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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 崔连群 山东省立医院 完全生物可吸收支架 (BVS)
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb BVS: PCI 手术的第四次革命 1977 球囊扩张 (PTCA) 金属裸支架 (BMS) 冠脉药物洗脱 支架 (DES) Absorb 全生物可吸收 血管支架 (BVS) 197719882001 今天 Data and images on file at Abbott Vascular. Histology images are from porcine animal models. 术后即刻 完全吸收 后
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 介入心脏治疗 : 过去没有满足的需求 当前的治疗选择不能阻断冠心病不断发展的特点 1. Yamaji K, et al. Very long-term (15 to 20 years) clinical and angiographic outcome after coronary bare metal stent implantation. Circ Cardiovasc Interv 2010;3(5):468-75. 2. SPIRIT III: Ischemia-driven TLR through 5 years. Stone GW, TCT 2011. BMS 长期事件发生率 1 DES 长期事件发生率 2
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 生物可吸收支架的临床需求 血管结构的支撑只是暂时的需要 * Vision Potential Benefits 理念 愿景 可能的好处 不在体内留下支架,改善患者长期的临床结果 I 1 使血管恢复至更加天然的状态,恢复血管的运动功能 消除慢性血管刺激及炎症的来源 对未来可能的血管治疗选择没有任何限制 缩短 DAPT 的治疗时长 2 允许进行无创影像学检查 (CCTA) 提高患者生存质量 使血管恢复至更加天然的状态,恢复血管的运动功能 消除慢性血管刺激及炎症的来源 对未来可能的血管治疗选择没有任何限制 缩短 DAPT 的治疗时长 2 允许进行无创影像学检查 (CCTA) 提高患者生存质量 *Serruys PW, et al., Circulation 1988; 77: 361. Serial study suggesting vessels stabilize 3-4 months following PTCA. 1 – Small platinum markers at scaffold edges remain for fluoroscopic landmarking. 2. The Absorb IFU indicates DAPT for a minimum of 6 months.
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 生物可吸收支架的探索
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. All illustrations are artists’ renditions 全吸收式生物血管支 架涂层 PDLLA 涂层 自然吸收,完全代 谢 与 XIENCE V 相似 的剂量密度及释 放曲线 依维莫司 聚乳酸 (PLLA) 自然吸收,完全 代谢 全吸收式生物血管 支架平台 雅培全吸收式生物血管支架的组成 XIENCE V 输送系统 出色的输送系统
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 依维莫司 /PDLLA 基质涂层 薄涂层 非晶状 1:1 依维莫司 /PLA 基质 全覆式涂层, 2-4 m 厚 可控药物释放 主干部分为 PLLA 晶状 提供支架完整性 特殊加工,增强径向支撑力 生物降解聚合物 聚合物主干部分 药物 / 聚合物基质
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 在周围血管细胞及血液中的水渗透到聚合物基质中 长聚合物链变得越来越短 1 3 6 24 Months Support Mass Loss Tie chains Initially, hydrolysis preferentially cleaves amorphous tie chains, leading to a decrease in molecular weight without altering radial strength When enough tie chains are broken, the device begins losing radial strength Molecular Weight 1218 Absorb 如何吸收
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 全生物可吸收支架应满足哪些要求??? 1 3 6 2 年 完全吸收 & 生物降 解 月 血小板沉积 白细胞聚集 SMC 增殖迁移 基质沉积 再内皮化 血管功能 Forrester JS, et al., J. Am. Coll. Cardiol. 1991; 17: 758. 血运重建恢复吸收 依维莫司释放 开始吸收 支撑 Oberhauser JP, et al., EuroIntervention Suppl. 2009; 5: F15-F22.
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb 血管支撑时间 ABSORB 至少可以在需要的时间内提供足够的血管支撑 径向支撑 (mmHg) XIENCE V 最小可接受塌陷压力 (300 mmHg)* *Agrawal, CM, et.al. Biomaterials. 1992; 13: 176-182. Absorb 径向支撑力 Devices subjected to simulated physiologic environment (fatigue testing). Tests performed at and data on file at Abbott Vascular.
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 91° 88° Serruys, PW., TCT 2009 ABSORB BVS Absorb 顺应性
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 典型猪冠脉组织学图片 (2x) 1 Month6 Months 12 Months 18 Months BVS Cohort B Photos taken by and on file at Abbott Vascular. Tests performed by and data on file at Abbott Vascular.
