择期经皮冠脉介入治疗对ST段抬高型心肌梗死的预后影响及相关因素分析

发布时间：2018-05-11 15:05

  本文选题：ST段抬高型心肌梗死 + 流行病学　； 参考：《吉林大学》2015年博士论文

【摘要】：【研究背景】 ST段抬高型心肌梗死（ST-segment elevation myocardial infarction, STEMI）的首要治疗目标是实现早期再灌注治疗，而早期再灌注治疗主要目的是尽快开通梗死相关血管（infart-related artery, IRA），因此直接经皮冠脉介入治疗（percutaneous coronary intervention, PCI）成为STEMI的首选治疗方案。在美国及欧洲发达国家如英国、瑞士等国，STEMI患者接受直接PCI的比例已高达70-90%，但我国由于受限于医疗条件（包括是否有能够实施直接PCI的医疗机构及24小时值班的急诊介入治疗团队等）和急诊转运能力的不足，通常难以在指南推荐的心梗起病后12小时内实施直接PCI。据卫计委网报介入治疗注册数据显示，我国每年仅有约3-5%的STEMI患者接受了直接PCI治疗，与此同时，约有7-10%的STEMI患者接受了择期PCI的治疗，按照每年全国新发STEMI500,000-600,000例推算，每年约有35,000到60,000例STEMI患者接受了择期PCI的治疗，这是一组相当庞大的数字。目前指南推荐：除存在自发或可诱发的进行性心肌缺血表现、心源性休克或严重血液动力学不稳定、严重心力衰竭及室性心律失常可行立即行PCI而无需考虑据起病的时间外，对于无心肌缺血表现，血液动力学和心电稳定患者，不推荐常规行择期PCI。 但近年来对“晚期开通血管”的获益一直存在着争议，该理论认为开通IRA能够阻止或减缓梗死面积扩展、梗死后心肌重塑和减少远期不良事件。但以OAT（Occluded Artery Trial）为首的一系列临床随机对照试验（randomized controlledtrail, RCT）对其结论提出了质疑。荟萃分析认为这种不一致的结论可能由于各临床研究入组患者的高度选择性及不同的心肌缺血状况所引起的，需实施更大规模及入组更据代表性患者的RCT来证实这一结论，但进一步开展此类研究不得不面临着巨大的伦理学障碍和极高的手术风险。如OAT研究实施过程中入选患者极其困难，平均每年各分中心入组不到2名患者。因此，贸然开展更大规模RCT研究的可能性已微乎其微，尤其在发达国家早已普及直接PCI的今天。 真实世界研究随着数据信息收集和计算能力的逐年提升而被医学界所重新关注和重视。针对严格解释性的RCT存在纳入人群限制较多，用药条件控制苛刻，使其结果虽内部真实性较高，但外延性较差及应用推广受限，更多研究运用真实世界研究方法分析来自临床实践中的海量数据用以观察某一干预措施对预后的影响等，同时能够克服入选患者人群代表性差、入组困难及研究结果时效性差等缺点。本研究也将基于真实世界研究方法，客观地描述我国目前医疗条件和治疗水平下STEMI后未接受早期再灌注治疗且病情相对稳定患者在临床实践中接受择期PCI治疗现况及预后影响因素，为今后相关指南的制定和临床试验的设计开展提供重要的线索和参考。 【研究目的】 观察STEMI后未接受早期再灌注治疗且病情相对稳定的患者接受择期PCI治疗与预后情况，并观察手术时机选择及梗死相关血管支配区域的缺血程度对接受择期PCI治疗患者的预后影响。 【研究方法】 本研究为前瞻性观察性队列研究，第一和第二部分利用北京地区住院及死亡注册数据信息，入选所有于2007-2010年间因STEMI住院的北京户籍居民，排除合并患有心源性休克，严重心功能不全及室性心律失常，肿瘤或肾功能衰竭的患者。建立Cox等比例风险回归模型和广义估计方程用于比较组间的主要不良心血管事件（major adverse cardiovascular events, MACE）。