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 toIR2.5 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.
RCT Entities:
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.
Authors: Gaik Nersesian; Felix Hennig; Marcus Müller; Johanna Mulzer; Dmytro Tsyganenko; Christoph Starck; Tom Gromann; Volkmar Falk; Evgenij Potapov; Felix Schoenrath Journal: Ann Cardiothorac Surg Date: 2019-01
Authors: Dariusz Dudek; Tomasz Rakowski; Adam Sukiennik; Michał Hawranek; Artur Dziewierz; Jacek Kubica; Piotr Suwalski; Robert Gil; Wojciech Wojakowski; Andrzej Ochała; Wiesław Mazurek; Krzysztof Żmudka; Mariusz Gąsior Journal: Postepy Kardiol Interwencyjnej Date: 2016-08-19 Impact factor: 1.426
Authors: F S van den Brink; T A Meijers; S H Hofma; A J van Boven; A Nap; A Vonk; P Symersky; K D Sjauw; P Knaapen Journal: Neth Heart J Date: 2020-03 Impact factor: 2.380