Βιοαποδομήσιμα Στεφανιαία Ικριώματα με βάση το μαγνήσιο. Magnesium Bioresorbable Coronary Scaffolds

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1 Βιοαποδομήσιμα Στεφανιαία Ικριώματα με βάση το μαγνήσιο. Magnesium Bioresorbable Coronary Scaffolds Βάιος Π. Τζίφος Δ/ντής Τμήματος Επεμβατικής Καρδιολογίας Ερρίκος Ντυνάν HC

2 Δεν υπάρχει σύγκρουση συμφερόντων στην ομιλία αυτή.

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10 Why Implant a Resorbable Scaffold?

11 Why Implant a Resorbable Scaffold?

12 Why Implant a Resorbable Scaffold?

13 Why Implant a Resorbable Scaffold?

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15 Magmaris Description Backbone resorbable Double eye radiopaque markers (Tantalum) permanent BIOlute Coating Backbone resorbable resorbable

16 MAGMARIS Technical Overview Acute recoil 1 Resolute Onyx DES Synergy DES Xience DES Orsiro DES Magmaris RMS Recoil [%] 1 BIOTRONIK data on file. Source: Schmidt W et al. In vitro performance investigation of bioresorbable scaffolds - Standard tests for vascular stents and beyond.cardiovascular Revascularization Medicine. 2016; 17(6):

17 Step One: Magnesium Hydroxide 0 m 1 m 3-9 m 12 m Magnesium Magnesium hydroxide Magnesium phosphate Amorphous Calcium phosphate Water passes the BIOlute coating and starts to oxidize the Magnesium backbone surface layer to Magnesium hydroxide. Magnesium + Water Magnesium hydroxide Physiological environment with high water content BIOTRONIK data on file Magmaris_Product_Presentation_EN_Approved_08.MAR.2018

18 Step Two: Magnesium Phosphate 0 m 1 m 3-9 m 12 m Magnesium Magnesium hydroxide Magnesium phosphate Amorphous Calcium phosphate Phosphate ions can pass the BIOlute coating. Together with Magnesium hydroxide they further react to Magnesium phosphate. Magnesium hydroxide + Phosphate Magnesium ions phosphate Physiological environment with high water content BIOTRONIK data on file Magmaris_Product_Presentation_EN_Approved_08.MAR.2018

19 Step Two: Magnesium Phosphate 0 m 1 m 3-9 m 12 m Magnesium Magnesium hydroxide Magnesium phosphate Amorphous Calcium phosphate Phosphate ions can pass the BIOlute coating. Together with Magnesium hydroxide they further react to Magnesium phosphate. Magnesium hydroxide + Phosphate Magnesium ions phosphate Physiological environment with high water content BIOTRONIK data on file Magmaris_Product_Presentation_EN_Approved_08.MAR.2018

20 Step Three: Amorphous Calcium Phosphate (ACP) 0 m 1 m 3-9 m 12 m Magnesium Magnesium hydroxide Magnesium phosphate Amorphous Calcium phosphate Calcium ions can pass the BIOlute coating. The magnesium phosphate reacts with calcium ions to form amorphous calcium phosphate with high water content. Magnesium ions are released. Magnesium phosphate + Calcium ions Amorphous Calcium phosphate Magnesium ions Physiological environment with high water content BIOTRONIK data on file Magmaris_Product_Presentation_EN_Approved_08.MAR.2018

21 Fast resorption time ~95% of the Magnesium is resorbed within 12 months 1 OCT post implantation 2 OCT at 6 months 2 OCT at 12 months 2 OCT at 36 months 2 Immediately after implantation, struts are well apposed to the vessel wall. While the Magnesium resorption process continues, endothelialization progresses. At 12 months after implantation, the Magnesium resorption is almost completed. At 36 months the lumen is well preserved with a homogeneous surface. 1 BIOTRONIK data on file 2 BIOSOLVE-II case, GER Courtesy of M. Haude, Lukaskrankenhaus Neuss, Germany 2015.

