Abstract
Background
Heart failure with mid-range ejection fraction (left ventricular ejection fraction between 40 to 49%) was introduced in the 2016 European Society of Cardiology guidelines for heart failure. The prognosis of the mid-range of left ventricular ejection fraction (LVEF) was less well assessed in patients treated with percutaneous coronary intervention (PCI).
Purpose
We aimed to assess the 2-year outcomes of patients with mid-range ejection fraction (LVEF between 40 to 49%) after PCI compared with reduced LVEF (<40%) and preserved LVEF (≥50) in the GLOBAL LEADERS study.
Methods
The GLOBAL LEADERS study was a multicenter, randomized trial comparing the efficacy and safety of two antiplatelet strategies in all-comers patients undergoing PCI with biolimus-A9 eluting stent.
Patients with available information of LVEF were eligible in the present analysis. Patients were classified according to their LVEF into three groups; preserved (LVEF ≥50), mid-range (LVEF 40–49%) and reduced (LVEF <40%) left ventricular ejection fraction. Clinical outcomes at 2 years after PCI were compared among three groups in the multivariable Cox regression analysis.
The primary outcome of present study was all-cause mortality at 2 years after PCI. The secondary outcomes were patient-oriented composite endpoint (POCE). Individual components of the composite endpoint, definite or probable stent thrombosis and bleeding academic research consortium (BARC) type 3 or 5 were also reported.
Results
Out of 15968 patients included in the GLOBAL LEADERS study, information of LVEF was available in 15008 patients (93.99%); 12,128 patients (80.81%) were in the group of preserved LVEF, 1,737 patients (11.57%) were in the mid-range LVEF group and 1,143 patients (7.62%) were in the reduced LVEF group.
The risk of all-cause mortality and POCE at 2 years were significantly different among the three groups. In an adjusted model, compared with the group of preserved LVEF, the hazard ratio for the all-cause mortality at 2 years rose from 1.89 (95% CI, 1.46–2.45) to 3.72 (95% CI, 2.95–4.70) in the group of mid-range and reduced LVEF respectively. Similar rises were observed for the POCE at 2 years from 1.27 (95% CI, 1.11–1.44) in the group of mid-range LVEF to 1.63 (95% CI, 1.42–1.87) in the group of reduced LVEF.
The risk of stroke, myocardial infarction, and definite or probable stent thrombosis in patients with mid-range LVEF was not different from patients with reduced LVEF (see figure). A similar risk of revascularization was observed among the three groups.
Outcomes among three LVEF categories
Conclusion
Patients with mid-range LVEF undergoing PCI had a different prognosis from patients with reduced LVEF and preserved LVEF in term of survival and composite ischemic endpoints at 2 years.