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 2 years 重量降低数据提示,术后 2-3 年支架 材料的重量下降 100% 尽管 2 年的物质损失数据表明, BVS 已几乎完全吸收,节杆的轮廓还存在 节杆周边区域无炎症反应 在第 2 , 3 及 4 年血管对 BVS 的反应 : 血管恢复及对植入物的适应 Tests performed by and data on file at Abbott Vascular. Alcian Blue Stain: Proteoglycan 3 years Photos taken by and on file at Abbott Vascular. 猪冠脉组织学图片, 2x 3 年后:节杆完全由细胞组织取代 4 年 Cohort A Device 4 年后:已看不出节杆的痕迹
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Absorb BVS 支架被功能性细胞基质所取代 Based on preclinical histology evidence. Data on file at Abbott Vascular.
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 初步证据显示血管运动更好的长期结果 血管直径 (mm) Methergine Acetylcholine -0.5 0 0.5 1 (N=15) 6 Months 1 (N=6) (N=19) 12 Months 2 (N=13)(N=9) 24 Months 3 (N=7) 血管舒张 血管收缩 ABSORB Cohort B1 ABSORB Cohort B2 ABSORB Cohort A (pre-drug infusion to post-drug infusion) 1. Adapted from Serruys, PW. ACC 2011 / 2. Adapted from Serruys, PW. ACC 2011 / 3. Adapted from Serruys, PW, et al. Lancet 2009; 373: 897-910.
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 晚期管腔增大 患者血管晚期管腔增大 TLR 减低 ABSORB Cohort B Serial Analysis** ABSORB Cohort A Unpaired Analysis* N = 25 N = 18 管腔面积 6.53 mm 2 6.36 mm 2 6.85 mm 2 N = 33 Scaffold Area 1.7% 管腔面积 7.2% Late Loss = 0.19 mm 管腔面积 6.04 mm 2 5.19 mm 2 5.46 mm 2 Scaffold Area 11.8% 管腔面积 10.85% Late Loss = 0.43 mm *Serruys, PW., TCT 2008**Serruys, PW., TCT 2011 术后即刻 6 个月 2 年
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 完全生物可降解支架的潜力 良性 NIH 支架内再狭窄 斑块消退 正性重构 完全管腔扩大 由于节杆消失,因节杆引起的贴壁不良和节杆的长期未覆盖所带来的 问题就变得无关紧要了
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 全面的 Absorb 临床研究项目 Note: Sample sizes reflect ABSORB patients only. >1,200 患者 来自 >31 国家 已经接受了 Absorb BVS 治疗 >1,200 patients treated to date reflects clinical trial patients plus non-trial, real-world experience. 2011 2012 2013 2014 2015 2016 Total Pts Studiedn=131n~865n~12,600n~17,734n~19,790 ABSORB III n = 2,000 Enrollment & Follow-Up ABSORB Japan n = ~375 Enrollment & Follow-Up 2 Y1 Y ABSORB China n = ~500 Enrollment & Follow-Up 2 Y1 Y ABSORB II n = ~500 2 Y3 Y1 Y Enrollment & Follow-Up ABSORB IV n = 3,000 Enrollment & Follow-Up ABSORB Diabetics n = ~2,000 In Planning ABSORB FIRST n = ~10,000 Enrollment & Follow-Up ABSORB PHYSIOLOGY n = ~35 2 Y1 Y Enrollment & Follow-Up ABSORB Extend n = ~1,000 2 Y3 Y1 Y Enrollment & Follow-Up ABSORB Cohort B n = 101; FIM 1 Y2 Y3 Y4 Y5 Y ABSORB Cohort A n = 30; FIM 5 Y 2 Y1 Y2 Y1 Y
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 19 ABSORB Cohort A 前瞻性、开放性、单组研究。 30 例患者在 4 家中心入选 器械尺寸: 3.0 x 12 mm 治疗:单个原发性病变 临床和成像终点的描述性分析 随访时间表: 主要研究人员: Patrick Serruys, John Ormiston QCA, OCT, IVUS, VH MSCT 随访 6 个月 12 个月 18 个月 24 个月 36 个月 48 个月 60 个月 基线 临床 Europe New Zealand
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 20 ABSORB Cohort A 在 6 个月到 5 年之间没有新的 MACE ;长达 5 年内未出现血栓 非分层 6 个月 30 例患者 12 个月 29 例患者 * 3 年 29 例患者 * 5 年 29 例患者 * 心源性死亡 n (%) 0 (0.0%) MI n (%) Q- 波 MI 0 (0.0%) 非 Q- 波 MI 1 (3.3%)**1 (3.4%)** 缺血性 TLR n (%) PCI 0 (0.0%) CABG 0 (0.0%) 分层 MACE n (%) 1 (3.3%)**1 (3.4%)** 分层 TLF n (%) 1 (3.3%)**1 (3.4%)** Serruys, PW., TCT 2011. * One patient withdrew consent 6 months. ** This patient also underwent a TLR, not qualified as ID-TLR (DS = 42%) followed by post-procedural troponin qualified as non-Q MI and died from his Hodgkin’s disease at 888 days post-procedure.
