Background: The role of intraaortic balloon counterpulsation (IABP) in cardiogenic shock is still a subject of intense debate despite the neutral results of the IABP-SHOCK II trial (Intraaortic Balloon Pump in Cardiogenic Shock II) with subsequent downgrading in international guidelines. So far, randomized data on the impact of IABP on long-term clinical outcomes in patients with cardiogenic shock complicating acute myocardial infarction are lacking. Furthermore, only limited evidence is available on general long-term outcomes of patients with cardiogenic shock treated by contemporary practice. Methods: The IABP-SHOCK II trial is a multicenter, randomized, open-label trial. Between 2009 and 2012, 600 patients with cardiogenic shock complicating acute myocardial infarction undergoing early revascularization were randomized to IABP versus control. Results: Long-term follow-up was performed 6.2 years (interquartile range 5.6–6.7) after initial randomization. Follow-up was completed for 591 of 600 patients (98.5%). Mortality was not different between the IABP and the control group (66.3% versus 67.0%; relative risk, 0.99; 95% CI, 0.88–1.11; P =0.98). There were also no differences in recurrent myocardial infarction, stroke, repeat revascularization, or rehospitalization for cardiac reasons (all P >0.05). Survivors’ quality of life as assessed by the EuroQol 5D questionnaire and the New York Heart Association class did not differ between groups. Conclusions: IABP has no effect on all-cause mortality at 6-year long-term follow-up. Mortality is still very high, with two thirds of patients with cardiogenic shock dying despite contemporary treatment with revascularization therapy. Clinical Trial Registration: URL: https://www.clinicaltrials.gov/ . Unique identifier: NCT00491036.
Background Conflicting results exist on whether initiation of intraaortic balloon pumping (IABP) before percutaneous coronary intervention (PCI) has an impact on outcome in this setting. Our aim was to assess the outcome of patients undergoing IABP insertion before versus after primary PCI in acute myocardial infarction complicated by cardiogenic shock. Methods The IABP-SHOCK II-trial randomized 600 patients with acute myocardial infarction and cardiogenic shock to IABP-support versus control. We analysed the outcome of patients randomized to the intervention group regarding timing of IABP implantation before or after PCI. Results Of 600 patients included in the IABP-SHOCK II trial, 301 were randomized to IABP-support. We analysed the 275 (91%) patients of this group undergoing primary PCI as revascularization strategy surviving the initial procedure. IABP insertion was performed before PCI in 33 (12%) and after PCI in 242 (88%) patients. There were no differences in baseline arterial lactate ( p = 0.70), Simplified Acute Physiology Score-II-score ( p = 0.60) and other relevant baseline characteristics. No differences were observed for short- and long-term mortality (pre vs. post 30-day mortality: 36% vs. 37%, odds ratio 0.99, 95% confidence interval (CI) 0.47–2.12, p = 0.99; one-year mortality: 56% vs. 48%, hazard ratio 1.08, 95% CI 0.65–1.80, p = 0.76; six-year-mortality: 64% vs. 65%, hazard ratio 1.00, 95% CI 0.63–1.60, p = 0.99). In multivariable Cox regression analysis timing of IABP-implantation was no predictor for long-term outcome (hazard ratio 1.08, 95% CI 0.66–1.78, p = 0.75). Conclusions Timing of IABP-implantation pre or post primary PCI had no impact on outcome in patients with acute myocardial infarction complicated by cardiogenic shock.
Background The incretin hormone Glucagon-like-peptide 1 (GLP-1) is a major stimulus for glucose dependent insulin secretion and holds cardioprotective efficacy. This has made the GLP-1 system a preferred target for diabetes therapy. Secretion of GLP-1 happens in response to nutritional but also inflammatory stimuli. Consequently, marked elevation of circulating GLP-1 levels were found in critically ill patients featuring marked association to markers of inflammation. Purpose Our study sought to investigate GLP-1 levels in patients with cardiogenic shock (CS) complicating myocardial infarction and a possible prognostic correlation to short- and long-term outcome. Methods We serially assessed circulating GLP-1 levels in a prospectively planned biomarker substudy in the IABP-SHOCK II trial. Blood samples were drawn during index PCI and at day 2. The blood was centrifuged immediately, and serum was frozen at −87°C. GLP-1 was measured with a standard ELISA-kit. All-cause mortality at short- (30 days), intermediate- (1 year) and long-term (6 years) follow-up was used for outcome assessment. Results In this study we found circulating GLP-1 to be markedly elevated in patients with myocardial infarction complicated by CS (n=172) at time of index PCI. Patients with fatal short-term outcome (n=70) exhibited higher GLP-1 levels (86 [45–130] pM) at ICU admission in comparison to patients with 30-day survival (48 [33–78] pM; p<0.001) (n=102). In repeated measures ANOVA the course of GLP-1 levels between baseline and day 2 showed a significant interaction between survivors and non-survivors (p=0.04). By univariate Cox-regression analysis GLP-1 levels >median were predictive of short- (hazard ratio [HR] 2.43; 95% confidence interval [CI] 1.50–3.94; p<0.001), intermediate- (HR 2.46; 95% CI 1.62–3.76; p<0.001) and long-term (HR 2.12; 95% CI 1.44–3.11; p<0.001) outcome. This association remained after multivariable correction (HR 2.01; 95% CI 1.37–3.07; p<0.001). In a landmark analysis we found a significant higher mortality in patients with GLP-1 levels >median from day 30 to 1 year (HR 2.56; 95% CI 1.08–6.09; p=0.03). In contrast, beyond 1 year up to 6 years no difference has been observed anymore (HR 1.02; 95% CI 0.41–2.58; p=0.96). Conclusions Elevated plasma levels of GLP-1 are an independent predictor for impaired prognosis in patients with myocardial infarction complicated by CS at short-, intermediate and long-term follow-up. In a landmark analysis this prognostic effect is sustained up to 1 year. The functional relevance of GLP-1 in this context is currently unknown and needs further investigations. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): German Research Foundation (DFG), German Heart Research Foundation
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