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Ellis S.G.,Cleveland Clinic | Kereiakes D.J.,Heart and Vascular Center | Metzger D.C.,Wellmont Holston Valley Medical Center | Caputo R.P.,St Josephs Hospital Health Center | And 12 more authors.
New England Journal of Medicine | Year: 2015

BACKGROUND: In patients with coronary artery disease who receive metallic drug-eluting coronary stents, adverse events such as late target-lesion failure may be related in part to the persistent presence of the metallic stent frame in the coronary-vessel wall. Bioresorbable vascular scaffolds have been developed to attempt to improve long-term outcomes. METHODS: In this large, multicenter, randomized trial, 2008 patients with stable or unstable angina were randomly assigned in a 2:1 ratio to receive an everolimus-eluting bioresorbable vascular (Absorb) scaffold (1322 patients) or an everolimus-eluting cobalt-chromium (Xience) stent (686 patients). The primary end point, which was tested for both noninferiority (margin, 4.5 percentage points for the risk difference) and superiority, was target-lesion failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization) at 1 year. RESULTS: Target-lesion failure at 1 year occurred in 7.8% of patients in the Absorb group and in 6.1% of patients in the Xience group (difference, 1.7 percentage points; 95% confidence interval, -0.5 to 3.9; P = 0.007 for noninferiority and P = 0.16 for superiority). There was no significant difference between the Absorb group and the Xience group in rates of cardiac death (0.6% and 0.1%, respectively; P = 0.29), target-vessel myocardial infarction (6.0% and 4.6%, respectively; P = 0.18), or ischemia-driven target-lesion revascularization (3.0% and 2.5%, respectively; P = 0.50). Device thrombosis within 1 year occurred in 1.5% of patients in the Absorb group and in 0.7% of patients in the Xience group (P = 0.13). CONCLUSIONS: In this large-scale, randomized trial, treatment of noncomplex obstructive coronary artery disease with an everolimus-eluting bioresorbable vascular scaffold, as compared with an everolimus-eluting cobalt-chromium stent, was within the prespecified margin for noninferiority with respect to target-lesion failure at 1 year. © 2015 Massachusetts Medical Society. All rights reserved.

Roussel M.G.,Heart and Vascular Center
Journal for Nurses in Professional Development | Year: 2015

The purpose of this study was to examine the difference in cardiac nurses' knowledge and perceived competency in the care of patients with heart failure (HF). Fifty-seven cardiac RNs completed the Advanced Heart Failure Clinical Competency Survey as a pretest/posttest measure. Each participant attended a 30-minute HF education session. Nurses' knowledge of HF significantly improved from 25.60 (SD = 2.92) pretest score to 27.30 (SD = 3.11) posttest score. The difference between the two means is statistically significant at the.001 level (t = -4.2, df = 56). © 2015 Wolters Kluwer Health, Inc.

Stone G.W.,Columbia University | Gao R.,Chinese Academy of Sciences | Kimura T.,Kyoto University | Kereiakes D.J.,Heart and Vascular Center | And 7 more authors.
The Lancet | Year: 2016

