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<0.05 7-18m FU Pfisterer M, et al. J Am Coll Cardiol. 2006;48(12):2584-2591.
Current ST status of 1st DES Outcomes associated with drug-eluting and baremetal stents: a collaborative network meta-analysis 27 trials provide data on definite stent thrombosis according to ARC criteria. 1-4 years FU Stettler C, et al. Lancet. 2007;370:937-948.
TAXUS CYPHER BMS Stettler C, et al. Lancet. 2007;370:937-948.
Current ST status of new generation of DES TAXUS ENDEAVOR XIENCE CYPHER Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis RESOLUTE PROMUS ELEMENT Palmerini T, et al. Lancet. 2012;379:1393-1402.
1-year definite ST was significantly lower with CoCr-EES than with BMS and PES, even lower than with Resolute. At 2-year follow-up, CoCr-EES were still associated with significantly lower rates of definite ST than BMS and PES. No other DES had lower definite ST rates compared with BMS at 2-year follow-up. Palmerini T, et al. Lancet. 2012;379:1393-1402.
Current ST status of BVS Acute ST 0.27% Subacute ST 0.57% late Very Late acute This may reflect an increase in the studies using BVS in patients with ACS. Lipinski M, et al. JACC Cardiovasc Interv. 2016;9:12-24. Puricel S, et al. J Am Coll Cardiol. 2016;67:921-931.
Lipinski M, et al. JACC Cardiovasc Interv. 2016;9:12-24.
Cause of DES ST Compliance With Antithrombotic Regimens at the Time of Stent Thrombosis Waksman R, et al. JACC Cardiovasc Interv. 2014;7(10):1093-102. Holmes DR Jr, et al. J Am Coll Cardiol. 2010;56(17):1357-1365. Urban P, et al. J Am Coll Cardiol. 2011;57:1445-1455.
OCT analysis of ST dissection malapposition Uncovered struts neoatherosclerosis Ruptured neoatherosclerosis Ruptured neoatherosclerosis Souteyrand G, et al. Eur Heart J. 2016;37(15):1208-1216.
Cause of BVS ST Similar to DES, ST is a particularly severe complication whose 12- month incidence was as high as 3%. None of the clinical characteristics was an independent predictor of ST. QCA features of small vessels were a hallmark of ST. Suboptimal post-procedural angiographic results, with even small deviations from the nominal BVS diameter, were associated with exponential increases in the risk of ST. The curve describing the positive predictive values of different post-procedural MLDs showed a steeper increase for values <2.4/2.8 mm. MLD values <2.1 mm (for the 2.5-/3.0-mm BVS) and 2.7 mm (for the 3.5-mm BVS) were associated with ST with a specificity of 90% and a sensitivity of 50%. Puricel S, et al. J Am Coll Cardiol. 2016;67:921-931.
ST risk assessment and prevention Patient, lesion, and stent selection Risk score calculation Technique DAPT compliance and interruption Claessen BE, et al. JACC Cardiovasc Interv. 2014;7(10):1081-1092.
Patient, lesion, and stent selection BMS lesion with low risk of restenosis and patients at increased risk of bleeding, scheduled for surgery, allergic to thienopyridines, and/or in whom compliance is questionable. New generation of DES (XIENCE, RESOLUTE, and PROMUS ELEMENT) provide the best combination of safety and efficacy. Fully bioabsorbable scaffold may reduce very late stent thrombosis, but long-term results of large-scale trials investigating the safety and efficacy are not yet available.
Risk score calculation Dangas GD, et al. JACC Cardiovasc Interv. 2012;5:1097-1105.
Low risk of ST intermediate High risk of ST Dangas GD, et al. JACC Cardiovasc Interv. 2012;5:1097-1105.
Technique Optimize the results of procedure Proper stent expansion and apposition Avoid residual dissection IVUS guided stent implantation Stent length, excessive use of stents is discouraged Provisional side-branch stenting approach might be preferable to routine CRUSH or CULOTTE stenting in bifurcation lesion
DAPT Recommendation Binder RK, et al. Eur Heart J. 2015;36(20):1207-1211.
12 10 8 6 4 2 0 MACCE and DAPT duration Low bleeding 1010.1 5.6 5.9 2 1.6 1.6 5.1 4.3 1.5 1.4 risk 6 months 12 months 30 months 1.1 2.4 2.42.6 1 1.9 0.6 0.6 0.6 1.3 1.6 1.2 0.8 0.5 0.3 0.3 Intermediate 0.2 0 0 Favor long DAPT OPTIMIZE RESET EXCELLENT PRODIGY ITALIC DES LATE DAPT OPTIMIZE RESET EXCELLENT PRODIGY ITALIC DES LATE DAPT Short DAPT Individualized DAPT management Low ischemic risk Long DAPT P<0.001 3.5 3 2.5 Bleeding and DAPT duration Intermediate 2.9 ischemic risk 2.3 Short DAPT = 3-12m Long DAPT = 12-36m Short DAPT High ischemic risk P=0.004 bleeding risk 3-6 months 6-12 months 12 months Long DAPT High bleeding risk 3 months 3-6 months 6-12 months P=0.001 2.5 Binder RK, et al. Eur Heart J. 2015;36(20):1207-1211. Palmerini T, Lancet. 2015;385(9985):2371-2382.
A DAPT score is recommended. A score of 2 is associated with a favorable benefit/risk ratio for prolonged DAPT while a score of <2 is associated with an unfavorable benefit/risk ratio.
2016 新指南对双抗疗程管理的推荐 : 依据疾病类型 再灌注方法和缺血及出血风险 CAD SIHD 急性 / 近期 ACS (NSTE-ACS 或 STEMI) 无 PCI 史或近期 CABG S/P PCI S/P CABG 药物治疗 溶栓 (STEMI) PCI (BMS 或 DES) CABG BMS DES 0 个月 6 个月 12 个月 III 类 : 无获益 I 类 : 至少 1 个月 ( 氯吡格雷 ) I 类 : 至少 6 个月 ( 氯吡格雷 ) 无出血高风险及明显出血 IIb 类 : >1 个月是合理的 IIb 类 : >6 个月是合理的 IIb 类 : 12 个月是合理的 ( 氯吡格雷 ) I 类 : 至少 12 个月 ( 氯吡格雷 替格瑞洛 ) I 类 : 最少 14 天, 理想情况下为至少 12 个月 ( 氯吡格雷 ) I 类 : 至少 12 个月 ( 氯吡格雷 普拉格雷 替格瑞洛 ) I 类 : CABG 术后继续接受 P2Y12 抑制剂治疗, 以完成 1 年 DAPT 无出血高风险及明显出血 IIb 类 :>12 个月是合理的 图底部的箭头表示延长 DAPT 的最佳疗程并不确定 Levine GN, et al. J Am Coll Cardiol. 2016 Mar 23. pii: S0735-1097(16)01699-5
Take home messages ST of new generation of DES is lower than 1 st DES, even lower than BMS. BVS may reduce very late ST, but long-term results are not yet available. Carefully selection of patient, lesion and stent may reduce the occurrence of ST. Optimize the results of PCI. Individualized DAPT is recommended.
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