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.
High-sensitivity C-reactive protein predicts future cardiovascular events in both healthy individuals and patients with unstable and stable coronary syndromes. Few data are available about the incidence and the relation to infl ammation of troponin elevation following percutaneous coronary intervention (PCI), a potential predictor of longterm outcome. We sought to confi rm the impact of embolization on long-term outcome and evaluate the ability of baseline infl ammation to predict troponin elevation induced by PCI. We prospectively analyzed 200 patients treated by PCI for stable or Braunwald IIA class unstable angina. The patients were recruited between January 1997 and May 1999, and the population was followed during a mean follow-up of 32 months. Major adverse cardiac events (MACEs) were defi ned as the occurrence of death, myocardial infarction or recurrent angina requiring repeat PCI, or coronary artery bypass grafting. During the follow-up period, 58 MACEs were observed. By multivariate analysis, independent predictors for the occurrence of MACEs were unstable angina and troponin I level after PCI (P < 0.0001 for both). No correlation was found between baseline infl ammation and signifi cant troponin I elevation post PCI and by multivariate analysis, no biological variable was a predictor of troponin I elevation post PCI. Baseline infl ammation cannot predict onset of minor myonecrosis damage (expressed by troponin elevation) induced by PCI, a significant predictor of long-term outcome in this setting.
Objective -To evaluate the short and long-term results of percutaneous coronary interventions (PCI) in patients aged 80 years or older and to identify predictors of event-free survival. Methods and results -Clinical and angiographic data from all patients undergoing percutaneous coronary intervention in our institution are prospectively collected and stored in a computerized database. The clinical and angiographic characteristics of all patients aged 80 years or older undergoing percutaneous coronary intervention between January 1994 and December 1999 were analysed retrospectively. Follow-up was obtained by interview or through the referring physician. One hundred and fifty-eight patients aged 80 years or older (median: 83.4; range: 80.2-92.2) underwent percutaneous coronary intervention in our institution during the study period.The initial angiographic success rate was 92%. In-hospital mortality was 8.2% and procedural success 84.8%. One-year and two-year survival were 81% and 72.2% respectively, while event free survival at 1 year and 2 years was 65.8% and 57%. Using the Cox proportional hazards method, we identified incomplete revascularization and low left ventricular ejection fraction (LVEF) as predictors of death at 2 years. Complete revascularization and stenting were independent predictors of 2-year event-free survival. Conclusion -Percutaneous coronary intervention can be performed safely in octogenarians. Complete revascularization, stenting and preserved left ventricular ejection fraction were independent predictors of better outcome in this population. (Acta Cardiol 2003; 58(4): 289-294)
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