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. BVS 产品优化的目标 Cohort A Cohort B Photos taken by and on file at Abbott Vascular. 支架节杆分布更加均匀 对血管壁的支撑更加均匀 径向支撑力更高 低晚期 “ 支架 ” 区域管腔丢失 可在室温下保存 提高产品压卧于球囊上的牢固度 没有改变的 : – 材料,涂层及主体 – 节杆厚度 – 药物释放曲线 – 完全降解时间
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 22 ABSORB Cohort B 前瞻性、开放性、单组研究。 101 例患者在 2 家中心入选 器械尺寸: 3.0 x 18 mm 治疗:最多 2 个原发性病变 临床和成像终点的描述性分析 随访时间表: 主要研究人员: John Ormiston, Patrick Serruys 基线 6 个月 12 个月 18 个月 24 个月 36 个月 48 个月 60 个月 B1 组 (n = 45) MSCT 跟踪 临床 B2 组 (n = 56) 欧洲 新西兰 澳大利亚
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 23 ABSORB Cohort B 根据 ARC 或方案定义无支架血栓形成 非分层 心源性死亡 (%) 心肌梗死 n (%) Q- 波 MI 非 Q- 波 MI 缺血引起的 TLR n (%) PCI CABG 分层 MACE n (%) 30 天 6 个月 n = 101 0 0 0 0 2(2.0) 3(3.0) 2 (2.0) 3 (3.0) 2 (2.0) 0 0 0 0 5 (5.0) MACE :心源性死亡、 MI 、缺血引起的 TLR 12 个月 n = 101 0 3(3.0) 0 7 (6.9) 0 4 (4.0) 24 个月 n = 100* 0 3(3.0) 0 9 (9.0) 0 6 (6.0) *1 例患者错过了 2 年随访 Patrick. Serruys., ACC 2013. 36 个月 n = 100* 0 3(3.0) 0 10 (10.0) 0 7 (7.0)
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. ABSORB BVS Cohort B 主要心脏不良事件发生率低 与 XIENCE 的历史数据相比较,有相似的 MACE 发生率 Patrick. Serruys., ACC 2013.
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. ABSORB BVS 临床数据 Late Loss 表现与 XIENCE 相似 BVS: 0.19 0.18 mm (n=42) XIENCE V: 0.10 0.23 mm (n=22) *One-year data is from ABSORB Cohort B Group 2 (n=56), two-year data is from Cohort B Group 1 (n=45) 6 个月 12 个月 BVS: 0.27 0.32 mm (n=56)BVS: 0.27 0.19 mm (n=38) XIENCE V: 0.23 0.29 mm (n=22)XIENCE V: 0.33 0.36 mm (n=100) 24 个月 Late Loss 在 12 至 24 个月期间保持不变 Serruys, PW., TCT 2011. 血管造影 Late Loss 表现与 XIENCE 相似,在 12 到 24 个月期间保持不变
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 26 ABSORB EXTEND 后续试验. FPI* : 2010 年 1 月 11 日 无假设检验,典型 PCI 终点 器械尺寸: 2.5, 3.0 mm ( 直径 ) ; 18, 28 mm ( 长度 ) ,或可用尺寸 病变长度 ≤ 28 mm 允许计划重叠 两个成像亚组: OCT (n=50 ,只计划重叠); MSCT (n=100) 随访时间表: 主要研究人员: Alexandre Abizaid 合作 PI : Antonio Bartorelli; Rob Whitbourn 30 天 6 个月 12 个月 24 个月 36 个月 临床随访 MSCT 随访 (n=100) OCT 随访 (n=50)
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 27 EXTEND (N=469) (S=540) 目标病变数 (%) 1 个病变受试者 93.0 2 个病变受试者 7.0 计划重叠率 (%) – 每例受试者 7.7 急救 (%) – 每例受试者 4.1 BVS1.5 金属 EES 2.3 其他支架 0.4 器械使用率 (%) – 每个支架 3.0 x 18 mm BVS80.4 3.0 x 28 mm BVS12.6 2.5 x 18 mm BVS7.0 Cohort B (N=101) (S=102) 99.0 1.0 NA 4.0 0.0 4.0 0.0 100 NA ABSORB EXTEND – 手术参数 注意: S 是研究支架总数。
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. ** No ABSORB BVS was implanted in the target lesion. MACE: Cardiac death, MI, Ischemia driven TLR TVF: Cardiac death, MI, Ischemia driven TLR, Ischemia driven non-TLR TVR ABSORB EXTEND 与 ABSORB COHORT B 比较 6 个月低 MACE 发生率 非分层 % (n) EXTEND * Cohort B (N=269)(N=101) 心源性死亡 % (n) 0.4 (1)**0.0 (0) 心梗 % (n) 2.6 (7)3.0 (3) Q 波 MI 1.1 (3)0.0 (0) 非 Q 波 MI 1.5 (4)3.0 (3) 缺血驱动性 TLR % (n) 0.4 (1)2.0 (2) CABG 0.0 (0) PCI 0.4 (1)0.2 (1) 缺血驱动性非靶病变 TVR % (n) 0.4 (1)0.0 (0) CABG0.4 (1)0.0 (0) PCI0.0 (0) 分层 MACE % (n) 3.0 (8)5.0 (5) 分层 TVF % (n) 3.3 (9)5.0 (5) * Reflects analysis with only adjudicated and cleaned data from the Mar 26 th, 2012 report.
