Safety and Clinical Safety and Clinical Performance of the Drug Performance of the Drug Eluting Absorbable Metal Eluting Absorbable Metal Scaffold in the Treatment Scaffold in the Treatment of Subjects with de Novo of Subjects with de Novo Lesions in Native Coronary Lesions in Native Coronary Arteries-BIOSOLVE-II Arteries-BIOSOLVE-II Michael Haude, MD Michael Haude, MD On behalf of the BIOSOLVE-II Investigators On behalf of the BIOSOLVE-II Investigators
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Safety and Clinical Performance of the Drug Eluting Absorbable Metal Scaffold in the Treatment of Subjects with de Novo Lesions in Native Coronary Arteries-BIOSOLVE-II.
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Safety and Clinical Performance of the Safety and Clinical Performance of the Drug Eluting Absorbable Metal Scaffold Drug Eluting Absorbable Metal Scaffold
in the Treatment of Subjects with de in the Treatment of Subjects with de Novo Lesions in Native Coronary Novo Lesions in Native Coronary
Arteries-BIOSOLVE-II Arteries-BIOSOLVE-II
Michael Haude, MDMichael Haude, MDOn behalf of the BIOSOLVE-II InvestigatorsOn behalf of the BIOSOLVE-II Investigators
Disclosure Statement of Financial InterestDisclosure Statement of Financial Interest
Compared to BIOSOLVE-I NIH Area was reduced by 73% from 0.30±0.41mm2 to 0.08±0.09mm2
Post-procedure 6-month
OCT AnalysisOCT AnalysisSubgroup N=30Subgroup N=30
ISA areaScaffold Area
Lumen area
Post-procedure
Mean ISA area (mm2) 0.16±0.16
Mean intraluminal mass area (mm2)* 0.00±0.00
Post-procedure 6-month
*Intraluminal mass is defined as a defect free from the vessel wall
ISA = Incomplete Strut Apposition
N=120 % 95% CI
TLF1 4 3.3 1.3-8.3
Cardiac Death 12 0.8 0.0-4.6
Target Vessel MI 1 0.8 0.0-4.6
Clinically driven TLR 2 1.7 0.2-5.9
CABG 0 0.0 0.0-3.1
Scaffold Thrombosis Definite or probable 0 0.0 0.0-3.1
Clinical ResultsClinical ResultsTLF rate at 6-monthTLF rate at 6-month
1. Composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization and CABG
2. 58 old smoker, CV RF: hypertension and hyperlipidemia, stable angina CCS Class II, treated with a DREAMS 2G 3.0x20mm in the distal RCA. Patient experienced an unwitnessed death 134 days post procedure. Since a cardiac cause could not be ruled out, patient was adjudicated as cardiac death by the Clinical Event Committee
Comparison of in-segment LLL Comparison of in-segment LLL in PROGRESS, BIOSOLVE-I and BIOSOLVE-IIin PROGRESS, BIOSOLVE-I and BIOSOLVE-II
-1.0 -0.5 0.0 0.5 1.0 1.5 2.0 2.5
Late Lumen Loss (mm)
0
20
40
60
80
100
Cum
ulati
ve F
requ
ency
(%)
0.83±0.51
0.52±0.48
0.27±0.37
BIOSOLVE-I (6-month)PROGRESS (4-month)
BIOSOLVE-II (6-month)
PROGRESS vs BIOSOLVE-II: p <0.0001BIOSOLVE-I vs BIOSOLVE-II: p=0.0010
R Erbel et al, Lancet 2007; 369:1869-75, M Haude. et al. Lancet 2013; 381:836-44.
-48% -37%
PROGRESS
N=63BIOSOLVE-I
N=46BIOSOLVE-II
N=123
TLF1 (%) 23.8 4.3 3.3
Cardiac Death (%) 0.0 0.0 0.8
Target Vessel MI (%) 0.0 0.0 0.8
Clinically driven TLR (%) 23.8 4.3 1.7
CABG 0.0 0.0 0.0
Scaffold Thrombosis Definite or probable 0.0 0.0 0.0
Clinical results at 6-month (4-month for PROGRESS)Clinical results at 6-month (4-month for PROGRESS)
1. Composite of cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization and CABG
Comparison of clinical results in PROGRESS, BIOSOLVE-I and Comparison of clinical results in PROGRESS, BIOSOLVE-I and BIOSOLVE-IIBIOSOLVE-II
R Erbel et al, Lancet 2007; 369:1869-75, M Haude. et al. Lancet 2013; 381:836-44.
ConclusionConclusion
• DREAMS 2G in BIOSOLVE-II demonstrates significantly improved in-segment LLL (0.27±0.37mm) compared to it`s precursor devices tested in the PROGRESS (0.83±0.37mm) and the BIOSOLVE-I study (0.52±0.48mm)
• Vasomotion of the scaffolded vessel segment was demonstrated at 6 months
• IVUS results in a subgroup of 30 subjects demonstrate a preservation of the scaffold area with a low neo-intimal area at 6-month
• No intra-luminal masses were observed by OCT at any time in a subgroup of 25 subjects
• DREAMS 2G in BIOSOLVE-II demonstrates a low TLF (3.3%) and TLR (1.7%) rate at 6-month, which is comparable to other absorbable scaffolds and permanent drug eluting stents
• No definite or probable scaffold thrombosis was observed with DREAMS 2G tested in BIOSOLVE-II or any of it`s precursor devices tested in PROGRESS and BIOSOLVE-I in a total of 232 subjects
Published Online in THE LANCET on October 12, 2015Published Online in THE LANCET on October 12, 2015http://dx.doi.org/10.1016/S0140-6736(15)00447-Xhttp://dx.doi.org/10.1016/S0140-6736(15)00447-X
acute 3-12 months 12 months1 month
Mgabsorption
Mgabsorption
Mgabsorption
Biotronik Magnesium ScaffoldBiotronik Magnesium ScaffoldMagnesium Absorption ProcessMagnesium Absorption Process