旁路血管成形术血运重建研究 (BARI)
研究概览
详细说明
背景:
在过去的二十年中,随着侵入性技术在越来越多的患者中的应用,对有症状的冠心病患者的管理有了很大的发展。
随着过去 20 年 CABG 手术的改进,对于大多数心肌缺血患者,手术心肌血运重建是可行的。 已经报道了几项多中心随机试验,比较了冠状动脉疾病患者的药物治疗和手术治疗。 基于三项最大的试验和广泛的观察性文献,关于在何种情况下药物或手术治疗似乎是首选方法似乎正在形成共识。
很明显,CABG 可以缓解绝大多数症状严重的患者的心绞痛。 同样明显的是,经验丰富的手术团队可以以非常低的风险执行该程序。 因此,CABG 适用于冠状动脉解剖结构合适、药物治疗无效的严重心绞痛患者以及冠状动脉左主干明显阻塞的患者。
对不太严重的心绞痛患者进行手术干预的时机是目前存在争议的一个问题。 然而,很明显,某些类别的患者在选择性搭桥手术后的生存率有所提高。 这些类别包括左主干冠状动脉狭窄、心室功能轻度受损的三重血管疾病患者,以及可能的其他临床定义的高危患者。 其余患有轻度、有症状的冠状动脉疾病的患者似乎可以负担得起推迟手术干预,直到症状恶化并需要姑息治疗。
一些在 1970 年代初期接受过 CABG 手术的患者的长期信息是可用的。 十年后,自体冠状动脉循环和旁路移植物中都出现了实质性的疾病进展。 调查人员报告说,多达三分之二的静脉旁路移植物闭合或变窄,并且在手术后 10 年内,多达二分之一的未旁路血管发生内在冠状动脉疾病。 症状较轻的患者的手术时机、减少移植血管和自然循环疾病进展的策略以及对使用乳内动脉对心脏进行血运重建的新兴趣是目前非常活跃的研究问题。
PTCA于1977年首次应用于人类冠心病。 在导管设计、球囊构造以及识别该手术的高危和低危患者方面取得了重大进展。 经验丰富的血管成形术团队现在可以在超过 90% 的尝试患者中成功扩张严重病变。 这一成功率可以在低于 1% 的手术死亡率和低于 5% 的心肌梗塞和/或急诊冠状动脉搭桥手术的情况下实现。 然而,多达三分之一的成功扩张患者将在接下来的六个月到一年内再次出现心绞痛,这反映了扩张病变的再狭窄。 这些人中的大多数可以成功地进行第二次扩张。
因此,有两种非常有效的干预措施可用于症状性冠状动脉疾病患者,这些患者需要通过一些机械手段进行姑息治疗。 每个人都有长处和短处。 PTCA 相对无创,最初需要较少的住院天数和较少的重症监护,并且保留静脉和纵隔用于 CABG(如果以后需要)。 然而,并非多支血管病变患者的所有病变都能扩张。 存在再狭窄和症状复发的重大风险,以及在 PTCA 失败后必须立即进行 CABG 手术的小但有限的风险,这大大增加了手术的风险。 CABG 手术导致更完全的血运重建和相对较低的短期移植物闭合,并且可以在大约等于 PTCA 的急性风险下完成。 然而,很明显,手术干预并不能改变患者患动脉粥样硬化的倾向;十年来,三分之二的移植物已因动脉粥样硬化或血栓形成而受到损害,并且在大约一半的患者中,天然的、未旁路的冠状动脉循环中出现了动脉粥样硬化的进展。 二次手术在技术上要困难得多,手术风险更高,症状缓解效果也更差。 有大量患有严重的、有症状的多支冠状动脉疾病的患者,他们不清楚应该首先应用 PTCA 还是 CABG。
1984 年 9 月,冠状动脉旁路移植手术研讨会建议考虑进行涉及手术和血管成形术的临床试验。 1985 年 1 月成立的 NHLBI 工作组建议该研究所考虑进行多支冠状动脉疾病的临床试验。 心脏病学咨询委员会一致推荐试验的设计和执行。 1985 年 9 月,国家心肺血液咨询委员会讨论了这项临床试验倡议,并热情推荐。
设计叙述:
因严重心绞痛或不稳定型心绞痛而在临床单位接受冠状动脉造影术的患者,有或没有既往心肌梗死,被要求参加该研究。 共有 2,013 名拒绝随机化的符合条件的患者和 422 名根据血管造影结果不符合条件的患者被要求参加随访登记。 其余患者随后在 1988 年 8 月至 1991 年 8 月期间被随机分配,914 人接受 CABG,915 人接受 PTCA。 基线数据包括临床资料、12 导联心电图以及有关冠状动脉造影特征、心绞痛和功能状态、药物、危险因素和生活质量的信息。 初始血运重建在随机分组后两周内进行。 血管造影(针对 1 年和 5 年的基线和子研究)和 ECG 由各自的核心实验室解释。 预定的 PTCA 多个阶段被计为一个程序。 在最初的血运重建期间没有使用新的介入装置,例如支架。 在进入研究后第 4 周至第 14 周以及第 1、3 和 5 年时在诊所进行随访,并在 6 个月、2 年和 4 年时进行电话联系。 在整个研究过程中,患者及其主治医师都强调了风险因素修正的重要性。 主要终点是全因死亡率。
该试验已延长至 2002 年 11 月,以完成对所有 BARI 患者的至少 10 年随访,确定 PTCA 与 CABG 在女性、黑人、糖尿病患者和老年人亚组中的相对疗效,并评估 BARI 对公共健康的影响。 在后续行动中,所有目前入组的患者都将进行年度电话访谈。 十年后,将对所有患者进行心电图检查,仅对随机分组的患者进行血脂水平检查。 自上次联系以来发生的所有住院治疗都将在年度电话联系中确定。 将评估前六周的心绞痛。 在每次与患者接触时,将指导患者在戒烟、锻炼和饮食方面进行行为矫正。 血管造影研究也将作为十年随访的一部分进行。 参与这些 BARI 活动第一阶段的四个中心将再次进行血管造影。 患者将包括从完成一年和五年血管造影的随机参与者中抽取的既定队列。
BARI 的一项子研究,即经济和生活质量研究 (SEQOL),最初由罗伯特伍德约翰逊基金会资助,旨在评估特定血运重建对患者生活质量、功能和经济(医院和医生费用)结果的影响随机分配给 BARI,并检查影响这些结果的治疗以外的因素。 从 1997 年 7 月开始,NHLBI 在 R01HL58324 资助下承担了对 SEQOL 的支持。 该拨款于 2002 年 6 月结束,将随机化 SEQOL 子研究队列(截至 1996 年 5 月 1 日尚存的 752 名受试者)的随访期延长至 10 年,以研究成本和生活质量的长期决定因素,并开发一个模型来预测技术变化对 CABG 和 PTCA 的结果和成本的影响。
本记录中列出的研究完成日期是从协议注册和结果系统 (PRS) 记录中输入的“结束日期”获得的。
研究类型
阶段
- 第三阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:平行线
合作者和调查者
调查人员
- Katherine Detre、University of Pittsburgh
出版物和有用的链接
一般刊物
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- Vander Salm TJ, Kip KE, Jones RH, Schaff HV, Shemin RJ, Aldea GS, Detre KM. What constitutes optimal surgical revascularization? Answers from the Bypass Angioplasty Revascularization Investigation (BARI). J Am Coll Cardiol. 2002 Feb 20;39(4):565-72. doi: 10.1016/s0735-1097(01)01806-x.
