中国pci指南解读陈君柱.ppt

1、2009年中国PCI指南解读,浙江大学医学院附属第一医院 陈君柱 教授,PCI的发展历史,1844 Bernard coins the term “cardiac catheterization”,1929 Forssmann peforms the 1st human cardiac catheterization,1958 Sones discovers the diagnostic coronary angiogram,1962 Ricketts and Abrams use the percutaneous approach in coronary arteries,1964 Dott

2、er introduces transluminal angioplasty,1977 Gruentzig peforms the 1st PTCA,1967 Judkins perfects the transfemoral approach,1986 Sigwart and Puel implant the 1st coronary stent,1994 1st coronary stent approved by the FDA,2003 FDA approval of 1st DES,2006 FDA panel on the safety of DES,2002 CE Mark on

3、 1st DES,背景,药物洗脱支架（DES）的广泛应用，成为PCI技术发展的里程碑 新技术的不断涌现 辅助药物治疗的发展 大量循证医学证据的出现 规范化治疗，保证医疗质量和安全,对医疗机构的要求,应为三级医院，设有心内科、心胸外科、血管造影室和重症监护室； 每年完成诊疗病例200例，治疗病例100例；术者需完成PCI每年50例； 血管造影并发症0.5%，介入治疗死亡率0.5%；,血管重建策略的选择,药物治疗,介入治疗,CABG,慢性稳定性心绞痛的指征,有较大范围心肌缺血的客观证据；/A 自体冠状动脉的原发病变常规置入支架；/A 静脉旁路血管的原发病变常规置入支架； /A 慢性完全闭塞病变；a

4、/C 外科手术高风险患者；a/B 多支血管病变无糖尿病，病变适合PCI ；a/B 多支病变合并糖尿病；b/C 经选择的无保护左主干病变；b,PCI与药物治疗的比较,早期荟萃分析,包括11个随机试验的荟萃分析; N = 2,950,Katritsis DG et al. Circulation. 2005;111:2906-12.,0,1,2,Risk ratio,PCI优势,药物治疗优势,COURAGE试验 - 设计,多中心随机对照临床试验 共筛选35,539个患者 共2,287个患者完成随机化 有心肌缺血证据 稳定性心绞痛 随机分组 PCI + 规范药物治疗 vs 单纯规范药物治疗 随访2.

5、5 to 7年 (平均4.6年),Boden WE, NEJM 2007; 356:1503-16,COURAGE试验 -结果,No. at risk 1,1381,01795983463840819230 1,1491,01395283363741720035,年份,单纯药物,PCI+药物,HR 1.05 95% CI 0.87-1.27 P=0.62,Boden WE, NEJM 2007; 356:1503-16,Survival free of death from any cause and nonfatal myocardial infarction,COURAGE试验 -结果,B

6、oden WE, NEJM 2007; 356:1503-16,Number at Risk,药物治疗组 1138 1073 1029917 717 468 302 38 PCI+药物组 1149 1094 1051929 733 488 312 44,Years,0,1,2,3,4,5,6,0.0,0.5,0.6,0.7,0.8,0.9,1.0,PCI+药物,单纯药物,7,Hazard ratio: 0.87 95% CI (0.65-1.16) P = 0.38,Overall Survival,COURAGE试验 -结果,The comparison between the PCI gr

7、oup and the medical-therapy group was significant at 1 year ( P0.001) and 3 years (P=0.02) but not at baseline or 5 years.,Boden WE, NEJM 2007; 356:1503-16,心绞痛发生率,25,50,75,100,88,87,34,42,28,33,28,26,Baseline 1 Year 3 Year 5 Year,P0.001,P=0.02,pNS,PCI + 药物组 单纯药物组,COURAGE试验 -结果,Large preponderence of

