IntroductionPrior studies suggested that a routine invasive approach in the management of non-ST-elevation acute coronary syndrome (NSTE-ACS) is beneficial in men, but the data are less conclusive in women. One study conducted exclusively in women found that routine invasive therapy was associated with a markedly increased risk of major bleeding. This pilot randomized controlled trial compared the safety of a routine invasive versus a selective invasive strategy among women.MethodsWomen with NSTE-ACS and an additional high-risk characteristic were randomized to a routine invasive versus a selective invasive strategy. The primary outcome was the risk of major bleeding. The secondary outcome was the first occurrence of all-cause death, myocardial infarction, stroke, re-hospitalization for ACS, or major bleeding within 6 months.ResultsTwenty-three women were assigned to routine invasive therapy and 17 to selective invasive therapy. Twenty-seven women (68%) had elevated troponin T (mean 0.33 ng/mL) and/or creatinine kinase-MB (mean 23 ng/mL). The risk of major bleeding was similar with both approaches (P = 0.99). At 6 months, the secondary outcome occurred in 9% of the routine invasive group versus 18% of the selective invasive group (risk ratio = 0.49, 95% confidence interval 0.09–2.63, P = 0.63).ConclusionThis pilot study demonstrated that a routine invasive approach is safe in women. There was suggestion of benefit from routine invasive therapy compared with selective invasive therapy. These data could be used to design an appropriately powered trial to determine the optimal management strategy among women with NSTE-ACS.Electronic supplementary materialThe online version of this article (doi:10.1007/s40119-015-0055-x) contains supplementary material, which is available to authorized users.
Percutaneous coronary intervention with bivalirudin plus bail-out glycoprotein IIb/IIIa inhibitors has been shown to be as effective as unfractionated heparin plus routine glycoprotein IIb/IIIa inhibitors in preventing cardiac ischemic events, but with a lower bleeding risk. It is unknown whether bivalirudin would have the same beneficial effects if compared with heparin when the use of glycoprotein IIb/IIIa inhibitors was similar between treatment arms. We searched the MEDLINE, Web of Science, and Cochrane databases from inception until March 2015 for randomized trials that compared bivalirudin to heparin in patients undergoing percutaneous coronary intervention. We required that the intended use of glycoprotein IIb/IIIa inhibitors was similar between the study groups. Summary estimates were principally constructed by the Peto method. Fifteen trials met our inclusion criteria, which yielded 25,824 patients. Bivalirudin versus heparin was associated with an increased hazard of stent thrombosis (odds ratio [OR] 1.49, 95% confidence interval [CI] 1.15-1.92, P = .002, I2 = 16.9%), with a similar hazard of myocardial infarction (OR 1.09, 95% CI 0.98-1.22, P = .11, I2 = 35.8%), all-cause mortality (OR 0.88, 95% CI 0.72-1.08, P = .21, I2 = 31.5%) and major adverse cardiac events (OR 1.04, 95% CI 0.94-1.14, P = .46, I2 = 53.9%). Bivalirudin was associated with a reduced hazard of major bleeding (OR 0.80, 95% CI 0.70-0.92, P = .001, I2 = 63.5%). The dose of heparin in the control arm modified this association; when the dose of unfractionated heparin in the control arm was ≥ 100 units/kg, bivalirudin was associated with a reduction in major bleeding (OR 0.55, 95% CI 0.45-0.68, P < .0001), but when the dose of unfractionated heparin was ≤ 75 units/kg, bivalirudin was not associated with reduction in bleeding (OR 1.09, 95% CI 0.91-1.31, P = .36). Among patients undergoing PCI, bivalirudin was associated with an increased hazard of stent thrombosis. Bivalirudin may be associated with a reduced hazard of major bleeding; however, this benefit was no longer apparent when compared with a dose of unfractionated heparin ≤ 75 units/kg.
Osteoarthritis has a significant impact on quality of life, only partly ameliorated by anti-arthritic drugs, as assessed by the WOMAC scale in this study population. Further, a study with larger sample size is needed to further support our findings.
