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Initial Invasive or Conservative Strategy for Stable Coronary Disease.
The New England Journal of Medicine ( IF 158.5 ) Pub Date : 2020-03-30 , DOI: 10.1056/nejmoa1915922
David J Maron 1 , Judith S Hochman 1 , Harmony R Reynolds 1 , Sripal Bangalore 1 , Sean M O'Brien 1 , William E Boden 1 , Bernard R Chaitman 1 , Roxy Senior 1 , Jose López-Sendón 1 , Karen P Alexander 1 , Renato D Lopes 1 , Leslee J Shaw 1 , Jeffrey S Berger 1 , Jonathan D Newman 1 , Mandeep S Sidhu 1 , Shaun G Goodman 1 , Witold Ruzyllo 1 , Gilbert Gosselin 1 , Aldo P Maggioni 1 , Harvey D White 1 , Balram Bhargava 1 , James K Min 1 , G B John Mancini 1 , Daniel S Berman 1 , Michael H Picard 1 , Raymond Y Kwong 1 , Ziad A Ali 1 , Daniel B Mark 1 , John A Spertus 1 , Mangalath N Krishnan 1 , Ahmed Elghamaz 1 , Nagaraja Moorthy 1 , Whady A Hueb 1 , Marcin Demkow 1 , Kreton Mavromatis 1 , Olga Bockeria 1 , Jesus Peteiro 1 , Todd D Miller 1 , Hanna Szwed 1 , Rolf Doerr 1 , Matyas Keltai 1 , Joseph B Selvanayagam 1 , P Gabriel Steg 1 , Claes Held 1 , Shun Kohsaka 1 , Stavroula Mavromichalis 1 , Ruth Kirby 1 , Neal O Jeffries 1 , Frank E Harrell 1 , Frank W Rockhold 1 , Samuel Broderick 1 , T Bruce Ferguson 1 , David O Williams 1 , Robert A Harrington 1 , Gregg W Stone 1 , Yves Rosenberg 1 ,
Affiliation  

BACKGROUND Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).

中文翻译:

稳定冠心病的初始侵入性或保守性策略。

背景 在患有中度或重度缺血的稳定型冠心病患者中,接受侵入性干预加药物治疗的患者的临床结果是否优于单独接受药物治疗的患者尚不确定。方法 我们将 5179 名中度或重度缺血患者随机分配到初始侵入性策略(可行时进行血管造影和血运重建)和药物治疗,或者如果药物治疗失败,则分配到单独药物治疗和血管造影的初始保守策略。主要结局是心血管原因死亡、心肌梗死或因不稳定心绞痛、心力衰竭或心脏骤停复苏而住院的复合结局。一个关键的次要结果是心血管原因或心肌梗塞导致的死亡。结果 在平均 3.2 年的时间里,有创策略组发生了 318 次主要结局事件,保守策略组发生了 352 次主要结局事件。6 个月时,侵入性策略组的累积事件发生率为 5.3%,保守策略组为 3.4%(差异,1.9 个百分点;95% 置信区间 [CI],0.8 至 3.0);5 年时,累积事件发生率分别为 16.4% 和 18.2%(差异,-1.8 个百分点;95% CI,-4.7 至 1.0)。关键次要结局的结果相似。主要结局的发生率对心肌梗死的定义很敏感;次要分析产生了更多临床重要性不确定的程序性心肌梗死。有创策略组有 145 人死亡,保守策略组有 144 人死亡(风险比,1.05;95% CI,0.83 比 1。32)。结论 在患有中度或重度缺血的稳定型冠心病患者中,我们没有发现证据表明,与初始保守策略相比,初始侵入性策略在中位时间为 3.2 年期间降低了缺血性心血管事件或全因死亡的风险. 试验结果对所使用的心肌梗塞的定义很敏感。(由国家心肺血液研究所和其他机构资助;ISCHEMIA ClinicalTrials.gov 编号,NCT01471522。)。试验结果对所使用的心肌梗塞的定义很敏感。(由国家心肺血液研究所和其他机构资助;ISCHEMIA ClinicalTrials.gov 编号,NCT01471522。)。试验结果对所使用的心肌梗塞的定义很敏感。(由国家心肺血液研究所和其他机构资助;ISCHEMIA ClinicalTrials.gov 编号,NCT01471522。)。
更新日期:2020-04-09
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