P782The evaluation of a nurse-led Sacubitril/Valsartan initiation and titration clinic

Abstract

Abstract Background Sacubitril/Valsartan is a new NICE-approved treatment for heart failure patients with NYHA 2–4 symptoms, LVEF<35% and on a stable dose of ACEi/ARB medication. The PARADIGM-HF trial was stopped early after showing an absolute risk reduction of cardiovascular death/hospitalisation of 5%. NICE specify that it should be initiated by a heart failure specialist with access to a multidisciplinary team. We set up a secondary care specialist nurse-led clinic in our trust in North England for Sacubitril/Valsartan initiation and monitoring. Purpose To assess compliance to NICE guidelines and establish the number of clinic visits required for dose titration. To compare demographics and treatment outcomes of our patients with the trial population. Methods A retrospective analysis of all patients prescribed Sacubitril/Valsartan over two years with a minimum follow up of 6 months. Data was collected from patient records and compared with NICE guidelines and the PARADIGM-HF trial (total population and Western European subset). Results 159 patients commenced Sacubitril/Valsartan. Table 1 shows demographic and therapy data and demonstrates our cohort is largely similar to the Western Europe cohort of Paradigm-HF. However, our patients had higher rates of MRA and complex device treatments. Prescribing was compliant with NICE guidelines in 97%. Failure to exceed the target 50% ACEi/ARB dose was the main reason for non-compliance in 60% (3/5). These 3 patients all discontinued. Overall 16% discontinued the drug (42% for hypotension) compared to 18% in the trial. No serious adverse reactions occurred. Mean number of clinic visits was 3.7±1.4. Table 1. Demographic and therapy data Cohort size Age Female % Ischaemic Aetiology % LVEF B-Blocker % MRA % CRT % ICD % North England 159 69.3±11.1 20 59 27 90 73 23 47 PARADIGM-HF full trial 8442 63.8±11.5 21 60 30 93 54 7 15 Western European Subset 1680 68.3±9.9 18 30 95 44 12 33 Conclusion Our cohort closely reflects the trial and the resultant NICE guidelines. More of our patients are treated with MRA and complex devices compared to PARADIGM-HF. This may be due to the quality of our service or may reflect our patient selection. Similar tolerability in our patients is reassuring as study patients are highly selected. Those receiving suboptimal ACE/ARB doses (therefore not NICE compliant) prior to initiation all failed to tolerate the new drug which cautions against straying from guidance. Our data shows a specialist nurse-led service can be delivered safely and effectively achieving therapeutic doses with a small number of patient visits. This data supports its deliverability in a non-trial setting.