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Media type:
E-Article
Title:
Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials
Contributor:
Grand, Johannes;
Miger, Kristina;
Sajadieh, Ahmad;
Køber, Lars;
Torp-Pedersen, Christian;
Ertl, Georg;
López-Sendón, José;
Pietro Maggioni, Aldo;
Teerlink, John R.;
Sato, Naoki;
Gimpelewicz, Claudio;
Metra, Marco;
Holbro, Thomas;
Nielsen, Olav W.
Description:
<jats:sec>
<jats:title>Background:</jats:title>
<jats:p>Hypotensive events and drops in systolic blood pressure (SBP-drop) are frequent in patients hospitalized with acute heart failure. We investigated whether SBP-drops are associated with outcomes in patients treated with serelaxin.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Methods:</jats:title>
<jats:p>Patient-level retrospective analyses of 4 prospective trials investigating serelaxin in acute heart failure. Main inclusion criteria were SBP 125 to 180 mm Hg, pulmonary congestion, and elevated NT-proBNP (N-terminal pro-B-type natriuretic peptide). SBP-drops were prospectively defined as SBP<100 mm Hg, or, if SBP remained >100 mm Hg, a drop from baseline of 40 mm Hg from baseline. Outcomes were a short-term composite outcome (worsening heart failure, hospital readmission for heart failure or all-cause mortality through 14 days) and 180-day mortality.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Results:</jats:title>
<jats:p>
Overall, 2559/11 226 (23%) patients had an SBP-drop. SBP-drop, versus no SBP-drop, was associated with a worse outcome: cumulative incidence of 180-day mortality (11% versus 9%, hazard ratio [HR]. 1.21 [95% CI, 1.05–1.39];
<jats:italic>P</jats:italic>
=0.009) and the short-term outcome (11% versus 9%, HR, 1.29 [95% CI, 1.13–1.49];
<jats:italic>P</jats:italic>
<0.001). Of the 2 SBP-drop components, an SBP<100 mm Hg was associated with the worst outcome compared with a 40 mm Hg drop: short-term outcome (11% versus 10%) and HRs of 1.32 (95% CI, 1.13–1.55;
<jats:italic>P</jats:italic>
=0.0005) and 1.22 (95% CI, 0.97–1.56;
<jats:italic>P</jats:italic>
=0.09), for each component respectively, with a
<jats:italic>P</jats:italic>
value for interaction of 0.05. SBP-drops were associated with a worse short-term outcome in the placebo group (HR, 1.46 [95% CI, 1.19–1.79];
<jats:italic>P</jats:italic>
=0.0003), but not in the serelaxin-group (HR, 1.18 [95% CI, 0.97–1.42];
<jats:italic>P</jats:italic>
=0.10);
<jats:italic>P</jats:italic>
interaction=0.003.
</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Conclusions:</jats:title>
<jats:p>SBP-drops in patients with acute heart failure and normal to high SBP at admission is associated with worse short- and long-term outcomes especially for SBP <100 mm Hg. However, in patients treated with the intravenous vasodilator serelaxin, SBP-drops seemed less harmful.</jats:p>
</jats:sec>
<jats:sec>
<jats:title>Registration:</jats:title>
<jats:p>
URL:
<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://www.clinicaltrials.gov">https://www.clinicaltrials.gov</jats:ext-link>
; Unique identifiers: NCT02064868, NCT02007720, NCT01870778, NCT00520806.
</jats:p>
</jats:sec>