Christian Jung, Bernhard Wernly, Maryna Masyuk, Malte Kelm, Anne Freund, Janine Pöss, Steffen Desch, Steffen Schneider, Ibrahim Akin, Sabrina Schlesinger, Benedikt Schrage, Uwe Zeymer, Holger Thiele
{"title":"对 CULPRIT-SHOCK 试验的贝叶斯再分析","authors":"Christian Jung, Bernhard Wernly, Maryna Masyuk, Malte Kelm, Anne Freund, Janine Pöss, Steffen Desch, Steffen Schneider, Ibrahim Akin, Sabrina Schlesinger, Benedikt Schrage, Uwe Zeymer, Holger Thiele","doi":"10.1093/ehjacc/zuae104","DOIUrl":null,"url":null,"abstract":"Background 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 versus 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. Methods We conducted a Bayesian re-analysis of the CULPRIT-SHOCK trial data using non-informative, skeptical, and enthusiastic priors. Relative risks (RR) with 95% highest posterior density intervals were calculated. We defined the Minimally 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. Results Bayesian re-analysis showed a median relative risk 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 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). Conclusion Our Bayesian reanalysis provides intuitive insights by quantifying probabilities of treatment effect sizes, offering further evidence favoring the culprit-lesion-only PCI strategy in AMI patients with cardiogenic shock 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.","PeriodicalId":11861,"journal":{"name":"European Heart Journal: Acute Cardiovascular Care","volume":null,"pages":null},"PeriodicalIF":3.9000,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A Bayesian Reanalysis of the CULPRIT-SHOCK Trial\",\"authors\":\"Christian Jung, Bernhard Wernly, Maryna Masyuk, Malte Kelm, Anne Freund, Janine Pöss, Steffen Desch, Steffen Schneider, Ibrahim Akin, Sabrina Schlesinger, Benedikt Schrage, Uwe Zeymer, Holger Thiele\",\"doi\":\"10.1093/ehjacc/zuae104\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background 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 versus 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. Methods We conducted a Bayesian re-analysis of the CULPRIT-SHOCK trial data using non-informative, skeptical, and enthusiastic priors. Relative risks (RR) with 95% highest posterior density intervals were calculated. We defined the Minimally 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. Results Bayesian re-analysis showed a median relative risk 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 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). Conclusion Our Bayesian reanalysis provides intuitive insights by quantifying probabilities of treatment effect sizes, offering further evidence favoring the culprit-lesion-only PCI strategy in AMI patients with cardiogenic shock 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.\",\"PeriodicalId\":11861,\"journal\":{\"name\":\"European Heart Journal: Acute Cardiovascular Care\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.9000,\"publicationDate\":\"2024-09-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Heart Journal: Acute Cardiovascular Care\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/ehjacc/zuae104\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Heart Journal: Acute Cardiovascular Care","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/ehjacc/zuae104","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
Background 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 versus 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. Methods We conducted a Bayesian re-analysis of the CULPRIT-SHOCK trial data using non-informative, skeptical, and enthusiastic priors. Relative risks (RR) with 95% highest posterior density intervals were calculated. We defined the Minimally 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. Results Bayesian re-analysis showed a median relative risk 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 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). Conclusion Our Bayesian reanalysis provides intuitive insights by quantifying probabilities of treatment effect sizes, offering further evidence favoring the culprit-lesion-only PCI strategy in AMI patients with cardiogenic shock 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.
期刊介绍:
The European Heart Journal - Acute Cardiovascular Care (EHJ-ACVC) offers a unique integrative approach by combining the expertise of the different sub specialties of cardiology, emergency and intensive care medicine in the management of patients with acute cardiovascular syndromes.
Reading through the journal, cardiologists and all other healthcare professionals can access continuous updates that may help them to improve the quality of care and the outcome for patients with acute cardiovascular diseases.