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Outcome of patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention during on- versus off-hours (a Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction [HORIZONS-AMI] trial substudy) 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infa Impact of treatment delay on mortality in ST-segment elevation myocardial infarction (STEMI) patients presenting with and without haemodynamic instability: results from the German prospective, multicentre FITT-STEMI trial National assessment of early β-blocker therapy in patients with acute myocardial infarction in China, 2001-2011: The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE)-Retrospective AMI Study Trends and Impact of Door-to-Balloon Time on Clinical Outcomes in Patients Aged <75, 75 to 84, and ≥85 Years With ST-Elevation Myocardial Infarction Fate of post-procedural malapposition of everolimus-eluting polymeric bioresorbable scaffold and everolimus-eluting cobalt chromium metallic stent in human coronary arteries: sequential assessment with optical coherence tomography in ABSORB Japan trial Early invasive versus non-invasive treatment in patients with non-ST-elevation acute coronary syndrome (FRISC-II): 15 year follow-up of a prospective, randomised, multicentre study Clinical value of post-percutaneous coronary intervention fractional flow reserve value: A systematic review and meta-analysis Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease: the NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps) Coronary Artery Plaque Characteristics Associated With Adverse Outcomes in the SCOT-HEART Study
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JOURNAL：CBSMD Article Link

心脏代谢临床试验中的黑洞 —— 不明原因死亡

CBSMD Keywords: cardivascular system; clinical study; trial design

Pre-reading

现代心脏代谢临床试验常将心血管死亡作为主要研究复合终点事件的一部分，由临床事件委员会（clinical event committees， CEC）明确死因。因可掌握信息不充分而无法判定死因的情况时有发生，属于临床试验终点事件的黑洞区域。 US FDA对经营管理好的临床试验的其中一项评价标准是无法明确死因的发生率应控制在罕见范围，而现实并非如此。“Frequency, Regional Variation, and Predictors of Undetermined Cause of Death in Cardiometabolic Clinical Trials: A Pooled Analysis of 9259 Deaths in 9 Trials”对9项心脏代谢临床试验的死亡原因进行了汇总分析，评估其中不明原因死亡（undetermined death）的发生率。


同期发表在《循环》上的评论文章“Classification of Deaths in Cardiovascular Outcomes Trials”

1. 介绍了心脏代谢临床试验将死亡分为心源性死亡及非心源性死亡这一通用做法的原因；

2. 指出在使用随机、对照、设盲临床设计评估新疗法有效性和安全性的同时，虽然可能的试验偏差可通过好的试验设计得以有效的规避，但对那些已知范围外未知的把控也体现了一项优质临床试验的科研质控水平。

3. 罗列了不同试验操作系统中导致无法判定死因的数量产生变化的三种情形：
(1)    完整记录缺失或死亡判定原因不充分；
(2)    死亡过程不可知(例如独居者死亡时间不确定且未经尸检明确)；
(3)    研究人员获得完整数据受限(例如随访知情同意撤回)。
4. 建议可通过加大对不明原因死亡事件的管理，进一步提高未来临床试验的数据质量，才能有效地通过试验得出心血管疗法是否确为安全或有效。


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