Vericiguat and NT-proBNP in patients with heart failure with reduced ejection fraction: analyses from the VICTORIA trial

被引:33
作者
Senni, Michele [1 ]
Lopez-Sendon, Jose [2 ]
Cohen-Solal, Alain [3 ]
Ponikowski, Piotr [4 ]
Nkulikiyinka, Richard [5 ]
Freitas, Cecilia [6 ]
Vlajnic, Vanja Miodrag [7 ]
Roessig, Lothar [5 ]
Pieske, Burkert [8 ,9 ]
机构
[1] Univ Milano Bicocca, Cardiovasc Dept, Cardiol Div, Osped Papa Giovanni XXIII, Milan, Italy
[2] Univ Autonoma Madrid, Hosp La Paz, IdiPaz Res Inst, Madrid, Spain
[3] Univ Paris Cite, Lariboisiere Hosp, AP HP, UMR S942 MASCOT, Paris, France
[4] Wroclaw Med Univ, Cardiol Dept, Wroclaw, Poland
[5] Bayer AG, Clin Dev, Wuppertal, Germany
[6] Bayer AG, Berlin, Germany
[7] Bayer US LLC, Data Sci & Analyt DS &, Whippany, NJ USA
[8] Charite, Dept Internal Med & Cardiol, Augustenburger Pl 1, D-13353 Berlin, Germany
[9] German Heart Ctr, Augustenburger Pl 1, D-13353 Berlin, Germany
来源
ESC HEART FAILURE | 2022年 / 9卷 / 06期
关键词
Heart failure; Heart failure with reduced ejection fraction; NT-proBNP; GLOMERULAR-FILTRATION-RATE; NATRIURETIC PEPTIDE; INHIBITION;
D O I
10.1002/ehf2.14050
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Aims Treatment response to vericiguat, based on baseline N-terminal pro-brain natriuretic peptide (NT-proBNP) subgroups specified in the protocol, was evaluated in the heart failure (HF) VICTORIA trial population by post hoc analysis of combined lower three quartiles [Q1-Q3] vs. the upper quartile [Q4]. Methods and results VICTORIA participants with available baseline NT-proBNP levels (n = 4805; 95.1% of total) were included. Compared with patients in Q1-Q3 (NT-proBNP: Q1, <= 1556 pg/mL; Q2, >1556-2816 pg/mL; and Q3, >2816-5314 pg/mL), patients in Q4 (NT-proBNP: >5314 pg/mL) were older (69.2 +/- 12.0 vs. 66.6 +/- 12.1 years), had lower mean ejection fraction (27.2 +/- 8.3% vs. 29.5 +/- 8.2%; P < 0.0001), and were more likely to be in New York Heart Association (NYHA) Class III (51.8 vs. 35.6%) or IV (2.4 vs. 1.0%). Compared with Q1-Q3, patients in Q4 had higher mean Meta-Analysis Global Group in Chronic Heart Failure risk score (27.3 +/- 6.6 vs. 23.5 +/- 6.4; P < 0.0001), had lower mean estimated glomerular filtration rate (eGFR; 51.5 +/- 25.5 vs. 65.0 +/- 26.8 mL/min/1.73 m(2); P < 0.0001) and haemoglobin (12.8 +/- 2.0 vs. 13.6 +/- 1.9 g/dL; P < 0.0001), and more had atrial fibrillation (48.7% vs. 43.1%; P = 0.0007) and were randomized while hospitalized for HF (14.8 vs. 9.9%; P < 0.0001). Target dose was achieved in 72.3 and 63.7% of patients in Q1-Q3 and Q4, respectively (P < 0.0001). Primary outcome (composite of time to cardiovascular death or first HF hospitalization) rates were 24.5 and 31.7 per 100 patient-years for vericiguat and placebo in Q1-Q3 [hazard ratio (HR) 0.78; 95% confidence interval (CI) 0.69-0.88, P < 0.001] and 73.6 and 63.6 in Q4 (HR 1.15; 95% CI 0.99-1.34, P = 0.070). Serious adverse events were more frequent in NT-proBNP Q4 (total population) compared with Q1-Q3 (38.3 vs. 32.3%; P = 0.0001), driven mainly by the placebo group. Adverse events leading to death were more frequent in Q4 than Q1-Q3 (5.8 vs. 2.4%; P < 0.0001). Conclusions Plasma NT-proBNP may help identify patients with worsening HF with reduced ejection fraction, in whom the beneficial effects of vericiguat may be highest. Patients with highest NT-proBNP values are probably too far advanced, suffering more co-morbidities, or still clinically unstable after decompensation to derive benefit from vericiguat.
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收藏
页码:3791 / 3803
页数:13
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