesions in different epicardial vessels Planned overlapping allowed in lesions 48 mm Scaffold diameters: 2.5, 3.0, 3.5 mm Scaffold lengths: 12**, 18, 28 mm * Non-German sites only. ** Sizes to be introduced into the trial once available.

53 ABSORB II RCT Enrollment 487 patients enrolled up to now - 14 to go! N of patients Months

54 BVS Expand and BVS-STEMI-First First Results of Wide Clinical Application All (N=127) MVD 33 (26%) Bifurcations 26 (21%) CTO 8 (6%) STEMI 23 (18%) Overlap 35 (28%) Total scaffold number 218 Scaffolds per procedure 1.7 Failure to deliver 7 (5.5%) Device succes 94.5% Days since procedure 68 ± 47 Primary endpoint: MACE at 12 months BVS Expand Longer diameter up to 4.0 mm Longer length: > 32 mm Bifurcations Calcified lesions ACS patients (non-stemi) No previous CABG or metallic stent in target vessel BVS-STEMI-First Single center registry BVS in STEMI OCT at baseline for apposition Failure to deliver: LCX:4, LAD: 1, RCA: 2 No adverse events reported van Geuns RJ, BVS EXPAND, CRT 2013

55 BVS group - safety

56

57 Patient with NSTEMI Case example

58 Why BVS was not implanted to 75% STEMI patients (n = 65)

59 BVS Expand: First Results of Wide Clinical Application N =36 Calcified (N=16) Non-Calcified (N =20) Lesion Length ± mm ± mm P=0.318 RD 3.09 ± 2.55 mm 2.50 ± 0.65 mm p=0.740 Mean Diameter 1.81 ± 0.34 mm 1.90 ± 0.56 mm p=0.446 MLD 0.87 ± 0.39 mm 1.09 ± 0.39 mm p=0.058 MD post 2.86 ± 0.33 mm 2.75 ± 0.46 mm p=0.626 MLD post 2.42 ± 0.36 mm 2.36 ± 0.47 mm p=0.740 Acute gain 1.59 ± 0.46 mm 1.28 ± 0.42mm p=0.077 Acute recoil 0.16 ± 0.33 mm 0.23 ± 0.21 mm p=0.682 Relative acute recoil 4 ± 12 % 8 ± 6% p=0.520 Courtesy Roberto Diletti van Geuns, BVS EXPAND, CRT 2013

60 ABSORB III RCT

61 Conclusions More recent BVS clinical data have shown: Safety and efficacy outcomes comparable to a best in class DES: - No scaffold thrombosis in Cohort A (5-year follow-up) and Cohort B (3-year follow-up); 0.7% and 0.9% scaffold thrombosis at 6 and 12 months in preliminary EXTEND results - MACE rates of 3.4% at 5 years in Cohort A, 10% at 3 years in Cohort B, and 2.9% and 4.2% at 6 and 12 months in preliminary EXTEND results - Late loss of 0.19 mm and 0.27 mm at 6 and 24 months respectively in Cohort B First indirect signs of vascular restoration as shown by: - Reappearance of vasomotion at vasoreative testing performed at 12 and 24 months - Evidence of late lumen gain (10.8% increase between 6 and 24 months in Cohort A and 7.2% between 6 and 24 months in Cohort B1 and between 1 and 3 years in Cohort B2 Promising safety and performance results in initial routine clinical practice

62 DeSolve Bioresorbable Coronary Scaffold

63 DeSolve Preclinical Studies AccelLab Montreal, Canada

64 DeSolve FIM Clinical Trial

65 6-month Clinical Outcomes

66 Speculative Explanations Possible reasons underlying the above observations from the propensity score adjusted analysis favoring Absorb: Acute (Revascularization) - Less stretch injury at deployment due to better scaffold sizing to target vessel segment diameter - Improved conformability of Absorb as compared to a metallic stent - No severe hinging inflexions that may negatively impact on flow and shear stress Mid term (Restoration) - Progressive loss of radial support and stiffness allowing vasomotion - Minimization of endothelial-dependent vasoconstriction Long term (Resorption) - Disappearance of mechanical caging restoring full vessel motility - Epicardial vessel capacitance restored Study funded by Abbott Vascular

67 Three generations of AMSscaffolds (2 bare generations, 1 drug-eluting generation) AMS-1 (Progress-I) DREAMS 3.1 (BIOSOLVE-I) Strut thickness of 165 µm 4-crown design Refined alloy with slower degradation Reduced strut thickness (120 µm) 6-crown design with optimized crosssection Paclitaxel-eluting bioabsorbable polymer Faxitron (in animal, 14 days) 45% less corrosion* 3,0/3.25/3.5 x 16 6F profile * Loss of strut material in animal trialsource: preclinical studies, data on file

68 Clinical study program AMS Bare AMS Drug eluting scaffold (DREAMS) Peripheral Coronary BEST-BTK (N=20) PROGRESS (N=63) INSIGHT (N=117) BIOSOLVE-I BEST-BTK: Bosiers et al. Vascular Disease Management 2005;2(4):86-91 PROGRESS: Erbel et al. Lancet 2007; 369: INSIGHT: Bosiers et al. Cardiovascular and Interventional Radiology 2008

69 Histological Images at 28, 90 and 180 days 28d 90d 180d* DREAMS 28d 90d 180d Reference (Taxus) Source: AccelLAB preclinical studies, data on file All photos same magnitude and scale *DREAMS vessels are smaller than actual due to shrinkage during tissue processing

70 Previous bare AMS devices demonstrated safety, but the perfect alloy has is not found IVUS Perfect ingrowth of AMS Safe in human coronary and peripheral arteries (150 patients) No death, no MI, no scaffold thrombosis, no distal embolization, no excessive inflammation Device success rate of 99.4% Absorbed as intended in several months Fully CT/MRI compatible OCT Source: Courtesy Dr Di Mario: PROGRESS AMS-1, long term results (15 months) showed perfect in growth

71 AMS allows non-invasive imaging of the stented vessel IVUS/OCT stent visibility MRI 16 MSCT MRI/MSCT No stent artefact Optimal vessel lumen imaging Source: Erbel et al, Herz Nr. 4

72 Summary Drug-eluting, bioabsobierbare Scaffolds werden die Stents der Zukunft mit dem Ziel ein intaktes Gefäß zu hinterlassen. Das Konzept der Gefäßrestaurierung basiert auf passageren Stützen mit Wirkstoffträgern.

73 Vasomotor Function in BVS Stented Artery 73

74 DREAMS has been investigated in the BIOSOLVE-I first-in-man study in 2010 First data will be presented at Euro PCR 2011

75 75

76 Bifurcations

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