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国际医学与有创治疗比较健康效果研究的临床意义与争议

Clinical Implications and Debates on the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches Trial.

机构信息

From the Department of Cardiovascular Medicine, Chiba University Graduate School of Medicine, Chiba, Japan.

Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan.

出版信息

Cardiol Rev. 2022;30(5):234-240. doi: 10.1097/CRD.0000000000000389. Epub 2021 Mar 19.

Abstract

The International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) was eagerly awaited study in the field of ischemic heart disease. Following the presentation and publication of ISCHEMIA, multiple opinions and viewpoints get complicated. The ongoing debates have been including the relevance of coronary revascularization, noninvasive diagnostic methods, and invasive ischemic testing in patients with stable ischemic heart disease (SIHD). Prior to ISCHEMIA, observational studies indicated the potential of coronary revascularization for improving clinical outcomes, while the randomized Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial did not support the plausible concept. Although the Fractional Flow Reserve Versus Angiography for Multivessel Evaluation (FAME) 2 trial implied the superiority of percutaneous coronary intervention over medical therapy alone, the clinical relevance of coronary revascularization to improve outcomes and quality of life has been questioned. As a consequence, the ISCHEMIA trial did not demonstrate clear benefits in reducing clinical events but showed antianginal effects of revascularization. This landmark trial also suggested the difficulties of noninvasive ischemia testing rather than computed tomography angiography. Despite the complex results, the ISCHEMIA trial may simplify the clinical indications of coronary revascularization in patients with SIHD. Future publications from the ISCHEMIA trial and debates on the results will sharpen our thinking and understanding.

摘要

国际比较医学疗效与有创治疗缺血性心脏病研究(ISCHEMIA)是缺血性心脏病领域备受期待的研究。ISCHEMIA 公布后,出现了多种观点和看法,使相关争论变得更加复杂。目前的争论包括在稳定性缺血性心脏病(SIHD)患者中进行血运重建、非侵入性诊断方法和有创缺血性检查的相关性。在 ISCHEMIA 研究之前,观察性研究表明血运重建有可能改善临床结局,而随机临床结局利用血运重建和强化药物评估(COURAGE)试验并不支持这一合理的概念。尽管血流储备分数与血管造影多血管评估(FAME)2 试验表明经皮冠状动脉介入治疗优于单纯药物治疗,但血运重建改善结局和生活质量的临床相关性一直受到质疑。因此,ISCHEMIA 试验并未显示出在减少临床事件方面的明显益处,但显示了血运重建的抗心绞痛作用。这项具有里程碑意义的试验还表明,无创性缺血检查而非计算机断层血管造影存在困难。尽管结果复杂,但 ISCHEMIA 试验可能简化了 SIHD 患者血运重建的临床适应证。来自 ISCHEMIA 试验的未来出版物和对结果的辩论将使我们的思维和理解更加敏锐。

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