Ahmed Shaheeda, Antman Elliott M, Murphy Sabina A, Giugliano Robert P, Cannon Christopher P, White Harvey, Morrow David A, Braunwald Eugene
TIMI Study Group, Cardiovascular Division, Brigham & Women's Hospital and the Department of Medicine, Harvard Medical School, USA.
J Thromb Thrombolysis. 2006 Apr;21(2):119-29. doi: 10.1007/s11239-006-5485-9.
Fibrinolysis for ST-segment elevation myocardial infarction (STEMI) reduces mortality, but its relative efficacy and risks are age-dependent. We aimed to quantify the outcomes of fibrinolysis and adjunctive antithrombin therapy for STEMI stratified by age.
We performed a meta-analysis of 11 published (1992-2001) randomized clinical trials of fibrinolysis in STEMI (sample size >or=3,000, no age limit, no placebo-controlled arms) identified by MEDLINE through June 2005. Event rates and odds ratios (OR) in elderly vs. younger patients were calculated for mortality, intracranial hemorrhage (ICH) and total stroke (CVA). Elderly patients were defined as >or=75 years (GUSTO I, TIMI 9B, GUSTO III, COBALT, ASSENT-2, InTIME-II TIMI-17, ASSENT-3, GUSTO V, and HERO-2), except when defined as >65 or >or=70 years by the study (INJECT and ISIS-3).
Elderly (n = 24,531) vs. younger (n = 123,568) patients had increased rates of mortality (19.7% vs. 5.5%), ICH (1.4% vs. 0.5%) and CVA (3.5 vs. 1.2%) by 30-35 days; the excess risk for these events was substantial (OR mortality 4.37, 95% CI 4.16-4.58; ICH 2.83, 2.47-3.24; CVA 2.92, 2.62-3.25; p < 0.001 for all).
Despite established mortality reductions with fibrinolysis for STEMI, elderly compared with younger patients, still have a three to four fold increased risk of mortality and adverse events when treated with fibrinolysis and antithrombin therapy in the modern era. These robust estimates of the anticipated rates for mortality, ICH, and CVA can be used as benchmarks to monitor the efficacy and safety of therapies in ongoing and newly completed clinical trials. We aimed to quantify the outcomes of death, intracranial hemorrhage (ICH), and total cerebrovascular accidents (CVA) in elderly compared with younger patients treated with fibrinolysis for STEMI based on a meta-analysis of 11 randomized clinical trials (1992-2001) of more than 3,000 patients. Elderly (n = 24,531) vs. younger (n = 123 568) patients had increased rates of mortality, ICH and CVA by 30-35 days; the excess risk was substantial (OR 4.37, 2.83, and 2.92 respectively, p < 0.001 for all). These robust estimates can be used as benchmarks to monitor the efficacy and safety of therapies in ongoing and newly completed clinical trials.
ST 段抬高型心肌梗死（STEMI）的纤溶治疗可降低死亡率，但其相对疗效和风险存在年龄依赖性。我们旨在量化按年龄分层的 STEMI 纤溶治疗及辅助抗凝血酶治疗的结果。
我们对 2005 年 6 月前通过 MEDLINE 检索到的 11 项已发表（1992 - 2001 年）的关于 STEMI 纤溶治疗的随机临床试验进行了荟萃分析（样本量≥3000，无年龄限制，无安慰剂对照组）。计算老年患者与年轻患者在死亡率、颅内出血（ICH）和全脑卒（CVA）方面的事件发生率及比值比（OR）。除研究（INJECT 和 ISIS - 3）定义为年龄>65 岁或≥70 岁外，老年患者定义为年龄≥75 岁（GUSTO I、TIMI 9B、GUSTO III、COBALT、ASSENT - 2、InTIME - II TIMI - 17、ASSENT - 3、GUSTO V 和 HERO - 2）。
到 30 - 35 天时，老年患者（n = 24531）与年轻患者（n = 123568）相比，死亡率（19.7%对 5.5%）、ICH（1.4%对 0.5%）和 CVA（3.5 对 1.2%）发生率升高；这些事件的额外风险很大（OR 死亡率 4.37，95%CI 4.16 - 4.58；ICH 2.83，2.47 - 3.24；CVA 2.92，2.62 - 3.25；所有 p < 0.001）。
尽管 STEMI 纤溶治疗已证实可降低死亡率，但在现代，老年患者与年轻患者相比，接受纤溶治疗和抗凝血酶治疗时，死亡率及不良事件风险仍高出三到四倍。这些对死亡率、ICH 和 CVA 预期发生率的可靠估计可作为基准，用于监测正在进行和新完成的临床试验中治疗方法的疗效和安全性。我们旨在基于对 11 项超过 3000 例患者参与的随机临床试验（1992 - 2001 年）的荟萃分析，量化老年 STEMI 患者与年轻患者接受纤溶治疗后的死亡、颅内出血（ICH）和全脑血管意外（CVA）结果。老年患者（n = 24531）与年轻患者（n = 123568）到 30 - 35 天时死亡率、ICH 和 CVA 发生率升高；额外风险很大（OR 分别为 4.37、2.83 和 2.92，所有 p < 0.001）。这些可靠估计可作为基准，用于监测正在进行和新完成的临床试验中治疗方法的疗效和安全性。
