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非 ST 段抬高急性冠脉综合征介入治疗 - 策略与选择 阜外心血管病医院 乔树宾

非 ST 段抬高急性冠脉综合征介入治疗 - 策略与选择 阜外心血管病医院 乔树宾. ACS. 2.3 million hospital admissions ACS ( 230 万/年 ACS 住院患者）. UA / NSTEMI. STEMI. 1.43 million admissions per year （143万/年患者占63% ）. 829,000 admissions per year （82.9万/年患者占36%）. ACS 住院患者 （ NSTE-ACS vs STEMI）.

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非 ST 段抬高急性冠脉综合征介入治疗 - 策略与选择 阜外心血管病医院 乔树宾

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  1. 非ST段抬高急性冠脉综合征介入治疗-策略与选择阜外心血管病医院 乔树宾

  2. ACS 2.3 million hospital admissions ACS ( 230万/年 ACS住院患者） UA / NSTEMI STEMI 1.43 million admissions per year （143万/年患者占63%） 829,000admissions per year （82.9万/年患者占36%） ACS住院患者（NSTE-ACS vs STEMI） National Center for Health Statistics. 2001.

  3. 血栓 炎症 细胞 少量平滑肌 细胞 激活的巨噬细胞 ACS主要发病机理 • 动脉粥样硬化斑块--不稳定或破裂 • 血栓形成

  4. ACS 无持续ST段抬高 ACS 伴持续ST段抬高 Adapted from Michael Davies Adapted from Michael Davies CK- MB or Troponin Troponin elevated or not ACS的病理生理基础

  5. ACS的临床分型 ACS 无 ST 段抬高的 ACS ST 段持续抬高的 ACS cTnT ( cTnI ) ≥0.1μg/L 或CK-MB≥正常上限的2倍 cTnT ( cTnI ) ＜0.1μg/L 或CK-MB<正常上限的2倍 STEMI NSTEMI UA

  6. 抗栓—不溶栓 抗血小板、抗凝 PCI ？！ 非ST段抬高ACS的治疗 • 抗血小板治疗 • 抗凝治疗 • 抗缺血治疗 • 调脂治疗 • 介入治疗 • 冠脉搭桥

  7. 诊 断 • 常规血生化，特别包括Tn T或I • 监测心电ST段的变化 • 超声心动图检查 如需排除主动脉夹层，做MRI； 排除肺栓塞行CT或核素检查 • 观察对抗缺血治疗的效果 • 评定危险记分 • 评价出血的危险性

  8. 临床因素 • 年龄 • 原有基础的左室功能 • 冠脉解剖 • 糖尿病及肾肺功能异常等其它合并病 • 心绞痛的病史特点 • 心电图或动态心电图 心肌缺血的表现 ST段和T波改变 • 肌钙蛋白 • Ｃ反应蛋白 • 纤维蛋白肽Ａ • BNP 或NTproBNP  NSTE-ACS危险分层

  9. NSTE-ACS危险分层方法 ----早期CAG的价值 • 早期冠脉造影目的： 病变范围和分布、狭窄程度和部位、适合何种血管重建术等。 • 早期冠脉造影 ------ 提高预后分层的可靠性 ------ 确定治疗方案的有效方法： ① 没有病变可迅速出院 ② 罪犯病变适合 PCI 者可立即介入治疗加快出院 ③ 左主干病变、复杂病变伴左室功能不全者迅速 CABG ------发现高危病人，使患者从早期血管重建术中获益

  10. ACC/AHA：治疗的选择（一） • 有创治疗： 1.尽管充分药物治疗仍发生静息或低水平活动心绞痛； 2.TnT或TnI升高； 3.新出现的ST压低； 4.HF体征和症状或新出现或加重的二尖瓣返流； 5.无创检查有高危的证据； 6.持续性室速； 7.六个月内曾PCI； 8.先前CABG； 9.危险积分属高危（TIMI，GRACE）； 10.左心室功能降低（LVEF<40%）

  11. ACC/AHA：治疗的选择（二） • 保守治疗： 计分属低危险（TIMI，GRACE） 无高危特征的患者或医生选择

  12. 2007-ESC介入治疗 紧急（Urgent） 1.患者出现持续性或反复胸痛，伴有或不伴有ST改变（≥2mm）或深的倒置T波，抗缺血治疗效果不好 2.出现心衰临床症状或血流动力学不稳定 3.致命性心律失常（VF、VT）

