Department of Cardiology, Pulmonology and Vascular Medicine, University Hospital and Medical Faculty, Heinrich-Heine University, Moorenstr. 5, 40225 Duesseldorf, Germany.
Cardiovascular Research Institute Düsseldorf (CARID), Medical Faculty, Heinrich-Heine University, Moorenstr. 5, 40225 Duesseldorf, Germany.
Eur Heart J Acute Cardiovasc Care. 2024 Oct 28;13(10):701-708. doi: 10.1093/ehjacc/zuae104.
The optimal revascularization strategy for patients with acute myocardial infarction (AMI), cardiogenic shock (CS), and multivessel disease remains controversial. The CULPRIT-SHOCK trial compared culprit lesion-only vs. immediate multivessel percutaneous coronary intervention (PCI), providing important data but leaving efficacy questions unresolved. To address lingering uncertainties and gain deeper insights, we performed a Bayesian reanalysis of the CULPRIT-SHOCK trial data.
We conducted a Bayesian re-analysis of the CULPRIT-SHOCK trial data using non-informative, sceptical, and enthusiastic priors. Relative risks (RRs) with 95% highest posterior density (HPD) intervals were calculated. We defined the minimal clinically important difference (MCID) as RR < 0.84. We performed subgroup analyses for key patient characteristics and assessed secondary outcomes and safety endpoints. Probabilities of benefit, achieving MCID, and harm were computed. Results are presented as median RR with probabilities of effect sizes. Bayesian reanalysis showed a median RR of 0.82 (95% HPD 0.66-1.04) with a non-informative prior, indicating a 95% probability of benefit and 59% probability of achieving MCID. Subgroup analyses revealed potentially stronger effects in males (RR 0.78, 73% probability of MCID), patients without diabetes (RR 0.76, 79% probability of MCID), and those with non-anterior ST-segment elevation MI (STEMI; RR 0.74, 76% probability of MCID). Secondary outcomes suggested potential benefits in mortality (RR 0.85) and need for renal replacement therapy (RR 0.72) but increased risks of recurrent MI (RR 2.84) and urgent revascularization (RR 2.88).
Our Bayesian reanalysis provides intuitive insights by quantifying probabilities of treatment effect sizes, offering further evidence favouring the culprit lesion-only PCI strategy in AMI patients with CS and multivessel disease. The analysis demonstrates a high probability of overall benefit, with a notable chance of achieving a minimally clinically important difference, particularly in specific subgroups. These findings not only support the consideration of culprit lesion-only PCI in certain patient populations but also underscore the need for careful risk-benefit assessment. Furthermore, our hypothesis-generating subgroup analyses, which show varying probabilities of achieving MCID, illuminate promising avenues for future targeted investigations in this critical patient population.
对于急性心肌梗死（AMI）合并心源性休克（CS）和多支血管病变的患者，最佳的血运重建策略仍存在争议。CULPRIT-SHOCK 试验比较了罪犯病变血运重建与即刻多支血管经皮冠状动脉介入治疗（PCI），提供了重要的数据，但仍未解决疗效问题。为了解决遗留的不确定性并获得更深入的见解，我们对 CULPRIT-SHOCK 试验数据进行了贝叶斯重新分析。
我们使用非信息性、怀疑性和热情性先验概率对 CULPRIT-SHOCK 试验数据进行了贝叶斯重新分析。计算了相对风险（RR）及其 95%最高后验密度（HPD）区间。我们将最小临床重要差异（MCID）定义为 RR<0.84。我们对关键患者特征进行了亚组分析，并评估了次要结局和安全性终点。计算了获益的概率、达到 MCID 的概率和危害的概率。结果以中位数 RR 及其效应大小的概率表示。贝叶斯重新分析显示，非信息性先验概率下的中位数 RR 为 0.82（95%HPD 0.66-1.04），表明有 95%的获益概率和 59%的达到 MCID 的概率。亚组分析显示，男性（RR 0.78，达到 MCID 的概率为 73%）、无糖尿病患者（RR 0.76，达到 MCID 的概率为 79%）和非前壁 ST 段抬高型心肌梗死（STEMI；RR 0.74，达到 MCID 的概率为 76%）患者可能具有更强的效果。次要结局提示死亡率（RR 0.85）和肾脏替代治疗（RR 0.72）的获益可能，而复发心肌梗死（RR 2.84）和紧急血运重建（RR 2.88）的风险增加。
我们的贝叶斯重新分析通过量化治疗效果大小的概率提供了直观的见解，进一步支持 AMI 合并 CS 和多支血管病变患者采用罪犯病变血运重建策略。该分析表明整体获益的概率较高，达到最小临床重要差异的可能性显著，尤其是在特定亚组中。这些发现不仅支持在某些患者群体中考虑罪犯病变血运重建，还强调需要仔细评估风险-获益比。此外，我们的假设生成亚组分析显示达到 MCID 的概率存在差异，为这一关键患者群体的未来有针对性的研究提供了有希望的途径。
