The American journal of cardiology
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Randomized Controlled Trial Multicenter Study Comparative Study
Frequency of edema in patients with pulmonary arterial hypertension receiving ambrisentan.
Edema is a common side effect of endothelin receptor antagonists. Ambrisentan is an endothelin type A-selective endothelin receptor antagonist approved for the treatment of pulmonary arterial hypertension. We examined the clinical outcomes of patients who developed edema with and without ambrisentan treatment in 2 phase III, randomized placebo-controlled trials, ambrisentan for the treatment of pulmonary arterial hypertension: results of the ambrisentan in pulmonary arterial hypertension, randomized, double-blind, placebo-controlled, multicenter, efficacy (ARIES) study 1 and 2 (ARIES-1 and ARIES-2) (n = 393). ⋯ Ambrisentan significantly improved the brain natriuretic peptide levels by -34% compared to the brain natriuretic peptide levels in the placebo group that had worsened by +11% (p <0.001). Ambrisentan reduced the brain natriuretic peptide concentrations similarly in patients with and without edema. In conclusion, the present subanalysis of patients with pulmonary arterial hypertension has revealed that ambrisentan therapy provides clinical benefit compared to placebo, even in the presence of edema.
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Randomized Controlled Trial Multicenter Study Comparative Study
Outcomes of patients with severe aortic stenosis at high surgical risk evaluated in a trial of transcatheter aortic valve implantation.
Recent randomized clinical trials have demonstrated that transcatheter aortic valve implantation (TAVI) reduces mortality in high-risk patients with aortic stenosis who are not candidates for aortic valve replacement (AVR). In similar patients who are acceptable candidates for AVR, TAVI provides equivalent outcomes to AVR. In this study, 900 patients with severe aortic stenosis at high surgical risk were evaluated as possible candidates for TAVI. ⋯ In conclusion, patients with severe AS who did not undergo TAVI or AVR had high mortality. In properly selected patients, TAVI and AVR improve outcomes. Renal failure is the strongest correlate for adverse outcomes, irrespective of treatment group.
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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR study).
AMR101 is an ω-3 fatty acid agent containing ≥96% pure icosapent-ethyl, the ethyl ester of eicosapentaenoic acid. The efficacy and safety of AMR101 were evaluated in this phase 3, multicenter, placebo-controlled, randomized, double-blinded, 12-week clinical trial (ANCHOR) in high-risk statin-treated patients with residually high triglyceride (TG) levels (≥200 and <500 mg/dl) despite low-density lipoprotein (LDL) cholesterol control (≥40 and <100 mg/dl). Patients (n = 702) on a stable diet were randomized to AMR101 4 or 2 g/day or placebo. ⋯ AMR101 4 g/day decreased LDL cholesterol by 6.2% (p = 0.0067) and decreased apolipoprotein B (9.3%), total cholesterol (12.0%), very-low-density lipoprotein cholesterol (24.4%), lipoprotein-associated phospholipase A(2) (19.0%), and high-sensitivity C-reactive protein (22.0%) versus placebo (p <0.001 for all comparisons). AMR101 was generally well tolerated, with safety profiles similar to placebo. In conclusion, AMR101 4 g/day significantly decreased median placebo-adjusted TG, non-HDL cholesterol, LDL cholesterol, apolipoprotein B, total cholesterol, very-low-density lipoprotein cholesterol, lipoprotein-associated phospholipase A(2), and high-sensitivity C-reactive protein in statin-treated patients with residual TG elevations.
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Randomized Controlled Trial Multicenter Study Comparative Study
Comparison of long-term outcome after percutaneous coronary intervention versus coronary artery bypass grafting in patients with unprotected left main coronary artery disease (from the CREDO-Kyoto PCI/CABG Registry Cohort-2).
The long-term outcome of percutaneous coronary intervention (PCI) compared to coronary artery bypass grafting (CABG) for unprotected left main coronary artery disease (ULMCAD) remains to be investigated. We identified 1,005 patients with ULMCAD of 15,939 patients with first coronary revascularization enrolled in the CREDO-Kyoto PCI/CABG Registry Cohort-2. ⋯ Stratified analysis using the SYNTAX score demonstrated that risk for a composite of death/MI/stroke was not different between the 2 treatment groups in patients with low (<23) and intermediate (23 to 33) SYNTAX scores (adjusted HR 1.70, 95% CI 0.77 to 3.76, p = 0.19; adjusted HR 0.86, 95% CI 0.37 to 1.99, p = 0.72, respectively), whereas in patients with a high SYNTAX score (≥33), it was significantly higher after PCI than after CABG (adjusted HR 2.61, 95% CI 1.32 to 5.16, p = 0.006). In conclusion, risk of PCI for serious adverse events seemed to be comparable to that after CABG in patients with ULMCAD with a low or intermediate SYNTAX score, whereas PCI compared with CABG was associated with a higher risk for serious adverse events in patients with a high SYNTAX score.
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Multicenter Study
Use and misuse of serum troponin assays in pediatric practice.
Cardiac troponin (cTn) is instrumental in screening and diagnosing myocardial ischemia in adults. However, the role of cTn screening in the pediatric population is less clear. The purpose of this study was to evaluate the current clinical practice, diagnostic and prognostic value, and resource utilization associated with cTn assays in the pediatric population. ⋯ For patients presenting with chest pain, approximately $162,000 was spent per positive result. In conclusion, cTn screening has strong prognostic value in pediatric patients, even in noncardiac diagnoses such as trauma or drug overdose. However, cTn screening in pediatric patients with chest pain provides minimal benefits and is associated with increased resource utilization, unless patients have constitutional symptoms, such as fever and/or electrocardiographic abnormalities.