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Cardiogenic Shock in the Setting of Acute Myocardial Infarction

2020; Lippincott Williams & Wilkins; Volume: 13; Issue: 3 Linguagem: Inglês

10.1161/circinterventions.120.009034

1941-7632

Islam Y. Elgendy, Harriette G.C. Van Spall, Mamas A. Mamas,

Cardiac Arrest and Resuscitation

HomeCirculation: Cardiovascular InterventionsVol. 13, No. 3Cardiogenic Shock in the Setting of Acute Myocardial Infarction Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBCardiogenic Shock in the Setting of Acute Myocardial InfarctionHistory Repeating Itself? Islam Y. Elgendy, MD, Harriette G.C. Van Spall, MD, MPH and Mamas A. Mamas, BM, BCh, DPhil Islam Y. ElgendyIslam Y. Elgendy Division of Cardiology, Massachusetts General Hospital and Harvard Medical School, Boston (I.Y.E.). , Harriette G.C. Van SpallHarriette G.C. Van Spall Department of Medicine, McMaster University, Hamilton, ON, Canada; Population Health Research Institute, Hamilton, ON, Canada (H.G.C.V.S.). and Mamas A. MamasMamas A. Mamas Correspondence to: Mamas A. Mamas, BM, BCh, DPhil, Cardiology, Keele Cardiovascular Research Group, Centre for Prognosis Research, Institute for Primary Care and Health Sciences, Keele University, David Weatherall Bldg, University Dr, Stoke on Trent ST5 5BG, United Kingdom. Email E-mail Address: [email protected] Keele Cardiovascular Research Group, Keele University, Stoke-on-Trent, United Kingdom (M.A.M.). Originally published10 Mar 2020https://doi.org/10.1161/CIRCINTERVENTIONS.120.009034Circulation: Cardiovascular Interventions. 2020;13:e009034This article is a commentary on the followingSex-Specific Management in Patients With Acute Myocardial Infarction and Cardiogenic ShockCardiogenic shock is a leading cause of in-hospital mortality among patients with acute myocardial infarction (AMI) with in-hospital mortality rates reported between 40% to 60%.1 Approximately 5% to 15% of patients with AMI develop cardiogenic shock, with females at greater risk.2,3 Studies examining sex-specific differences in the management and outcomes of patients with AMI have shown that females are typically older, have a greater burden of comorbidities, and are less likely than males to receive guideline-directed therapies and timely revascularization.4,5 Collectively, these factors contribute to the higher risk of heart failure, cardiogenic shock, and mortality in females than in males with AMI. Similarly, previous studies assessing sex-specific differences in patients with cardiogenic shock have shown that females are older, have a higher burden of comorbidities, are less likely to receive revascularization and hemodynamic support, and have higher mortality rates2,6; however, these studies were based on registries.See Article by Rubini Gimenez et alIn this issue of Circulation: Cardiovascular Interventions, Gimenez et al7 present the findings of an exploratory analysis examining the sex differences in clinical presentation, management, and outcomes among patients enrolled in the CULPRIT SHOCK trial (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock), a multicenter randomized controlled trial (RCT) comparing culprit-only versus multivessel revascularization strategies for patients with AMI and multivessel disease presenting with cardiogenic shock.7 Similar to other contemporary coronary intervention trials, females were under-represented in CULPRIT SHOCK, representing only 24% of the enrolled patients. Females were older and had a higher prevalence of diabetes mellitus, hypertension, and renal insufficiency but a lower prevalence of smoking. Females were also more likely to present with nonanterior ST-segment–elevation myocardial infarction. While mechanical circulatory support devices were comparably used in both sexes, females were less likely to receive therapeutic hypothermia. Despite these differences, women did not have a higher incidence of the primary end point (ie, composite of mortality or requirement for renal replacement therapy) or mortality at 30 days and at 1 year, following adjustments for differences in baseline characteristics. Furthermore, similar to the principal findings of the CULPRIT SHOCK trial, a culprit-only strategy was superior to multivessel revascularization for the primary end point with no statistically significant sex interaction detected.7 Thus, there was no evidence that culprit vessel revascularization had a sex-specific effect among presenting with AMI and cardiogenic shock.The findings of CULPRIT SHOCK are consistent with other studies that explored sex-specific effects of invasive care in the setting of AMI complicated by cardiogenic shock, such as the SHOCK trial where no sex interaction for the benefit of early revascularization was demonstrated8 or the IABP-SHOCK II trial (Intraaortic Balloon Pump in Cardiogenic Shock II) where no significant sex differences in clinical outcomes were reported and no sex interaction for IABP treatment was observed.9Since the CULPRIT SHOCK trial compared 2 revascularization strategies (ie, culprit-only versus multivessel revascularization), all