Lindner Clinical Trial Center

Cincinnati, OH, United States

Lindner Clinical Trial Center

Cincinnati, OH, United States
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Reddy V.Y.,Mount Sinai School of Medicine | Reddy V.Y.,Homolka Hospital | Sievert H.,Cardiovascular Center Frankfurt | Halperin J.,Mount Sinai School of Medicine | And 68 more authors.
JAMA - Journal of the American Medical Association | Year: 2014

Importance While effective in preventing stroke in patients with atrial fibrillation (AF), warfarin is limited by a narrow therapeutic profile, a need for lifelong coagulation monitoring, and multiple drug and diet interactions. OBJECTIVE To determine whether a local strategy of mechanical left atrial appendage (LAA) closure was noninferior to warfarin. Design, Setting, and Participants Protect AFwas a multicenter, randomized (2:1), unblinded, Bayesian-designed study conducted at 59 hospitals of 707 patients with nonvalvular AF and at least 1 additional stroke risk factor (CHADS2score≥1). Enrollment occurred between February 2005 and June 2008 and included 4-year follow-up through October 2012. Noninferiority required a posterior probability greater than 97.5%and superiority a probability of 95%or greater; the noninferiority margin was a rate ratio of 2.0 comparing event rates between treatment groups. Interventions Left atrial appendage closure with the device (n = 463) or warfarin (n = 244; target international normalized ratio, 2-3). Main Outcomes and Measures A composite efficacy end point including stroke, systemic embolism, and cardiovascular/unexplained death, analyzed by intention-to-treat. Results At a mean (SD) follow-up of 3.8 (1.7) years (2621 patient-years), there were 39 events among 463 patients (8.4%) in the device group for a primary event rate of 2.3 events per 100 patient-years, compared with 34 events among 244 patients (13.9%) for a primary event rate of 3.8 events per 100 patient-years with warfarin (rate ratio, 0.60; 95%credible interval, 0.41-1.05), meeting prespecified criteria for both noninferiority (posterior probability, <99.9%) and superiority (posterior probability, 96.0%). Patients in the device group demonstrated lower rates of both cardiovascular mortality (1.0 events per 100 patient-years for the device group [17/463 patients, 3.7%] vs 2.4 events per 100 patient-years with warfarin [22/244 patients, 9.0%]; hazard ratio [HR], 0.40; 95%CI, 0.21-0.75; P =.005) and all-cause mortality (3.2 events per 100 patient-years for the device group [57/466 patients, 12.3%] vs 4.8 events per 100 patient-years with warfarin [44/244 patients, 18.0%]; HR, 0.66; 95%CI, 0.45-0.98; P =.04). Conclusions and Relevance After 3.8 years of follow-up among patients with nonvalvular AF at elevated risk for stroke, percutaneous LAA closure met criteria for both noninferiority and superiority, compared with warfarin, for preventing the combined outcome of stroke, systemic embolism, and cardiovascular death, as well as superiority for cardiovascular and all-cause mortality. © 2014 American Medical Association. All rights reserved.


PubMed | Lindner Clinical Trial Center, University of California at Los Angeles, Los Angeles Biomedical Research Institute, Duke University and 3 more.
Type: Journal Article | Journal: Journal of the American Heart Association | Year: 2016

Diagnostic testing in the care of patients newly presenting with symptoms suggestive of coronary artery disease may influence risk factor management, independent of test type or test results. However, little is known about changes in medications and lifestyle after anatomical or functional testing.We examined what factors influenced preventive medical therapy and lifestyle practices at 60days among 10003 symptomatic patients (53% women; mean age 61years) randomly assigned to anatomical testing with coronary computed tomographic angiography or functional testing (NCT01174550). We also assessed the association of preventive changes with major cardiovascular events. There were no differences in medications/lifestyle at baseline. At 60days, relative to baseline, the computed tomographic angiography strategy was associated with a higher proportion of patients newly initiating aspirin (11.8% versus 7.8%), statins (12.7% versus 6.2%), and -blockers (8.1% versus 5.3%), compared to functional testing (P<0.0001 for each). No significant differences between computed tomographic angiography and functional testing strategies were observed for initiation of exercise, quitting smoking, or weight loss in overweight/obese patients, though overall prevalence of healthy eating was higher after computed tomographic angiography (P=0.002) while obese/overweight status was lower (P=0.040). Positive initial test results and revascularization demonstrated stronger associations with preventive medications and lifestyle than test type. Medication initiation was not associated with fewer cardiovascular events.Positive initial test results and revascularization are primary drivers of changes in preventive medical and lifestyle practices, with test type making secondary contributions. However, substantial opportunities exist to further reduce cardiovascular risk.URL: https://www.clinicaltrials.gov. Unique identifier: NCT01174550.


Srivatsa S.S.,Fresno Community Hospital | Srivatsa S.S.,Christ Hospital | Srivatsa S.S.,Lindner Clinical Trial Center | Taylor M.D.,Cincinnati Childrens Hospital Medical Center | And 9 more authors.
International Journal of Cardiovascular Imaging | Year: 2012

Liquefactive necrosis within a large spheroid zone of mitral annular calcification (LNMAC) is an atypical but increasingly recognized variant of mitral annular calcification (MAC). ProposedMRI, echo, and CT imaging criteria for diagnosis of this unusual disease entity are discussed along with a review of the prognosis, histopathology, and management implications. A comprehensive ECHO, CT, and MRI imaging approach to diagnostic differentiation from other cardiac masses, allowing characterization of the differing components of this unusual lesion is emphasized. Differentiation from surrounding myocardium, and demonstration of peripheral ring type hyperenhancement, or hyperintense signal in the wall of this lesion, seen with specific inversion recovery MRI sequences is presented as a major diagnostic criterion. The relationship of these MRI image findings to underlying pathology is also discussed. An illustrative case vignette is provided for clinical reference. © Springer Science+Business Media, B.V. 2011.

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