Initial Invasive or Conservative Strategy for Stable Coronary Disease
Initial Invasive or Conservative Strategy for Stable Coronary Disease
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DOI：
10.1056/nejmoa1915922
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发表时间：
2020-04-09
影响因子：
158.5
通讯作者：
Rosenberg, Yves
中科院分区：
文献类型：
--
作者：
Maron, David J.;Hochman, Judith S.;Rosenberg, Yves
背景在稳定型冠心病和中度或重度缺血患者中，接受侵入性干预加药物治疗的患者的临床结局是否优于单纯接受药物治疗的患者尚不确定。方法我们将5179例中度或重度缺血患者随机分配至初始侵入性策略组（血管造影术和血运重建术（可行时））和药物治疗，或者如果药物治疗失败，则单独使用药物治疗和血管造影术的初始保守策略。主要结局是心血管原因死亡、心肌梗死或因不稳定型心绞痛住院、心力衰竭或心脏骤停复苏的复合终点。一个关键的次要结局是心血管原因或心肌梗死导致的死亡。结果在中位数为3.2年的时间里，有创策略组发生了318起主要结局事件，保守策略组发生了352起。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 - 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敏感;二次分析产生了更多临床重要性不确定的手术性心肌梗死。有145例死亡发生在侵入性策略组，144例死亡发生在保守策略组（风险比，1.05; 95%CI，0.83 - 1.32）。结论在稳定性冠心病和中度或重度缺血患者中，我们没有发现证据表明初始侵入性策略与初始保守策略相比，降低缺血性心血管事件或任何原因死亡的风险，中位数为3.2年。试验结果对所使用的心肌梗死定义敏感。（由国家心肺血液研究所和其他机构资助; ISCHEMIA ClinicalTrials.gov编号，。稳定型冠心病患者被随机分配到血管造影和血运重建（如适用）的初始侵入性策略或单独药物治疗。在3.2年时，两组间缺血事件的估计发生率无显著差异。这些结果对心肌梗死的定义敏感。
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, .)Patients with stable coronary disease were randomly assigned to an initial invasive strategy with angiography and revascularization if appropriate or to medical therapy alone. At 3.2 years, there was no significant difference between the groups with respect to the estimated rate of ischemic events. The findings were sensitive to the definition of myocardial infarction.