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. ABSORB BVS 临床数据 - 在更加复杂的患者中也保持一致的表现 在更加复杂的 EXTEND 研究中低 ID-TLR 发生率 Abizaid A. ABSORB EXTEND 6-month clinical data, ACC 2012. 在 ABSORB EXTEND 中允许支架重叠(最多 2 个)因此病变长度更长
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. ABSORB EXTEND/Cohort B MACE (12 个月 ) Note: MACE is defined as the composite of cardiac death, MI, and ischemia-driven TLR 在险人数 术后时程 ( 日 ) 037194393 Cohort B101999694 EXTEND250244242237 Note: The datasets are from different trials, and displayed for descriptive purposes only
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Note: MACE is defined as the composite of cardiac death, MI, and ischemia-driven TLR 术后时程(日) 037194393 SPIRIT Pooled482475462435 EXTEND250244242237 Protocol MACE 0.0% 5.0% 10.0% 15.0% 术后时程 ( 月 ) 012345678910111213 4.4% 6.1% Absorb Extend First 250 patients SP123 XV patients with 2.5x18 or 3x18 or 3x28 ABSORB EXTEND/SPIRIT MACE (12 个月 ) Note: The datasets are from different trials, and displayed for descriptive purposes only
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. Source: Dr. Antonio Colombo Live Case, EuroPCR 2012 病例 1: 真实世界应用 63 岁 — 多支血管病变, LCX 中度钙化, LAD 重度钙化 为释放 Absorb 进行广泛的病变准备 ( 旋磨 ) 结果 : LCX 2 个 Absorb 支架, LAD 4 个 Absorb 支架,结果令人满意 病例 2: 首次手术,年轻患者 61 岁, 首次手术 RCA 中段局灶性简单病变, Absorb 植入 后获得满意结果 病例 3: 长期结果 Cohort A 5 年随访 2 年时显示晚期管腔获得,保持至 5 年 影像学显示 “ 黄金管腔 ” 提示血管修复 真实世界应用 Absorb 真实世界应用 EuroPCR 2012 手术转播
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. ABSORB BVS 的长期获益及其改善长期结果的可能 Images courtesy of Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands, ABSORB A 5 yr “ 黄金管道 ”
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 生物可吸收支架满足了临床的需求 血管结构的支撑只是暂时的需要 * Vision Potential Benefits 理念 愿景 可能的好处 不在体内留下支架,改善患者长期的临床结果 I 1 使血管恢复至更加天然的状态,恢复血糖的运动功能 消除慢性血管刺激及炎症的来源 对未来可能的血管治疗选择没有任何限制 缩短 DAPT 的治疗时长 2 允许进行无创影像学检查 (CCTA) 提高患者生存质量 *Serruys PW, et al., Circulation 1988; 77: 361. Serial study suggesting vessels stabilize 3-4 months following PTCA. 1 – Small platinum markers at scaffold edges remain for fluoroscopic landmarking. 2. The Absorb IFU indicates DAPT for a minimum of 6 months.
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. *Young patient defined as <65 years of age / (1) Thyssen et al. Contact Dermatitis 2007 / (2) Koster, Lancet, Vol 356, 12/2/00 CCTA images courtesy of K Nieman, Erasmus Medical Center, Rotterdam, Netherlands. 首次手术, 年轻患者 * 当术后无创检查可能对患者有益时 有再次接受介入治疗风险的患者 有金属过敏的患者 Absorb 对某几类患者可能有特别的益处 无创影像 学检查 如( CCTA ) 可用于期 或晚期 BVS 患者随 访 年轻患者可能将来会需要行介入 手术,永久植入物会阻碍或使手 术变得更加复杂 生物可吸收支架将为未来的介入手 术保留更多的治疗选择 大约有 8.6% 的人有镍合金过敏 1 , 从支架中释放的镍和钼所致过 敏反应可能是触发支架内再狭 窄的机制之一 2
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©2012 Abbott. All rights reserved. AP2937781 Rev. A Information contained herein for use with physicians outside the US and Japan only. Absorb is authorized for sale in CE Mark countries. Please check the regulatory status of the device for countries where CE marking is not the regulation in force. Not to be reproduced, distributed or excerpted. 谢谢 36
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