Das D. Circ Heart Fail. 2017 Sep;10(9). pii: e004112.
In patients with heart failure (HF), the sinus node inhibitor Ivabradine was approved after the Ivabradine and outcomes in chronic HF (SHIFT [Systolic Heart Failure Treatment With the IF Inhibitor Ivabradine Trial]) trial. Das D et al., conducted a study to specify the proportion of patients with HF eligible for Ivabradine and the representativeness of the SHIFT trial enrollees compared with those in the Swedish Heart Failure Registry.
26404 patients with clinical HF were analysed from the Swedish Heart Failure Registry and classified into SHIFT type (LVEF <40%, NYHA class II–IV, sinus rhythm, and HR ≥70 beats per minute) and non-SHIFT type. Baseline attributes and medication use were compared and in a subset of patients, change in eligibility over time was outlined at 6 months and 1 year.
A total of 14.2% patients (n=3741) were SHIFT type and 85.8% patients (n=22 663) were non-SHIFT type. From the 26404 patients, 45.5% (n=12024) were inpatients with 15.8% (n=1895) patients being SHIFT type and 84.2% (n=10129) being non-SHIFT type. Patients selected were bound to be younger, men, and had lower left ventricular ejection fraction, ischemic heart disease, diabetes mellitus and more recent onset HF (<6 months; all, p<0.001). While 88.9% of SHIFT type and 88.5% of non-SHIFT type (p=0.421) patients acquired selected β-blockers, only 58.8% SHIFT type and 67.3% non-SHIFT type (p<0.001) patients were on >50% of target dose. 5420 and 6840 patients had repeat registrations within 6 and 12 months, respectively. At 6 months, 10.2% (n=555 of 5420) of SHIFT eligible patients became ineligible and 4.6% (n=252 of 5420) of non-SHIFT–type patients became eligible.
At 12 months, 10.6% (n=724 of 6840) of SHIFT type patients became ineligible, and 4.9% (n=335 of 6840) non-SHIFT–type patients became eligible. 77.3% (n=4188 of 5420) of ineligible patients remained ineligible at 6 months, 77.3% (n=5287 of 6840) patients remained eligible and ineligible at 12 months. (Figure 1)
Thus, it was concluded that 14.2% of patients with chronic HF were eligible for treatment with Ivabradine in SHIFT-type patients from SwedeHF. SHIFT-type patients have a definite clinical profile with an extensive percentage of individuals not reaching target β-blocker dose as compared to non-SHIFT type patients. With Ivabradine over a 12-month period, 5% and 11% of patients became eligible and ineligible, respectively, thus observation of patients is necessary for eligibility. Acknowledging the use of these agents in the context of a broader population will be important and essential to ensure the delivery of efficacious care as therapeutics for chronic HF are continue to advance.
Figure 1: Assessment of SHIFT eligibility from the Swedish Heart Failure Registry at baseline, 6 months, and 12 months after initial registration/clinical visit
LVEF: Left Ventricular Ejection Fraction; NYHA: New York Heart Association; HR: Heart Rate
