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吴永健 中国医学科学院 北京协和医学院 心血管病研究所 阜外心血管医院

糖尿病患者多支血管病变的处理 - 介入治疗还是搭桥手术？. Randomized Comparison of Percutaneous Coronary Intervention With Coronary Artery Bypass Grafting in Diabetic Patients. 吴永健 中国医学科学院 北京协和医学院 心血管病研究所 阜外心血管医院. J Am Coll Cardiol 2010;55:432–40. 研 究 背 景. 糖尿病 9240000 前期 148200000. 26.5 32.9 24%. 14.2

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吴永健 中国医学科学院 北京协和医学院 心血管病研究所 阜外心血管医院

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  1. 糖尿病患者多支血管病变的处理 -介入治疗还是搭桥手术？ Randomized Comparison of Percutaneous Coronary Intervention With Coronary Artery Bypass Grafting in Diabetic Patients 吴永健 中国医学科学院 北京协和医学院 心血管病研究所 阜外心血管医院

  2. J Am CollCardiol 2010;55:432–40

  3. 研 究 背 景 糖尿病9240000 前期148200000 26.5 32.9 24% 14.2 17.5 23% 15.6 22.5 44% World 2000, 151 million 2010, 221 million 15.6 22.5 44% 1.0 1.3 33% N Engl J Med. 2010 Mar 25;362(12):1090-101

  4. 研 究 背 景 Eur Heart J,2006,27(21):2573-2579

  5. 研 究 背 景 Among patients with treated diabetes, CABG conferred long term survival benefit, whereas the 2 initial trategies were equivalent regarding survival for patients without diabetes. J Am Coll Cardiol 2007;49:1600–6

  6. 研 究 背 景 Lancet. 2009 Apr 4;373(9670):1190-7

  7. 研 究 背 景

  8. 研 究 背 景

  9. 研 究 背 景

  10. 缺乏临床随机对照研究-对比PCI和CABG治疗糖尿病多支病变缺乏临床随机对照研究-对比PCI和CABG治疗糖尿病多支病变

  11. 69% DES Cypher 研究方法 Operators in both treatment arms were encouraged to perform as complete a revascularization as possible. Contemporary techniques, such as arterial revascularization and off-pump procedures, were encouraged in patients randomized to CABG. The PCI strategy included the unrestricted use of stents and routine administration of abciximab.

  12. 研究方法 Sample size estimate. CABG has historically been assumed to be superior to PCI in patients with diabetes and multivessel disease. The sample size was calculated at 600 patients, based on event rates in the ARTS (Arterial Revascularization Therapy Study) , as well as the ability to enroll this number over approximately 3 years. We used an exploratory noninferiority design model. The most favorable assumption was that the composite of death, MI, and stroke would occur at a rate of 9.0% in the PCI arm and at 12.5% in the surgical arm, suggesting that an odds ratio of 0.69 in favor of PCI (with upper CI boundary of 1.3) would allow us to declare PCI as noninferior

  13. 研究结果

  14. 研究结果

  15. 研究结果 When the patients who underwent CABG were compared with the subset of patients who received drug-eluting stents (69% of patients), the primary outcome rates were 12.4% and 11.6% (HR: 0.93, 95% CI: 0.51 to 1.71; p 0.82), respectively

  16. 研 究 讨论 DES和CABG治疗糖尿病患者多支病变均是安全的 死亡/心肌梗死/中风 13.0% vs. 10.5%, HR 1.25 (0.75–2.09) p=0.393 DES组血运重建率显著高于CABG组, 30% vs. 5% HR 6.18 (2.40–15.94) P<0.001 CABG组脑中风和出血发生率高于DES组 脑中风， 2.8% vs. 0.4%, HR 0.14 (0.02–1.14) P=0.066 TIMI出血，6.1% vs. 1.2%, HR 0.19 (0.06–0.67) P=0.009

  17. 研 究 讨论 J Am Coll Cardiol. 2010, 16;55(11):1067-75

  18. 研 究 讨论 PCI 1761 例 vs. CABG 908例

  19. 研究讨论 PCI组心脏病事件的发生率超出预计，达13%，高于CABG组 —病变复杂程度提高 ARTS 3.0 53mm SYNTAX 4.6 86mm CARDia 3.6 71mm

  20. 研 究 讨论 N Engl J Med 2009;360:2503-15

  21. 研 究 讨论 Am Heart J 2008;155:215–23

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