Randomized comparison of optimal medical therapy in. The iabp shock ii trial was a randomised, openlabel, multicentre trial. Unselected extensive univariable testing was performed including all database variables potentially associated with mortality. Following the line of the iabpshock trial and the iabpshock ii trial. Randomized comparison of optimal medical therapy in addition. The results of the intraaortic balloon pump in cardiogenic shock ii iabpshock ii trial, 1 now reported in the journal, show that in patients with acute myocardial infarction and hemodynamic. Cardiogenic shock classification baran 2019 emcrit. Intraaortic balloon pump in cardiogenic shock complicating acute myocardial infarction.
Therefore, public education regarding early warning signs of ami is a duty of all health care professionals. Evidence for the use of iabp in mi and cardiogenic shock. Objective to assess iabp efficacy in acute myocardial infarction data sources human studies found in pubmed, embase, and cochrane libraries through. Intraaortic balloon support for myocardial infarction with cardiogenic shock. Intraaortic balloon pumps in patients with cardiogenic stroke. In patients with acute mi complicated by cardiogenic shock, does an intraaortic. Intraaortic balloon pump in cardiogenic shock complicating acute. In the largest randomised trial iabp shock ii, iabp. Iabp shock ii trial and the 30day and 12month results, including the primary end point have been previously published. Data from the 302 patients enrolled in the randomized shock trial between april 1993 and november 1998 are presented. Intraaortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock iabp shock ii.
Data extracted from this multicenter study show that, in the patients with ami, 1. Clinical update management of cardiogenic shock holgerthiele1,e. There were no significant differences in reinfarction rr 260, 95% ci. Intraaortic balloon pump therapy for acute myocardial. However, previous trials in cardiogenic shock showed a mortality benefit only. Patients ineligible for the trial were enrolled in a prospective shock registry.
Time to event kaplanmeier lancet, 20 1 pt border to get rid of zen logo. Intraaortic balloon pump in cardiogenic shock ii american college. In this study, the incidence of cardiogenic shock after hospitalization was 7. However, the association of adrenaline with mortality was not dependent on the doses of other vasopressors. Intraaortic balloon counterpulsation in acute myocardial infarction.
It was for these reasons that the iabpshock ii trial was designed, aiming to show that the iabp can improve. Augmentation of diastolic pressure during balloon inflation contributes to the coronary circulation and the presystolic deflation of the balloon reduces the resistance to systolic output. The primary goal of intraaortic balloon pump iabp treatment is to increase myocardial oxygen supply and decrease myocardial oxygen demand. Iabpshock ii risk score american college of cardiology. Also, previous t rials showed that the concomitant presence of hem odynamic shock plus hyperlactatemia 4. Iabp failed to reduce 30day mortality in patients with cardiogenic shock. Time to event kaplanmeier thiele et al, lancet, 20 1 pt border to get rid of zen logo. Patients were randomly assigned within 12 h of shock diagnosis to initial medical.
Methods study design the trial design of the prospective, randomised, openlabel, controlled iabpshock ii trial at 37 german centres, and the 30 day results including the primary. The use of vasopressin as an adjunctive vasopressor in shock was reinvigorated by landry and colleagues and then carefully assessed in the vasopressin versus norepinephrine infusion in patients with septic shock vasst trial. The trial design of the randomized, openlabel, multicenter iabp shock ii trial and the 30day and 12month results, including the primary end point have been previously published. Despite this rise in cardiogenic shock, the proportion of patients with cardiogenic shock who were treated using mechanical circulatory support. Cardiogenic shock, the most severe form of acute heart failure, is characterized by i myocardial contractile dysfunction resulting in the inability of the left ventricle to maintain adequate cardiac output i. Aug 06, 2019 cardiogenic shock is a physiologic state in which inadequate tissue perfusion results from cardiac dysfunction, most often systolic. The primary end point of the study, 30day allcause mortality, was monitored by. Key takeaways this substudy of the iabpshock ii trial sought to develop an easytouse, readily available risk prediction score for shortterm mortality in patients with amirelated cs undergoing pci. Extracorporeal life support during cardiac arrest and. A new study appears to challenge the traditional assertion that.