22 The Magnesium program

23 Results from the BIOSOLVE-II trial

24 BIOSOLVE-II Clinical Results at 36-Month Follow-up 6 Months 12 Months 24 Months 36 Months n = 120 % n = 118 % n = 120 % n = 117 % TLF Death Cardiac Death , ,2 1.7 Non-cardiac death , ,4,5 2.6 Target Vessel MI Clinically driven TLR CABG Scaffold Thrombosis definite or probable Composite of TLF: cardiac and unknown death, target vessel myocardial infarction, clinically driven target lesion revascularization and CABG. All events have been adjudicated by a clinical event committee 1. Unwitnessed death 134 days post PCI of distal RCA, no autopsy available 2. Unwitnessed death 395 days post PCI of the mid RCA, no autopsy available 3. Patient died of cancer 4. Patient died of pulmonary infection leading to septic shock 5. Patient died of intracerebral hemorrhage Magmaris_Product_Presentation_EN_Approved_07.Jun.2018

25 BIOSOLVE-II/III Study Design Primary Endpoint BIOSOLVE-II: In-segment LLL at 6-month BIOSOLVE-III: Procedure Success Secondary Endpoints at 1, 6, 12, 24, 36mo for the pooled BIOSOLVE-II & III data TLF* rate Cardiac death Target Vessel MI Clinically driven TLR Definite and probable scaffold thrombosis Coordinating Clinical Investigator Prof. M.Haude, Lukaskrankenhaus GmbH, Neuss, Germany Corelab Cardialysis, Rotterdam, The Netherlands Medstar, Washington DC, USA BIOSOLVE-II Prospective FIM enrolling 123 patients with de novo coronary artery stenosis 1-month, Clinical FUP 6-month Clinical FUP Angiographic FUP IVUS / OCT Vasomotion 12-month Clinical FUP Voluntary Angiographic IVUS / OCT Vasomotion 24-month, Clinical FUP 36-month, Clinical FUP BIOSOLVE-III Pivotal trial enrolling 61 patients with de novo coronary artery lesion 1-month, Clinical FUP 6-month, Clinical FUP 12-month Clinical FUP Mandatory Angiographic FUP 24-month, Clinical FUP 36-month, Clinical FUP * Composite of cardiac and unknown death, target vessel myocardial infarction, clinically driven target lesion revascularization and CABG Haude M. et al. EuroIntervention Jul 20;13(4):

26 BIOSOLVE-II/III Study Design Primary Endpoint BIOSOLVE-II: In-segment LLL at 6-month BIOSOLVE-III: Procedure Success Secondary Endpoints at 1, 6, 12, 24, 36mo for the pooled BIOSOLVE-II & III data TLF* rate Cardiac death Target Vessel MI Clinically driven TLR Definite and probable scaffold thrombosis Coordinating Clinical Investigator Prof. M.Haude, Lukaskrankenhaus GmbH, Neuss, Germany Corelab Cardialysis, Rotterdam, The Netherlands Medstar, Washington DC, USA BIOSOLVE-II Prospective FIM enrolling 123 patients with de novo coronary artery stenosis 1-month, Clinical FUP 6-month Clinical FUP Angiographic FUP IVUS / OCT Vasomotion 12-month Clinical FUP Voluntary Angiographic IVUS / OCT Vasomotion 24-month, Clinical FUP 36-month, Clinical FUP BIOSOLVE-III Pivotal trial enrolling 61 patients with de novo coronary artery lesion 1-month, Clinical FUP 6-month, Clinical FUP 12-month Clinical FUP Mandatory Angiographic FUP 24-month, Clinical FUP 36-month, Clinical FUP AHA/ ACC Lesion Class B2/C* Calcification Moderate/Severe* 53 (43.4) 53 (80.3) 13 (10.7) 16 (24.2)

27 BIOSOLVE-II/III Baseline and Lesion Characteristics 6 months 12 months n = 181 % n = 180 % TLF Cardiac Death Target Vessel MI Clinically driven TLR CABG Scaffold Thrombosis definite or probable Cardiac death: Autopsy report revealed no scaffold thrombosis in the coronary tree and the patient most likely died due to ventricular arrhythmia caused by the initial STEMI; Unknown death: Unwitnessed death, no autopsy available 1 Composite of TLF: cardiac and unknown death, target vessel myocardial infarction, clinically driven target lesion revascularization and CABG. All events have been adjudicated by a clinical event committee. Haude M. et al. EuroIntervention Jul 20;13(4):

