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Utilizing Percutaneous Ventricular Assist Devices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
Published on: June 12, 2021
Intraaortic balloon support for myocardial infarction with cardiogenic shock
Holger Thiele1, Uwe Zeymer, Franz-Josef Neumann
1University of Leipzig-Heart Center, Department of Internal Medicine/Cardiology, Leipzig, Germany. thielh@medizin.uni-leipzig.de
Insights
Intra-aortic balloon counterpulsation (IABP) did not significantly lower 30-day mortality for acute myocardial infarction patients with cardiogenic shock. This randomized trial found no survival benefit, challenging its guideline status.
Area of Science:
- Cardiology
- Critical Care Medicine
- Interventional Cardiology
Background:
- Intra-aortic balloon counterpulsation (IABP) is a guideline-recommended treatment for cardiogenic shock complicating acute myocardial infarction.
- Current evidence primarily stems from registry data, with limited randomized clinical trials.
- The IABP-SHOCK II trial aimed to provide robust evidence on IABP's efficacy in this critical patient population.
Purpose of the Study:
- To evaluate the effectiveness of intra-aortic balloon counterpulsation (IABP) in reducing 30-day all-cause mortality in patients with cardiogenic shock complicating acute myocardial infarction.
- To assess the impact of IABP on secondary clinical outcomes and safety in this patient group.
Main Methods:
- A randomized, prospective, open-label, multicenter trial involving 600 patients with cardiogenic shock complicating acute myocardial infarction.
- Patients were assigned to either intraaortic balloon counterpulsation (IABP group, n=301) or no IABP (control group, n=299).
- All patients received early revascularization and optimal medical therapy; the primary endpoint was 30-day all-cause mortality.
Main Results:
- No significant difference in 30-day all-cause mortality between the IABP group (39.7%) and the control group (41.3%) was observed (P=0.69).
- Secondary endpoints, including hemodynamic stabilization, ICU length of stay, and renal function, showed no significant variations between groups.
- Rates of major bleeding, peripheral ischemic complications, sepsis, and stroke were similar in both the IABP and control groups.
Conclusions:
- Intra-aortic balloon counterpulsation (IABP) does not significantly reduce 30-day mortality in patients experiencing cardiogenic shock due to acute myocardial infarction when an early revascularization strategy is employed.
- The findings suggest a re-evaluation of IABP's role as a standard treatment in this specific clinical scenario is warranted based on this high-quality randomized trial data.
Background:
In current international guidelines, intraaortic balloon counterpulsation is considered to be a class I treatment for cardiogenic shock complicating acute myocardial infarction. However, evidence is based mainly on registry data, and there is a paucity of randomized clinical trials.
Methods:
In this randomized, prospective, open-label, multicenter trial, we randomly assigned 600 patients with cardiogenic shock complicating acute myocardial infarction to intraaortic balloon counterpulsation (IABP group, 301 patients) or no intraaortic balloon counterpulsation (control group, 299 patients). All patients were expected to undergo early revascularization (by means of percutaneous coronary intervention or bypass surgery) and to receive the best available medical therapy. The primary efficacy end point was 30-day all-cause mortality. Safety assessments included major bleeding, peripheral ischemic complications, sepsis, and stroke.
Results:
A total of 300 patients in the IABP group and 298 in the control group were included in the analysis of the primary end point. At 30 days, 119 patients in the IABP group (39.7%) and 123 patients in the control group (41.3%) had died (relative risk with IABP, 0.96; 95% confidence interval, 0.79 to 1.17; P=0.69). There were no significant differences in secondary end points or in process-of-care measures, including the time to hemodynamic stabilization, the length of stay in the intensive care unit, serum lactate levels, the dose and duration of catecholamine therapy, and renal function. The IABP group and the control group did not differ significantly with respect to the rates of major bleeding (3.3% and 4.4%, respectively; P=0.51), peripheral ischemic complications (4.3% and 3.4%, P=0.53), sepsis (15.7% and 20.5%, P=0.15), and stroke (0.7% and 1.7%, P=0.28).
Conclusions:
The use of intraaortic balloon counterpulsation did not significantly reduce 30-day mortality in patients with cardiogenic shock complicating acute myocardial infarction for whom an early revascularization strategy was planned. (Funded by the German Research Foundation and others; IABP-SHOCK II ClinicalTrials.gov number, NCT00491036.).
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