Between 2009 and 2012, 600 patients with cardiogenic shock. The iabpshock ii trial failed to show that mechanical support with iabp. Cardiogenic shock cs is a clinical condition of inadequate tissueend organ perfusion due to cardiac dysfunction hypotension sbp 2. The trial randomised postangio patients n 600 to either iabp or no iabp.
Apr 11, 2017 a model was developed on the randomized population of the iabp shock ii trial n 600 using a stepwise multivariable cox proportional hazards regression analysis with forward selection technique. There was neither improvement in 30day mortality, nor 1year mortality, nor in any of the secondary outcomes eg. Decreased urine output after the insertion of iabp can occur because of juxtarenal balloon positioning. The balloon pump has been the flagship modality for treating cardiogenic shock in spite of scant evidence supporting its use. Cardiogenic shock complicating acute myocardial infarction. Importance intraaortic balloon pump iabp therapy is a widely used intervention for acute myocardial infarction with cardiogenic shock. The iabpshock ii trial failed to show that mechanical support with iabp improved outcomes in ami with cardiogenic.
In the largest randomised trial iabpshock ii, iabp support did not reduce 30 day mortality compared with control. It was for these reasons that the iabp shock ii trial was designed, aiming to show that the iabp can improve. Nov 16, 20 however, previous trials in cardiogenic shock showed a mortality benefit only at extended followup. Intraaortic balloon support for myocardial infarction with cardiogenic. The shock trial enrolled patients in 36 centers between 1993 and 1998 68. Longterm 6year outcome of the randomized iabp shock ii trial. Percutaneous coronary intervention for cardiogenic shock in. Holger thiele at the european society of cardiology congress, munich, august 27, 2012. Iabpshock ii trial 2012 the link above points to the evenmoreinteresting 1year followup of the iabpshockii patients.
Principles of intraaortic balloon pump counterpulsation. In the only adequately powered randomized trial of iabp in cs secondary to myocardial infarctioniabpshock ii intraaortic balloon pump in cardiogenic shock ii trialshort and midterm followup data at 30 days and 1 year showed no survival benefit with iabp support in comparison to control, nor any benefit with respect to secondary. Longterm 6year outcome of the randomized iabpshock ii trial. Recently, the findings of the iabpshock ii trial have markedly changed recommendations on the use of the intraaortic balloon pump in patients with shock. One of the new clinical trial updates we will hear about is the 1year data from the intraaortic balloon pump in cardiogenic shock ii iabp shock ii trial, an important, some would say seminal, trial in patients with cardiogenic shock and acute myocardial infarction mi. Sep 18, 2012 recently nejm published the results from the german shock ii trial.
Jul 04, 2012 cardiogenic shock a serious complication of a heart attack myocardial infarction. Intraaortic balloon pump in cardiogenic shock ii full text view. Angiopoietin2 in acute myocardial infarction complicated. Oct 28, 2012 the balloon pump has been the flagship modality for treating cardiogenic shock in spite of scant evidence supporting its use. The iabpshock ii trial is a multicenter, randomized, open label trial. Intraaortic balloon pump in cardiogenic shock complicating. Angiopoietin 2 ang 2 is a mediator of capillary leakage, and increased ang 2 levels were associated with poor inhospital outcome in a pilot study in cardiogenic shock cs. In the largest randomised trial iabpshock ii, iabp support did not. Differentiating acute coronary syndromes although the government statistics described above are derived from data classified according to chd and ami.