- Gurm HS, Whitlow PL, Kip KE; BARI Investigators. The impact of body mass index on short- and long-term outcomes inpatients undergoing coronary revascularization. Insights from the bypass angioplasty revascularization investigation (BARI). J Am Coll Cardiol. 2002 Mar 6;39(5):834-40. doi: 10.1016/s0735-1097(02)01687-x.
- Kip KE, Alderman EL, Bourassa MG, Brooks MM, Schwartz L, Holmes DR Jr, Califf RM, Whitlow PL, Chaitman BR, Detre KM. Differential influence of diabetes mellitus on increased jeopardized myocardium after initial angioplasty or bypass surgery: bypass angioplasty revascularization investigation. Circulation. 2002 Apr 23;105(16):1914-20. doi: 10.1161/01.cir.0000014967.78190.bb.
- Szczech LA, Best PJ, Crowley E, Brooks MM, Berger PB, Bittner V, Gersh BJ, Jones R, Califf RM, Ting HH, Whitlow PJ, Detre KM, Holmes D; Bypass Angioplasty Revascularization Investigation (BARI) Investigators. Outcomes of patients with chronic renal insufficiency in the bypass angioplasty revascularization investigation. Circulation. 2002 May 14;105(19):2253-8. doi: 10.1161/01.cir.0000016051.33225.33.
- Srinivas VS, Brooks MM, Detre KM, King SB 3rd, Jacobs AK, Johnston J, Williams DO. Contemporary percutaneous coronary intervention versus balloon angioplasty for multivessel coronary artery disease: a comparison of the National Heart, Lung and Blood Institute Dynamic Registry and the Bypass Angioplasty Revascularization Investigation (BARI) study. Circulation. 2002 Sep 24;106(13):1627-33. doi: 10.1161/01.cir.0000031570.27023.79.
- Bittner V, Hardison R, Kelsey SF, Weiner BH, Jacobs AK, Sopko G; Bypass Angioplasty Revascularization Investigation. Non-high-density lipoprotein cholesterol levels predict five-year outcome in the Bypass Angioplasty Revascularization Investigation (BARI). Circulation. 2002 Nov 12;106(20):2537-42. doi: 10.1161/01.cir.0000038496.57570.06.
- Schwartz L, Kip KE, Frye RL, Alderman EL, Schaff HV, Detre KM; Bypass Angioplasty Revascularization Investigation. Coronary bypass graft patency in patients with diabetes in the Bypass Angioplasty Revascularization Investigation (BARI). Circulation. 2002 Nov 19;106(21):2652-8. doi: 10.1161/01.cir.0000038885.94771.43.
- Frye RL, Brooks MM, Nesto RW; Bypass Angioplasty Revascularization Investigation. Gap between clinical trials and clinical practice: lessons from the Bypass Angioplasty Revascularization Investigation (BARI). Circulation. 2003 Apr 15;107(14):1837-9. doi: 10.1161/01.CIR.0000066419.24566.28. No abstract available.
- Alderman EL, Kip KE, Whitlow PL, Bashore T, Fortin D, Bourassa MG, Lesperance J, Schwartz L, Stadius M; Bypass Angioplasty Revascularization Investigation. Native coronary disease progression exceeds failed revascularization as cause of angina after five years in the Bypass Angioplasty Revascularization Investigation (BARI). J Am Coll Cardiol. 2004 Aug 18;44(4):766-74. doi: 10.1016/j.jacc.2004.05.041.
- Hlatky MA, Boothroyd DB, Melsop KA, Brooks MM, Mark DB, Pitt B, Reeder GS, Rogers WJ, Ryan TJ, Whitlow PL, Wiens RD. Medical costs and quality of life 10 to 12 years after randomization to angioplasty or bypass surgery for multivessel coronary artery disease. Circulation. 2004 Oct 5;110(14):1960-6. doi: 10.1161/01.CIR.0000143379.26342.5C. Epub 2004 Sep 27.
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