  13. 早期<72小时 1.Tn T或I↑ 2.动态ST或T改变（有症状或无症状） 3.糖尿病 4.肾功能异常（GFR<60ml/min/1.73m2） 5.左心室功能降低（LVEF<40%） 6.梗塞后心绞痛 7.有MI病史 8.6个月内行PCI ,有CABG史 9.中高GRACE危险记分

  14. 不做或择期做 • 无再发胸痛 • 无心衰的体征 • 无新的ECG改变（就诊6-12小时） • TnT 或I正常（就诊6-12小时）

  15. Invasive Management of UA/NSTEMI Meta-analysis:  Death/MI at 17 mo. F/U Odds Ratio Death or MI Trial Inv Cons TIMI 3B 5.1% 8.1% 27.2% VANQWISH 28.0% MATE 12.0% 8.9% 4.3% 11.4% FRISC II 4.0% 5.3% TACTICS VINO 4.8% 14.8% RITA 3 7.4% 10.9% OR 0.82, P=0.001 TOTAL 7.4% 11.0% 0.2 0.5 1 2 5 Mehta SR et al. JAMA 2005;293:2908-17 Favors Conservative Favors Invasive

  16. Invasive Management of UA/NSTEMI Meta-analysis: Subgroups Death or MI at Followup Trial Inv (%) Cons (%) Odds Ratio P value Overall 12.2 14.4 0.82 0.001 Trials < 1999* 19.3 19.6 0.99 0.92 Trials > 1999† 9.4 12.4 0.73 0.0001 0.69 0.001 Troponin +ve 10.0 14.0 0.89 0.42 Troponin –ve 6.7 7.4 Any Marker +ve 14.7 17.4 0.82 0.012 Any Marker -ve 7.7 8.5 0.90 0.40 0.5 1 2 Favors Invasive Favors Conservative *TIMI 3B, VANQWISH and MATE † FRISC II, TACTICS, VINO, RITA 3 Data by troponin status available only in FRISC II, TACTICS, RITA 3 Mehta SR et al. JAMA 2005;293:2908-17

  17. FRISC-II Mortality at One-Year Invasive Vs. Conservative Management Strategies .04 Non-Invasive (n = 1235) .03 Probability of Death .02 Invasive (n = 1222) .01 Invasive Noninvasive RR (95 % CI) 2.2 % 4.0 % 0.56 (0.35 - 0.89) p = 0.018 0 0 30 90 180 360 Wallentin, Lancet 2000

  18. FRISC II: 5 Year Outcomes Lagerqvist B. World Congress of Cardiology 2006; September 4, 2006, Barcelona, Spain.

  19. FRISC II: 5 Year Outcomes Death or MI at 5 years in high-, medium-, and low-risk patients Lagerqvist B. World Congress of Cardiology 2006; September 4, 2006, Barcelona, Spain.

  20. Routine vs Selective InvasiveStrategies in ACS Composite of Death or Myocardial Infarction Favors Routine Invasive Favors Selective Invasive No./Total (%) Routine Invasive Selective Invasive Source TIMI IIIB 86/740 (11.6) 101/733 (13.8) VANQWISH 152/462 (32.9) 139/458 (30.3) MATE 16/111 (14.4) 11/90 (12.2) FRISC II 127/1222 (10.4) 174/1235 (14.1) TACTICS 81/1114 (7.3) 105/1106 (9.5) VINO 4/64 (6.3) 15/67 (22.4) RITA 3 95/895 (10.6) 118/915 (12.9) OR - 0.82 95% CI, 0.72-0.93 P < 0.001 Total 561/4608 (12.2) 663/4604 (14.4) 0.1 1.0 10 Odds Ratio (95% CI) Adapted from Mehta S, et al. JAMA. 2005;293;2908-2917.

  21. TIMI 3B 2.2 1.9 VANQWISH 4.5 1.3 MATE 0.9 3.3 FRISC II 1.1 0.9 TACTICS 1.4 0.7 VINO 1.6 4.5 RITA 3 1.6 0.7 Subtotal 1.8 1.1 TIMI 3B 2.8 3.3 VANQWISH 13.4 11.7 MATE 10.0 6.9 FRISC II 1.2 3.0 TACTICS 1.9 2.8 VINO 1.6 9.4 RITA 3 5.2 7.3 Subtotal 3.8 4.9 Invasive Rx in ACS: Early and Late Mortality Study Inv (%) Cons (%) Odds Ratio, 95% CI Mortality during hospitalization OR 1.60, P=0.007 Mortality after discharge OR 0.76, P=0.01 0.1 0.2 0.5 1 2 5 10 Mehta SR et al. JAMA 2005;293:2908-17 Favors Selective Favors Routine

