performed in patients who received reduced dose NOAC, there were no observed strokes or systemic embolic events in NOAC-treated patients and the bleeding risk was comparable with warfarin. The principle limitation of our study pertains to the observational nature of this analysis, which limits our ability to draw any causal inferences because of residual unmeasured confounding. In addition, we rely on billing codes for patient characteristics and outcome adjudication. As such, we lack clinical characteristics, such as mitral valve dysfunction, left atrial enlargement, left ventricular dysfunction, and other factors that may predispose to cardioembolism. Our data should be taken in this context and should be seen as one piece of the available literature to guide treatment decisions in this group of patients.Nonetheless, these observational data provide a glimpse at real-world clinical outcomes associated with NOAC use for patients with HCM and AF, a group not well studied in existing or ongoing clinical trials. Our data suggest that patients with HCM and AF can be safely and effectively treated with the NOACs.
Aims
To assess the proportion of patients with heart failure and reduced ejection fraction (HFrEF) who are eligible for sacubitril/valsartan (LCZ696) based on the European Medicines Agency/Food and Drug Administration (EMA/FDA) label, the PARADIGM‐HF trial and the 2016 ESC guidelines, and the association between eligibility and outcomes.
Methods and results
Outpatients with HFrEF in the ESC‐EORP‐HFA Long‐Term Heart Failure (HF‐LT) Registry between March 2011 and November 2013 were considered. Criteria for LCZ696 based on EMA/FDA label, PARADIGM‐HF and ESC guidelines were applied. Of 5443 patients, 2197 and 2373 had complete information for trial and guideline eligibility assessment, and 84%, 12% and 12% met EMA/FDA label, PARADIGM‐HF and guideline criteria, respectively. Absent PARADIGM‐HF criteria were low natriuretic peptides (21%), hyperkalemia (4%), hypotension (7%) and sub‐optimal pharmacotherapy (74%); absent Guidelines criteria were LVEF>35% (23%), insufficient NP levels (30%)
and sub‐optimal pharmacotherapy (82%); absent label criteria were absence of symptoms (New York Heart Association class I). When a daily requirement of ACEi/ARB ≥ 10 mg enalapril (instead of ≥ 20 mg) was used, eligibility rose from 12% to 28% based on both PARADIGM‐HF and guidelines. One‐year heart failure hospitalization was higher (12% and 17% vs. 12%) and all‐cause mortality lower (5.3% and 6.5% vs. 7.7%) in registry eligible patients compared to the enalapril arm of PARADIGM‐HF.
Conclusions
Among outpatients with HFrEF in the ESC‐EORP‐HFA HF‐LT Registry, 84% met label criteria, while only 12% and 28% met PARADIGM‐HF and guideline criteria for LCZ696 if requiring ≥ 20 mg and ≥ 10 mg enalapril, respectively. Registry patients eligible for LCZ696 had greater heart failure hospitalization but lower mortality rates than the PARADIGM‐HF enalapril group.
Quinolone-related Achilles tendinopathy is frequent among heart transplant patients, especially in the presence of renal dysfunction or lengthy post-transplantation survival. If no alternative anti-bacterial therapy is available for high-risk patients, close clinical surveillance should be warranted.
The implementation of measures and lifestyles that help prevent CAV should be a priority of postheart transplantation management. Research should urgently evaluate mTOR inhibitors for the treatment of established CAV.
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