8、 procedural MIsdeath and spontaneous MI actually less after PCI,30% of OMT patients “crossed over” because of failure of OMT alone,Boden WE, NEJM 2007; 356:1503-16,COURAGE核医学亚组分析,Shaw LJ et al: Circ 117: 283, 2008,PCI+药物治疗(n=159),单纯药物治疗(n=155),33.3% with 5%ischemia reduction(P=0.0004),18.9% with 5%i

9、schemia reduction,Index,6-18 months,Mean = 2.7% (95% CI = -1.7% to -3.8%),8.2%(7.2-9.3%)P=0.63,5.5%(4.7-6.3%),Index,6-18 months,Mean = 0.5% (95% CI = -1.6% to 0.6%),8.6%(7.5-9.8%),8.1%(6.9-9.4%)P0.0001,近期荟萃分析,Schomig et al: JACC 52: 894, 2008,PCI与药物治疗 指南推荐,对多数轻度心绞痛（CCS -级）患者可先选择药物治疗； 对心绞痛症状较重或希望保持良好

10、体能的患者可考虑PCI； 有中、重度心肌缺血的稳定性心绞痛患者PCI可改善长期生存率； Blood is better than drugs for the ischemic myocardium - David Holmes, MD, FACC,PCI与CABG的比较,缓解心绞痛 不需要再次介入 完全再血管化 费用高 创伤大,费用相对低 恢复快 急性并发症减少 再狭窄问题 再次血管重建率高,裸支架时代CABG更占优势,PCI vs. CABG,Off pump技术 微创手术 动脉桥血管使用 围手术期管理,技术的进步 支架设计改进 DES的问世,费用高 创伤大 恢复时间长,再狭窄 再次血管重建

11、,?,近年来随着介入技术的进展，PCI与CABG差距逐渐缩小,PCI vs. CABG,Sirolimus-eluting stent 3.7 stents per patient Avg total length: 73 mm n = 607,ARTS-II研究,Historical Controls from ARTS I: 1202 patients with multivessel coronary lesions 18.2% diabetic 28% 3 vessel disease 7.5% type C lesions,607 patients with multivessel

12、coronary lesions 26.2% diabetic 54% 3 vessel disease 13.9% type C lesions,CABG n = 602,Bare Metal Stent 2.8 stents per patient Avg total length: 48 mmn = 600,Endpoints: Primary Major adverse cardiac and cerebrovascular events (MACCE), including death, cerebrovascular event, myocardial infarction, an

13、d revascularization, at 1 year for the comparison of CABG treated patients in the ARTS I trial with sirolimus-eluting stent patients in the ARTS II trial Secondary MACCE at 30 days, 6 months, 3 and 5 years. Total cost at 30 days Cost effectiveness, quality of life at 6 mo, and 1, 3, and 5 years,ARTS

14、 II研究：存活率比较,p = 0.001,p = 0.003,p = 0.46,1年不良事件比较,随访1年时，ARTS II DES组和ARTS I CABG组间不良事件率无明显差别； ARTS I BMS组的不良事件率较其它两组明显升高。,ARTS II研究：1年不良事件比较,p=NS,p=NS,p=NS,p=NS,ARTS II研究：结论,P0.01,Left Main Disease (isolated, +1, +2 or +3 vessels),3 Vessel Disease (revasc all 3 vascular territories),SYNTAX研究：入组条件,De

15、 novo disease,Limited Exclusion Criteria Previous interventions Acute MI with CPK2x Concomitant cardiac surgery,23 US Sites,62 EU Sites,+,SYNTAX研究设计,*TAXUS Express,Event Rate 1.5 SE. *Fishers Exact Test,ITT population,P=0.37*,4.3%,3.5%,1年后全因死亡比较,0.6%,2.2%,ITT population,P=0.003*,Event Rate 1.5 SE. *

