生物可吸收支架和聚合物涂层可降解 支架能消除支架内血栓吗? 钱菊英,MD, FACC,FESC 复旦大学附属中山医院上海市心血管病研究所
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1 生物可吸收支架和聚合物涂层可降解 支架能消除支架内血栓吗? 钱菊英,MD, FACC,FESC 复旦大学附属中山医院上海市心血管病研究所
2 PCI milestones Pre Post Biodegradable polymer? 1 st revolution 1977 PTCA 2 nd revolution 1988 BMS 3 rd revolution 2000 DES Bioresorbable scaffold? 4 th revolution Dissection, acute closure restenosis Stent thrombosis?
3 Current ST status of BRS
4 Igaki-Tamai Stent
5 the XINSORB Scaffold First-in-man Study 30 patients in the intention-totreat population 27 patients analyzed with QCA at 6 months 1 definite 2y FU 3.3% 19 patients analyzed by IVUS and OCT 3 patients excluded 1 bailout stenting used 2 personally refused angiographic FU XINSORB scaffold n=200 RCT Study RCT n=400 1:1 TIVOLI stent n=200 1 definite 6m FU in XINSORB scaffold (0.5%) vs. 0 ST in TIVOLI stent 1y Clinical FU; Clinical laboratory; QoL; Angiography (mandatory); IVUS; IVUS-VH; OCT 30 patients clinically assessed at 1, 3, 6, 9 and 12 month
6 Early stage of Abbott BVS ABSORB Cohort A: 29 4y, ST=0 BVS 1.0 ABSORB Cohort B: 53 5y, ST=0 BVS 1.1 Dudek D, et al. EuroIntervention. 2012;7: Serruys PW, et al. J Am Coll Cardiol. 2016;67:
7 ABSORB II Study 1.00% 0.90% 0.80% 0.70% 0.60% 0.50% 0.30% 0.20% 0.10% 0.00% 1y FU 0.90% 0.60% P=0.55 P= definite ST definite or probable ST BVS XIENCE Design of ABSORB II study Serruys PW, et al. Lancet. 2015;385:43-54.
8 ABSORB China 1y FU 0.45% 0.35% 0.30% 0.25% 0.20% 0.15% All P=1.0 Design of ABSORB China study 0.10% 0.05% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% 0% 0.00% 0.00% ALL definite ST probable ST BVS acute ST XIENCE subacute ST late ST Gao R, et al. J Am Coll Cardiol. 2015;66:
9 ABSORB Japan 2.00% 1.50% 1.00% 1.50% 0.80% 1y FU All P> % 0.80% 0.50% 0.00% 0% 0% 0% definite acute subacte late 2.00% 1.50% 1.00% 1.50% 1.50% 1.10% 0.80% 0.80% Design of ABSORB Japan study 0.50% 0.00% definite or probable 0% 0% acute subacte late BVS XIENCE Kimura T, et al. Eur Heart J. 2015;36:
10 ABSORB III Study 1y FU P=0.21 P= % 1.40% 1.20% 1.40% 1.50% P= % 0.80% 0.60% 0.70% 0.70% P= % 0.90% P= % Design of ABSORB III study 0.20% 0.00% definite ST definite or probable ST BVS 0.20% Kereiakes DJ, et al. Am Heart J. 2015;170: Ellis SG, et al. N Engl J Med. 2015;373: % 0% acute ST subacute ST Late ST XIENCE
11 ABSORB Extend Study ABSORB EXTEND Study prospective, single-arm, open-label clinical study 800 patients at up to 100 sites lesions 28 mm in length and reference vessel diameter of mm Treatment of a maximum of two de novo native coronary artery lesions is permitted. Abizaid A, et al. EuroIntervention. 2015;10:
12 1.40% 1.20% 1.00% P= % P= % P= % 0.80% 0.60% 0.20% 0.60% 0.50% P= % 0.10% 0.50% P= % 0.00% definite or probable definite probable early (0-30 days) BVS XIENCE late (30 days-1 year) Stone GW, et al. Lancet. 2016;387:
13 9-12m FU The incidence of ST in BVS was much higher than in XIENCE group in ABSORB III Study. Cassese S, et al. Lancet. 2016;387:
14 Device Thrombosis (definite or probable) (%) ST in ABSORB III Study Any QCA RVD <2.25 mm 1-year results Absorb vs. Xience 4.6% vs. 1.5% respectively Diff [95%CI] = 3.1 [-0.3, 6.4] All QCA RVD 2.5 mm 1-year results Absorb vs. Xience 0.8% vs. 0.5% respectively Diff [95%CI] = 0.3 [-0.5, 1.1] 10% 8% Absorb XIENCE N=375 10% 8% Absorb XIENCE N=1623 6% 6% 4% 4% 2% 2% 0% Days Post Index Procedure 0% Days Post Index Procedure Stone GW. TCT 2015