The intraaortic balloon pump in cardiogenic shock ii iabpshock ii trial randomized 600 patients with acute mi complicated by cardiogenic. Thiele h1, zeymer u, neumann fj, ferenc m, olbrich hg, hausleiter j, richardt g, hennersdorf m, empen k, fuernau g, desch s, eitel i, hambrecht r, fuhrmann j, bohm m, ebelt h, schneider s, schuler g, werdan k. Intraaortic balloon counterpulsation in acute myocardial. Randomisation performed centrally via internet based program. Largest randomized mult icenter trial in cs complicating ami no significant difference primary endpoint 30day mortality 39. The use of angiotensin ii in distributive shock critical. Iabp may improve mortality among patients with cardiogenic. Shock is a clinical syndrome characterised by hypotension i. The primary end point of the study, 30day allcause mortality, was monitored by the data and safety monitoring board. Intraaortic balloon pump in cardiogenic shock ii full.
Listing a study does not mean it has been evaluated by the u. Guidelines, which previously strongly recommended it, have recently undergone substantial change. Magnusohman2,steffendesch1,ingoeitel1,andsuzannedewaha1 1medical clinic ii. It is a major, and frequently fatal, complication of a variety of acute and chronic disorders, occurring most commonly following acute myocardial infarction mi. Iabp shock ii trial 2012 the link above points to the evenmoreinteresting 1year followup of the iabp shock ii patients. This led thiele and colleagues to conduct the largest randomized trial on cardiogenic shock with 600.
Jun 25, 2007 intraaortic balloon pump in cardiogenic shock ii iabp shock ii the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. The study suggests intraaortic balloon pumps iabp dont work as well as we think. Evidence for overturning the guidelines in cardiogenic shock. Despite rapid invasive treatment, circulatory support using positive inotropes and mechanical support with intraaortic balloon counterpulsation iabp, and evaluation of several new treatments during the last decade, the mortality in patients with cardiogenic shock still exceeds 50%. The results of the intraaortic balloon pump in cardiogenic shock ii iabp shock ii trial, 1 now reported in the journal, show that in patients with acute myocardial infarction and hemodynamic. Sep 27, 2016 in a contemporary randomized controlled trial in cs, iabpshock ii, the median dose of adrenaline was 0. However, previous trials in cardiogenic shock showed a mortality. In a contemporary randomized controlled trial in cs, iabpshock ii, the median dose of adrenaline was 0. Angiopoietin2 in acute myocardial infarction complicated by. Iabpshock ii trial strength largest randomized shock trial 600 patients included within 32 month contemporary cs treatment 95 % revasc. The iabpshock ii trial is a multicenter, randomized, openlabel trial. Between june 16, 2009, and march 3, 2012, we screened 790 patients with. The interest in the use of noncatecholamine vasopressors for the treatment of hypotension and shock has increased in recent years.
Cardiogenic shock a serious complication of a heart attack myocardial infarction. Intraaortic balloon support for myocardial infarction with. Cardiogenic shock is a physiologic state in which inadequate tissue perfusion results from cardiac dysfunction, most often systolic. Cardiogenic shock cs is the most common cause of death for patients hospitalized with acute myocardial infarction mi. Haemolysis from mechanical damage to red blood cells can reduce the haematocrit by up to 5%. A model was developed on the randomized population of the iabpshock ii trial n 600 using a stepwise multivariable cox proportional hazards regression analysis with forward selection technique. Mechanical circulatory support in cardiogenic shock. The present analysis therefore reports 6 and 12 month results. This randomised trial concludes with what ive always thought.
The iabpshock ii trial was a randomised, openlabel, multicentre trial. Intraaortic balloon pump in cardiogenic shock ii iabp. Oct 04, 2012 intraaortic balloon support for myocardial infarction with cardiogenic shock. Eligible patients had predominant left ventricular dysfunction resulting in cardiogenic shock within 36 h of mi. Patients with cardiogenic shock complicating acute myocardial infarction who were undergoing early revascularisation and optimum medical therapy were randomly assigned 1. Treatment with the intraaortic balloon pump iabp is the most common form of mechanical support for the failing heart. Iabpshock ii hotline esc final 082012 clinical trial results. Before 2012, american and european guidelines supporte d iabp use in cardiogenic shock with a class i recommendation. It has been interesting following the email correspondance between our hospital cardiac intensivists and cardiologists.