patients enrolled in the trial underwent revascularization. While the findings of the current report should be placed into the context of a study not powered to answer questions of sex-related differences in outcomes/treatment effects in cardiogenic shock, it would suggest that the adjusted clinical outcomes of women with cardiogenic shock in the setting of AMI (when revascularized) are similar to those of men. In contrast, in the real world, registry data suggests that women with cardiogenic shock are less likely to receive revascularization, as compared with men,2,6 even though revascularization was an independent predictor of survival at 1 year among women but not in men,6 and no sex interaction was observed for the benefit of early revascularization in the SHOCK trial.8 Such inequalities in the receipt of revascularization in the real world contribute to worse cardiogenic shock outcomes seen in females in real-world registry studies and represent an important challenge that our clinical services need to meet, to avoid unnecessary deaths in this high-risk group of patients.While the investigation by Gimenez et al7 is a welcomed contribution to our knowledge base in sex differences in cardiogenic shock, it highlights persistent gaps in the enrollment of females in cardiovascular clinical trials, even those pertaining to cardiogenic shock, a condition which occurs more frequently in women. Females continue to be under-represented in most trials evaluating therapeutic interventions in patients with AMI. While there is a female predominance in cardiogenic shock following AMI (as high a 60%),2 females accounted for only one-third of participants in the SHOCK and IABP-SHOCK II trials8,9 and one quarter of participants in the CULPRIT SHOCK trial conducted 2 decades later.7Care in clinical settings relies on high-quality evidence generated in randomized clinical trials, which need to recruit the populations in whom such therapies will be used in the real world. Adequate enrollment of females is needed in RCTs so that the treatment effect in females is adequately represented in the primary results, and there is a representative sample of each sex to investigate sex-specific treatment responses. Without trials balanced in recruitment and adequately powered to detect sex-specific differences, our estimates of efficacy and safety may not be applicable to both sexes; we may be subjecting women to ineffective or harmful therapies or underutilizing treatments that may be able to provide greater benefits.There are several factors that may explain the under-representation of females in RCTs, and these merit investigation. Trial-level factors such as sex-specific eligibility criteria, process of informed consent, and setting of recruitment have been implicated in the under-enrollment of females in high-impact RCTs.10 In addition, the role of sex differences in informed consent and in financial or logistical barriers that may preclude participation in follow-up visits is worth exploring. Clinical trialists should aim to recruit trial participants proportionate to sex prevalence of the disease. Strategies could include increasing awareness, diversifying study teams, developing more succinct, patient-centered documents for informed consent, eliminating restrictive eligibility criteria, and reducing barriers to enrollment and follow-up by either remunerating patients or using databases for follow-up.Stakeholders, such as funders and journal editors, have an important role to play in encouraging researchers to enroll sufficient numbers of both sexes and to report the presence or absence of sex differences in RCTs. The fact that women represent only one in 4 patients recruited to an RCT in cardiogenic shock, 2 decades after similar recruitment challenges in another landmark cardiogenic shock trial should give us pause to consider why history is repeating itself and what we can do to change this.DisclosuresNone.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.For Disclosures, see page 2.Correspondence to: Mamas A. Mamas, BM, BCh, DPhil, Cardiology, Keele Cardiovascular Research Group, Centre for Prognosis Research, Institute for Primary Care and Health Sciences, Keele University, David Weatherall Bldg, University Dr, Stoke on Trent ST5 5BG, United Kingdom. Email [email protected]co.ukReferences1. Goldberg RJ, Spencer FA, Gore JM, Lessard D, Yarzebski J. Thirty-year trends (1975 to 2005) in the magnitude of, management of, and hospital death rates associated with cardiogenic shock in patients with acute myocardial infarction: a population-based perspective.Circulation. 2009; 119:1211–1219. doi: 10.1161/CIRCULATIONAHA.108.814947LinkGoogle Scholar2. Abdel-Qadir HM, Ivanov J, Austin PC, Tu JV, Džavík V. Sex differences in the management and outcomes of ontario patients with cardiogenic shock complicating acute myocardial infarction.Can J Cardiol. 2013; 29:691–696. doi: 10.1016/j.cjca.2012.09.020CrossrefMedlineGoogle Scholar3. Kolte D, Khera S, Aronow WS, Mujib M, Palaniswamy C, Sule S, Jain D, Gotsis W, Ahmed A, Frishman WH, et al. Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States.J Am Heart Assoc. 2014; 3:e000590. doi: 10.1161/JAHA.113.000590LinkGoogle Scholar4. Jneid H, Fonarow GC, Cannon CP, Hernandez AF, Palacios IF, Maree AO, Wells Q, Bozkurt B, Labresh KA, Liang Let al; Get With the Guidelines Steering Committee and Investigators. Sex differences in medical care and early death after acute myocardial infarction.Circulation. 2008; 118:2803–2810. doi: 10.1161/CIRCULATIONAHA.108.789800LinkGoogle Scholar5. Arora S, Stouffer GA, Kucharska-Newton AM, Qamar A, Vaduganathan M, Pandey A, Porterfield D, Blankstein R, Rosamond WD, Bhatt DL, et al. Twenty year trends and sex differences in young adults hospitalized with acute myocardial infarction.Circulation. 2019; 139:1047–1056. doi: 10.1161/CIRCULATIONAHA.118.037137LinkGoogle Scholar6. Isorni MA, Aissaoui N, Angoulvant D, Bonello L, Lemesle G, Delmas C, Henry P, Schiele F, Ferrières J, Simon Tet al; FAST-MI Investigators. Temporal trends in clinical characteristics and management according to sex in patients with cardiogenic shock after acute myocardial infarction: the FAST-MI programme.Arch Cardiovasc Dis. 2018; 111:555–563. doi: 10.1016/j.acvd.2018.01.002CrossrefMedlineGoogle Scholar7. Gimenez MR ZU, Desch S, de Waha-Thiele S, Ouarrak T, Poess J, Meyer-Saraei R, Schneider S, Fuernau G, Stepinska J, Huber K, et al. Sex-specific management in patients with acute myocardial infarction and cardiogenic shock: a substudy of the CULPRIT-SHOCK Trial.Circ Cardiovasc Interv. 2020; 13:e008537–. doi: 10.1161/CIRCINTERVENTIONS.119.008537MedlineGoogle Scholar8. Hochman JS, Sleeper LA, Webb JG, Sanborn TA, White HD, Talley JD, Buller CE, Jacobs AK, Slater JN, Col J, et al. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should we emergently revascularize occluded coronaries for cardiogenic shock.N Engl J Med. 1999; 341:625–634. doi: 10.1056/NEJM199908263410901CrossrefMedlineGoogle Scholar9. Fengler K, Fuernau G, Desch S, Eitel I, Neumann FJ, Olbrich HG, de Waha A, de Waha S, Richardt G, Hennersdorf M, et al. Gender differences in patients with cardiogenic shock complicating myocardial infarction: a substudy of the IABP-SHOCK II-trial.Clin Res Cardiol. 2015; 104:71–78. doi: 10.1007/s00392-014-0767-2CrossrefMedlineGoogle Scholar10. Van Spall HG, Toren A, Kiss A, Fowler RA. Eligibility criteria of randomized controlled trials published in high-impact general medical journals: a systematic sampling review.JAMA. 2007; 297:1233–1240. doi: 10.1001/jama.297.11.1233CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Osman M, Syed M, Kheiri B, Bianco C, Kalra A, Cigarroa J, Mamas M, Dawn Abbott J, Grines C, Fonarow G and Balla S (2022) Age stratified sex‐related differences in incidence, management, and outcomes of cardiogenic shock, Catheterization and Cardiovascular Interventions, 10.1002/ccd.30177, 99:7, (1984-1995), Online publication date: 1-Jun-2022. Ya'Qoub L, Gad M, Faza N, Kunkel K, Ya'acoub R, Villablanca P, Bagur R, Alasnag M, Eng M and Elgendy I (2022) Sex differences in outcomes of transcatheter edge‐to‐edge repair with MitraClip: A meta‐analysis, Catheterization and Cardiovascular Interventions, 10.1002/ccd.30110, 99:6, (1819-1828), Online publication date: 1-May-2022. Elgendy I, Wegermann Z, Li S, Mahtta D, Grau-Sepulveda M, Smilowitz N, Gulati M, Garratt K, Wang T and Jneid H (2022) Sex Differences in Management and Outcomes of Acute Myocardial Infarction Patients Presenting With Cardiogenic Shock, JACC: Cardiovascular Interventions, 10.1016/j.jcin.2021.12.033, 15:6, (642-652), Online publication date: 1-Mar-2022. Elbadawi A, Barssoum K, Megaly M, Rai D, Elsherbeeny A, Mansoor H, Shishehbor M, Abdel‐Latif A, Gulati M and Elgendy I (2021) Sex Differences in Trends and In‐Hospital Outcomes Among Patients With Critical Limb Ischemia: A Nationwide Analysis, Journal of the American Heart Association, 10:18, Online publication date: 21-Sep-2021. Bukhari S, Fatima S and Elgendy I (2021) Cardiogenic shock in the setting of acute myocardial infarction: Another area of sex disparity?, World Journal of Cardiology, 10.4330/wjc.v13.i6.170, 13:6, (170-176), Online publication date: 26-Jun-2021. Elgendy I, Mahtta D and Paniagua D (2020) Multivessel PCI for Acute Myocardial Infarction: Where Do We Stand After The COMPLETE Trial?, Current Cardiology Reports, 10.1007/s11886-020-01340-y, 22:9, Online publication date: 1-Sep-2020. Elgendy I and Pepine C (2020) What is the Real Message of the ISCHEMIA Trial from a Clinician's Perspective?, European Cardiology Review, 10.15420/ecr.2020.27, 15 Related articlesSex-Specific Management in Patients With Acute Myocardial Infarction and Cardiogenic ShockMaria Rubini Gimenez, et al. Circulation: Cardiovascular Interventions. 2020;13 March 2020Vol 13, Issue 3 Advertisement Article InformationMetrics © 2020 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.120.009034PMID: 32151160 Originally publishedMarch 10, 2020 KeywordsEditorialscardiogenic shockcoronary artery diseaserandomized controlled trialsexmyocardial infarctionpercutaneous coronary interventionPDF download Advertisement