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Noninferiority of heart failure nurse titration versus heart failure cardiologist titration. ETIFIC multicenter
Juana Oyanguren1, Lluisa Garcia-Garrido2, Magdalena Nebot-Margalef3
1Servicio de Cardiología, Hospital Universitario Galdakao-Usansolo, OSI Barrualde-Galdakao-Osakidetza, Servicio Vasco de Salud, Galdakao, Bizkaia, Spain; BIOCRUCES, Instituto de Investigación Sanitaria, Bizkaia, Spain.
Insights
Heart failure nurses effectively managed medication titration, achieving higher doses of beta-blockers and ACE inhibitors compared to cardiologists. This approach led to more patient visits and reduced heart failure hospitalizations.
Area of Science:
- Cardiology
- Pharmacology
- Nursing
Background:
- Medications like beta-blockers, ACE inhibitors, ARBs, and MRAs are crucial for managing heart failure (HF) with reduced ejection fraction (HFrEF).
- Dose-dependent effects necessitate careful titration, yet suboptimal dosing is prevalent in clinical practice.
- Optimizing drug therapy in HF patients is essential for improving outcomes.
Purpose of the Study:
- To compare the safety and efficacy of medication dose titration by heart failure (HF) nurses versus HF cardiologists in patients with HFrEF.
- To evaluate the effectiveness of HF nurse-led titration for key HF medications.
- To assess clinical outcomes and adverse events associated with different titration strategies.
Main Methods:
- A multicenter, noninferiority randomized controlled open-label trial (ETIFIC) involving 320 hospitalized patients with new-onset HFrEF.
- Patients were randomized to titration by HF nurses (n=164) or HF cardiologists (n=156).
- Primary endpoint: mean relative beta-blocker dose at 4 months; secondary endpoints: other drug doses, adverse events, and HF hospitalizations at 6 months.
Main Results:
- HF nurses achieved significantly higher mean relative doses of beta-blockers (71.1% vs 56.3%) and ACE inhibitors (72.6% vs 56.1%) compared to cardiologists (P < .001 for both).
- No significant difference was observed in ARB or MRA doses between groups.
- HF nurse titration involved more outpatient visits (6.4 vs 2.8) and resulted in fewer HF hospitalizations (0.7% vs 5.5%, P=.01).
Conclusions:
- HF nurse titration is noninferior to HF cardiologist titration for managing HFrEF medications.
- HF nurses achieved higher doses of key medications and improved clinical outcomes, including reduced HF hospitalizations.
- This study highlights the significant role of specialist nurses in optimizing HF pharmacotherapy.
Introduction And Objectives:
Beta-blockers, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin-II-receptor-blockers (ARB), and mineralocorticoid-receptor antagonists decrease mortality and heart failure (HF) hospitalizations in HF patients with reduced left ventricular ejection fraction. The effect is dose-dependent. Careful titration is recommended. However, suboptimal doses are common in clinical practice. This study aimed to compare the safety and efficacy of dose titration of the aforementioned drugs by HF nurses vs HF cardiologists.
Methods:
ETIFIC was a multicenter (n=20) noninferiority randomized controlled open label trial. A total of 320 hospitalized patients with new-onset HF, reduced ejection fraction and New York Heart Association II-III, without beta-blocker contraindications were randomized 1:1 in blocks of 4 patients each stratified by hospital: 164 to HF nurse titration vs 156 to HF cardiologist titration (144 vs 145 analyzed). The primary endpoint was the beta-blocker mean relative dose (% of target dose) achieved at 4 months. Secondary endpoints included ACE inhibitors, ARB, and mineralocorticoid-receptor antagonists mean relative doses, associated variables, adverse events, and clinical outcomes at 6 months.
Results:
The mean±standard deviation relative doses achieved by HF nurses vs HF cardiologists were as follows: beta-blockers 71.09%±31.49% vs 56.29%±31.32%, with a difference of 14.8% (95%CI, 7.5-22.1), P <.001; ACE inhibitors 72.61%±29.80% vs 56.13%±30.37%, P <.001; ARB 44.48%±33.47% vs 43.51%±33.69%, P=.93; and mineralocorticoid-receptor antagonists 71%±32.12% vs 70.47%±29.78%, P=.86; mean±standard deviation visits were 6.41±2.82 vs 2.81±1.58, P <.001, while the number (%) of adverse events were 34 (23.6) vs 30 (20.7), P=.55; and at 6 months HF hospitalizations were 1 (0.69) vs 9 (5.51), P=.01.
Conclusions:
ETIFIC is the first multicenter randomized trial to demonstrate the noninferiority of HF specialist-nurse titration vs HF cardiologist titration. Moreover, HF nurses achieved higher beta-blocker/ACE inhibitors doses, with more outpatient visits and fewer HF hospitalizations. Trial registry number: NCT02546856.
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