Background Compared with metallic drug-eluting stents, bioresorbable vascular scaffolds (BVS) offer the potential to improve long-term outcomes of percutaneous coronary intervention. Whether or not these devices are as safe and effective as drug-eluting stents within the first year after implantation is unknown. Methods We did a patient-level, pooled meta-analysis of four randomised trials in which 3389 patients with stable coronary artery disease or a stabilised acute coronary syndrome were enrolled at 301 academic and medical centres in North America, Europe, and the Asia-Pacific region. These patients were randomly assigned to the everolimus-eluting Absorb BVS (n=2164) or the Xience cobalt-chromium everolimus-eluting stent (CoCr-EES; n=1225). The primary endpoints were the 1-year relative rates of the patient-oriented composite endpoint (all-cause mortality, all myocardial infarction, or all revascularisation) and the device-oriented composite endpoint of target lesion failure (cardiac mortality, target vessel-related myocardial infarction, or ischaemia-driven target lesion revascularisation). All analyses were by intention to treat. The four randomised trials included in our meta-analysis are all registered with ClinicalTrials.gov, numbers NCT01751906, NCT01844284, NCT01923740, and NCT01425281. Findings The summary treatment effect for the 1-year relative rates of the patient-oriented composite endpoint did not differ significantly different between BVS and CoCr-EES (relative risk [RR] 1·09 [0·89-1·34], p=0·38). Similarly, the 1-year relative rates of the device-oriented composite endpoint did not differ between the groups (RR 1·22 [95% CI 0·91-1·64], p=0·17). Target vessel-related myocardial infarction was increased with BVS compared with CoCr-EES (RR 1·45 [95% CI 1·02-2·07], p=0·04), due in part to non-significant increases in peri-procedural myocardial infarction and device thrombosis with BVS (RR 2·09 [0·92-4·75], p=0·08). The relative rates of all-cause and cardiac mortality, all myocardial infarction, ischaemia-driven target lesion revascularisation, and all revascularisation did not differ between BVS and CoCr-EES. Results were similar after multivariable adjustment for baseline imbalances, and were consistent across most subgroups and in sensitivity analysis when two additional randomised trials with less than 1 year of follow-up were included. Interpretation In this meta-analysis, BVS did not lead to different rates of composite patient-oriented and device-oriented adverse events at 1-year follow-up compared with CoCr-EES. Funding Abbott Vascular. © 2016 Elsevier Ltd.

Rose-Jones L.J.,Heart and Vascular Center
Heart Failure Clinics | Year: 2014

Atrial fibrillation (AF) is exceedingly common in patients with heart failure (HF), as they share common risk factors. Rate control is the cornerstone of treatment for AF; however, restoration of sinus rhythm should be considered when more than minimal symptoms are present. Life-threatening ventricular arrhythmias are responsible for the primary mode of death in patients with NYHA I, II, or III HF. Although implantable cardioverter defibrillators protect against sudden cardiac arrest, many patients will present with VT or ICD shocks. Antiarrhythmic drug therapy beyond beta-blocker therapy remains fundamental to the termination of acute VT and the prevention of ICD shocks. © 2014 Elsevier Inc.

Razavi M.K.,Heart and Vascular Center | Mustapha J.A.,Metro Heart and Vascular | Miller L.E.,Miller Scientific Consulting Inc.
Journal of Vascular and Interventional Radiology | Year: 2014

Purpose The need for specialty devices to improve the technical outcome of endovascular interventions is dependent on the rate of early failure in such procedures. This meta-analysis assessed procedural outcomes of such interventions to elucidate the rate of early procedural failures and the need for such specialty devices.Materials and Methods MEDLINE and EMBASE were searched for contemporary studies (2000-2012) reporting procedural or short-term outcomes for revascularization of infrapopliteal atherosclerotic lesions. A random-effects metaanalysis was performed, which included post hoc comparisons among treatment groups.Results A total of 42 studies with 52 treatment arms representing 3,660 unique patients were included. Technical success rates were higher with bare metal stents (BMSs; 98.6%) than with atherectomy (92.2%; P <.05) or percutaneous transluminal angioplasty (PTA; 91.2%; P =.01), and higher with drug-eluting stents (DESs) than with PTA (P <.001). DES use had higher primary patency rates than atherectomy (P <.05), BMS use (P <.001), and PTA (P <.01). The 30-day rate of target lesion revascularization was significantly higher with PTA (8.1%) than with BMSs (2.2%; P <.05) and DESs (1.1%; P <.05). Thirty-day rates of major unplanned amputation (range, 1.5%-4.4%) and mortality (range, 0.9%-3.3%) were comparable among treatment groups. Significant heterogeneity among studies was noted for most PTA outcomes. Publication bias was evident for most PTA and DES outcomes.Conclusions Early failure of percutaneous therapies in patients with infrapopliteal atherosclerotic lesions is device- and technique-dependent. Specialty devices designed to reduce technical failure rates may therefore be of benefit in this selected group of patients. Study results are confounded by inconsistent data reporting, heterogeneity of treatment effects, and publication bias. © 2014 SIR.

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