  22. CRUSADE: Invasive Cardiac Procedures in the US Procedures Performed (non-transfer) Diagnostic Cath 64 %—Within 48 hours 41 % —Within 24 hours 27 % Percutaneous Intervention 35 %—Within 48 hours 25 % Coronary Bypass Grafting 11 %

  23. TIMACS Tim ing of Intervention in patients with A cute C oronary S yndromes An International Randomized Trial of Early Versus Delayed Invasive Strategies in Patients with Non-ST Segment Elevation Acute Coronary Syndromes FUNDED BY THE CANADIAN INSTITUTES OF HEALTH RESEARCH Grant #150904

  24. Study Objective To determine whether early intervention is superior to delayed intervention in patients with high risk non-ST segment elevation acute coronary syndrome

  25. Design, Eligibility Criteria and Protocol UA or NSTEMI 2 of 3 Criteria: Age > 60, ischemic EKG Δ or ↑ biomarker AND suitable for revascularization Excluded Contraindication for LMWH or high risk of bleeding or not a suitable candidate for revascularization ASA, clopidogrel, GP IIb/IIIa antagonist as per routine practice RANDOMIZE* *Center chose randomization ratio 1:1, 1:2 or 2:1 Early: Delayed Early Invasive Coronary angiography as soon as possible (no later than 24 hours) followed by PCI or CABG Delayed Invasive Coronary angiography any time >36 hrs followed by PCI or CABG Follow-up at 30 days and 6 months

  26. Outcomes Primary Composite of Death, new MI or Stroke at 6 mo. Secondary Composite of: Death, new MI or refractory ischemia Death, new MI, stroke, refractory ischemia or repeat revascularization Stroke

  27. Study Flow Chart TIMACS OASIS 5 N=1,633 TIMACS Stand Alone N=1,398 + TIMACS Total N=3,031 30 Day and 6 month Follow-up 3,029 Lost to Follow-up: 4

  28. Recommended Medical Treatment ASA, clopidogrel GP IIb/IIIa inhibitor at discretion of attending physician (especially if pt is not on a thienopyridine) Antithrombin: OASIS 5: Either fondaparinux or enoxaparin TIMACS stand alone: UFH or LMWH or fondaparinux or bivalirudin (investigator discretion) Beta blocker Statin

  29. Participating Countries Europe 1065 North America 650 Asia 846 South America 442 Australia 28

  30. TIMACS Steering Committee

  31. Study Organization Coordinating Center: PHRI, McMaster University S. Mehta, S. Yusuf, S. Jolly, C. Horsman, S. Chrolavicius, B. Meeks DSMB: P. Sleight (chair), J. Anderson, D. DeMets, D. Johnstone, D. Holmes Adjudication Committee Chair: C. Joyner Coordinator: M. Lawrence

  32. Criteria for Crossover from Delayed Group to Early Group Refractory ischemia New MI Hemodynamic instability Crossover from Early to Delayed: 11.9% Crossover from Delayed to Early: 25%

  33. Interventions and Timing Iqr=interquartile range

  34. Baseline Characteristics

  35. In-Hospital Medications

  36. Primary and Secondary Outcomes *At 30 days: 5.9 vs 4.2%, HR 1.39, 95% CI 1.00-1.95, P=0.047

  37. Primary OutcomeDeath, MI, or Stroke Death/MI/Stroke at 180 days Delayed Early 0.10 Cumulative Hazard 0.06 HR 0.85 95% CI 0.68-1.06 P= 0.15 0.02 0.0 0 30 60 90 120 150 180 Days No. at Risk Delayed 1438 1328 1269 1254 1234 1229 1211 Early 1593 1484 1413 1398 1391 1382 1363

  38. Secondary OutcomeDeath, MI, or refractory ischemia Death/MI/RI at 180 days Delayed 0.12 Early 0.08 Cumulative Hazard 0.04 0.0 0 30 60 90 120 150 180 Days No. at Risk Delayed 1438 1303 1243 1230 1209 1205 1187 Early 1593 1485 1417 1402 1394 1386 1366 HR 0.72 95% CI 0.58-0.79 P=0.002