研究择期PCI（起病后2-28天）与单纯药物保守治疗相比是否改善其预后及其最佳的手术时机。第三部分研究抽取一部分患者进一步分析缺血程度是否为影响其择期手术选择的关键因素。 【研究结果】 本研究结果主要分为三大部分： 1.探讨择期PCI对STEMI后相对稳定患者的预后影响 本部分研究共纳入15,799例STEMI患者，其中5,417例接受起病后第2-28天的择期PCI治疗，另10,382例仅接受常规药物治疗。PCI组的2年累及MACE事件率显著低于保守治疗组[10.1％vs.20.4％，协变量调整后的危险比（hazardratio，HR）为0.417，95％可信区间（confidence intervals, CI）为0.375-0.464，P0.001]。在经倾向性评分匹配后的患者亚组中，调整的HR为0.494（95％CI为0.442-0.551，P0.001）。此外，混合效应模型中发现PCI的使用呈与MACE事件的发生成负相关[调整后的比值比（odds ratio, OR），0.451，95％CI，0.392-0.538, P0.001]。总之，对于梗死后相对稳定且未接受早期再灌注治疗的患者，行择期PCI可以显著减少2年主要终点事件的发生，显著提高无事件生存率及患者改善预后。 2.探讨择期PCI手术时机选择现况及预后的影响 本部分研究共入选5,417例STEMI患者，分别有55.9％，35.4％和8.7％接受了起病后第2-7天，8-14天和15-28天的择期PCI治疗。基线资料分析时发现患者年龄和首诊医院等级与手术时间的选择相关。三组间的1年累及MACE事件率无显著性差异（7.1％，5.8％和6.3％，对数秩检验P=0.272），且多因素调整后的手术时间本身也非MACE事件的独立危险因素（P0.05）。总之，择期PCI的时机选择在临床实践中各不相同且受多种因素影响，研究未发现某一时间段的手术出现特别的临床获益，但起病后第二周内的绝对事件数较少。 3.探讨MaR对STEMI后相对稳定患者行择期PCI的预后影响 本部分研究共纳入满足入选标准的436例于起病后12-72小时就诊且病情相对稳定的STEMI患者，其中218例行择期PCI治疗和另218例仅接受适宜药物治疗。每名患者的MaR均由联合Aldrich-ST评分和Selvester-QRS评分评估所得。主要终点是主要心血管不良事件包括心血管死亡，再梗或再血运重建治疗。在MaR35％的患者中，2年累及的主要终点事件率分别为9.2％（PCI组）和5.3％（OMT组）（调整后的HR PCI vs.OMT为1.855；95％CI，，0.617-5.575；P=0.271）；在MaR≥35％的患者中，2年累及的主要终点事件率分别为12.8％（PCI组）和23.1％（OMT组）（调整后的HR PCI vs.OMT为0.448；95％CI为0.228-0.884；P=0.021）。总之，心梗后晚期就诊患者行择期PCI的获益与MaR相关。在MaR≥35％的患者中，接受PCI治疗与OMT治疗相比，可以显著减少2年主要终点事件，改善患者预后，但在MaR 35％的患者，未发现上述获益。 【研究结论】 综上，我们发现择期PCI可以显著减少STEMI后相对稳定患者2年的MACE终点事件的发生，而择期PCI手术时机的选择在实践中差异巨大且受患者自身病情及首诊医院的影响，但并未发现某一手术时机对患者的预后产生显著性影响，尽管第二周手术的绝对事件率较低。进一步研究发现STEMI后相对稳定的患者行择期PCI的获益与其自身MaR相关。在MaR≥35％的患者中，接受PCI治疗与OMT治疗相比，可以显著减少2年MACE的发生并改善患者预后。在MaR35％的患者，未发现上述获益。本系列研究描述了目前STEMI后相对稳定患者的治疗现况并分析了影响其预后的危险因素，这将为今后相关指南的制定和临床试验的设计开展提供重要的线索及参考。
[Abstract]:BACKGROUND OF THE STUDY

