A secondary efficacy variable, change in normalized total atheroma volume for the entire artery, was also prespecified. J Am Soc Echocardiogr. After 24 months, patients had evaluable serial IVUS examinations. This procedure was designed to obtain a series of cross-sectional images at sites identical to the original examination. The disposition of these patients is summarized in Figure 1. He has consulted for a number of pharmaceutical companies without financial compensation.
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Hydroxymethylglutaryl-CoA reductase inhibitors , Thrombophilia , Venous thrombosis , Randomized clinical trial Introduction Venous thrombosis VT , the collective term for deep vein thrombosis of the leg, pulmonary embolism, or both, is the third most common vascular disease after myocardial infarction and ischaemic stroke.
However, after this publication, other studies in which prevalent user bias was excluded by design have been published. This finding should be interpreted with caution as it comes from a non-randomized study. Recently published findings from randomized clinical trials of statin therapy suggest some effect of lowering levels of von Willebrand factor vWF and D-dimer.
Not knowing a clear pathophysiological mechanism behind the supposed causal association between statin use and a reduced risk of recurrent VT, may explain the lack of conducting such a costly and endeavouring trial. For this purpose, the effect of rosuvastatin use on several coagulation markers was assessed. We undertook the study in accordance with the Declaration of Helsinki and International Conference on Harmonization guidelines for Good Clinical Practice.
All participants gave written informed consent prior to participation. Participants Participants were recruited at three anticoagulation clinics in the Netherlands Leiden, Hoofddorp, and Rotterdam , which monitor anticoagulant treatment with vitamin K antagonists of patients with VT in well-defined geographic areas.
Individuals aged 18 years or older with initial or recurrent confirmed symptomatic proximal deep vein thrombosis or pulmonary embolism who were allowed to stop oral anticoagulant treatment by their treating physician, were eligible for the study. The study baseline visit was defined at the time of the last regular visit of the patient to the anticoagulation clinic.
After informed consent, participants were screened on acquired risk factors for thrombosis through a questionnaire and tested on liver and kidney function. The duration of the study was 28 days, based on the consideration that some small, non-randomized studies showed beneficial effects of statins on the coagulation system as early as after a 3-day statin administration. All blood drawings were performed between am and pm.
Blood was collected in tubes containing sodium citrate 3. Laboratory technicians, who were unaware of which participants were rosuvastatin-users, performed the assays after all participants had completed the study. We decided to use this set of coagulation assays as these could globally indicate if and by which pathway rosuvastatin reduces thrombophilia.
Compliance Adherence to the study protocol was assessed in two ways. First, participants who were randomized for rosuvastatin took the first tablet within the presence of an investigator. Second, compliance of rosuvastatin use was monitored by measuring total cholesterol levels at baseline and at end of study in all participants. Statistical analysis The general characteristics of the participants are reported as means and ranges.
Coagulation factors were log-transformed if not normally distributed this happened to be the case for D-dimer. All analyses were set to be done by intention to treat, which was set to a modified intention to treat in the final analyses since there were post randomization exclusions. Since, we observed that more men were randomized to non-rosuvastatin use and that non-rosuvastatin users were slightly older than those who were randomized to rosuvastatin, we a priori decided to perform both unadjusted and age and sex adjusted analysis by means of linear regression methods to determine the between participant difference of various coagulation factors.
Furthermore, we evaluated the change in coagulation factor levels at an individual level. One post hoc analysis was performed in which we excluded all participants who reported signs or symptoms of an infection during the study, as infections can influence coagulation factors.
A total of participants were randomized between December and December , with assigned to the rosuvastatin-therapy group, and to the non-rosuvastatin group. The reported reasons for not completing the study are noted in Figure 1.
Table 1 presents baseline characteristics. Other reported exposures were balanced at baseline. Table 1.
Patients underwent IVUS of a single vessel that had not been intervened upon at baseline. Patients then underwent follow-up IVUS 2 years later to evaluate change in atherosclerosis, which was assessed by a core lab in a time-sequence blinded manner i. A total of patients had baseline and follow-up IVUS. Regression in percent atheroma volume was observed in
ASTEROID: IVUS shows regression with rosuvastatin
Treatment of rosuvastatin for 24 months was associated with atherosclerosis regression evidenced by an increase in the minimum lumen diameter and a decrease in percent diameter stenosis in patients with coronary artery disease. Whether your application is business, how-to, education, medicine, school, church, sales, marketing, online training or just for fun, PowerShow. And, best of all, most of its cool features are free and easy to use. You can use PowerShow. Or use it to find and download high-quality how-to PowerPoint ppt presentations with illustrated or animated slides that will teach you how to do something new, also for free. Or use it to upload your own PowerPoint slides so you can share them with your teachers, class, students, bosses, employees, customers, potential investors or the world.
Rosuvastatin reduces coronary artery disease progression over time in the ASTEROID trial
The study measured the effects of statin monotherapy on atherosclerosis progression. Previous studies have demonstrated a decrease in the progression of the condition through this method, but failed to stop the stenotic progression. The authors hypothesized that treatment with rosuvastatin therapy for 24 months would effect atherosclerosis regression through the reduction of low density lipoprotein cholesterol LDL-C. It enrolled patients aged 18 or older with angiographic evidence of coronary artery disease CAD.