当前位置:科学网首页 > 小柯机器人 >详情
稳定型冠心病的初始侵入治疗方案并不优于保守方案
作者:小柯机器人 发布时间:2020/3/31 13:15:08

稳定型冠心病初始侵入或保守治疗方案的疗效比较,这一成果由美国斯坦福大学医学院David J. Maron联合纽约大学格罗斯曼医学院Judith S. Hochman团队合作完成。相关论文发表在2020年3月30日出版的《新英格兰医学杂志》上。

对于稳定型冠心病、中度或重度缺血的患者,接受侵入性干预联合药物治疗的临床结局是否优于仅药物治疗尚不明确。

研究组招募了5179例中度或重度缺血患者,将其随机分配至初始侵入性方案联合药物治疗,或初始保守的药物治疗,若失败则行血管造影术。主要结局是心血管原因死亡,心肌梗塞,或因不稳定型心绞痛、心力衰竭或再次发作的心脏骤停而导致住院的复合结果。

中位随访3.2年后,侵入性治疗组发生了318个主要结局事件,保守方案组发生了352个。第6个月时,侵入性治疗组的累积事件发生率为5.3%,保守方案组为3.4%;第5年时,两组间累积事件发生率分别为16.4%和18.2%。

关键的次要结局结果相似。主要结局发生率对心肌梗死的定义敏感。二次分析产生了更多临床不确定的介入相关心肌梗塞。侵入性治疗组死亡145例,保守策略组死亡144例,风险比为1.05。

总之,对于稳定型冠心病、中度或重度缺血的患者,没有证据表明,与初始保守方案相比,初始侵入性方案可降低缺血性心血管事件或全因死亡的风险。

附:英文原文

Title: Initial Invasive or Conservative Strategy for Stable Coronary Disease | NEJM

Author: David J. Maron, M.D.,, Judith S. Hochman, M.D.,, Harmony R. Reynolds, M.D.,, Sripal Bangalore, M.D., M.H.A.,, Sean M. O’Brien, Ph.D.,, William E. Boden, M.D.,, Bernard R. Chaitman, M.D.,, Roxy Senior, M.D., D.M.,, Jose López-Sendón, M.D.,, Karen P. Alexander, M.D.,, Renato D. Lopes, M.D., Ph.D.,, Leslee J. Shaw, Ph.D.,, Jeffrey S. Berger, M.D.,, Jonathan D. Newman, M.D., M.P.H.,, Mandeep S. Sidhu, M.D., M.B.A.,, Shaun G. Goodman, M.D.,, Witold Ruzyllo, M.D., Ph.D.,, Gilbert Gosselin, M.D.,, Aldo P. Maggioni, M.D.,, Harvey D. White, D.Sc.,, Balram Bhargava, M.D., D.M.,, James K. Min, M.D.,, G.B. John Mancini, M.D.,, Daniel S. Berman, M.D.,, Michael H. Picard, M.D.,, Raymond Y. Kwong, M.D., M.P.H.,, Ziad A. Ali, M.D., D.Phil.,, Daniel B. Mark, M.D., M.P.H.,, John A. Spertus, M.D., M.P.H.,, Mangalath N. Krishnan, D.M.,, Ahmed Elghamaz, M.D.,, Nagaraja Moorthy, M.D., D.M.,, Whady A. Hueb, M.D.,, Marcin Demkow, M.D.,, Kreton Mavromatis, M.D.,, Olga Bockeria, M.D., Ph.D.,, Jesus Peteiro, M.D., Ph.D.,, Todd D. Miller, M.D.,, Hanna Szwed, M.D., Ph.D.,, Rolf Doerr, M.D.,, Matyas Keltai, M.D., Ph.D., D.Sc.,, Joseph B. Selvanayagam, M.B., B.S., D.Phil.,, P. Gabriel Steg, M.D.,, Claes Held, M.D., Ph.D.,, Shun Kohsaka, M.D.,, Stavroula Mavromichalis, M.S.,, Ruth Kirby, R.N.,, Neal O. Jeffries, Ph.D.,, Frank E. Harrell, Jr., Ph.D.,, Frank W. Rockhold, Ph.D.,, Samuel Broderick, M.S.,, T. Bruce Ferguson, Jr., M.D.,, David O. Williams, M.D.,, Robert A. Harrington, M.D.,, Gregg W. Stone, M.D.,, and Yves Rosenberg, M.D., M.P.H.

Issue&Volume: 2020-03-30

Abstract: Abstract

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.

DOI: 10.1056/NEJMoa1915922

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1915922

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home