Impact of ISCHEMIA Trial on Clinical Practice

H. Yamasaki
{"title":"Impact of ISCHEMIA Trial on Clinical Practice","authors":"H. Yamasaki","doi":"10.7793/jcad.26.001","DOIUrl":null,"url":null,"abstract":"ISCHEMIA (Initial Invasive or Conservative Strategy for Stable Coronary artery disease) trial was a large, international, multi center, prospective, randomized controlled clinical trial comparing initial invasive plus optimal medical therapy (OMT) strategy versus conservative management plus OMT strategy in stable coronary artery disease patients with moderate to severe ischemia. It is still too early to describe the overall impact of ISCHEMIA trial partly because the result is still in the process of slowly being digested in the cardiology and general communities, but also because COVID-19 pandemic has greatly altered recent cardiology practices in the US and worldwide. However, one thing is very likely. Based on the result of this trial, cardiologists will be asked more often to be cautious about indications for revascularization. A proof of ischemia alone cannot be justified for initial invasive strategy in a stable coronary artery disease patients who are optimally medically managed and asymptomatic or minimally symptomatic. In the early days of angioplasties, “Oculo-stenotic reflex” was frowned upon as a too premature attitude of angioplasty treatment for an anatomically significant coronary stenosis but otherwise unknown hemodynamic or clinical importance. After the ISCHEMIA trial, cardiologists may be asked to shy away from “Ischemia-invasive reflex” in the appropriate context in stable coronary artery disease patients who are optimally medically treated and asymptomatic or minimally symptomatic. According to the result of this trial, proof of significant ischemia is not a “ Carte Blanche ” for early invasive management strategy. On the other hand, this trial did show durable improvement of angina symptoms in the invasive arm compared to conservative arm, thus, as long as the goal of the management is clearly stated to reduce angina and to improve quality of life, early invasive strategy for stable coronary artery disease patients is justifiable in the post ISCHEMIA era. angiogram performed before randomization to exclude unpro-tected left main disease and non-obstructive coronary artery disease. Severe left ventricular systolic dysfunction with ejection fraction <35%, chronic kidney disease patients with GFR below 30 ml/min/1.73 m 2 , recent acute coronary syndrome patients, de-compensated heat failure, and unstable angina patients were also excluded.","PeriodicalId":73692,"journal":{"name":"Journal of coronary artery disease","volume":"1 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of coronary artery disease","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.7793/jcad.26.001","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
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Abstract

ISCHEMIA (Initial Invasive or Conservative Strategy for Stable Coronary artery disease) trial was a large, international, multi center, prospective, randomized controlled clinical trial comparing initial invasive plus optimal medical therapy (OMT) strategy versus conservative management plus OMT strategy in stable coronary artery disease patients with moderate to severe ischemia. It is still too early to describe the overall impact of ISCHEMIA trial partly because the result is still in the process of slowly being digested in the cardiology and general communities, but also because COVID-19 pandemic has greatly altered recent cardiology practices in the US and worldwide. However, one thing is very likely. Based on the result of this trial, cardiologists will be asked more often to be cautious about indications for revascularization. A proof of ischemia alone cannot be justified for initial invasive strategy in a stable coronary artery disease patients who are optimally medically managed and asymptomatic or minimally symptomatic. In the early days of angioplasties, “Oculo-stenotic reflex” was frowned upon as a too premature attitude of angioplasty treatment for an anatomically significant coronary stenosis but otherwise unknown hemodynamic or clinical importance. After the ISCHEMIA trial, cardiologists may be asked to shy away from “Ischemia-invasive reflex” in the appropriate context in stable coronary artery disease patients who are optimally medically treated and asymptomatic or minimally symptomatic. According to the result of this trial, proof of significant ischemia is not a “ Carte Blanche ” for early invasive management strategy. On the other hand, this trial did show durable improvement of angina symptoms in the invasive arm compared to conservative arm, thus, as long as the goal of the management is clearly stated to reduce angina and to improve quality of life, early invasive strategy for stable coronary artery disease patients is justifiable in the post ISCHEMIA era. angiogram performed before randomization to exclude unpro-tected left main disease and non-obstructive coronary artery disease. Severe left ventricular systolic dysfunction with ejection fraction <35%, chronic kidney disease patients with GFR below 30 ml/min/1.73 m 2 , recent acute coronary syndrome patients, de-compensated heat failure, and unstable angina patients were also excluded.
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缺血试验对临床实践的影响
缺血(Initial Invasive or Conservative Strategy for Stable冠心病)试验是一项大型、国际、多中心、前瞻性、随机对照临床试验,比较初始有创+最佳药物治疗(OMT)策略与保守治疗+ OMT策略对中度至重度缺血的稳定期冠心病患者的疗效。现在描述缺血试验的总体影响还为时过早,部分原因是结果仍处于心脏病学和普通社区缓慢消化的过程中,但也因为COVID-19大流行极大地改变了美国和全世界最近的心脏病学实践。然而,有一件事是很有可能的。根据这项试验的结果,心脏病专家将被要求更经常地对血运重建术的适应症保持谨慎。对于经最佳医学治疗且无症状或症状轻微的稳定冠状动脉疾病患者,仅凭缺血的证据不能作为初始侵入策略的理由。在血管成形术的早期,“眼狭窄反射”被认为是一种过早的血管成形术治疗态度,用于解剖上重要的冠状动脉狭窄,但其他方面血流动力学或临床重要性未知。在缺血试验后,心脏病学家可能会被要求在适当的情况下避免“缺血侵袭性反射”,这些患者是稳定的冠状动脉疾病患者,他们经过了最佳的药物治疗,无症状或症状最小。根据这项试验的结果,证明明显缺血并不是早期有创治疗策略的“全权委托”。另一方面,与保守组相比,该试验确实显示出有创组心绞痛症状的持续改善,因此,只要治疗的目标明确为减少心绞痛和提高生活质量,在缺血后时代,对稳定型冠状动脉疾病患者采取早期有创策略是合理的。随机分组前进行血管造影以排除无保护的左主干疾病和非阻塞性冠状动脉疾病。排除了射血分数<35%的严重左室收缩功能不全、GFR低于30 ml/min/1.73 m2的慢性肾病患者、近期急性冠状动脉综合征患者、失代偿性热衰竭患者和不稳定型心绞痛患者。
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