16、Fishers Exact Test,1年后脑血管事件比较,P=0.98*,ITT population,7.7%,7.6%,Event Rate 1.5 SE. *Fishers Exact Test,1年后全部心脑血管事件比较,5.9%,13.7%,ITT population,P0.0001*,Event Rate 1.5 SE. *Fishers Exact Test,1年后再次血管重建比较,糖尿病 N=452,非糖尿病 N=1348,Death/CVA/MI,MACCE,Death/CVA/MI,MACCE,P=0.96,P=0.0025,P=0.08,P=0.97,糖尿病亚组分析,

17、Patient 1,Patient 1,Patient 2,Patient 2,LCx 70-90%,RCA3 70-90%,LCx 100%,LAD 99%,RCA 100%,Syntax积分法：三支病变比较,13.5%,14.4%,P=0.71*,Syntax低分区亚组(0-22),P=0.19*,12,12,左主干病变,三支病变,Syntax低分区亚组(0-22),16.6%,11.7%,P=0.10*,Syntax中分区亚组(23-32),P=0.02*,15.5%,12.6%,Mean baseline SYNTAX Score CABG27.2 3.0 TAXUS27.0 2.7,

18、左主干病变,三支病变,P=0.54*,Syntax中分区亚组(23-32),Syntax高分区亚组(33),23.3%,10.7%,P0.001*,21.5%,8.8%,P=0.002*,P=0.008*,25.3%,12.9%,Mean baseline SYNTAX Score CABG42.1 7.6 TAXUS43.8 9.1,左主干病变,三支病变,Syntax高分区亚组(33),PCI与CABG 指南推荐,适合PCI 中等范围以上心肌缺血或有存活心肌，伴前降支受累的单支或双支病变 能够进行完全血管重建的病变 有外科手术禁忌证、要接受非心脏手术者 ACS，尤其是急性心肌梗死的患者,适合

19、CABG 左主干病变 多支血管病变伴EF50% 伴有前降支近端明显狭窄的双支病变 病变不适合PCI或其效果不理想者 前降支闭塞而无前壁MI者 PCI不成功或不能进行完全血管重建的患者,慢性稳定性心绞痛的指征,有较大范围心肌缺血的客观证据；/A 自体冠状动脉的原发病变常规置入支架；/A 静脉旁路血管的原发病变常规置入支架； /A 慢性完全闭塞病变；a/C 外科手术高风险患者；a/B 多支血管病变无糖尿病，病变适合PCI ；a/B 多支病变合并糖尿病；b/C 经选择的无保护左主干病变；b,非ST抬高ACS的指征,对不稳定性心绞痛和非ST段抬高心梗应进行危险分层（TIMI、GRACE）； 对极高危患

20、者行紧急PCI（2h内）；a/B 对中高危患者行早期PCI（72h内）；/A 对低危患者不推荐常规PCI；/C 对PCI患者常规支架置入；/C 对中高危患者围手术期应强化抗血小板、抗凝治疗；,STEMI的处理流程,PCI方法的选择,BMS,晚期血栓事件极少 不需长期使用双重抗血小板治疗 费用相对较低 支架内再狭窄和再次血管重建问题,DES,支架内再狭窄率明显降低 再次血管重建率减少 晚期血栓问题 需长期使用双重抗血小板治疗 费用较高,DES vs BMS,支架内晚期血栓形成的原因,抗血小板药物强度和疗程不足,内皮化延迟,复杂PCI,支架聚合物过敏/炎症,支架内血栓,DES和BMS死亡率的比较,

21、In the BASKET LATE Trial, cardiac death trended higher in the DES group than in the BMS group during the year following clopidogrel discontinuation (1.2% vs 0%, P=.09). Data from the PREMIER registry looked exclusively at AMI patients who received DES and suggested that patients who discontinued thi

22、enopyridine therapy early within 30 days in this instance were significantly more likely to die over the next 11 months (P.0001).,BASKET LATE Trial: Cardiac death in DES vs BMS (%),PREMIER Registry Data: All cause death according to minimum 30 day thienopyridine therapy duration (%),7.5,0.7,0,2,4,6,8,Stopped thienopyridines