  39. Secondary OutcomeDeath, MI, stroke, RFI or Rep Intervention Delayed 0.20 Early 0.15 Cumulative Hazard 0.10 0.05 0.0 0 30 60 90 120 150 180 Days No. at Risk Delayed 1438 1250 1166 1150 1128 1118 1097 Early 1593 1400 1321 1304 1287 1276 1256 Death/MI/RI/Stroke/Rep Int at 180 days HR 0.84 95% CI 0.71-0.99 P=0.039

  40. Safety Outcomes

  41. Pre-specified Subgroups Characteristic N Early % Delayed % HR (95% CI) Interaction p-Value Overall 3031 9.7 11.4 0.85 ( 0.68 - 1.06 ) Age < 65 1293 6.5 6.5 0.98 ( 0.64 - 1.52 ) >=65 1736 12.3 14.8 0.83 ( 0.64 - 1.07 ) 0.463 Female 1052 9.7 12.3 0.77 ( 0.54 - 1.12 ) Male 1976 9.8 10.9 0.89 ( 0.68 - 1.18 ) 0.540 No ST deviation 1523 7.6 8.7 0.88 ( 0.62 - 1.26 ) ST deviation 1508 11.7 14.3 0.81 ( 0.61 - 1.07 ) 0.722 No elevated marker 668 10.5 10.5 1.00 ( 0.62 - 1.60 ) Elevated Marker 2363 9.5 11.7 0.81 ( 0.63 - 1.04 ) 0.423 GRACE 0-140 2070 7.7 6.7 1.14 ( 0.82 - 1.58 ) GRACE >=141 961 14.1 21.6 0.65 ( 0.48 - 0.88 ) 0.0097 0.33 0.5 0.7 1.00 1.5 2.0 3.0 Early better Delayed better Hazard Ratio (95% CI)

  42. GRACE Risk Score: Primary Outcome HR 0.65 95% CI 0.48-0.88 P=0.005 Death, MI or Stroke at 6 mo. Interaction P=0.0097 HR 1.14 95% CI 0.82-1.58 P=0.43 Low/Int Risk GRACE Score < 140 N=2070 High Risk GRACE Score >= 140 N=961

  43. Conclusions Overall, we found no significant difference between an early and a delayed invasive strategy for prevention of death, MI or stroke (primary outcome). However, in the subgroup at highest risk (GRACE score > 140), an early invasive strategy was superior to a delayed invasive strategy for prevention of death, MI or stroke The early invasive strategy also had a large impact on reducing the rate of refractory ischemia by 70%. There were no significant differences in major bleeding or other safety concerns between the two strategies

  44. Implications Most patients with ACS can be managed safely with either an early or a delayed invasive strategy In a subset of patients at highest risk (GRACE score>140), early intervention is superior and these patients should be taken to the cath lab as early as possible In all other patients, the decision regarding timing of intervention can depend on other factors, such as cath lab availability and economic considerations.

  45. TIMACSAn International Randomized Trial of Early Versus Delayed Invasive Strategies in Patients with Non-ST Segment Elevation Acute Coronary Syndromes 对比非ST段抬高的急性冠状动脉综合征患者早期与延迟干预治疗的 国际随机研究—中国亚组

  46. TIMACSAn International Randomized Trial of Early Versus Delayed Invasive Strategies in Patients with Non-ST Segment Elevation Acute Coronary Syndromes 共有815名患者入选本研究 早期介入组 446名，随访率98.4% 延迟介入组 369名，随访率98.8% 临床基线、合并用药及冠造结果两组无统计学差异 冠造的平均时间 早期介入组18.4小时 延迟介入组72.6小时

  47. TIMACSAn International Randomized Trial of Early Versus Delayed Invasive Strategies in Patients with Non-ST Segment Elevation Acute Coronary Syndromes 180天随访主要终点事件（死亡、心梗、卒中） 早期介入组 9.0% 延迟介入组 14.6% （P=0.01） - 死亡 早期介入组 3.6% 延迟介入组 3.3% （P=0.79） - 心梗 早期介入组 5.2% 延迟介入组 10.8% （P=0.002） - 卒中 早期介入组 0.2% 延迟介入组 0.5% （P=0.87）

  48. TIMACSAn International Randomized Trial of Early Versus Delayed Invasive Strategies in Patients with Non-ST Segment Elevation Acute Coronary Syndromes 180天随访次要终点事件 死亡、心梗、难治性心肌缺血 早期介入组 14.6% 延迟介入组 22.0% （P=0.01） 死亡、心梗、卒中、难治性心肌缺血、再次血运重建 早期介入组 26.7% 延迟介入组 30.4% （P=0.25）

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