Biodegradable Stents An update and work-in
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1 Biodegradable Stents An update and work-in in-progress Department of Cardiology, Hideo Tamai, M.D.
2 Metallic stents... Background induce a varing degree of thrombogenesis eg, subacute thrombosis in complex lesions or late thrombosis after brachytherapy. induce neointimal hyperplasia which may lead to restenosis. become obstacles to repeat PCI and CABG, if needed. long-term safety (>10 years) is unknown. Biodegradable stents are expected to solve these problems. Moreover, biodegradable stents may act as an optimal vehicle for specific local therapy with drugs and genes.
3 IGAKI-TAMAI Stent Material: PLLA ( poly-l-lactic lactic acid ) monofilament, molecular mass:183kd Design: zigzag helical coil self-expanding expanding ability (+) Thickness: 0.17mm (0.007inch) Length: 12mm Surface area: 24% Deployment: thermal balloon expandable covered sheath system
4 Methods From September 1998 through April 2000, 63 lesions in 50 patients electively underwent PLLA Igaki-Tamai stent implantation for coronary artery stenosis. All patients received 10,000 U of intravenous heparin before the procedure. Oral aspirin (81mg/day for 6 months) and ticlopidine (200mg/day for 1 month; the usual dose in Japan) were administered after implantation. Coronary angiography and intracoronary ultrasound (IVUS) were performed before, immediately after the procedure and at 6-6 and 12-month (24- and 36-month, if possible) after the procedure and assessed by QCA and QCU.
5 Patient and Lesion Characteristics No. of patients: 50 (male 44, female 6) Age: 61±11yrs 11yrs Hypertension: 24 (48%) Diabetes: 16 (32%) CCS Class 3, 4: 19 (38%) No. of lesion: 63 (de novo 59, restenosis 4) Target lesion ( LAD) : 28 (44%) AHA/ACC classification: type B1: 16 (25%) type B2: 36 (57%) type C: 11 (17%) Lesion length: 13.5± mm Reference diameter: 2.95±0.46 mm
6 Restenosis & TLR Rates (%) (%) 30 Restenosis 30 TLR Per Lesion Per Patient month month month month
7 Pathohistology of Restenosis (3 Mos) Excised tissue by DCA H.E. x 4 x 4 x 10 proliferation of fibroblastic cells with a myxoid stromal component
8 Changes in MLD and %DS (mm) (%) pre post 6Mo 12Mo 24Mo 36Mo n=63 n=63 n=60 n=46 n=38 n=25
9 Long-term (3-year) Results Death : 0 QMI : 1/50* (2.0%) CABG : 0 Stent thrombosis : 1/50* (2.0%) Repeat PCI (6Mo) : 6/50 (12.0%) (12Mo) : 7/50 (14.0%) (36Mo) : 8/50 (16.0%) *same patient
10 Kaplan-Meier Survival Curve 1.8 Death-free MACE-free Mo 24Mo 36Mo Death-free 100% 100% 100% MACE-free 86.0% 86.0% 83.0% (days)
11 IVUS Images of Representative Case pre post 3Mo CSA=10.12 CSA= Mo 12Mo 24Mo CSA=12.59 CSA=12.91
12 CAG 24Mo f/u (7/11/2000) 42Mo f/u (8/5/2002)
13 proximal to stent DCA in-stent
14 QCA Results (proximal to stent) pre post 6Mo MLD 0.41mm MLD 3.05mm MLD 2.42mm
15 QCU Results (in-stent) 24Mo pre (42Mo) post 6Mo VA 10.9 LA 5.0 VA 7.4 LA 2.9 VA 10.1 LA 3.9 VA 11.4 LA 8.2 (mm 2 )
16 Histological Findings proximal to stent 42 Mos H.E.
17 Histological Findings in-stent 42 Mos H.E.
18 Pig at 4 weeks, LAD, HE, x5 Drug Injury Score = 2.2 Control Injury Score = 2.3
19 p= p= Drug Control Injury Score 1.2 Iinflammation Score Drug : n=8 Control : n=6
20 5 4 p= Drug Control 3 p= NI Thickness 2.37 NI Area Drug : n=8 Control : n=6
21 IGAKI-TAMAI STENT Biodegradable Peripheral Stent Material composition : PLLA (poly-l-lactic lactic acid) medical grade Stent design : zigzag helical coil Strut thickness : inch (0.24 mm) Radio-opaque opaque markers : 2 gold markers Currently available diameters : 6, 7, 8 mm Currently available length : 16 mm
22 Histological Findings IJS = 0.03 HE
23 Histological Findings IJS = 0.03 EVG
24 Histological Findings IJS = 0.55 HE
25 Histological Findings IJS = 0.55 EVG
26 Relations between IJS and NIT 3 Neointimal Thickness (mm) Vessel Injury Score Y = * X; R^2 =.748, p=0.0001
27 Summary of Results Stent implantation was successfully performed in all cases. Although there was only one case of QMI due to stent thrombosis in the hospital, no death or CABG was observed within 12 months. The restenosis and TLR rates were acceptable. All revascularizations were performed successfully.
28 Conclusions This study suggests the feasibility, safety and efficacy of the Igaki-Tamai biodegradable stent in humans over a long-term period.
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