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从 TIMACS 研究结果再议 NSTEACS 介入时机

从 TIMACS 研究结果再议 NSTEACS 介入时机. 福建医科大学附属协和医院心内科 福建省冠心病研究所 陈良龙 MD PhD FACC. NSTE-ACS ： Pathogenesis. Vulnerable Plague Not totally occlusive thrombosis White thrombus. Yeghiazarians Y, et al. N Engl J Med. 2000;342:101-114. 背景. 早期 尽早造影，明确病变，对后续治疗策略有指导意义； 减少等待期间不良事件的发生 [1] ； 缩短住院时间。

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从 TIMACS 研究结果再议 NSTEACS 介入时机

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  1. 从TIMACS研究结果再议NSTEACS介入时机 福建医科大学附属协和医院心内科 福建省冠心病研究所 陈良龙 MD PhD FACC

  2. NSTE-ACS：Pathogenesis • Vulnerable Plague • Not totally occlusive thrombosis • White thrombus Yeghiazarians Y, et al. N Engl J Med. 2000;342:101-114.

  3. 背景 • 早期 • 尽早造影，明确病变，对后续治疗策略有指导意义； • 减少等待期间不良事件的发生[1]； • 缩短住院时间。 • 延迟 • 在积极抗血小板、抗凝、稳定斑块等治疗基础上，介入治疗并发症少，安全系数更高 [2]; • 等待期间可能发生不良事件乃至死亡; • 延长住院时间/增加费用。 1.Neumann FJ, et al JAMA 2003;290:1593–9. 2.Smith SC et al. Circulation 2001;103:3019–41.

  4. 目前指南I类推荐指征 • UA/NSTEMI 患者,若有下列情况应早期介入 • 具有任何高危因素 • 病变适合PCI • 无影响PCI的严重合并症

  5. 问题与焦点 • 介入治疗的最佳时机尚不确定 • 早期：多早？ • 延迟：多长？ • 哪些患者需要尽早治疗？要多早？ • 目前的RCT研究结果不一致[1,2]。 1.Neumann FJ, et al JAMA 2003;290:1593–9. 2. Riezebos RK, et al. Heart 2009;95:807-12.

  6. Timing of Intervention in Patients with Acute Coronary Syndromes(TIMACS)

  7. Trial schema: TIMACS

  8. Endpoint • Primary endpoint • composite of death, MI, stroke at 6 m. • Secondary endpoints • composite of death, MI, refractory ischemia at 6m. • composite of death, MI, stroke, refractory ischemia, repeat revascularization at 6m.

  9. Primary and secondary outcomes in TIMACS, early vs delayed strategies *Primary end point Mehta SR, et al. N Engl J Med 2009;360:2165-75.

  10. Results: Primary endpoint

  11. Results: Second endpoint

  12. Rates of death, MI, or stroke within six months according to GRACE score *Low/intermediate risk=GRACE score <140 High risk=GRACE score >140 *Prespecified analysis

  13. Kaplan–Meier Cumulative Risk of the Primary Outcome Stratified According to GRACE Risk Score High risk >140 Low-to- intermediate risk ≤140 High risk:>140; Low-to-intermediate risk: ≤140.（GRACE Risk Score）

  14. Conclusion • 与延迟干预相比，早期干预对于NSTE-ACS患者6个月不良事件发生率没有显著差异; • NSTE-ACS患者接受早期干预安全性良好; • 高危患者（GRACE评分＞140）可从早期干预策略获益； • 早期干预可显著减少NSTE-ACS患者再发心绞痛的发生率，且不增加出血风险；

  15. 其他随机临床试验 • ABOARD • ISAR-COOL • OPTIMA

  16. Trial Flow: ABOARD Primary endpoint Peak troponin value during hospitalization Second endpoint Death, MI, urgent revascularization, or recurrent ischemia at 1m Montalescot G, et al. JAMA 2009;302:947-54.

  17. ABOARD研究结果 Montalescot G, et al. JAMA 2009;302:947-54.

  18. 结论 • 对于NSTE-ACS患者, 即刻（1小时）与延迟（次工作日）介入治疗策略比较 • 不能减少肌钙蛋白定义的MI • 不能减少1个月时的死亡、MI、紧急血运重建或 复发心肌缺血 Montalescot G, et al. JAMA 2009;302:947-54.

  19. Trial schema: ISAR-COOL Endpoint: death, MI at 30d

  20. ISAR-COOL研究结果 • This outcome was attributable to events occurring before catheterization; • after catheterization, both groups incurred 11 events each (P=.92). Neumann FJ, et al JAMA 2003;290:1593–9.

  21. 结论 • 对于不稳定ACS患者, 与早期介入治疗+强化抗血小板比较， • 延迟介入治疗+延长抗栓治疗并不能改善临床结局（死亡、MI）， • 相反地，后者在等待期增加了约50%的事件。 Montalescot G, et al. JAMA 2009;302:947-54.

