Abstract 18395: Safety of Continuing Ivabradine Treatment During Hospitalization for Worsening of Heart Failure in the SHIFT Study

Background: Chronic medical treatment is usually adapted during hospitalizations for worsening heart failure (HWHF). Ivabradine, a heart rate (HR)-slowing agent that inhibits the funny current (If) in the sinus node, when added to standard of care reduced the relative risk of HWHF by 26% in the Systolic Heart failure treatment with the If inhibitor ivabradine Trial (SHIFT). Upon HWHF in SHIFT, ivabradine could be maintained even though patients were in acute/unstable HF. This post hoc exploratory analysis assessed the safety of continuing administration of ivabradine during HWHF in SHIFT. Methods: The safety of ivabradine within the 30 days following the first HWHF admission was assessed in patients receiving either ivabradine or placebo presenting with at least 1 adjudicated HWHF during the trial. The safety of ivabradine within the 30 days following the first HWHF admission in patients who continued study drug (CSD) versus those that discontinued study drug (DSD) during hospitalization within each treatment arm were compared. Results: Baseline characteristics of patients who were at least once HWHF were comparable between the ivabradine (n = 447) and placebo (n = 619) arms. During HWHF, study drug was continued in 70% of ivabradine- and 73% of placebo-treated patients. Within the 30 days following the first HWHF admission, serious adverse events were reported in 10.1% of ivabradine- (CSD: 11.1%, DSD: 7.6%) and 12.6% placebo-treated patients (CSD: 14.2%, DSD: 8.4%). Cardiovascular death was reported in 0.7% of ivabradine- (CSD: 0.6%, DSD: 0.8%) and 0.6% of placebo-treated patients (CSD: 0.9%, DSD: 0%). Conclusions: The safety profile of ivabradine in patients within 30 days following admission for HWHF was comparable to placebo, regardless of whether patients continued or discontinued study drug.