Key result
Impella 2.5 hemodynamic support during PCI reduced 90-day major adverse events compared to IABP in patients with 3-vessel coronary disease and LVEF ≤30% (39.5% vs 51.0%; P=0.039).
Why the study?
Does Impella 2.5 hemodynamic support reduce major adverse events compared to intra-aortic balloon pump in patients with 3-vessel coronary artery disease and LVEF ≤30% undergoing PCI?
RCT (n=325)
Stratified
Does Impella 2.5 hemodynamic support reduce major adverse events compared to intra-aortic balloon pump in patients with 3-vessel coronary artery disease and LVEF ≤30% undergoing PCI?
In patients with 3-vessel coronary artery disease and severely reduced LVEF undergoing PCI, hemodynamic support with Impella 2.5 significantly reduces 90-day major adverse events compared to an intra-aortic balloon pump.
Supports Impella 2.5 over IABP for high-risk PCI; extends randomized evidence for hemodynamic support in severe LV dysfunction.
OBJECTIVES: To evaluate the efficacy of hemodynamic support using Impella 2.5 (IR2.5) vs intra-aortic balloon pump (IABP) in patients with 3-vessel coronary artery disease (3VD). BACKGROUND: PROTECT II demonstrated favorable 90-day outcomes in patients with impaired LVEF and left main or 3VD undergoing PCI with hemodynamic support with IR2.5 compared to IABP. It is unclear if this was due to a specific benefit in a patient sub-population and if certain patients may derive particular benefit from PCI with IR2.5 support. METHODS: Patients in PROTECT II were stratified upon enrollment into the left main/last patent vessel or 3VD subgroups and randomized to IR2.5 or IABP within those groups. Patients in the 3VD substratum were required to have LVEF ≤30%. RESULTS: Among the 3VD subgroup (n = 325 patients; IR2.5 167, IABP 158) patients were well matched, except for prior heart failure or CABG, which were more common in the IR2.5 group (both P ≤ 0.01). Mean number of lesions treated was 3.0 ± 1.5 vs. 2.9 ± 1.4 (P = 0.61). At 30 days after PCI, patients that received IR2.5 compared to IABP support trended toward a reduction in incidence of major adverse events (MAE): 32.9% vs. 42.4% (P = 0.078). At 90 days after PCI, there was a significant difference favoring IR2.5 for incidence of MAE: 39.5% vs. 51.0% (P = 0.039), with this effect being consistent across multiple clinical subgroups. Use of IR2.5 was an independent predictor of improved 90-day outcomes. CONCLUSIONS: Patients with 3VD and reduced LVEF show improved outcomes when PCI is performed with IR2.5 hemodynamic support.
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Kovacic et al. (2015) conducted an RCT in 3-vessel coronary artery disease and impaired ventricular function (n=325). Impella 2.5 vs. Intra-aortic balloon pump (IABP) was evaluated on Incidence of major adverse events (MAE) at 90 days (p=0.039). Impella 2.5 hemodynamic support during PCI reduced 90-day major adverse events compared to IABP in patients with 3-vessel coronary disease and LVEF ≤30% (39.5% vs 51.0%; P=0.039).
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