  22. Trial schema: OPTIMA Endpoint: death, MI, at 30d and 6m Riezebos RK, et al. Heart 2009;95:807-12.

  23. OPTIMA研究结果* • *No deaths occurred in either group Riezebos RK, et al. Heart 2009;95:807-12.

  24. 结论 • 对于NSTE-ACS患者，与延迟介入治疗（24-48H）比较： • 尽管有强化的抗栓治疗，早期介入治疗（24H）还是增加MI • 对于非顽固NSTE-ACS患者，介入治疗至少应延迟至入院后24H进行 Montalescot G, et al. JAMA 2009;302:947-54.

  25. 4 RCTs总结 • For Pts with high risk, • too early or too late intervention is harmful. • 24 h may be the proper time window in setting of intensive antithrombotic therapy

  26. The Answers • 多早？ • 在有效抗栓基础上， • 约在入院后24H,是早期PCI的最佳窗口 • 哪些患者早做？ • 高危者(包括血流动力学不稳定\恶性心律失常) • 无禁忌者

  27. Fighting CVD U U 感 谢！

  28. Reconsideration of Interventional Therapeutic Time Window for NSTE-ACS——Hint from the Result of TIMACS Chen Lianglong MD, PhD, FACC Cardiology, Union Hospital, Fujian Medical University

  29. NSTE-ACS：Pathogenesis • Vulnerable Plague • Not totally occlusive thrombosis • White thrombus Yeghiazarians Y, et al. N Engl J Med. 2000;342:101-114.

  30. Background • Early intervention might prevent ischemic events that could occur while the pts are awaiting a delayed procedure. • Alternatively, by treating pts with intensive antithrombotic therapy and delaying intervention for several days, procedure-related complications might be avoided with intervention on a more stable plaque.

  31. Current CLASS-I recommendations • An early invasive strategy is indicated for pts with UA/NSTEMI • who have any of the high-risk features & • who have coronary lesions amenable to PCI & • who have no serious comorbidities.

  32. Uncertain • the optimal timing of such intervention remains controversial. • Early strategy: how early • delayed strategy: how prolonged

  33. Timing of Intervention in Patients with Acute Coronary Syndromes (TIMACS)

  34. Trial schema: TIMACS

  35. Endpoint • Primary endpoint • composite of death, MI, stroke at 6 m. • Secondary endpoints • composite of death, MI, refractory ischemia at 6m. • composite of death, MI, stroke, refractory ischemia, repeat revascularization at 6m.

  36. Primary and secondary outcomes in TIMACS, early vs delayed strategies *Primary end point Mehta SR, et al. N Engl J Med 2009;360:2165-75.

  37. Results: Primary endpoint

  38. Results: Second endpoint

  39. Rates of death, MI, or stroke within six months according to GRACE score *Low/intermediate risk=GRACE score <140 High risk=GRACE score >140

  40. Kaplan–Meier Cumulative Risk of the Primary Outcome Stratified According to GRACE Risk Score High risk >140 Low-to- intermediate risk ≤140 High risk:>140; Low-to-intermediate risk: ≤140.（GRACE Risk Score）

  41. Conclusions • Early intervention did not differ greatly from delayed intervention in preventing the primary outcome． • but it did reduce the rate of the composite secondary outcome of death, myocardial infarction, or refractory ischemia • and was superior to delayed intervention in high-risk patients.

  42. Other RCTs • ABOARD • ISAR-COOL • OPTIMA

  43. Trial Flow: ABOARD Primary endpoint Peak troponin value during hospitalization Second endpoint Death, MI, urgent revascularization, or recurrent ischemia at 1m Montalescot G, et al. JAMA 2009;302:947-54.

  44. ABOARD-Results Montalescot G, et al. JAMA 2009;302:947-54.

  45. Conclusion • In pts with NSTE-ACS, a strategy of immediate intervention compared with a strategy of intervention deferred to the next working day (mean,21h) did not result in a difference in MI as defined by peak troponin level. Montalescot G, et al. JAMA 2009;302:947-54.

  46. Trial schema: ISAR-COOL Endpoint: death, MI at 30d

  47. ISAR-COOL:Results • This outcome was attributable to events occurring before catheterization; • after catheterization, both groups incurred 11 events each (P=.92). Neumann FJ, et al JAMA 2003;290:1593–9.

  48. Conclusion • In pts with unstable coronary syndromes, deferred intervention for prolonged antithrombotic pretreatment does not improve the outcome compared with immediate（early） intervention accompanied by intense antiplatelet treatment.

  49. Trial schema: OPTIMA Endpoint: death, MI, at 30d and 6m Riezebos RK, et al. Heart 2009;95:807-12.

  50. OPTIMA: Results* • *No deaths occurred in either group Riezebos RK, et al. Heart 2009;95:807-12.

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