15 Device thrombosis (%) ST in ABSORB III Study 5% QCA RVD <2.25mm (N=375) QCA RVD 2.25 mm (N=1623) 4% 3.3% It is discouraged to deploy a BVS in a vessel 3% 2% 1% 0% Absorb Xience whose diameter is smaller than 2.25 mm. 1.5% 1.3% 0.6% 0.6% 0.3% 0.0% 0.0% 0-30 day 30 day - 1 year 0-30 day 30 day - 1 year Stone GW. TCT 2015
16 Current ST status of DES with biodegradable polymer
17 Stent platform Thickness of struts Current available DES with biodegradable polymer Drugs Polymer Thickness of polymer Available from Company BioMatrix 316L 120μm Biolimus A9 PLA 2008 Biosensors Nobori 316L Biolimus A9 PLA 2013 TERUMO EXCEL 316L 100μm sirolimus PLA 2005 JW medical TIVOLI Co-Cr Alloy 80μm sirolimus PLGA 2012 Essen NOYA Co-Cr Alloy 81μm sirolimus DL-PLA 2010 Medfavour HELIOS Co-Cr Alloy 80μm sirolimus PLGA 9-19μm 2006 Kinhely BuMA 316L 100μm sirolimus PLGA μm 2010 SinoMedical Firehawk Co-Cr Alloy 86μm sirolimus PLA N/A 2014 MicroPort
18 ST of BioMatrix stent 4.50% 4.00% 3.50% 3.00% 2.50% 2.00% 1.50% 1.00% 0.50% P= % 4.20% P= % 1.60% P= % P= % 2.20% P= % 4.20% 6.00% 5.00% 4.00% 3.00% 2.00% 1.00% P= % 5.20% P= % 1.90% P= % 0.50% P= % 2.90% P= % 5.20% 0.00% definite early (1m) late (1m-1y)very late (> 1y) BioMatrix CYPHER overall 0.00% definite or probable LEADERS Study 5-year trail profile early (1m) late (1m-1y)very late (> 1y) BioMatrix CYPHER Windecher S. et al. Lancet. 2008;372: Serruys PW, et al. JACC Cardiovasc Interv. 2013;6: overall
19 ST of Nobori stent 5y FU of Nobori I Study 3.50% P= % 3.00% 2.50% 2.00% 1.50% P= % P= % 1.00% 0.50% 0.00% 0.00% 0.00% 0.00% 0.00% 0.00% definite or probable early (1m) late (1m-1y) very late (>1y) Nobori TAXUS Danzi GB, et al. Circ J. 2014;78: Chevalier B, er al. EuroIntervention. 2014;11:
20 ST of EXCEL stent Han YL, et al. EuroIntervention. 2012; 8:
21 ST of TIVOLI stent 12m FU 0.70% 0.60% P= % 0.50% P= % P=1.0 P=0.67 P= % 0.10% 0.20% 0.20% 0.20% 0.20% 0.20% 0.20% 0.10% Firebird2 P= % 0.10% TIVOLI 0.00% definite or probable definite probable acute (0-1 day) TIVOLI Firebird2 subacute (2-30 days) late ( days) Han YL, et al. JACC Cardiovasc Interv. 2014;7:
22 ST of NOYA stent 2y FU Xu B, et al. EuroIntervention. 2012;8:
23 ST of HELIOS stent y FU P=1.0 P= % 0.70% P= % Y 2Y 3Y HELIOS PARTNER Yuan F, et al. Chin Med J. 2014;127:
24 ST of BuMA stent P= y FU P L G A P B M A L 1.40% 1.20% 1.00% 0.80% 0.60% 0.20% 0.00% 0.50% 1.30% definite or probable ST P= % 0.20% P= % 0.30% 0.30% 0.30% 0.00% 0.50% 0.30% definite probable acute subacute late BuMA EXCEL P=0.03 P=0.71 P=0.31 eg technology Xu B, et al. J Am Coll Cardiol. 2016;67:
25 ST of Firehawk stent Flow chart of TARGET 1 Study Firehawk stent Gao RL, et al. EuroIntervention. 2013;9:75-83.
26 Zhang YJ, et al. Chin Med J. 2014;127:
27 Take home messages Stent deployment injury stent thrombosis. No stent, no thrombosis. Neither BVS nor DES with biodegradable polymer can eliminate the stent thrombosis. The incidence of ST in DES with biodegradable polymer is similar to that of traditional DES with durable polymer, showing excellent safety. Overall, the incidence of ST in BVS is comparable to that of DES. However, it is discouraged to deploy a BVS in vessels with small diameter. Carefully selection of patient, lesion and stent may reduce the occurrence of ST.
28 Thank You!
新型 DES 和 BVS 血栓发生现状及应对策略 钱菊英,MD, FACC,FESC 复旦大学附属中山医院上海市心血管病研究所
新型 DES 和 BVS 血栓发生现状及应对策略 钱菊英,MD, FACC,FESC 复旦大学附属中山医院上海市心血管病研究所 OCC2016 Increase of LST and death for first generation DES after stop of 6m DAPT BASKET-LATE Study P
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