BackgroundSeveral approaches to clinical trial monitoring, including the Risk Based Monitoring (RBM) are aimed at the protection of the human subjects (safety), improved data quality, and ultimately, reducing the cost of drug development and operations. There exists minimal evidence globally about the perceptions and the level of confidence among the clinical staff on the merits of RBM. The present study assessed the perception among clinical research staff globally (developed and emerging countries) on the applicability and adaptability of RBM.MethodsAn electronic questionnaire survey consisting of twelve items was developed, validated, and then circulated globally via email to three thousand clinical research staff members at various investigational sites. This survey collected information on the use of RBM and factors that relate to clinical trial cost, data quality, subject safety, and the readiness to adopt RBM practices. The survey responses were summarized and analyzed by using the information e.g. responder's age, sex, clinical research role, global location, and experience in clinical research trials.ResultsResponses were received from ten countries, six emerging and four developed. Of the 3000 surveys sent to emerging (1,000) and developed (2,000) countries, a total response of 595 (261 vs 334) participants was received, respectively. The emerging versus developed group had 100 vs 137 participants with complete responses (CR); 34 vs 35 participants with partial responses (PR); and 127 vs 162 participants were disqualified with no exposure (NE) responses. About 67% of the overall responders were investigators, followed by 23%, 10% coordinator and other staff respectively. There was not significant difference in feedback between the researchers in developing versus emerging countries (p = 0.20) with regards to their perception of RBM reducing the overall cost of conducting a clinical research. Responders from emerging countries had a more favorable response than in the developed countries. Similarly, when asked if RBM will be more effective in addressing data quality (p = 0.006), patient safety (p = 0.05) and findings fraud/fabrication (p = 0.01), researchers from emerging countries indicated more confidence than researchers from developed countries. There was also a significant difference in the readiness to adopt RBM between responders of emerging versus developed markets (p < 0.0001).ConclusionThis unique study performed across ten emerging and developed countries strongly supported the need for systematic global training, education, and implementation of RBM regulatory guidance, with an aim for better safety of subjects and improved quality of clinical trial data. Furthermore, studies with larger sample sizes are recommended to provide an evidence-based approach.
Myocardial perfusion imaging (MPI) is commonly used to detect ischemia. Concerns about silent ischemia may encourage orders for MPI in asymptomatic patients. Factors contributing to this practice are poorly described and the clinical utility is questionable.We conducted a single center retrospective cohort investigation on Veterans who underwent MPI between December 2010 and July 2011. We gathered data on symptoms, baseline characteristics, results of MPI, and cardiovascular events within 1 year. MPI were categorized using 2009 appropriate use criteria (AUC).Of 592 patients, 127 (21.5%) had no symptoms at the time of MPI. Comparing symptomatic and asymptomatic patients, no differences were observed in baseline characteristics except abnormal ECG, more common in asymptomatic patients (n = 86, 67.7% vs. n = 232, 49.9% for symptomatic patients, P < 0.0001). Asymptomatic MPI were more commonly inappropriate (n = 26, 21.5% vs. n = 31, 6.7% for appropriate/uncertain, P < 0.0001). Detection of ischemia between patients with and without symptoms was not different (P = 0.86); however, among asymptomatic MPI that also demonstrated ischemia, none were inappropriate (n = 10 appropriate, n = 7 uncertain). In multivariate regression, 2 factors were associated with asymptomatic status, abnormal ECG (odds ratio [OR] 2.29, 95% confidence interval [CI] 1.5–3.49) and age over the median (OR 0.63, 95% CI: 0.41–0.95).A substantial portion of MPI tests are ordered for patients without symptoms. When compared to symptomatic patients, MPI for asymptomatic patient were more commonly inappropriate; however, the prevalence of ischemia was similar. MPI may be clinically relevant in some asymptomatic patients and decisions to test should be based on the AUC.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.