28 BIOSOLVE-IV Study Design Design Prospective, single-arm, multi-center registry. Single de novo coronary artery lesions in up to two coronary arteries, RVD between mm and 21 mm Primary Endpoint Target lesion Failure (TLF*) at 12 months Endpoint analysis possible every 200 subjects Secondary Endpoints (at 6 months, 1-5 years) TLF Clinically Driven TLR and TVR Cardiac Death Target Vessel MI Scaffold Thrombosis Procedure and Device Success Coordinating Clinical Investigator Dr. S. Verheye Europe & Dr. M. Lee Asia Pacific Countries and sites Up to 25 countries Up to 70 sites 1,065 subjects with de novo coronary artery stenosis 6-month Clinical FUP 12-month Clinical FUP 24-month Clinical FUP 36-month Clinical FUP 48-month Clinical FUP 60-month Clinical FUP *TLF: composite of cardiac death, target vessel MI, clinically driven TLR and CABG

29 Baseline and Lesion Characteristics Baseline Characteristics n (%) Age (mean ± SD) 62.3±11.1 Male 154 (77.0) Hypertension 126 (63.0) Hyperlipidemia 128 (64.0) Smoking 123 (61.5) Diabetes mellitus 43 (21.5) Insulin dependent 6 (14.0) Non-insulin dependent 37 (86.0) History of MI 35 (17.5) Previous percutaneous Intervention 48 (24.0) NSTEMI 29 (14.5) Lesion Location n (%) LAD 110 (51.4) LCx 42 (19.6) RCA 62 (29.0) Lesion Characteristics* n (%) Lesion Length (mm ± SD) 14.5 ± 4.2 RVD (mm ± SD) 3.3 ± 0.3 AHA/ ACC Lesion Class B1/B2 137 (64.0) AHA/ ACC Lesion Class B2/C 37 (17.3) Calcification Moderate 14 (6.5)

30 12 m Clinical Results 6-month 12-month n=198 % n=198 % TLF Cardiac Death Target Vessel MI CD-TLR CABG Scaffold Thrombosis Definite or probable DAPT interruption 5 days after the procedure

31 PSP & The 4 Ps

32 The 4Ps Guideline

33 ENHC Magmaris Real World Registry 2/2017 σήμερα 30 ασθενείς, 38 βλάβες, 49 BRS Φύλο άρρεν (%) 27 (90%) Ηλικία (μέσος όρος), έτη 61 (10,2) Αρτηριακή υπέρταση (%) 18 (60%) Δυσλιπιδαιμία (%) 10 (33,3%) Σακχαρώδης διαβήτης (%) 1 (3,3%) Κάπνισμα (%) 11 (36,6%) Κληρονομομικό ιστορικό: (%) 8 (26,6%) Στομιακή στένωση (%) 3 (10%) Διχασμοί (%) 1 (3,3%) In-stent restenosis (%) 2 (6,7%) Χρόνια ολική απόφραξη (%) 1 (3,3%) Επιμήκης βλάβη (%) 15 (50%) Σημαντική ασβέστωση (%) 4 (13,3%)

34 ENHC Magmaris Real World Registry Αποτελέσματα Καρδιακός θάνατος (%) 0 (0.0%) Επαναγγείωση σε αγγείοστόχο 0 (0.0%) (%) Επαναγγείωση σε βλάβηστόχο 2 (6.6%) (%) Νέα βλάβη (%) 1 (3.3%) Έμφραγμα σε αγγείοστόχο 2 (6.6%) (%) Θρόμβωση (%) 1 (3.3%)

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48 Patient and lesion characteristics recommended for the treatment with MAGMARIS

49 Conclusion - The guidelines recognize two different resorbable scaffold technologies polymeric and metal (magnesium) scaffolds. - Magmaris proved safety and efficacy in BIOSOLVE-II; BIOSOLVE-III and BIOSOLVE-IV up to 3 years follow-up. - - Available evidence on the magnesium scaffold is limited to observational studies. - Relevant endpoints like TLF and thrombosis rates are in line with state-of-the-art DES. - Initial results of the Magnesium BRS clinical program appear encouraging but further evaluation is needed.

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