The primary goal of ST - segment elevation myocardial infarction ( STEMI ) is to achieve early reperfusion therapy , and early reperfusion therapy is primarily aimed at providing immediate PCI for patients with STEMI as soon as possible . In the United States and European developed countries such as the UK , Switzerland and the like , there are only about 3 - 5 % of STEMI patients receiving direct PCI . At the same time , there are about 7 - 10 % of STEMI patients receiving direct PCI . At the same time , there are about 7 - 10 % of STEMI patients receiving elective PCI . At the same time , there are only about 3 - 5 % of STEMI patients undergoing elective PCI .

However , in recent years , there has been a debate on the benefit of " late - opening vessels " , which is considered to prevent or mitigate infarct size expansion , post - infarction myocardial remodeling , and reduce long - term adverse events . However , a series of clinical randomized controlled trials led by OAT is considered to be extremely difficult , with an average of less than 2 patients per year . Therefore , the possibility of a larger RCT study has been minimal , especially in developed countries today .

The real world research has been paid more attention and paid attention to by the medical community as the data information collecting and calculating ability increases year by year . For the strict interpretation of RCT , there are many disadvantages such as the limited population limit and the strict control of the medication condition , but also can overcome the disadvantages of the poor representation , the difficulty of enrollment and the poor timeliness of the research results .

Purpose of research

To observe the prognosis of patients with STEMI who did not receive early reperfusion therapy and the relatively stable condition of the disease , and observe the influence of the time of operation and the degree of ischemia on the infarct - related vascular innervation area on the prognosis of patients undergoing elective PCI .

Methodology of research

This study was a prospective observational cohort study in which the first and second sections were enrolled in all Beijing - based residents hospitalized for STEMI from 2007 - 2010 to exclude patients with cardiac shock , severe cardiac insufficiency and ventricular arrhythmias , tumors or renal failure . Cox proportional hazards regression models and generalized estimation equations were established to compare major adverse cardiovascular events ( MACEs ) between groups . The outcome of elective PCI ( 2 - 28 days post - onset ) and the optimal timing of surgery were studied . Part three of the study was to extract a part of the patients to further analyze whether the degree of ischemia was the key factor affecting the choice of elective surgery .

Outcome of the study

The results of this study are mainly divided into three parts :

1 . To investigate the influence of elective PCI on the prognosis of patients with STEMI after STEMI

In this part , 15,799 STEMI patients were enrolled . Of these , 5,417 patients received elective PCI on Day 2 - 28 after onset of onset and 10,382 were treated with routine medication only . The rate of events in 2 years in PCI group was significantly lower than that of conservative treatment group ( 10.1 % vs.20 . 4 % ) . The risk ratio after covariant adjustment was 0.417 , 95 % confidence intervals ( CI ) was 0.375 - 0.464 , P0.001 respectively . In the subgroup of patients with the matched propensity score , the adjusted HR was 0.494 ( 95 % CI 0.442 - 0.551 , P0.001 ) . In addition , the use of PCI was found in the mixed effect model to be negatively correlated with the incidence of the event , odds ratio ( OR ) , 0.4451 , 95 % CI , 0.392 - 0.538 , P0.001 respectively . In conclusion , PCI could significantly reduce the occurrence of 2 - year primary endpoint events , significantly improve the event - free survival rate and improve the prognosis for patients with relatively stable infarction and no early reperfusion therapy .

2 . To explore the effect of choosing the timing of elective PCI on the status quo and prognosis

In this part , 5 , 417 STEMI patients were enrolled , 55.9 % , 35.4 % and 8.7 % received elective PCI treatment on Days 2 - 7 , 8 - 14 and 15 - 28 days after onset of disease . There was no significant difference in the incidence rate between the three groups ( 7.1 % , 5.8 % and 6.3 % , log - rank test P = 0.272 ) .

3 . To investigate the effect of MaR on the prognosis of patients with STEMI after elective PCI

In this part , 436 patients with STEMI who met the criteria of inclusion were enrolled in 12 - 72 hours post - onset and were relatively stable , of whom 218 were treated with elective PCI and another 218 were treated with appropriate medication . The primary endpoint was major cardiovascular adverse events including cardiovascular death , reinfarction , or revascularization . The primary endpoint event rate in 2 years was 9.2 % in patients with MaR35 % ( PCI group ) and 5.3 % ( OMT group ) ( adjusted HR PCI vs . OMT = 1.855 ;
95 % CI , 0.617 - 5.575 ;
P=0.271)锛

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